Corbus Pharmaceuticals Holdings Inc（CRBP）资讯与事件CRBPCorbus Pharmaceuticals Holdings Inc

Corbus CEO Anticipates CRB-701 and CRB-913 Clinical Milestones

"We've continued to build momentum as we prepare for two potentially impactful clinical development milestones in September: commencing enrollment of TEMPO-1, our Phase 3 study of CRB-701 in oropharyngeal cancer, and the data readout of CANYON-1, our Phase 1b study of CRB-913 in obesity. Both programs represent opportunities to address areas of significant unmet medical need," said Yuval Cohen, Chief Executive Officer of Corbus. "CRB-701 has the potential to bring a much-needed therapeutic option for the growing oropharyngeal cancer patient population, for whom approved and other investigational therapies have shown little promise. CRB-913 is a unique daily oral obesity drug candidate with a mechanism of action entirely orthogonal to the GLP-1 class and with the potential for both weight loss and long-term weight management. We look forward to a productive second half of 2026 as we work to improve patient outcomes and generate meaningful value for shareholders."

Corbus Pharmaceuticals Last Patient Completes Final Visit in CANYON-1 Trial

Corbus Pharmaceuticals announced the last patient has completed their last clinical visit in the company's CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study is on track for topline data readout in September. CRB-913 is a once-daily highly peripherally restricted oral CB1 inverse agonist potentially offering an orthogonal approach to weight loss and long-term weight management and a new therapeutic option for obesity beyond GLP-1 and other incretin-targeting therapies.

Corbus Pharmaceuticals Receives FDA Clearance for CRB-701 Registrational Study

Corbus Pharmaceuticals announced that the FDA has cleared the start of the company's registrational study of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate, in second-line oropharyngeal squamous cell carcinoma. TEMPO-1 is a randomized controlled study designed to evaluate the efficacy and safety of CRB-701 compared with investigator's choice of capecitabine, cetuximab or docetaxel. The study's primary endpoint is objective response rate, which is intended to support a potential accelerated approval; overall survival is intended to support potential conversion to full approval. The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone.