OncoC4 Announces First Patient Dosing in Phase 1 Clinical Trial of ONC-783 for the Treatment of Advanced Solid Tumors

— 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 —

ROCKVILLE, Md., Aug. 17, 2026 /PRNewswire/ -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today 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.

"This milestone demonstrates OncoC4's leading position in developing first-in-class cancer therapeutics," said Dr. Yang Liu, CEO and Chief Scientific Officer, "CD24 is expressed in nearly 70% of human cancers ¹, and abnormal glycosylation in malignant cells produces the neoCD24 epitope that is largely absent from the normal tissues. By exploiting this cancer-specific epitope, ONC-783 is designed to maximize selectivity for tumor cells while minimizing the risk of on-target/off-tumor toxicity that has limited other T-cell engagers."

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.

About ONC-783-001

ONC-783-001 is a Phase 1 open-label, dose-escalation study in the United States (U.S.) to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. OncoC4 has engaged several clinical centers across the U.S. to recruit patients for ONC-783-001 including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial registration number is NCT07408258.

About the NeoCD24 Platform

CD24 is expressed in nearly 70% of human cancers¹, along with a significant level of expression also in normal tissues, where it plays a key role in regular cell growth, tissue maintenance, and immune system function. Targeting CD24 as a cancer treatment has been challenging due to the lack of selectivity to tumor cells. OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumor-specific antigen that is largely absent from normal tissues, enabling the development of cancer-specific therapeutics targeting CD24. OncoC4 is developing several first-in-class cancer treatments based on the neoCD24 platform.

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 treatment of cancer and immunological diseases. OncoC4's pipeline features assets with first-in-class and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned bispecific antibody candidate targeting PD-1 and VEGF. ONC-841 is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.

More information: www.oncoc4.com. 

CONTACTS

Media Relations
Pan Pan
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Investor Relations
Ryan Cui
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References

1. Ju-Han Lee, Seo-Hee Kim, Eung-Seok Lee, Young-Sik Kim CD24 overexpression in cancer development and progression: a meta-analysis Oncol Rep 2009 Nov;22(5):1149-56. doi: 10.3892/or_00000548.

SOURCE OncoC4