Immune-Onc Therapeutics Selected for Oral Presentation at American Society of Hematology (ASH) Annual Meeting to Showcase New Data from Phase 1b Study of IO-202 in Chronic Myelomonocytic Leukemia

PALO ALTO, CA, November 5, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the latest data from the Phase 1b expansion cohort of its first-in-class anti-LILRB4 antibody, IO-202, in combination with azacitidine (AZA) for the treatment of chronic myelomonocytic leukemia (CMML), has been selected for an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting, to be held December 7-10 in San Diego, California.

CMML is a rare and aggressive form of leukemia with limited treatment options and poor survival outcomes. Currently, the only approved therapies for CMML are hypomethylating agents (HMAs), including AZA, which yield a 7-17% complete remission (CR) rate.2 IO-202, a humanized monoclonal antibody that targets leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), offers a promising therapeutic option for this patient population.

“We are pleased with the positive interim data for IO-202 in CMML patients,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “These results highlight the potential of IO-202 to redefine treatment for CMML, a disease with very limited therapeutic options. We look forward to working closely with regulators to explore its potential as a frontline therapy for this underserved patient population.”

New data beyond what was published in the ASH abstract #1008 will be included in the oral presentation on December 9, 2024.

Oral presentation details:

Publication Number: 1008

Title: IO-202, a Novel Anti-LILRB4 Antibody, with Azacitidine for Hypomethylating Agent-Naive Chronic Myelomonocytic Leukemia: Phase 1b Expansion Cohort Results

Presenter: Gabriel N. Mannis, M.D., associate professor of medicine, division of hematology, Stanford Cancer Institute, Stanford University

Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Defining and Treating Chronic Myelomonocytic Leukemia

Session Date and Time: Monday, December 9, 2024: 4:30 PM - 6:00 PM PT

Presentation Time: 5:45 PM PT

Room: Manchester Grand Hyatt San Diego, Grand Hall D

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year,2 or about 1,100 annual cases.3 CMML is characterized by a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) and dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7-17% complete response rate.2

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

ABOUT IO-202

IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron, and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

 
MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

1. Consensus proposal for revised International Working Group 2023 response criteria for higher-risk myelodysplastic syndromes. Blood 2023; 141 (17): 2047–2061. doi.org/10.1182/blood.2022018604

2. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022; 97(3):352-372. doi: 10.1002/ajh.26455.

3. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008; 112(1):45-52. doi: 10.1182/blood-2008-01-134858

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Immune-Onc Therapeutics to Present Additional Positive Interim Data from IO-202 Phase 1b Expansion Cohort in Patients with Chronic Myelomonocytic Leukemia (CMML) at the 2024 EHA Annual Congress

- Strength of clinical data presented to date support a registrational CMML study -

PALO ALTO, CA, June 14, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced the company will present additional positive interim Phase 1b expansion cohort data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16.

CMML is a rare hematologic malignancy with poor survival outcomes, incurable with conventional therapy, and has no effective standard of care. Currently, hypomethylating agents (HMA), including azacitidine (AZA), are the only FDA-approved treatment option for CMML with only a 7-17% complete remission (CR) rate.

Promising early-cycle responses, including a 53.8% (7 out of 13) CR rate (4 CR, 1 CR equivalent, and 2 CR bilineage), based on International Working Group 2023 response criteria, were observed in CMML patients treated with IO-202 in combination with AZA, with CRs lasting to ten months and ongoing. The Phase 1b interim data continue to demonstrate that IO-202 is well tolerated.

“Chronic myelomonocytic leukemia remains a disease with poor prognosis and risk of progression into acute myeloid leukemia (AML), resulting in a critical need for innovative medicines,” said IO-202 Phase 1b investigator Courtney DiNardo, M.D., MSCE, professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX. “We are encouraged by Phase 1b trial data showing early and sustained complete remissions among CMML patients, regardless of their prognosis or mutation status. This supports the potential of IO-202 in combination with azacitidine as a frontline therapy for CMML patients, and we are pleased to share these data with the medical community at EHA this year.”

“IO-202 has favorable tolerability, a well-understood mechanism of action, and a consistent efficacy response that supports further study as a treatment option in both AML and CMML patients,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We look forward to continued collaborations with our investigators and the FDA to plan and conduct our registrational study in frontline CMML patients.”

Poster presentation details:

Abstract Number: P792 (here)

Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort

Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA

Session Title: Myelodysplastic Syndromes – Clinical

Session Date and Time: Friday, June 14, 6-7 p.m. CEST

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, 1 or about 1,100 annual cases.² CMML is characterized by the presence of a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow.¹ Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.¹

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

ABOUT IO-202

IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

---

1. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858

2. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Mar 1;97(3):352-372. doi: 10.1002/ajh.26455.

Immune-Onc Therapeutics Announces Presentation of IO-202 Phase 1b Interim Data of Patients with Chronic Myelomonocytic Leukemia (CMML) at 2024 European Hematology Association (EHA) Annual Congress

- IO-202, in combination with azacitidine, has demonstrated clinically meaningful benefit for frontline CMML patients -

- IO-202 is a first-in-class humanized IgG1 monoclonal antibody targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) -

PALO ALTO, CA, May 14, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced the company will present Phase 1b interim data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16.

Promising early responses, including 4 out of 5 efficacy evaluable patients achieving complete remission (CR), were observed in the Phase 1b expansion study of hypomethylating agents-naïve CMML patients using the preliminary recommended Phase 2 dose of IO-202 in combination with azacitidine (AZA). Hypomethylating agents, including AZA, are the only FDA-approved treatment option for CMML, with only a 7-17% CR rate.¹ Phase 1b interim data demonstrate that IO-202 is well tolerated in combination with azacitidine. All patients who achieved CR exhibited high baseline LILRB4 expression on bone marrow blasts, supporting the mechanism of action of IO-202 as a targeted therapy with antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Study enrollment is ongoing, and additional clinical data will be presented at EHA.

“CMML is an incurable cancer with a poor prognosis and limited treatment options. We are highly encouraged by the early complete responses seen in our evaluable patient pool,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We believe that the addition of IO-202 to the standard of care treatment, such as azacitidine, has the potential to change the treatment landscape of CMML.” 

Poster presentation details:

Abstract Number: P792 (here)

Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort

Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA

Session Title: Myelodysplastic Syndromes – Clinical

Session Date and Time: Friday, June 14, 6-7 p.m. CEST

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, 1 or about 1,100 annual cases.² CMML is characterized by the presence of a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow.¹ Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.¹

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

ABOUT IO-202

IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

---

1. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858

2. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Mar 1;97(3):352-372. doi: 10.1002/ajh.26455.

