OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors

2024-04-23

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ONC-841 is a potential first-in-class SIGLEC 10 antibody designed to block an innate and potentially adaptive immune checkpoint and prevent cancer evasion of immune cells Anti-tumor T cells, NK cells and macrophages can be rejuvenated within the tumor microenvironment following ONC-841 treatment Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected 2H 2025 ROCKVILLE, Md., April 23, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced that the United States Food and Drug Administration (“FDA”) has cleared the investigational new drug (“IND”) application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors. “SIGLEC 10 is an immune checkpoint that inhibits the activation of both innate and adaptive immune cells. In cancer, this can lead to reduced anti-tumor immunity within the tumor microenvironment (“TME”), creating a protected setting for cancer cells to thrive,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “ONC-841 is designed to block this immune checkpoint to rejuvenate immune cell activity for tumor destruction within the TME. We are excited to begin clinical development of ONC-841 in advanced solid tumors.” SIGLEC 10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from some other Siglecs such as SIGLEC 15. ONC-841 is a humanized antagonist anti-SIGLEC 10 monoclonal antibody and, to our knowledge, is the first SIGLEC 10 antagonist to enter clinical development. OncoC4 discovered SIGLEC 10 negatively regulates antibody-dependent cell mediated cytotoxicity (ADCC) in addition to other known functions. ONC-841 was selected and developed based on the ability to enhance antibody-dependent CD16a signaling, a surrogate for ADCC and function of natural killer (NK) cells and macrophages, key innate immune cells involved in tumor killing. Preclinical studies supporting the IND application demonstrated ONC-841 increased the phagocytosis of cancer cells and improved the function of tumor-infiltrating T cells. Additional in vivo syngeneic and xenograft tumor models showed enhanced immune rejection of tumor cells following treatment with ONC-841. Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in the second half of 2025. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has two first-in-class clinical stage SIGLEC programs, including AI071, a Phase 2 ready SIGLEC agonist designed for difficult to treat immune related adverse events, and ONC-841, a Phase 1 ready SIGLEC 10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: . CONTACTS OncoC4 Investor Contact: Alexandra Folias LifeSci Advisors afolias@lifesciadvisors.com Media Contact: Mari Purpura LifeSci Advisors mpurpura@lifesciadvisors.com

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