Companies

Corbus Wins FDA Clearance for CRB-701 Phase 3 Trial

The Tip Desk · August 6, 2026 · 3 min read

Cash of $117.9 million is expected to fund operations into 2028 as the company prepares two September clinical milestones.

Corbus Pharmaceuticals Holdings, Inc. (CRBP), a clinical-stage company developing therapies in oncology and obesity, obtained FDA clearance to proceed with TEMPO-1, a registrational study of CRB-701 in second-line oropharyngeal cancer, and said it expects to begin enrollment in September 2026.

The clearance converted the broad FDA alignment the company described in the first quarter into a defined trial: TEMPO-1 is planned for 250 patients and is described as the first registrational trial specifically designed to evaluate a targeted treatment in that patient population. CRB-701 is a next-generation Nectin-4 antibody-drug conjugate licensed from CSPC Megalith Biopharmaceutical Co. Ltd. in China, with Fast Track designations for oropharyngeal squamous cell carcinoma and cervical cancer.

Chief Executive Officer Yuval Cohen said the company had continued to build momentum toward two September milestones: starting TEMPO-1 and reporting CANYON-1 data for CRB-913, an oral CB1 inverse agonist in obesity.

CANYON-1, a Phase 1b dose-ranging study of 240 patients over a 12-week treatment period plus a 4-week safety follow-up, reached last patient last visit. The company remains on track to report topline data in September 2026. In the first quarter it had completed enrollment and the first clinical visit.

Corbus also anticipates reporting CRB-701 plus Keytruda combination data in first-line oropharyngeal cancer patients in the first quarter of 2027 to support potential further registration-enabling trials. It presented second-line and later monotherapy data from the Phase 1/2 study in head and neck and cervical cancers at the 2026 ASCO annual meeting.

In the second quarter, the company appointed Leonardo Viana Nicacio as Chief Medical Officer, Nishant Saxena as Chief Business Officer, and Brent Pfeiffenberger to the board. The hires were intended to strengthen senior leadership through registrational studies and commercialization readiness.

The net loss widened to $35.0 million, or $1.81 a share, for the three months ended June 30, 2026, from $17.7 million, or $1.44 a share, a year earlier. Operating expenses increased $17.0 million to $36.2 million from $19.2 million. The increase was primarily attributable to higher clinical development expenses, including a $10.0 million development milestone payment under the CRB-701 licensing agreement.

Research and development expense was $31.2 million in the quarter, compared with $15.2 million a year earlier. General and administrative expense was $5.0 million. Weighted-average shares outstanding, basic and diluted, were 19.4 million.

Cash, cash equivalents, and investments were $117.9 million as of June 30, 2026. That balance is expected to fund operations into 2028 based on current operating plans and planned expenditures. Cash and cash equivalents were $23.4 million, and investments were $94.6 million.

Cohen said CRB-701 has the potential to bring a therapeutic option for the growing oropharyngeal cancer population, for whom approved and other investigational therapies have shown little promise, and that CRB-913 is a daily oral obesity candidate with a mechanism of action entirely orthogonal to the GLP-1 class. He said the company looks forward to a productive second half of 2026.

The company is headquartered in Norwood, Massachusetts.