Immune-Onc Therapeutics Announces Orphan Drug Designation Granted by USFDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic MyelomonocyticLeukemia (CMML)

Phase 1 study of IO-202 in combination with azacitidine currently enrolling newly diagnosed CMML patients

PALO ALTO, CA, February 21, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML). IO-202 received Fast Track Designation for treatment of relapsed or refractory CMML in 2023. In addition, Fast Track and Orphan Drug Designations for IO-202 were granted by the FDA for the treatment of acute myeloid leukemia (AML) in 2022 and 2020, respectively.

IO-202 is a first-in-class antagonist antibody with specific, high affinity binding to Leukocyte Immunoglobulin-Like Receptor subfamily B4 (LILRB4) and serves as a targeted therapy with broad potential in blood cancers, autoimmune and inflammatory diseases. IO-202 in combination with azacitidine (AZA) is currently in a Phase 1 dose expansion clinical trial (NCT04372433), enrolling newly diagnosed patients with CMML who have not received any hypomethylating agents (HMA). A dose escalation trial of IO-202 has been completed, showing clinical efficacy in relapsed or refractory AML and CMML, either as a monotherapy or in combination with AZA. IO-202 has been shown to be well tolerated in all patients treated to date.

“Although current therapeutic options for CMML can improve a patient’s quality of life, there is a high unmet need for effective disease-modifying approaches that are potentially curative,” said Charlene Liao Ph.D., chief executive officer and board chair of Immune-Onc. “We are very proud that the FDA has granted IO-202 Orphan Drug Designation for the treatment of CMML. We look forward to continued collaborations with our investigators and the FDA as we work to bring this potentially important therapy to patients with hard-to-treat blood cancers.”

The FDA grants Orphan Drug Designation to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, including exemption of FDA application fees and tax credits for qualified clinical testing, and conveys seven years of marketing exclusivity for a drug approved to treat an orphan disease in the United States.

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, or about 1,100 annual cases1. CMML is characterized by the presence of a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow2. Current FDA approved therapies for CMML are all hypomethylation agents, including azacitidine, that attempt to control CMML without enhancement to overall survival.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

ABOUT IO-202

IO-202 is a first-in-class antagonist antibody with specific, high affinity binding to LILRB4. IO-202 is a humanized IgG1 antibody with Fc effector function to kill LILRB4hi cells via antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). As such, IO-202 is a targeted therapy with broad potential in both blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for treatment for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and for the treatment of patients with relapsed or refractory chronic myelomonocytic leukemia (CMML). The FDA has also granted Orphan Drug Designations to IO-202 for the treatment of AML and for the treatment of CMML.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

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1. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858

2. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Mar 1;97(3):352-372. doi: 10.1002/ajh.26455.

Immune-Onc Therapeutics Announces Clinical Trial Collaboration to Evaluate IO-108 in a Randomized Global Phase 1b/2 Study for First-Line Treatment of Advanced Liver Cancer

– Collaboration to evaluate IO-108 in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin®) as a potential first-line therapy for hepatocellular carcinoma –

PALO ALTO, CA, February 20, 2024 – Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage biopharmaceutical company dedicated to advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced a Phase 1b/2 clinical trial collaboration with Roche to evaluate Immune-Onc’s IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC). Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.

“We are excited to work with Roche to accelerate the development of IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc. “IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumors as monotherapy and in combination with T cell checkpoint inhibitors. The collaboration marks a significant milestone in establishing IO-108 as the preferred myeloid checkpoint inhibitor for combination with standard of care immunotherapy regimens in solid tumors.”

Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer. 

ABOUT THE RANDOMIZED CLINICAL TRIAL

The Phase 1b/2 global, randomized HCC study is part of Roche’s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab (“triplet”) versus atezolizumab and bevacizumab (“doublet”), the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. 

Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival. 

Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108.

Tecentriq® (atezolizumab) and Avastin® (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

Learn more about the trial here.

ABOUT HEPATOCELLULAR CARCINOMA

According to the American Cancer Society1, more than 800,000 people are diagnosed with liver cancer each year worldwide. It is also one of the leading causes of cancer deaths worldwide, accounting for more than 700,000 deaths each year. The number of people diagnosed is predicted to rise, with the incidence of liver cancer increasing by 55.0% and the number of deaths increasing by 56.4% between 2020 and 20402. Hepatocellular carcinoma is the most common form of liver cancer in the United States, making up almost 90% of cases3. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD), and cirrhosis resulting from these conditions4.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was presented at the 2023 American Association for Cancer Research annual meeting and demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. IO-108 is being studied in several expansion cohorts in adult cancer patients as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab). A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC). 

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

---

1. American Cancer Society. About Liver Cancer. Accessed Dec. 7, 2023 at https://www.cancer.org/content/dam/CRC/PDF/Public/8698.00.pdf

2. The latest global burden of liver cancer: A past and present threat. Clin Mol Hepatol. 2023 Apr; 29(2): 355–357.

3. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021;7:6. doi.org/10.1038/s41572-020-00240-3

4. Epidemiology of non-alcoholic fatty liver disease and hepatocellular carcinoma. JHEP Rep. 2021 Aug; 3(4): 100305. doi: 10.1016/j.jhepr.2021.100305

Immune-Onc Therapeutics Presents IO-202 Phase 1 Data in Patients with Relapsed or Refractory AML and CMML at the EHA Annual Meeting 2023

- IO-202 (anti-LILRB4) is well tolerated, with encouraging clinical responses in both monotherapy and combination therapy -

- FDA granted Fast Track designation to IO-202 for the treatment of relapsed or refractory CMML -

PALO ALTO, CA, June 7, 2023 – Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells, today announced Phase 1 data for IO-202, a first-in-class humanized IgG1 monoclonal antibody targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3). Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic Leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.

“AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease. Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment. CMML is a rare leukemia overlap syndrome characterized by the accumulation of monocytes in the blood and bone marrow, with both myeloproliferative and myelodysplastic features,” said IO-202 Phase 1 investigator, Courtney DiNardo, M.D., MSCE, associate professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX. “These results, showing strong safety and promising clinical activity as both monotherapy and in combination with a standard-of-care chemotherapy for monocytic AML and CMML, suggest that LILRB4 may be an important therapeutic target for hard-to-treat blood cancers.”

