Announcement • Apr 24
Corbus Pharmaceuticals Holdings, Inc. Announces Updated Clinical Data for CRB-701 At ASCO 2026 Corbus Pharmaceuticals Holdings, Inc. announced that updated clinical data from its Phase 1/2 study of CRB-701, a next generation Nectin-4 ADC, in both head and neck squamous cell carcinoma (HNSCC) and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2 in Chicago, IL. The data will include clinical response durability as well as HNSCC patient subgroup analysis. Corbus previously presented dose optimization data from the study, including encouraging efficacy and safety findings, at the 2025 European Society for Medical Oncology Congress (ESMO 2025). Oral Presentation A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer. Poster Presentation: A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. The abstracts will be available on the ASCO website on May 21, 2026 at 5:00 p.m. ET. Corbus expects to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026. Corbus also anticipates reporting data with CRB-701 in combination with Keytruda in first-line HNSCC patients in Fourth Quarter 2026 to support potential further registration-enabling trials. CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China. Announcement • Apr 15
Corbus Pharmaceuticals Holdings, Inc. Announces Last Patient First Visit in CANYON-1 Study of CRB-913 for the Treatment for Obesity Corbus Pharmaceuticals Holdings, Inc. announced the last patient has been enrolled and completed the first clinical visit (Last Patient First 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 to be completed in the summer of 2026. 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. The CANYON-1 Phase 1b clinical trial is a 16-week, double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic participants, and is being conducted at multiple clinical sites in the United States. The trial includes a placebo cohort and three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily (QD). A dose titration regimen is included in the design, with all CRB-913 participants commencing at 20 mg/day and then titrating up to either 40 mg/day or beyond that to 60 mg/day, depending on their respective cohorts. Participants are dosed for 3 months and are then monitored for an additional month post-dosing. Phase 1b data will build upon Phase 1a findings that demonstrated weight loss of nearly 3% at 14 days in individuals with obesity. Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 in December 2025. The SAD portion of the trial enrolled 64 participants across 8 cohorts. The MAD portion enrolled 48 participants across 4 cohorts, including a dedicated obese cohort. The highest SAD dose tested was 600 mg/day, and the highest MAD dose tested was 150 mg/day. In the dedicated obese MAD cohort (150 mg/day), all CRB-913-treated participants (n=9), and none in the placebo group (n=3), experienced weight loss. The CRB-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Weight loss started early and deepened with time. CRB-913 was safe and well-tolerated across all cohorts and all doses studied, including demonstrating a very favorable GI profile with no reports of vomiting, constipation or nausea. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative. Announcement • Apr 08
Corbus Pharmaceuticals Holdings, Inc. Announces Resignation of Chief Medical Officer Dr. Dominic Smethurst, Effective June 30, 2026 Corbus Pharmaceuticals Holdings, Inc. was notified by Dominic Smethurst, the Company's Chief Medical Officer, of his resignation, effective June 30, 2026. Corbus also announced that Dr. Dominic Smethurst, MA, MRCP is stepping down from his role as Chief Medical Officer; his last day with the company will be June 30, 2026.