Corbus Pharmaceuticals Holdings, Inc.

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.

•1mo ago

Corbus Pharmaceuticals Announces Positive Topline Data from CANYON-1 Study of Daily Oral CRB-913 for the Treatment of Obesity

Corbus Pharmaceuticals reported positive topline data from the CANYON-1 Phase 1b trial of CRB-913 in obesity, with statistically significant weight loss at all three doses and a placebo-adjusted mean weight loss of 5.0% at 12 weeks for the 60 mg dose (p<0.0001 at every dose), with no plateau observed. Safety was the key differentiator: psychiatric adverse events were broadly in line with GLP-1 drugs, with no suicidality and only one transient depressive symptom among 188 dosed participants, and GI events were markedly lower than oral semaglutide and orforglipron in cross-trial comparisons. Corbus plans FDA engagement and a Phase 2 monotherapy study in the first half of 2027, is evaluating combining CRB-913 with GLP-1 therapy, and will present the data at ObesityWeek 2026 in November.

•1mo ago

Corbus Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Corbus Pharmaceuticals appointed Leonardo Nicacio as Chief Medical Officer, granting him inducement equity awards effective August 16, 2026. The compensation package includes nonstatutory stock options for 191,676 shares at an exercise price of $10.09 and 58,333 restricted stock units, both subject to four-year vesting schedules. Corbus is a clinical-stage biotech company focused on oncology and obesity therapies, including pipeline assets CRB-701 and CRB-913.

•2mo ago

Corbus Pharmaceuticals Announces Last Patient Last Visit in CANYON-1 Study of CRB-913 for the Treatment of Obesity

Corbus Pharmaceuticals announced the last patient last visit in its Phase 1b CANYON-1 study of CRB-913 for obesity, putting the company on track for topline data in September 2026. The 16-week, double-blind, dose-ranging study enrolled 240 participants across 20 mg, 40 mg, and 60 mg cohorts to evaluate the safety and efficacy of the oral CB1 inverse agonist. Prior Phase 1a data demonstrated a mean 2.9% placebo-adjusted weight loss by Day 14 with a favorable gastrointestinal profile compared to GLP-1 therapies.

•2mo ago

Corbus Pharmaceuticals Announces FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer

The FDA cleared Corbus Pharmaceuticals to initiate the TEMPO-1 registrational study of CRB-701 in second-line oropharyngeal squamous cell carcinoma, with enrollment expected to start in September 2026. The randomized controlled study will enroll approximately 250 patients, using objective response rate as the primary endpoint to support potential accelerated approval and overall survival for conversion to full approval. Clearance was supported by Phase 1/2 data showing a 42.9% confirmed ORR in this patient population, addressing an unmet need for an estimated 14,000 eligible U.S. patients annually.

•3mo ago

Corbus Pharmaceuticals Appoints Leonardo Viana Nicacio, M.D. as Chief Medical Officer

Corbus Pharmaceuticals appointed Leonardo Viana Nicacio, M.D. as Chief Medical Officer, bringing over 20 years of experience in oncology drug development to the clinical-stage company. Dr. Nicacio’s background includes advancing the ADC TIVDAK at Seagen, which aligns with Corbus’s strategic focus on CRB-701, a next-generation ADC for Nectin-4-expressing tumors. The company expects to initiate the registrational TEMPO-1 study of CRB-701 this summer and report topline data from the CANYON-1 obesity study of CRB-913 in late summer.

•3mo ago

Corbus Pharmaceuticals Reports Updated CRB-701 Phase 1/2 Clinical Data Demonstrating Robust Activity in 2L Oropharyngeal and Cervical Cancers

Corbus Pharmaceuticals reported updated Phase 1/2 data for CRB-701, showing a 42.9% confirmed objective response rate in second-line oropharyngeal squamous cell carcinoma (OPSCC) and 34.4% in cervical cancer at the 3.6 mg/kg dose. The drug demonstrated a manageable safety profile with only 2.8% treatment discontinuations and no Grade 5 events, supporting its potential in HPV-driven tumors with high Nectin-4 expression. The company is on track to initiate the registrational TEMPO-1 study in OPSCC in summer 2026, having reached broad alignment with the FDA on trial design for potential accelerated approval.

•5mo ago

Corbus Pharmaceuticals Announces the Appointment of Nishant Saxena as Chief Business Officer and Schedules a Pre-2026 ASCO CRB-701 Data Conference Call

Corbus Pharmaceuticals appointed Nishant Saxena, former Managing Director at Evercore, as its first Chief Business Officer to support the company's transition to registrational-stage development. The company scheduled a conference call for May 26 to discuss updated Phase 1/2 data for its lead oncology asset CRB-701, which will be presented at the ASCO Annual Meeting in late May. Corbus also highlighted upcoming milestones for its obesity asset CRB-913, including the completion of the 240-patient CANYON-1 Phase 1b study this summer.

•5mo ago

Corbus Pharmaceuticals to Host In-Person and Virtual KOL Event at ASCO 2026

Corbus Pharmaceuticals will host a KOL event at ASCO 2026 to present updated Phase 1/2 data for CRB-701 in head and neck squamous cell carcinoma (HNSCC). The study includes 75 HNSCC participants and 317 total participants with advanced solid tumors, focusing on clinical response durability and subgroup analysis. The company recently secured broad alignment with the FDA on the registration path for CRB-701 in HNSCC, marking a step toward potential approval.

•5mo ago

Corbus Pharmaceuticals Announces Abstracts Accepted for Presentation at ASCO 2026 Featuring Updated Clinical Data for CRB-701

Corbus Pharmaceuticals announced that updated clinical data from its Phase 1/2 study of CRB-701 will be presented at the ASCO 2026 Annual Meeting, covering head and neck and cervical cancers. The company provided developmental guidance, expecting to initiate a registrational study for CRB-701 in second-line HNSCC by mid-2026 and report combination data with Keytruda in Q4 2026. CRB-701 is a next-generation Nectin-4 ADC licensed from CSPC Megalith Biopharmaceutical and holds Fast Track designations in both oncology indications.

•6mo ago