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] - 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] - An ongoing Phase 1/2 clinical trial is assessing the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors with high Nectin-4 expression, with data to be presented at ESMO 2025 [3][9] Company Overview - Corbus Pharmaceuticals is a clinical stage oncology and obesity company focused on innovative scientific approaches to serious illnesses, with a pipeline that includes CRB-701, CRB-601, and CRB-913 [4] - CRB-601 is an anti-integrin monoclonal antibody targeting TGFβ activation on cancer cells, while CRB-913 is a CB1 receptor inverse agonist for obesity treatment [4]