“We are very encouraged with the efficacy data of IO-202 as a single agent and in combination with azacitidine in heavily pre-treated patients with R/R AML and CMML,” said Paul Woodard, MD, chief medical officer of Immune-Onc. “Based on the data, we have developed a patient enrichment strategy for the ongoing dose expansion phase of the study to select AML patients who would most likely respond to IO-202. We are also pleased to receive the FDA Fast Track designation for IO-202 for the treatment of R/R CMML, which follows the R/R AML Fast Track designation received in 2022. We look forward to working closely with the FDA and trial investigators to accelerate the clinical development of IO-202 in hematologic malignancies.”

The Phase 1 multicenter, open-label, dose escalation study of IO-202 assessed the safety and tolerability of IO-202 in successive cohorts of patients with R/R AML with monocytic differentiation and R/R CMML as its primary objective. Secondary and exploratory objectives included pharmacokinetics, immunogenicity, pharmacodynamic (PD) biomarker effects, and clinical response rate of IO-202 as a monotherapy and in combination with azacitidine (AZA).

Treatment with IO-202 was well tolerated. There were no dose-limiting toxicities observed and a maximum tolerated dose was not reached. In the monotherapy treatment cohorts, one CMML patient demonstrated clinical benefit for more than one year and one AML patient achieved a partial response (PR). In combination therapy cohorts, Complete Remission (CR) has been achieved and is on-going for over 10 months in an AML patient with high LILRB4 expression. Additionally, 3 out of 5 CMML patients achieved clinical benefit including Optimal Marrow Response.

Based on the promising results of the dose escalation part of the study and utilizing a biomarker driven patient selection strategy, the Company has opened dose expansion cohorts to enroll AML patients with monocytic differentiations and high LILRB4, and CMML patients (IO-202-CL-001; NCT04372433).

Poster presentation details are as follows:

Abstract Number: P536
Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients.
Presenter: Courtney DiNardo, M.D., MSCE, Associate Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title: Acute myeloid leukemia - Clinical
Session Date and Time: Friday, June 9, 6:00 p.m. - 7:00 p.m. CEST

Abstracts and full session details can be accessed through the EHA Online Program Planner.

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody (mAb) with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential in blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 causes depletion of cells expressing high LILRB4 through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), converts a “don’t kill me” to a “kill me” signal by activating T cell killing and converts a “don’t find me” to a “find me” signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: The Phase 1 trial is currently enrolling expansion cohorts of patients with monocytic (LILRB4 high) acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) in combination with standard-of-care agents such as azacitidine +/- venetoclax (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020, as well as Fast Track designations for relapsed or refractory AML in 2022 and relapsed or refractory CMML in 2023. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3)), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics to Present Encouraging Phase 1 Data for IO-108 at AACR Annual Meeting 2023

- Phase 1 data show encouraging clinical benefit for IO-108 as a monotherapy and when combined with pembrolizumab, suggesting potential to overcome resistance to T-cell checkpoint inhibitors -

- Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023 -

PALO ALTO, CA, April 14, 2023 – Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced encouraging Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4). The data will be presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, April 18. Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will also be presented on April 18 as a late-breaking poster at AACR 2023.

 “We are very encouraged to see promising signs of clinical activity across multiple solid tumor types and a favorable safety profile with our first-in-class myeloid checkpoint inhibitor, IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc. “Our data demonstrates the utility of IO-108 as a new therapeutic modality to address key unmet needs for patients with solid tumors that do not respond to, develop resistance to, or relapse following, treatment with T cell checkpoint inhibitors.”

The Phase 1 dose escalation study of IO-108 is intended to evaluate primary objectives of safety and tolerability, and secondary and exploratory objectives of pharmacokinetics, immunogenicity, pharmacodynamic (PD) biomarker effects, and antitumor activity of IO-108 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. The trial enrolled 25 advanced cancer patients with relapsed/refractory solid tumors. Patients received escalating doses of IO-108 (60 mg -1800 mg) intravenously once every three weeks (Q3W). Treatment with IO-108 was well-tolerated to the maximum administered dose (1800 mg Q3W); the maximum tolerated dose was not reached. Among 23 evaluable patients (11 monotherapy, 12 combination therapy plus 1 crossover), results showed 1 complete response and 4 stable disease patients in the monotherapy cohorts and 3 partial responses and 4 stable disease patients in the combination cohorts.

The 4 responding patients remain on study with an ongoing treatment duration of 8 to 12+ months as of abstract submission. Clinical benefit correlated with baseline characteristics and post-treatment changes in PD biomarkers including reprogramming of myeloid cells and activation of T cells.

“Treating patients who are refractory to treatment with T-cell immune checkpoint inhibitors remains an ongoing challenge across many tumor types,” said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “I am very encouraged by these results, particularly the complete response to IO-108 monotherapy treatment in the Merkel cell carcinoma patient who had progressed on prior anti-PD-1 treatments. These findings suggest that LILRB2 is a critically important immunotherapy target.”

The initial data from dose escalation supports further development of IO-108. The preliminary recommended Phase 2 dose (RP2D) is 1200 mg Q3W which is projected to achieve full receptor occupancy in at least 90% of patients. The ongoing IO-108 Phase 1 study is actively enrolling several biomarker-driven dose expansion cohorts, using IO-108 at RP2D as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab), both in the U.S. and China.

Immune-Onc oral and poster presentation details are as follows:

Abstract Number: 9498
Title: A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors: Dose escalation study
Presenter: Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon.
Session Title: Novel Immunotherapy Combination Clinical Trials
Session Date and Time: Tuesday, April 18, 2:30 p.m. - 4:30 p.m. ET
Presentation Number: CT040

Abstract Number: LB217
Title: A novel bispecific LILRB4/CD3 antibody with potent killing of monocytic acute myeloid leukemia cells
Presenter: Charlene Liao, Ph.D., chief executive officer of Immune-Onc Therapeutics, Inc.
Session Title: Late-Breaking Research: Immunology 2
Session Date and Time: Tuesday, April 18, 9:00 a.m. - 12:30 p.m. ET
Location: Poster Section 36, Poster Board #10 

Abstracts and full session details can be accessed through the AACR Online Program Planner

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity. 

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or tislelizumab). 

 ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that reverse immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, a first-in-class antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1, IO-312, a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3), and multiple undisclosed programs. 

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Announces IO-108 Phase I Clinical Trial Results Selected for Oral Presentation at AACR Annual Meeting 2023

- Oral presentation highlights interim clinical data from Phase 1 dose escalation study of IO-108, a novel myeloid checkpoint inhibitor targeting LILRB2 (ILT4) as a monotherapy and in combination with pembrolizumab in patients with solid tumors -

- Company announces late-breaking abstract from new preclinical program, IO-312, a novel LILRB4 x CD3 bispecific antibody for acute myeloid leukemia -

PALO ALTO, CA, March 14, 2023 – Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) is selected for oral presentation at the American Association for Cancer Research (AACR) Annual Meeting being held April 14 - 19, 2023 in Orlando, Florida. In addition, preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023.

