Lara Wilson 2/21/24 Lara Wilson 2/21/24

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

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

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
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.

Lara Wilson 2/20/24 Lara Wilson 2/20/24

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

– 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.

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

American Cancer Society. About Liver Cancer. Accessed Dec. 7, 2023 at https://www.cancer.org/content/dam/CRC/PDF/Public/8698.00.pdf
The latest global burden of liver cancer: A past and present threat. Clin Mol Hepatol. 2023 Apr; 29(2): 355–357.
Hepatocellular carcinoma. Nat Rev Dis Primers. 2021;7:6. doi.org/10.1038/s41572-020-00240-3
Epidemiology of non-alcoholic fatty liver disease and hepatocellular carcinoma. JHEP Rep. 2021 Aug; 3(4): 100305. doi: 10.1016/j.jhepr.2021.100305

Lara Wilson 6/7/23 Lara Wilson 6/7/23

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

Lara Wilson 4/14/23 Lara Wilson 4/14/23

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.

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

Lara Wilson 3/14/23 Lara Wilson 3/14/23

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:

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

ABOUT IO-108

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

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.

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

Lara Wilson 3/3/23 Lara Wilson 3/3/23

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 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.

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

Lara Wilson 4/20/22 Lara Wilson 4/20/22

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

Lara Wilson 4/19/22 Lara Wilson 4/19/22

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 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.

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