Corbus Pharmaceuticals Holdings, Inc. is an oncology company, which engages in research, development, and commercializing therapeutics for cancer and obesity. Its pipeline includes CRB-701, an antibody drug conjugate (ADC) that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFß expressed on cancer cells, and CRB-913, a highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist for the treatment of obesity. The company was founded in April 2009 and is headquartered in Norwood, MA.
Corbus Pharmaceuticals Announces First Patient Dosed in TEMPO-1 Registrational Study of CRB-701 in Patients with 2L+ Oropharyngeal Cancer
Corbus Pharmaceuticals dosed the first patient in TEMPO-1, a registrational study of its Nectin-4-targeted ADC CRB-701 in 2L+ oropharyngeal squamous cell carcinoma.
The randomized 250-patient trial uses ORR as the primary endpoint intended to support accelerated approval, with overall survival backing a potential conversion to full approval.
The FDA cleared the study design based on Phase 1/2 data showing a 42.9% confirmed ORR, 6.3-month median DoR, and 5.6-month median PFS (ongoing) at the 3.6 mg/kg dose.
Roughly 14,000 U.S. OPSCC patients annually are eligible for 2L treatment, a population management says has seen little standard-of-care change since PD-1 inhibitors.