“We are very excited that our interim clinical data of IO-108 is selected for oral presentation at AACR 2023. This reflects the clinical significance and broad market potential of IO-108 as monotherapy and in combination with an anti-PD-1 for treatment in a variety of solid tumors. Such a distinguished recognition, together with the acceptance of our IO-312 late breaking abstract for poster presentation at the meeting, signifies the strength and breadth of our pioneering myeloid checkpoint inhibitor programs across multiple cancer types” said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. “Immune-Onc has built a strong oncology pipeline guided by our deep expertise in myeloid biology and drug development, and we are proud that our first-in-class myeloid checkpoint inhibitors are demonstrating clinical benefits in Phase 1 studies for patients with some of the hardest-to-treat cancers.”

Details of Immune-Onc’s AACR 2023 presentations are as follows:

Abstract Number: 9498
Title: A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors: Dose escalation study
Presenter: Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon.
Session Title: Novel Immunotherapy Combination Clinical Trials
Session Date and Time: Tuesday, April 18, 2:30 p.m. - 4:30 p.m. ET
Presentation Number: CT040

Abstract Number: LB217
Title: A novel bispecific LILRB4/CD3 antibody with potent killing of monocytic acute myeloid leukemia cells
Presenter: Charlene Liao, Ph.D., chief executive officer of Immune-Onc Therapeutics, Inc.
Session Title: Late-Breaking Research: Immunology 2
Session Date and Time: Tuesday, April 18, 9:00 a.m. - 12:30 p.m. ET
Location: Poster Section 36, Poster Board #10 

Abstracts and full session details can be accessed through the AACR Online Program Planner

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity. 

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or tislelizumab). 

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that reverse immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics to Showcase Leadership in Myeloid Biology and Drug Development at Upcoming Scientific and Investor Conferences

PALO ALTO, CA, March 3, 2023 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, announced today its plans to present on the company’s myeloid biology research and clinical stage programs at three upcoming scientific and investor conferences in March. The presentations will highlight the potential of Immune-Onc’s pipeline of first-in-class myeloid checkpoint inhibitors to transform current treatment approaches for blood cancers and solid tumors.

Keystone Symposia: Cancer Immunotherapy: Mechanisms of Response Versus Resistance
Date: Sunday, March 5 – Thursday, March 9
Location: Alberta, Canada

At the prestigious Keystone Symposia on Cancer Immunotherapy, Immune-Onc’s Scientific Founder, Dr. Chengcheng Alec Zhang will join the company's Chair of the Scientific Advisory Board (SAB), Dr. Michael Karin and Senior Director of Translational Research, Dr. Xiao Min Schebye for a series of pivotal presentations highlighting foundational research and insights driving our evolving understanding of mechanisms of response and resistance to cancer immunotherapy, and in particular, the LILRB family of immune inhibitory receptors as a promising class of therapeutic targets. 

Oral Presentation Details:

Date: Monday, March 6
Presenter: Dr. Michael Karin, Immune-Onc SAB chair and professor of pharmacology at University of California, San Diego
Title: Inflammation and Cancer: A Double-Edged Sword
Oral Session: Dysfunctional Immune Cells in the TME

Date: Wednesday, March 8
Presenter: Dr. Xiao Min Schebye, senior director of translational research at Immune-Onc
Title: Anti-LAIR1 Antagonistic Antibodies Block Collagen-mediated Suppression of T Cell Activation
Oral Session: Workshop 2

Date: Wednesday, March 8
Presenter: Dr. Chengcheng Alec Zhang, scientific founder of Immune-Onc and the Morton H. Sanger Professorship in Oncology and Michael L. Rosenberg Scholar for Biomedical Research at University of Texas Southwestern Medical Center
Title: LILRBs - Myeloid Checkpoint Targets for Cancer Treatment
Oral Session: Innate Immune Pathways and the Anti-Tumor Response

2nd Year Anniversary Symposium of the Myeloid Network

Date: Thursday, March 9 from 11:00 a.m. - 2:30 p.m. ET
Title: Novel Myeloid Checkpoint Inhibitors as Next Generation Cancer Immunotherapy
Location: Virtual

Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc will present an overview of the company’s work advancing the field of myeloid checkpoint inhibitors at the 2nd Year Anniversary Symposium of the Myeloid Network. The Myeloid Network seeks to connect researchers worldwide to promote communication and advancement of research and medicine in the field of myeloid cell biology. “I think your work represents the biotechnology industry outstandingly and I would love to feature your work as the final talk of our annual symposium,” said Judith Varner, Ph.D., co-founder of the Myeloid Network, professor of pathology and medicine and co-leader in solid tumor therapeutics at UC San Diego’s Moores Cancer Center in the invitation extended to Dr. Liao.

Oppenheimer 33rd Annual Healthcare Conference

Date: Monday, March 13 - Wednesday, March 15
Presentation: Tuesday, March 14 (4:00-4:30 p.m. ET) 

Dr. Liao will present a corporate overview on Tuesday, March 14 at 4:00 - 4:30 p.m. ET (Track 2) and will participate in virtual one-on-one meetings.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that reverse immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Announces Close of Series B Extension Financing, Bringing Total Round to $131 Million

– Proceeds will advance development of Immune-Onc’s lead clinical programs IO-108 and IO-202 while expanding its immuno-oncology pipeline of differentiated myeloid checkpoint inhibitors –

– Immune-Onc will participate in an industry panel and provide additional corporate and clinical updates during investor and prospective partner meetings at the upcoming J.P. Morgan 41st Annual Healthcare Conference –

PALO ALTO, CA, January 5, 2023 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints today announced the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing. This extension was led by existing investor Triwise Capital and with participation from new investors including Proxima Ventures, among others. In addition, the company has received continued strategic capital investments from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP) and Wuxi Biologics HealthCare Venture. 

Proceeds from the financing will be used to accelerate development of Immune-Onc’s lead clinical candidates, IO-108 and IO-202, and advance the selection of additional novel myeloid checkpoint inhibitor programs. Immune-Onc will provide additional corporate and clinical progress updates during 1:1 investor and prospective partner meetings at the upcoming J.P. Morgan 41st Annual Healthcare Conference.

