FDA grants Fast Track designation for Corbus' CRB-701 in recurrent/metastatic HNSCC

Corbus Pharmaceuticals Holdings, Inc.

FDA granted Fast Track for CRB-701 to treat HNSCC after prior platinum and anti-PD(L)-1 therapy.
Second Fast Track designation for CRB-701; first was for cervical cancer in December 2024.
Phase 1/2 dose optimization data to be presented at ESMO 2025 on October 19, 2025.
CRB-701 is a next-generation Nectin-4 targeting ADC with site-specific cleavable linker and MMAE payload (DAR 2).
Ongoing Phase 1/2 trial evaluating safety, PK, and efficacy in advanced solid tumors with high Nectin-4 expression.

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