— ONC-783 is the first-and-only clinical-stage T-cell engager targeting a cancer-specific glycoform of CD24 (neoCD24) —

— Subcutaneous formulation designed to provide gradual systemic exposure, potentially mitigating CRS risk —

OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, announced dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company's investigational T-cell engager developed based on the proprietary neoCD24 platform.

ONC-783 is the world's first and only clinical stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). The drug candidate is designed to address the limitations of existing immunotherapies by selectively targeting the tumor-specific epitope while redirecting T cells for potent anti-tumor activity. Preclinical studies have demonstrated broad anti-tumor activity for ONC-783 across multiple solid tumor and hematologic malignancies, including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, ovarian cancer, glioblastoma, and mantle cell lymphoma, which supports the potential of ONC-783 as a treatment across multiple tumor types. In addition, a subcutaneous formulation was developed for ONC-783 to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers.

"We are extremely excited to partner with OncoC4 to explore the potential of targeting neoCD24 to bring clinical benefit for cancer patients with limited treatment options," added Dr. Aiwu Ruth He, Professor of Medicine and medical oncologist at Columbia University Irving Medical Center in New York City. "Advanced solid tumors remain a significant challenge, and this innovative mechanism offers a promising new approach for patients who have progressed or intolerant to standard therapy."

ONC-783 is being tested in ONC-783-001, a Phase 1 trial in the US for patients with advanced solid tumors. The first study patient was successfully dosed at Columbia University Irving Medical Center. The treatment was well tolerated. No severe Adverse Events, Cytokine Release Syndrome, or Immune Effector Cell-Associated Neurotoxicity Syndrome have been observed to date. OncoC4 will continue the innovation in cancer immunotherapy and remain committed to the development of first-in-class therapeutics to address the unmet needs in cancer treatments.