"Immune-Onc had an incredible year of growth and development with two myeloid-checkpoint inhibitor programs progressing in the clinic in the U.S. and China for multiple types of cancer where great unmet needs remain,” said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. “We are confident in the long-term growth prospects for Immune-Onc and believe that our progress this past year provides a compelling foundation for continued success in 2023. We are on track to deliver on several key milestones for our lead clinical candidates, including obtaining proof-of-concept results in leukemia and solid tumor expansion cohorts for IO-202 and IO-108, respectively, completing dose escalation for IO-202 in solid tumors, and further characterizing clinical biomarkers and/or mechanisms of actions for our checkpoint inhibitors that may ultimately lead to new clinical programs.”  

2022 Clinical & Corporate Highlights:

 Clinical:

• Dosed the first patient in the expansion cohorts of the company’s ongoing Phase 1 study for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors

• Dosed the first patient with IO-108 in a Phase 1 clinical trial in China for patients with advanced solid tumors following the Center for Drug Evaluation of the China National Medical Products Administration approving the company’s Investigational New Drug application

• Dosed the first solid tumor patient in the company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3)

• Granted Fast Track designation by the U.S. Food and Drug Administration for IO-202 for the treatment of patients with relapsed or refractory acute myeloid leukemia

Corporate:

• Entered a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”) to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), as part of its ongoing clinical development program in the U.S.

• Entered into a clinical trial collaboration and supply agreement to evaluate IO-108 and IO-202 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China

• Appointed Austin L. Gurney, Ph.D., and Barbara J. Klencke, M.D., to the company’s Board of Directors and Christopher Whitmore as chief financial officer

• Won the 2022 BayHelix “R&D Achievement of the Year” award

• Named the top 5 woman-led life science companies in the San Francisco Bay Area

Participation at upcoming industry panel:

• The Future of Checkpoint Inhibitors and Immuno-Oncology at Fierce JPM Week on Jan 10.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that reverse immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

 Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics to Present Trial in Progress Poster for Phase 1 Study of IO-202 in Patients with Advanced Solid Tumors at the Society for Immunotherapy of Cancer Annual Meeting

– The multicenter Phase 1 study is currently enrolling and evaluating IO-202 as monotherapy and in combination with an anti-PD-1 for the treatment of solid tumors –

PALO ALTO, CA, November 10, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that it will present a Trial in Progress poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held in Boston and virtually from November 8 –12, 2022.

 The poster presentation will highlight the trial design, dosing regimen, and study protocol for the company's ongoing Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187).

“Our Phase 1 study of IO-202 supports a differentiated myeloid checkpoint inhibitor with best-in-class potential to provide benefit for patients with solid tumors,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “IO-202 blocks the LILRB4 pathway - specifically, interaction with its multiple ligands including apolipoprotein E and fibronectin - enabling the potential to reactivate or enhance anti-tumor T cell immune responses in patients with solid tumors.”

“In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML. We plan to combine IO-202 with various anti-PD-1s such as pembrolizumab and tislelizumab, among others. We look forward to continuing to build a strong body of evidence to support IO-102 as a novel immunotherapy with broad potential across multiple oncology indications,” he added.

This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab or other anti-PD-1s in multiple solid tumor types. Various biomarkers will be explored to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.

Details of the presentation are as follows:

Title: A Phase 1 Trial of IO-202, An Antagonist Antibody Targeting Myeloid Checkpoint LILRB4 (ILT3), as Monotherapy and in Combination with Pembrolizumab in Adult Patients with Advanced Relapsed or Refractory Solid Tumors Abstract #: 747 Presentation Session: Clinical Trials in Progress Session Date and Time: Thursday, November 10, 2022, 9:00 AM - 9:00 PM ET
Location: Boston Convention & Exhibition Center, Hall C

Poster presentations will be accessible in person and virtually. All accepted abstracts will be available in a Journal for ImmunoTherapy of Cancer (JITC) supplement. For more information about the 37th SITC annual meeting, please visit https://www.sitcancer.org/home.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane receptor expressed by monocytic myeloid cells, including dendritic cells, monocytes, monocytic myeloid-derived suppressor cells and tumor-associated macrophages. LILRB4 inhibits antigen-presenting cell function, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the 2021 American Association for Cancer Research (AACR) Annual Meeting.

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a “don’t kill me” to a “kill me” signal by activating T cell killing and converts a “don’t find me” to a “find me” signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Appoints Two New Members to its Board of Directors

– Austin L. Gurney, Ph.D. and Barbara J. Klencke, M.D. bring deep expertise in oncology drug discovery and development –

PALO ALTO, CA, November 8, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the appointments of Austin L. Gurney, Ph.D. and Barbara J. Klencke, M.D. to the company’s board of directors.

"We are excited and honored to welcome two well-known and respected biopharmaceutical leaders to our Board of Directors, joining us in our mission to develop novel myeloid checkpoint inhibitors for cancer patients,” said Charlene Liao, Ph.D., founder, chief executive officer and chair of Immune-Onc. "Austin and Barbara have a deep understanding of the discovery and development process for breakthrough cancer therapies, experience that both complements and expands the expertise of our Board. Our company and patients will benefit from their R&D leadership and perspectives."

“Immune-Onc’s pioneering role in developing myeloid checkpoint inhibitors as next generation immunotherapies has impressed me,” said Dr. Gurney. “I am excited to work with the team to advance its growing portfolio of first-in-class and potentially best-in-class molecules through research and development, and ultimately to patients.”

“Immune-Onc’s pipeline of novel myeloid checkpoint inhibitors represents a new and promising therapeutic approach for the treatment of solid tumors and hematologic malignancies,” said Dr. Klencke. “It is a privilege to join the Board and I look forward to working with the leadership team to help progress the clinical development of this exciting new class of immunotherapy.”

Austin Gurney, Ph.D. is a biotech industry veteran with over two decades of experience in the discovery and development of novel therapeutics. He was chief scientific officer, senior vice president of research at OncoMed Pharmaceuticals where he held various management roles of increasing responsibility between 2004 and 2017. During this time, he and his teams discovered and developed five first-in-class therapeutic agents. Prior to OncoMed, Austin worked at Genentech where his research led to the discovery of several growth factors and cytokines. He has authored or co-authored more than 60 published scientific papers and is listed as an inventor on over 600 patents related to therapeutic applications in immunology and cancer. Austin received his Ph.D. in biology from Case Western Reserve University.

