Corbus Starts Phase 3 Oropharyngeal Cancer Trial

The Tip Desk · November 10, 2026 · 3 min read

The clinical-stage company dosed the first TEMPO-1 patient and reported 5% mean weight loss at 12 weeks on 60 mg CRB-913, with cash of $115.3 million expected to fund operations into 2028.

Corbus Pharmaceuticals Holdings, Inc. (CRBP), a clinical-stage company focused on oncology and obesity, dosed the first patient in TEMPO-1, a Phase 3 registrational study of sutantatug envedotin in second-line and later oropharyngeal squamous cell carcinoma, after the U.S. Food and Drug Administration cleared the trial in July 2026.

The start converted the company’s prior-quarter plan to commence enrollment in September. Chief Executive Officer Yuval Cohen said the commencement marks a transition to late-stage clinical development. TEMPO-1 is a randomized controlled study of 250 patients comparing sutantatug envedotin with investigators’ choice of capecitabine, cetuximab or docetaxel. Objective response rate is the primary endpoint for potential accelerated approval; overall survival is the primary endpoint for potential conversion to full approval. The company said it anticipates reporting sutantatug envedotin plus Keytruda combination data in first-line oropharyngeal cancer in the first quarter of 2027.

Sutantatug envedotin is a Nectin-4-targeting antibody drug conjugate licensed from CSPC Megalith Biopharmaceutical Co. Ltd. The FDA has granted Fast Track designations for oropharyngeal squamous cell carcinoma and cervical cancer.

In obesity, Corbus reported topline results from CANYON-1, a 16-week, double-blind, placebo-controlled, dose-ranging Phase 1b study of CRB-913, a highly peripherally restricted oral CB1 inverse agonist. The trial enrolled 254 obese, non-diabetic adults at multiple U.S. sites. Participants received 20 mg, 40 mg or 60 mg once daily, or placebo, for 12 weeks, followed by four weeks of safety follow-up. The data showed statistically significant weight loss at all three doses, with the 60 mg dose achieving a mean weight loss of 5% at 12 weeks. No plateau was observed at any dose.

The company said CRB-913 was associated with a favorable safety profile and fewer and milder gastrointestinal adverse events based on a cross-trial comparison with published data of marketed oral GLP-1 drugs. It said the data support CRB-913’s potential to establish a new class of oral, non-incretin obesity medicines. Late-breaking CANYON-1 data were scheduled for presentation at ObesityWeek 2026 on November 15, 2026. Corbus said it plans to engage the FDA on a development plan and is evaluating the potential to combine CRB-913 with GLP-1 therapy.

For the three months ended September 30, 2026, Corbus reported a net loss of approximately $37.8 million, or $1.81 a share, compared with a net loss of approximately $23.3 million, or $1.90 a share, a year earlier. Operating expenses increased $14.4 million to approximately $38.8 million from approximately $24.4 million. The company said the increase was primarily attributable to a $15.0 million development milestone incurred in the third quarter pursuant to the CSPC licensing agreement for sutantatug envedotin.

Research and development expense was $34.2 million, up from $20.9 million. General and administrative expense was $4.6 million, up from $3.6 million. Weighted-average shares outstanding rose to 20.8 million from 12.3 million.

Cash, cash equivalents, and investments were $115.3 million as of September 30, 2026. The company said that amount is expected to fund operations into 2028 based on current operating plans and planned expenditures.

Leonardo Viana Nicacio, M.D., was appointed Chief Medical Officer in August 2026.