Corbus Pharmaceuticals (NASDAQ:CRBP) Chief Executive Yuval Cohen outlined the company’s near-term clinical readout schedule and development plans for its two lead drug candidates during a Jefferies fireside chat hosted by biotech analyst Amin Makarem.
Cohen said the Norwood, Massachusetts-based drug developer has fewer than 40 employees and is advancing two distinct clinical assets: CRB-701, a Nectin-4 antibody-drug conjugate licensed from CSPC in China in 2023, and CRB-913, an oral daily CB1 receptor-targeting drug being studied for obesity.
Corbus Highlights CRB-701 Data in Cervical and Head and Neck Cancer
Cohen said the company’s recent ASCO presentation reflected maturing Phase 1 data for CRB-701 in two solid tumor types: cervical cancer and head and neck cancer. In cervical cancer, he said the confirmed overall response rate is now in the “mid-30s,” which he described as roughly twice the response rate seen with Tivdak, the only antibody-drug conjugate approved in second-line cervical cancer.
He said durability data are also beginning to emerge, with duration of response already at eight months and growing, and progression-free survival at more than four months and growing. Cohen added that a meaningful number of patients remain on treatment.
For cervical cancer, Cohen said Corbus has alignment with the U.S. Food and Drug Administration around a single registrational study using physician’s choice as the control arm. He said the plan includes accelerated approval based on an interim response-rate analysis and final approval based on overall survival.
In head and neck cancer, Cohen said the key finding from the recent data was that CRB-701 showed a strong bias toward HPV-positive disease, particularly oropharyngeal cancer. He said the company observed around a 43% overall response rate in HPV-positive patients, while efficacy in HPV-negative patients was modest.
Cohen attributed the difference to Nectin-4 expression, saying published research has shown that oropharyngeal head and neck cancers are enriched for Nectin-4. He also compared the pattern to data previously reported for PADCEV in frontline head and neck cancer, saying Pfizer’s data showed a similar bias toward HPV-positive or oropharyngeal patients.
Pivotal Study to Focus on Oropharyngeal Cancer
Cohen said Corbus has FDA alignment for a single registrational study in oropharyngeal cancer, with accelerated approval based on interim response rate and final approval based on overall survival. The control arm will be physician’s choice, and Cohen said the study is expected to begin this summer.
He said the company plans to enroll based on anatomical definition rather than requiring HPV testing. Cohen said Corbus is following precedent from other companies that have used anatomical criteria and argued that requiring a companion diagnostic for p16 testing could add cost, delay treatment and enrollment, and introduce uncertainty because p16 testing is not standardized and can be inaccurate.
The Phase 3 TEMPO-1 study will include 125 patients in each arm, according to Cohen. He said the design is similar to other second-line head and neck cancer studies but differs in its inclusion criteria, which will focus on oropharyngeal patients. The study also includes an adaptive feature that could allow Corbus to add patients if the control arm performs better than expected.
Cohen said Corbus estimates there are about 14,000 patients per year in the U.S. eligible for second-line oropharyngeal cancer treatment, though only about 5,000 currently elect to receive second-line therapy. He described the existing treatment options as limited, including taxanes, methotrexate or 5-FU in some cases.
Frontline Combination Data Expected Early Next Year
Corbus is also evaluating CRB-701 in combination with KEYTRUDA in the frontline setting. Cohen said the company expects to have about two dozen patients available for objective response-rate analysis by early next year.
He said Corbus will be watching to see whether the combination can show efficacy similar to what PADCEV demonstrated in HPV-positive or oropharyngeal patients, while avoiding PADCEV’s high levels of peripheral neuropathy. If the data are promising, Cohen said Corbus would seek to engage the FDA on the design of a frontline study in combination with pembrolizumab.
Obesity Readout for CRB-913 Expected in September
Cohen also discussed CRB-913, the company’s oral CB1 inverse agonist being studied in obesity. He said the last patient first visit in the CANYON-1 study occurred April 10, and the company expects top-line data around September after the final patient completes the study in August.
He said Corbus may present fuller data at an obesity conference in November if possible, or at another clinical conference such as ADA, but added that the company does not plan to hold back the top-line results.
Cohen cautioned investors not to overinterpret the earlier Phase 1 weight-loss signal, which showed about 3% placebo-adjusted weight loss at day 14, because of the small sample size. However, he said every CB1 inverse agonist tested clinically has produced weight loss, and the main question for CRB-913 is safety, especially neuropsychiatric adverse events.
He contrasted CRB-913 with monlunabant, saying that drug had 111 neuropsychiatric events among 180 treated patients. Cohen said CANYON-1 will be a larger and longer study than Corbus’ SAD/MAD trial and described the upcoming safety readout as potentially “pretty binary.”
Cash Runway Extends Into 2028
Cohen said Corbus had $138 million in cash, which he said is expected to fund operations into the first quarter of 2028.
He identified two major upcoming milestones: the CANYON-1 obesity readout expected around September and early next year’s frontline CRB-701 plus KEYTRUDA data.
About Corbus Pharmaceuticals (NASDAQ:CRBP)
Corbus Pharmaceuticals Holdings, Inc is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of therapeutic candidates for rare, life-threatening inflammatory and fibrotic diseases. The company’s lead investigational therapy, lenabasum, is a synthetic, oral cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation by harnessing the body’s innate resolution pathways. Corbus operates by advancing small-molecule compounds through preclinical and clinical studies to address unmet medical needs in autoimmune and inflammatory disorders.
Lenabasum is currently under evaluation in a Phase 3 clinical trial for diffuse cutaneous systemic sclerosis (dcSSc) and in a Phase 2 study for cystic fibrosis–related inflammation.