Barbara J. Klencke, M.D. is a world-class drug developer and research & development expert, having made significant contributions to the oncology community with the development and approval of several first-in-class therapies. Since 2015, she has served as the chief medical officer of Sierra Oncology Inc., a publicly traded clinical-stage biopharmaceutical company recently acquired by GSK in 2022. From 2011 to 2015, Barbara served as senior vice president of global development at Onyx Pharmaceuticals, acquired by Amgen Inc. in 2013. She also led a variety of both early- and late-stage oncology programs while at Genentech, Inc. from 2003 to 2011.

Barbara received her M.D. from the University of California, Davis (UC Davis) and completed her internal medicine residency and hematology/oncology fellowship at the University of California, San Francisco (UCSF) and remained at UCSF as an assistant professor of medicine in oncology focusing on clinical research from 1995 – 2002.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

– IO-108 is being studied as a monotherapy and in combination with select anti-PD-1 antibodies in multiple expansion cohorts of solid tumors –

– Clinical supply agreement with Regeneron accelerates Immune-Onc’s solid tumor clinical development program –

PALO ALTO, CA, October 17, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the dosing of the first patient in the expansion cohorts of its ongoing Phase 1 study for IO-108. The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) (“Regeneron”) to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), as part of its ongoing clinical development program.

IO-108 is a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors.

“We are incredibly excited to have enrolled the first patient in an expansion cohort of the IO-108 study. To date, IO-108 has been well tolerated and has demonstrated promising clinical activity in various tumor types, both as a monotherapy and in combination with an anti-PD-1 antibody,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “Additionally, on the heels of initiating this important phase of our study, we are excited to enter into a supply agreement with Regeneron, which enables us to accelerate the global development of IO-108 in multiple expansion cohorts of select solid tumors. We hope to establish our pipeline products as the preferred combination agents with T cell checkpoint inhibitors and other standard of care therapies.”

The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types). Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo®). Immune-Onc retains global development and commercial rights to IO-108.

“I have been very encouraged by both the pre-clinical and early clinical data observed for IO-108 in the ongoing Phase 1 study, and look forward to better understanding how combination therapy with various anti-PD1 therapies can further activate the body’s immune system to attack some of the hardest-to-treat cancers,” said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “Currently, 70-80 percent of cancer patients with solid tumors do not achieve durable responses to T-cell checkpoint therapies alone, and people with many types of cancer have yet to benefit from the promise of this class of immunotherapy. This underscores the need for investigating novel combination regimens.”

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity. 

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors. 

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China

– Collaboration with BeiGene is part of Immune-Onc’s global clinical development strategy targeting the LILRB family of myeloid checkpoints –

PALO ALTO, CA, October 10, 2022 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced it has entered into a clinical trial collaboration and supply agreement with to evaluate Immune-Onc’s first-in-class myeloid checkpoint inhibitors, IO-108 and IO-202, in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China.

 “We are delighted to partner with BeiGene. The preclinical and clinical data to date of our first-in-class LILRB antagonists IO-108 and IO-202 have shown that there is great potential in combining our myeloid checkpoint inhibitors with T cell checkpoint inhibitors, such as tislelizumab, to potentially improve clinical outcomes,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “By expanding our reach with BeiGene in China, we have an opportunity to treat a broader array of patients with significant unmet medical needs.”

“We are thrilled to partner with Immune-Onc to evaluate the combination of tislelizumab with their novel myeloid checkpoint inhibitors IO-108 and IO-202,” added Lai Wang, Ph.D., Global Head of R&D of BeiGene. “Based on strong preclinical and emerging clinical data, we believe there is good synergy between PD-1 and LILRB antagonists for the treatment of solid tumors. We look forward to working with Immune-Onc to explore the possibility of combination therapy with our products, which may bring more treatment options to cancer patients in China.”

Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

 The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody. The company is actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.   

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a “don’t kill me” to a “kill me” signal by activating T cell killing and converts a “don’t find me” to a “find me” signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

 Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-108 in Patients with Advanced Solid Tumors in China

– IO-108 is the first LILRB2-targeting antibody administered to Chinese patients –

– Implementation of IO-108 program in China initiates Immune-Onc’s global clinical development plan; Phase 1 trial has completed dose escalation in the U.S. in solid tumor patients –

PALO ALTO, CA, September 9, 2022 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the first patient has been treated with IO-108, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), in a Phase 1 clinical trial in China for patients with advanced solid tumors.

The multicenter Phase 1 trial in China will evaluate the safety, tolerability, pharmacokinetics, and efficacy of IO-108 alone and in combination with anti-PD-1 as a potential treatment option for patients with advanced solid tumors.

The implementation of the IO-108 program in China is part of the Company’s strategic plan to develop IO-108 globally.  A Phase 1 trial for IO-108 has completed dose escalation in the U.S. in solid tumor patients, which determined a preliminary recommended Phase 2 dose (RP2D) and multiple expansion cohorts have now opened. The objective of the Phase 1 trial in China is to leverage the clinical data obtained in the U.S. to enable concurrent clinical development in China and the U.S. and accelerate the overall IO-108 development program. Immune-Onc is leading the way in China in the development and potential commercialization of myeloid checkpoint inhibitors, such as IO-108.

“IO-108 is the very first LILRB2-targeting antibody administered to patients in China,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “The successful initiation of this study in China supports our vision and mission in developing first-in-class immunotherapy globally. This is an important milestone for the company and further demonstrates our global clinical and regulatory capabilities.”

“We are excited to work with top institutions and investigators in China to potentially bring a first-in-class therapeutic to Chinese patients. As a myeloid checkpoint inhibitor, IO-108 has demonstrated the ability to relieve immunosuppression in the tumor microenvironment by blocking LILRB2. The combination of IO-108 and anti-PD-1 may enable more patients across multiple solid tumor types to benefit from immune checkpoint inhibitors,” commented by Maggie Gu, China general manager of Immune-Onc. “We are planning to advance additional novel myeloid checkpoint inhibitors in our portfolio to clinical trials in China to bring new therapeutic options to patients and address high unmet medical needs.”

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. This data enables the company to accelerate the global development of IO-108 in multiple expansion cohorts in select cancers as a monotherapy and in combination with T cell checkpoint inhibitors. The IO-108 Phase 1 clinical trial in China (NCT05508100) is currently enrolling patients.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

– Company announces completion of Phase 1 dose escalation ahead of schedule for IO-108, a first-in-class antibody targeting LILRB2 (ILT4) –

– Signals of clinical activity observed in multiple tumor types for IO-108 as a single agent and in combination with an anti-PD-1 –

PALO ALTO, CA, July 14, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the appointment of Christopher Whitmore as chief financial officer. In addition, the company provided a clinical progress update on IO-108, its first-in-class antagonist antibody targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B2 (LILRB2, also known as ILT4) of myeloid checkpoints. 

