Corbus Pharmaceuticals Holdings, Inc. reports clinical-stage drug-development news in oncology and obesity. Updates center on CRB-701, a next-generation Nectin-4 antibody-drug conjugate licensed from CSPC Megalith Biopharmaceutical, including data presentations in head and neck squamous cell carcinoma and cervical cancer, FDA interactions and Fast Track designations.
Company news also covers CRB-913, a peripherally restricted oral CB1 inverse agonist for obesity, and CRB-601, an anti-integrin monoclonal antibody targeting TGFβ activation. Recurring items include clinical trial disclosures, medical-meeting presentations, management conference appearances, governance changes and operating or financial results.
Corbus Pharmaceuticals (CRBP) dosed the first patient in its TEMPO-1 registrational study of CRB-701 for previously treated oropharyngeal cancer. The randomized, controlled study is designed for 250 patients with second-line or later oropharyngeal squamous cell carcinoma. It compares CRB-701 with an investigator’s choice of capecitabine, cetuximab or docetaxel. Objective response rate, a measure of tumor shrinkage, is the primary endpoint intended to support potential accelerated approval; overall survival is intended to support potential full approval.
The FDA allowed TEMPO-1 to proceed based on results from an ongoing Phase 1/2 study. Among patients with second-line or later disease treated at the 3.6 mg/kg dose, CRB-701 produced a confirmed objective response rate of 42.9%, median response duration of 6.3 months and median progression-free survival of 5.6 months (ongoing).
Corbus Pharmaceuticals (CRBP) reported positive topline Phase 1b data showing 5% mean weight loss with oral CRB-913 after 12 weeks.
The 16-week double-blind, placebo-controlled CANYON-1 trial enrolled 254 obese, non-diabetic adults across three once-daily dose cohorts (20, 40, 60 mg) and placebo. At week 12, least-squares mean percent weight change was 0.0% for placebo and 2.8%, 3.3% and 5.0% for the 20, 40 and 60 mg groups, all placebo-adjusted and statistically significant (p<0.0001). Among participants receiving 60 mg who completed treatment, 44.4% lost at least 5% of baseline weight, 6.7% lost more than 7.5%, and the maximum loss was 13.4%, with no plateau observed.
CRB-913 was generally well tolerated, with discontinuations due to adverse events of 3.1%-13.1%, no serious or severe psychiatric events, one transient moderate depressive symptom among 188 treated participants, and mostly mild, non–dose-dependent gastrointestinal events. Corbus plans a Phase 2 monotherapy study in the first half of 2027 and will present detailed data at ObesityWeek® 2026.
Corbus Pharmaceuticals (CRBP) will host a virtual conference call and webcast on Monday, September 14, 2026, at 8:00 a.m. EDT to discuss topline data from CANYON-1, a Phase 1b study of obesity candidate CRB-913.
The 16-week double-blind, placebo-controlled, dose-ranging trial enrolls 240 obese, non-diabetic adults across multiple U.S. sites, with once-daily oral doses of 20 mg, 40 mg, or 60 mg CRB-913 versus placebo. All CRB-913 participants start at 20 mg/day and titrate to their assigned dose, receive 12 weeks of treatment, and then have a four-week safety follow-up. Investigator Harold Bays, M.D., will join as a guest speaker, and a replay will be available on the Corbus website.
Corbus Pharmaceuticals (NASDAQ: CRBP) reported that its Compensation Committee approved inducement equity awards for new Chief Medical Officer Leonardo Nicacio, effective August 16, 2026, under Nasdaq Listing Rule 5635(c)(4). The awards were granted outside Corbus’ stockholder-approved equity plans as a material inducement to his employment.
The package includes a nonstatutory stock option for up to 191,676 shares of common stock at an exercise price of $10.09, with a ten-year term, vesting 25% on the first anniversary and the remaining 75% in equal monthly installments over 36 months, subject to continued service. It also includes 58,333 restricted stock units vesting in four equal annual installments, each RSU converting into one share upon vesting, contingent on continued service.
Corbus Pharmaceuticals (NASDAQ: CRBP) reported Q2 2026 net loss of approximately $35.0 million, or $1.81 per share, versus $17.7 million, or $1.44 per share, a year earlier. Operating expenses rose to about $36.2 million from $19.2 million, mainly due to higher clinical costs including a $10.0 million milestone payment under the CRB-701 license.
