Corbus Pharmaceuticals Secures FDA Fast Track Status For CRB-701, Its Nectin-4 Targeting ADC, Advancing Development In Head And Neck Squamous Cell Carcinoma

Corbus Pharmaceuticals Holdings, Inc., a clinical-stage company focused on oncology and obesity, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This designation applies to patients whose cancer has progressed after treatment with platinum-based chemotherapy and an anti-PD(L)-1 therapy. The FDA had previously granted Fast Track status to CRB-701 in December 2024 for the treatment of relapsed or refractory metastatic cervical cancer.

CRB-701, also known as SYS6002, is a next-generation antibody-drug conjugate (ADC) that targets Nectin-4, a protein highly expressed in certain cancers. The ADC uses a site-specific, cleavable linker and maintains a precise drug-antibody ratio of 2, with MMAE as the cytotoxic payload. Fast Track designation is intended to accelerate the development and review process for therapies that address serious conditions and have the potential to meet unmet medical needs. The safety, pharmacokinetics, and preliminary efficacy of CRB-701 are currently being evaluated in an ongoing Phase 1/2 clinical trial involving patients with advanced solid tumors characterized by high Nectin-4 expression. 

The trial is being conducted across the United States and Europe and includes patients primarily with HNSCC and cervical cancer. Earlier this year, Corbus presented promising dose escalation data from this trial at the ASCO-GU 2025 meeting. The company has also announced that it will present the first data from its Phase 1/2 dose optimization study of CRB-701 at the ESMO 2025 conference on October 19, 2025. 

These updates are expected to provide further insights into the potential of CRB-701 as a targeted treatment option for patients with cancers driven by Nectin-4 expression. The FDA’s Fast Track designation for CRB-701 underscores its potential as an important therapy for difficult-to-treat cancers and highlights Corbus Pharmaceuticals’ commitment to advancing innovative treatments for patients with significant unmet needs.