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

According to the company, ONC-783 is the world's first and only clinical-stage T-cell engager targeting the cancer-specific glycoform of CD24, known as neoCD24. The candidate is designed to selectively target the tumour-specific epitope while redirecting T cells for anti-tumour activity.

Preclinical studies have demonstrated broad anti-tumour activity for ONC-783 across multiple solid tumour and haematologic malignancies, including pancreatic, lung, breast, colorectal and ovarian cancers, as well as glioblastoma and mantle cell lymphoma. A subcutaneous formulation of ONC-783 has also been developed to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers.

ONC-783 is being evaluated in the ONC-783-001 Phase 1 trial in the US for patients with advanced solid tumours. The first study patient was successfully dosed at Columbia University Irving Medical Centre. The treatment was well tolerated, with no severe adverse events, Cytokine Release Syndrome or Immune Effector Cell-Associated Neurotoxicity Syndrome observed to date.

The ONC-783-001 study is an open-label, dose-escalation Phase 1 trial designed to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced or metastatic solid tumours. The study is focused on colorectal, ovarian, pancreatic and breast cancers.

OncoC4 has engaged several clinical centres across the US to recruit patients for the ONC-783-001 trial, including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial is registered under NCT07408258.

CD24 is expressed in nearly 70 percent of human cancers and is also significantly expressed in normal tissues, where it plays a role in regular cell growth, tissue maintenance and immune system function. Targeting CD24 as a cancer treatment has been challenging because of the lack of selectivity for tumour cells.

OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumour-specific antigen that is largely absent from normal tissues. This discovery has enabled the company to develop cancer-specific therapeutics targeting CD24, with several first-in-class cancer treatments being developed through its neoCD24 platform.

Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company engaged in the discovery and development of novel biologics for cancer and immunological diseases. Its pipeline features assets with first-in-class and best-in-class potential targeting novel and well-validated targets across oncology and immunological diseases.