Corbus obtained FDA clearance for TEMPO-1, a Phase 3 registrational study (n=250) of CRB-701 in second-line oropharyngeal squamous cell carcinoma, with enrollment expected to start in September 2026. The company completed last patient last visit in the 240-patient CANYON-1 Phase 1b obesity study of CRB-913 and plans topline data in September 2026. Leadership was strengthened with a new Chief Medical Officer, Chief Business Officer, and Board member. Corbus held $117.9 million in cash, cash equivalents, and investments as of June 30, 2026, which it expects to fund operations into 2028.
Corbus Pharmaceuticals (NASDAQ: CRBP) reported that the last patient has completed the final clinical visit in its CANYON-1 Phase 1b trial of CRB-913 for obesity, keeping topline data on track for September 2026.
CANYON-1 is a 16‑week, double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic adults in the U.S., testing once-daily oral doses of 20 mg, 40 mg and 60 mg versus placebo with a dose-titration regimen and a 4‑week safety follow-up. CRB-913 is described as a highly peripherally restricted CB1 inverse agonist, aiming to offer an orthogonal, non-incretin oral approach to weight loss. The study follows Phase 1a data indicating differentiated GI tolerability versus GLP‑1 therapies and preclinical mouse data showing approximately 15-fold lower brain penetration than the CB1 inverse agonist monlunabant.
Corbus Pharmaceuticals (NASDAQ: CRBP) reported that the U.S. FDA has cleared initiation of TEMPO-1, a registrational Phase 2 study of CRB-701, a next-generation Nectin-4–targeted antibody drug conjugate, in second-line oropharyngeal squamous cell carcinoma (OPSCC). The randomized controlled trial will enroll approximately 250 patients and compare CRB-701 to investigator’s choice of capecitabine, cetuximab or docetaxel. The primary endpoint is objective response rate to support a potential accelerated approval, with overall survival intended to support potential full approval. Corbus expects to begin enrollment in September 2026.
The FDA decision follows Phase 1/2 data in 2L+ OPSCC at a 3.6 mg/kg dose, where CRB-701 achieved a confirmed objective response rate of 42.9%, median duration of response of 6.3 months, and median progression-free survival of 5.6 months (ongoing). OPSCC is estimated to represent about half of U.S. second-line head and neck cancer cases, with roughly 14,000 patients annually eligible for 2L treatment and about 7,000 deaths. CRB-701 has two FDA Fast Track designations in head and neck squamous cell carcinoma and cervical cancer.
Corbus Pharmaceuticals (NASDAQ: CRBP) appointed Leonardo Viana Nicacio, M.D. as Chief Medical Officer. He brings over 20 years of oncology experience, including leadership roles at Seagen, Stemline, AstraZeneca and Protara.
Corbus plans to initiate the TEMPO-1 registrational CRB-701 study in 2L OPSCC in summer 2026 and expects CANYON-1 CRB-913 obesity data in late summer 2026.
Corbus Pharmaceuticals (NASDAQ:CRBP) reported updated Phase 1/2 data for CRB-701, a Nectin-4 targeted ADC, in second-line (2L) HPV-associated tumors.
At 3.6 mg/kg, confirmed ORR was 42.9% in 2L OPSCC and 34.4% in 2L cervical cancer, with ongoing median DOR of 6.3 and 8.0 months, and PFS of 5.6 and 4.3 months, respectively. In a 317-patient safety population, discontinuations related to CRB-701 were 2.8%. Ocular AEs occurred in 66.2% of patients, with 12.6% Grade 3 and one Grade 4 case; ocular AE-related discontinuations were 1.9%. Corbus plans a registrational 2L OPSCC trial (TEMPO-1) in summer 2026 and has FDA alignment on randomized study designs in 2L OPSCC and 2L cervical cancer.
Corbus Pharmaceuticals (Nasdaq: CRBP) appointed former Evercore Managing Director Nishant Saxena as its first Chief Business Officer and scheduled a May 26, 2026 conference call to review updated Phase 1/2 data for Nectin‑4 ADC CRB-701 in HNSCC and cervical cancer.
The company highlighted expected summer 2026 milestones, including initiating a registrational CRB-701 study in second-line HNSCC and completing the 240-patient CANYON-1 Phase 1b study of obesity candidate CRB-913, plus multiple CRB-701 presentations and an HNSCC KOL event at the 2026 ASCO meeting.