Corbus Pharmaceuticals Holdings Inc (CRBP) News & EventsCRBPCorbus Pharmaceuticals Holdings Inc

Corbus Pharmaceuticals Doses First Patient in CRB-701 Trial

Corbus Pharmaceuticals announced that the first patient has been dosed in its TEMPO-1 registrational study of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate, in second-line and beyond oropharyngeal squamous cell carcinoma.

Corbus Pharmaceuticals Announces CANYON-1 Trial Data for CRB-913

Corbus Pharmaceuticals announced topline data from the company's CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The data demonstrated statistically significant and clinically meaningful weight loss at all three doses with the 60 mg dose achieving a mean weight loss of 5% at 12 weeks. CRB-913 was associated with a favorable safety profile and fewer gastrointestinal adverse events based on cross-trial comparison with published data of currently marketed oral GLP-1 drugs. These data support CRB-913's potential to establish a new class of oral, non-incretin obesity medicines. CRB-913 demonstrated rapid, statistically significant and clinically meaningful weight loss at all dose levels, with no evidence of plateauing at any of the doses. Weight loss response rates were significantly higher across all three CRB-913 cohorts compared to the placebo cohort. All participants who completed the study and received CRB-913 at the 60 mg dose lost weight, with 44.4% losing at least 5.0% from baseline. Similarly, 6.7% of the participants in that cohort lost more than 7.5% of their weight from baseline. The highest recorded weight loss for this cohort was 13.4% from baseline. CRB-913 was generally safe and well tolerated. Treatment discontinuations due to AEs with CRB-913 were in line with those recorded with approved oral GLP-1s and markedly less than the 13%-42% study discontinuation rate reported with monlunabant. Treatment emergent psychiatric AEs were infrequent, mild to moderate, and transient. There were no serious or severe psychiatric AEs reported in the study. There were no cases of suicidality and only one case of transient depressive symptom out of a total of 188 participants dosed with CRB-913. Psychiatric AEs were noted across all cohorts, including placebo, and generally showed no dose-related patterns. The most common psychiatric AE was irritability, and all cases were mild. Psychiatric AEs were broadly in line with those reported for clinical studies for liraglutide, semaglutide and tirzepatide. The psychiatric AEs were lower than those seen with monlunabant, a recently studied but subsequently discontinued CB1 inverse agonist with significantly higher brain penetration than CRB-913. GI AEs were mild or moderate across all CRB-913 doses, with no serious or severe cases reported and were generally not dose-dependent. The emerging GI profile appears more tolerable than the oral GLP-1 class with markedly less vomiting, constipation, and nausea.

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."