“Chris brings a wealth of industry experience to Immune-Onc at an exciting stage in the company’s evolution,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “His impressive track record of success and diverse experience across disciplines, including finance and operations, will be impactful to Immune-Onc’s continued success.” 

“It’s an incredibly exciting time to join Immune-Onc, as the company continues to advance its promising pipeline of novel myeloid checkpoint inhibitors. I look forward to working with this talented and passionate management team to accelerate the development of Immune-Onc's portfolio of products that may improve outcomes for cancer patients who currently have limited treatment options,” said Mr. Whitmore.

Mr. Whitmore is a highly accomplished financial executive who has more than 20 years of experience in strategic finance, accounting, operations, investor relations and organizational development. He joins Immune-Onc from Notable Labs, where he served as chief financial officer since 2021. Prior to that, he served as vice president of finance and administration for Harpoon Therapeutics. During his tenure there, he supported the company’s crossover financing, initial public offering, licensing and collaboration, follow-on financings and public company operations. Mr. Whitmore previously held management positions at Immune Design (now part of Merck & Co.), AcelRx Pharmaceuticals and Sangamo Therapeutics. He started his career at KPMG LLP, where he served in the audit practice. He received his B.A. in business economics from the University of California, Santa Barbara, and holds an active CPA license.

Immune-Onc also announced successful completion of dose escalation in the first-in-human clinical trial (NCT05054348) of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), for the treatment of solid tumors. 

In the study, adult patients with advanced or refractory solid tumors were treated with IO-108 at 60, 180, 600 or 1,800 mg in monotherapy and at 180, 600 or 1,800 mg in combination with 200 mg of pembrolizumab, an anti-PD-1 antibody, administered intravenously every three weeks. IO-108 has been well-tolerated at up to 1,800 mg, either as a monotherapy or in combination with pembrolizumab, without dose-limiting toxicity so far.

Additionally, early signals of clinical activity were observed in multiple tumor types with demonstrated monotherapy efficacy. This supports the clinical development plan to advance IO-108 into select cancers for dose expansion as monotherapy and in combination with anti-PD-(L)1 and/or standard of care therapies. A biomarker strategy will include evaluation of a specific, sensitive and proprietary LILRB2 antibody for immunohistochemistry to enable tumor selection with an increased probability of success.

“We are very pleased with the rapid enrollment and early completion of dose escalation of IO-108 in solid tumor patients. Emerging data from our first-in-human study demonstrate that IO-108 has an excellent safety and tolerability profile. We are also encouraged by signals of clinical activity in multiple tumor types,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “We look forward to advancing IO-108 into multiple expansion cohorts in specific tumor types as monotherapy and in combination with T cell checkpoint inhibitors.”

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

In the ongoing Phase 1 study of IO-108 in adult patients with advanced or refractory solid tumors in the U.S. (NCT05054348), to date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. This data enables the company to accelerate the global development of IO-108 in multiple expansion cohorts in select cancers as a monotherapy and in combination with T cell checkpoint inhibitors. The company has received the IND clearance in China and plans to evaluate IO-108 in solid tumors in China in 2H 2022.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has established strategic research collaborations with The University of Texas, Albert Einstein College of Medicine and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays and tools to interrogate the biology of and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Receives China Investigational New Drug (IND) Approval for the Phase 1 Study of IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Solid Tumors

– Multicenter Phase 1 study to evaluate IO-108 as both monotherapy and in combination with pembrolizumab in China –

– Represents the first LILRB2-targeting antibody with IND clearance in China and the company’s fourth IND globally –

– A Phase 1 trial evaluating IO-108 in patients with advanced solid tumors is currently enrolling in the U.S. –

PALO ALTO, CA, May 16, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 1 study of IO-108, a novel antagonist antibody targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors.

“NMPA’s timely acceptance and approval of the IND for IO-108 represents a remarkable milestone for the company,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “It is our first IND submission and clearance outside the U.S., and our company’s fourth IND globally. Antagonist antibodies targeting the LILRB family of myeloid checkpoints represent a promising new approach in cancer immunotherapy that are expected to be complementary to and synergistic with T-cell checkpoint inhibitors such as anti-PD-1 or anti-PD-L1. We look forward to bringing these first-in-class therapeutics to cancer patients in China.” 

“IO-108 is a significant program in our pipeline of myeloid checkpoint inhibitors and the first LILRB2-targeting antibody with IND submission and clearance in China,” commented by Maggie Gu, China general manager of Immune-Onc. “We look forward to working closely with investigators to launch and execute the high-quality Phase 1 clinical trial to explore IO-108’s potential in treating solid tumors in China, concurrently with the U.S. Phase 1 clinical trial."

The multicenter Phase 1 study will consist of a monotherapy cohort, a combination therapy cohort, and a dose expansion cohort to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IO-108 alone and in combination with pembrolizumab. The Chinese study will also confirm the recommended Phase 2 dose selected from the U.S. Phase 1 clinical trial of IO-108 in solid tumors. Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab in indication-specific expansion cohorts in China.

ABOUT LILRB2 (ILT4)

LILRB2, also known as ILT4, is expressed mostly by myeloid cells, including monocytes, macrophages, dendritic cells, and neutrophils. In solid tumors, activation of LILRB2 by its ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, induces a tolerogenic phenotype in myeloid cells, thereby suppressing T cell activation and promoting tumor immune evasion.

ABOUT IO-108

IO-108 binds to LILRB2 with high affinity and specificity and blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression including HLA-G, ANGPTLs, SEMA4A, and CD1d. Ex vivo studies show that treatment with IO-108 produces pro-inflammatory activity and an enhanced antigen-presenting cell (APC) phenotype to multiple stimuli, including T cell activators, and STING and TLR agonists. As a single agent, IO-108 reverts the anti-inflammatory myeloid cell phenotype caused by “tumor conditioning” to pro-inflammatory phenotype and promotes the differentiation of monocytes and immature dendritic cells into pro-inflammatory dendritic cells, which are critical in generating productive anti-tumor immune responses. IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. Moreover, IO-108 monotherapy inhibits the growth of solid tumors in a preclinical model, which is associated with immune cell activation. IO-108 presents a favorable pharmacokinetic and safety profile in preclinical models.

 In the ongoing Phase 1 study of IO-108 in adult patients with advanced or refractory solid tumors in the US (NCT05054348), IO-108 has been well-tolerated to date, both as a monotherapy and in combination with pembrolizumab. The company has received the IND clearance in China and plans to evaluate IO-108 in solid tumors in China in 2H 2022.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in 2020 and Fast Track Designation for treatment of relapsed or refractory AML in 2022. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1 for collagen-rich solid tumors, and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has strategic research collaborations with The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays, and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics Announces the Selection of Clinical Development Candidate IO-106, a First-in-Class Myeloid and Stromal Checkpoint Inhibitor Targeting LAIR1

IO-106 is the third development candidate arising from Immune-Onc’s pioneering pipeline of myeloid checkpoint inhibitors, a new class of immunotherapy that aims to overcome immune resistance in cancer

The Company will present a scientific poster at the Society for Immunotherapy of Cancer (SITC) Tumor Immune Microenvironment: A Holistic Approach Workshop

PALO ALTO, CA, April 20, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the selection of IO-106, a first-in-class myeloid and stromal checkpoint inhibitor targeting the inhibitory receptor, Leukocyte‐Associated Immunoglobulin‐Like Receptor 1 (LAIR1), for clinical development. The Company will present a scientific poster on the therapeutic potential of anti-LAIR1 antibodies at the Society for Immunotherapy of Cancer (SITC) Tumor Immune Microenvironment: A Holistic Approach Workshop on April 21st in San Diego, CA.

LAIR1 is an immune inhibitory receptor expressed on lymphocytes and myeloid cells that correlates with worse survival in several cancers. LAIR1 is activated by collagen which is highly abundant in the stroma of many solid tumor types and is thought to contribute to immune suppression. The data being presented suggest that LAIR1 antagonist antibodies reverse collagen-mediated immune suppression on T cells and myeloid cells in the solid tumor microenvironment, thereby promoting anti-tumor immunity.

“IO-106 is now the third clinical candidate in our pipeline and a testament to the depth and rigor of our science,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “Immune-Onc was founded on groundbreaking science that first illuminated the role of the previously unexplored LILRB family of myeloid checkpoints in cancer. This research has rapidly advanced a completely new field of study and class of cancer immunotherapy that goes beyond T cells to overcome immune resistance and the limitations of current treatment options. We are very excited about potential development opportunities for IO-106 and look forward to sharing our progress in the near future.”

ABOUT LAIR1

LAIR1 is an immune inhibitory receptor of the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) and is expressed on lymphocytes and myeloid cells. Research shows that LAIR1 expression correlates with worse survival in several cancers. LAIR1 is activated by collagen, which is highly abundant in the stroma of many solid tumor types and is thought to contribute to immune suppression. LAIR1 is being targeted as a myeloid and stromal checkpoint in cancer immunotherapy.

ABOUT IO-106

IO-106 is a first-in-class monoclonal antibody that antagonizes LAIR1. It has broad potential in collagen-rich solid tumors and could be a candidate for combination therapy with PD-1 inhibitors and other immunotherapies. Preclinical research shows that IO-106 can reverse collagen-mediated immune suppression and mobilize anti-tumor immunity of multiple cell types including lymphocytes and myeloid cells. IO-106 entered into Investigational New Drug application (IND)-enabling studies with targeted IND submission in 1H202.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in 2020 and Fast Track Designation for treatment of relapsed or refractory AML in 2022. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1 for collagen-rich solid tumors, and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has strategic research collaborations with The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays, and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306

Immune-Onc Therapeutics to Participate in the Raymond James LILRB/ILT Symposium on Myeloid Checkpoint Therapeutics in Cancer

PALO ALTO, CA, April 19, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the Company will present at the virtual LILRB/ILT Symposium: A Deep Dive into Myeloid Checkpoint Therapeutics in Cancer on Tuesday, April 26, 2022, at 2:00 PM EDT, hosted by Raymond James biotech analysts. Charlene Liao, Ph.D., chief executive officer of Immune-Onc and Paul Woodard, M.D., chief medical officer, will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond. Dr. Chengcheng (Alec) Zhang, Professor of Physiology at UT Southwestern Medical Center and Scientific Founder of Immune-Onc, will give an expert presentation on the LILRB/ILT family of receptors as myeloid checkpoint targets in immuno-oncology at 2:30 PM EDT.

“As a private company and a leader in LILRB/ILT family of myeloid checkpoint target validation and therapeutics development, we are pleased to be invited to the Raymond James LILRB/ILT Symposium,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “Immune-Onc was founded on groundbreaking science that first illuminated the role of the previously unexplored LILRB family of myeloid checkpoints in cancer. This research has rapidly advanced a completely new field of study and class of cancer immunotherapy that goes beyond T cells to overcome immune resistance and the limitations of current treatment options. We look forward to sharing our pipeline progress on the same stage with our Scientific Founder Dr. Alec Zhang.”

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in 2020 and Fast Track Designation for treatment of relapsed or refractory AML in 2022. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1, and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has strategic research collaborations with The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays, and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306 

Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors

Phase 1 multicenter dose-escalation and dose-expansion trial evaluating IO-202 as a monotherapy and in combination with an anti-PD-1 is initiated and expected to enroll 200 patients with advanced solid tumors

This is the second clinical trial for the IO-202 program; its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as monotherapy and in combination with azacitidine

IO-202 is one of three first-in-class programs from Immune-Onc’s pipeline of myeloid checkpoint inhibitors targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB)

PALO ALTO, CA, April 12, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187).

"We are very pleased to announce the initiation of our Phase 1 study of IO-202 in solid tumors, a significant achievement in our development strategy targeting the LILRB family of myeloid checkpoints to overcome immune suppression in the tumor microenvironment,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “We believe by targeting the LILRB4 checkpoint, IO-202 may reverse the immunosuppressive effects of tumor associated monocytic myeloid cells, enhance dendritic cell function, and promote T cell activation – thereby, unleashing the antitumor activities of the immune system and increasing the therapeutic benefit of T cell checkpoint inhibitors. We look forward to conducting this study and assessing the potential of IO-202 as a monotherapy and in combination with pembrolizumab across multiple solid tumor types.”

This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab in multiple solid tumor types. Various biomarkers will be explored to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane receptor expressed by monocytic myeloid cells, including dendritic cells, monocytes, monocytic myeloid-derived suppressor cells and tumor-associated macrophages. LILRB4 inhibits antigen-presenting cell function, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the 2021 American Association for Cancer Research (AACR) Annual Meeting.

ABOUT IO-202

IO-202 is a first-in-class LILRB4 antagonist antibody with broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a “don’t kill me” to a “kill me” signal by activating T cell killing and converts a “don’t find me” to a “find me” signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical studies showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1, and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has strategic research collaborations with The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays, and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306