FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma

NORWOOD, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. A Fast Track designation for relapsed or refractory metastatic cervical cancer was granted by the FDA in December 2024.

CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE as the payload. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions that demonstrate the potential to fill an unmet medical need.

An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression. Corbus presented dose escalation data at ASCO-GU 2025 from the Phase 1/2 clinical trial of CRB-701 (SYS6002) (NCT06265727) that is being conducted in the U.S. and Europe. The Company will be presenting the first data from its Phase 1/2 dose optimization at ESMO 2025 on October 19, 2025. The study enrolled primarily HNSCC and cervical patients.

Corbus Pharmaceuticals Holdings, Inc. is a clinical stage oncology and obesity company and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visitcorbuspharma.com. Connect with us onX,LinkedInandFacebook.

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