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

Core Insights - Corbus Pharmaceuticals has received Fast Track designation from the FDA for CRB-701, aimed at treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and anti-PD(L)-1 therapy [1][2] - The company previously received a Fast Track designation for CRB-701 for relapsed or refractory metastatic cervical cancer in December 2024 [1] - CRB-701 is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, featuring a site-specific, cleavable linker and a drug antibody ratio of 2, utilizing MMAE as the payload [2] Clinical Development - An ongoing Phase 1/2 clinical trial is assessing the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors associated with high Nectin-4 expression [3] - Dose escalation data from the Phase 1/2 clinical trial of CRB-701 was presented at ASCO-GU 2025, with the first data from the Phase 1/2 dose optimization set to be presented at ESMO 2025 on October 19, 2025 [3][9] - The study primarily enrolled patients with HNSCC and cervical cancer [3] Company Overview - Corbus Pharmaceuticals is a clinical stage oncology and obesity company focused on innovative scientific approaches to serious illnesses [4] - The company's pipeline includes CRB-701, CRB-601 (an anti-integrin monoclonal antibody), and CRB-913 (a CB1 receptor inverse agonist for obesity treatment) [4] - Corbus is headquartered in Norwood, Massachusetts [4]