Immune-Onc Therapeutics Announces Positive Results from Phase 1 Dose Escalation Study of IO-108 in Advanced Solid Tumors Published in the Journal for ImmunoTherapy of Cancer
- Data demonstrates potential for IO-108 to enhance immune activation and overcome resistance in advanced solid tumors as a monotherapy and in combination with pembrolizumab -
PALO ALTO, CA, November 21, 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 the publication of Phase 1 dose-escalation study results of IO-108, its first-in-class antibody targeting LILRB2 (also known as ILT4), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society for Immunotherapy of Cancer (SITC).
The paper, entitled “Phase 1 Dose Escalation Study of IO-108, an Anti-LILRB2 Antibody, in Patients with Advanced Solid Tumors,” details the safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamic biomarker results from 25 patients with advanced solid tumors enrolled in a first-in-human study of IO-108 as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody.
In the IO-108 monotherapy cohort, the overall response rate was 9%, with one patient achieving a durable complete response (CR) for over two years. The CR was observed in a patient with treatment-refractory Merkel cell carcinoma whose prior treatment included two lines of immunotherapy (pembrolizumab, followed by a combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4)).
Among 13 efficacy-evaluable patients treated with the combination of IO-108 plus pembrolizumab, 3 patients (2 cholangiocarcinoma and 1 colon cancer, all microsatellite-stable cancer types that typically do not respond to T-cell checkpoint inhibitors) had a partial response (23%).
Biomarker analysis revealed pharmacodynamic changes consistent with increased T-cell infiltration in tumors, indicating an activated tumor microenvironment in patients with clinical benefit in both monotherapy and combination therapy. Results also demonstrated that IO-108 was well-tolerated at all dose levels, with no dose-limiting toxicities observed.
“The durable responses observed in this heavily pretreated patient population underscore the therapeutic potential of IO-108 as both a monotherapy and in combination with T-cell immune checkpoint inhibitors,” said IO-108 Phase 1 investigator and first author of the paper, Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “These findings provide compelling evidence that targeting myeloid-cell immune checkpoint LILRB2 offers a novel and promising approach to cancer treatment.”
“The durable responses observed in this heavily pretreated patient population underscore the therapeutic potential of IO-108 as both a monotherapy and in combination with T-cell immune checkpoint inhibitors,” said IO-108 Phase 1 investigator and first author of the paper, Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “Our findings provide compelling evidence that targeting myeloid-cell immune checkpoint LILRB2 offers a novel approach to cancer treatment.”
“We are very proud of our positive data published in the Journal for ImmunoTherapy of Cancer (JITC),” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “Our data suggest that IO-108 could play a pivotal role as a monotherapy and combination therapy with T-cell immune checkpoint inhibitors and support the broader clinical exploration of IO-108 as a versatile therapeutic option for patients with advanced solid tumors.”
Immune-Onc is advancing the development of IO-108 in a Phase 1b/2 global, randomized study that is part of Roche’s Morpheus-Liver program. The study will evaluate IO-108 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care in patients with locally advanced, metastatic and/or unresectable liver cancer with no prior systemic treatment. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival.
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 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
