OncoC4 Doses First Patient in Phase 1 Trial for SIGLEC10 Inhibitor ONC-841 for Solid Tumors

OncoC4, Inc., a biopharmaceutical company specializing in cancer and immunological disease treatments, announced that the first patient has been treated in their Phase 1 ONC-841-002 trial. This study is investigating ONC-841, a promising SIGLEC10 blocking antibody, for the treatment of solid tumors. ONC-841 is designed to counteract tumor evasion of the immune system, potentially revitalizing T cells, NK cells, and macrophages within the tumor microenvironment. Initial safety, pharmacokinetics, and clinical activity results from ONC-841 monotherapy are anticipated in 2025.

The ONC-841-002 trial is an open-label, dose-escalation study involving patients with advanced or metastatic solid tumors. Participants will receive intravenous ONC-841 at varying doses every four weeks at multiple U.S. clinical centers. The trial's principal investigator is Dr. Tianhong Li from the University of California, Davis Comprehensive Cancer Center. The first patient was enrolled under the care of Dr. John Hamm at the Norton Cancer Institute in Louisville, Kentucky. Initial data on the safety and efficacy of ONC-841 are expected in 2025.

Yang Liu, PhD, Co-Founder, CEO, and CSO of OncoC4, emphasized the significance of dosing the first patient in the trial. He highlighted the potential of ONC-841 to treat various malignancies by activating anti-tumor immunity within the tumor microenvironment. Dr. Liu expressed excitement about the broad therapeutic promise of ONC-841 and eagerly awaits the preliminary Phase 1 data in 2025.

Dr. Hamm, the site investigator at Norton Cancer Institute, shared his enthusiasm about participating in the trial. He acknowledged the need for better cancer treatments and noted the rapid advancements in cancer care that clinical trials have facilitated, especially in recent years.

ONC-841 is a humanized antagonist anti-SIGLEC10 monoclonal antibody, the first of its kind to enter clinical development. SIGLEC10 is an inhibitory receptor gene widely found in tumor-infiltrating immune cells and is involved in tumor evasion through its interaction with CD24 on tumor cells. ONC-841 disrupts this interaction, promoting the activation of NK cells, macrophages, and T cells. In preclinical studies, ONC-841 increased phagocytosis of cancer cells and improved the function of tumor-infiltrating T cells and innate cells. It also enhanced antibody-dependent CD16a signaling, an indicator of antibody-dependent cell-mediated cytotoxicity (ADCC).

OncoC4, headquartered in Rockville, Maryland, is a privately held, late clinical-stage biopharmaceutical company. It focuses on discovering and developing novel biologics for cancer and immunological diseases. OncoC4’s most advanced program is BNT316/ONC392 (gotistobart), a Phase 3 anti-CTLA-4 antibody designed to enhance anti-tumor activity while maintaining its protective function against autoimmune diseases. The company is also targeting the CD24-Siglec pathway, an innate immune checkpoint discovered by its co-founders. OncoC4 has two first-in-class clinical-stage SIGLEC programs: AI-071, a Phase 2 ready SIGLEC agonist for difficult-to-treat immune-related adverse events, and ONC-841, a Phase 1 SIGLEC10 antagonist for solid tumors. Their portfolio includes preclinical programs targeting the CD24 cancer immune evasion pathway.

The Norton Cancer Institute in Louisville and Southern Indiana, where the first patient was treated, is renowned for its comprehensive cancer care. The institute offers a multidisciplinary approach, providing the latest treatments and technology for cancer prevention, diagnosis, care, and survivorship. Norton Cancer Institute's specialists cover a wide range of oncology subspecialties and offer advanced medical, surgical, and radiation therapies. The institute also participates in numerous innovative clinical trials and provides extensive support services for patients and families.