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OncoC4 Begins Phase 1 Human Trials for NeoCD24 Cancer Therapy

Rockville-based OncoC4 has administered the first dose of ONC-783 to a patient with advanced solid tumors, marking the clinical debut of a T-cell engager designed to target neoCD24. This Phase 1 trial, conducted at Columbia University Irving Medical Center, aims to validate a novel approach to tumor-specific immunotherapy.

OncoC4 Begins Phase 1 Human Trials for NeoCD24 Cancer Therapy
Photo: Bio & News

The investigational drug ONC-783 represents a shift in how CD24 is approached in oncology. While CD24 appears in roughly 70% of human cancers, its presence in healthy tissue has historically complicated treatment. OncoC4’s proprietary platform identifies a specific glycoform, neoCD24, which is largely absent from normal cells. By focusing exclusively on this epitope, the company aims to maximize anti-tumor activity while reducing the off-target toxicity often associated with conventional T-cell engagers.

Dr. Yang Liu, CEO and Chief Scientific Officer of OncoC4, noted that the subcutaneous delivery method is engineered to provide gradual systemic exposure, potentially lowering the risk of severe immune responses like Cytokine Release Syndrome. Preliminary reports from the trial indicate the initial dose was well tolerated without serious adverse events. Dr. Aiwu Ruth He, a lead investigator at Columbia University Irving Medical Center, emphasized that this mechanism offers a necessary alternative for patients who have exhausted or failed to respond to standard therapies. The study, registered as NCT07408258, is currently recruiting across multiple U.S. sites, including MD Anderson Cancer Center, to evaluate the safety and efficacy of the treatment in patients with breast, pancreatic, ovarian, and colorectal cancers.

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