Corbus Pharmaceuticals Launches Phase 3 Cancer Trial, Teases More Obesity Drug Data

Key Points

• Corbus launched the Phase 3 TEMPO-1 trial of CRB-701 in previously treated oropharyngeal cancer, aiming to generate data that could support accelerated approval. In earlier-stage data, the drug showed an approximately 43% response rate, with minimal reported neuropathy and skin effects.
• In a mid-stage study of about 250 patients, obesity candidate CRB-913 delivered roughly 5% placebo-adjusted weight loss after three months. The CEO reported no suicidality and mild, transient depression and anxiety events, while noting longer-term outcomes remain to be assessed.
• Corbus plans to present more CRB-913 results, including waist circumference and BMI measures, at ObesityWeek; it also expects an exploratory update on CRB-701 combined with pembrolizumab in frontline cancer treatment in the first quarter of next year.

Corbus Pharmaceuticals NASDAQ: CRBP has started a Phase 3 study of its cancer drug CRB-701 and expects an exploratory readout from a separate frontline combination study in the first quarter of next year, CEO Yuval Cohen said at the Guggenheim Healthcare Innovation Conference.

Cohen also discussed results from a mid-stage obesity study of CRB-913, an experimental once-daily pill designed to limit exposure to the brain. The company plans to present more comprehensive data from that trial at ObesityWeek later in the week, he said.

Cancer drug advances to Phase 3

• Corbus Pharmaceuticals NASDAQ: CRBP Gives a Bold Buy Signal

CRB-701 is an antibody-drug conjugate that targets Nectin-4 and carries the chemotherapy payload MMAE. Cohen said the drug was designed to be more stable than Padcev, another Nectin-4-targeting therapy, with the aim of reducing peripheral neuropathy and skin-related side effects.

Corbus has launched its Phase 3 TEMPO-1 registrational study in patients with oropharyngeal cancer who have received prior treatment. Cohen said the company hopes to generate enough data to file for accelerated approval, though he did not provide a timeline for a filing or interim readout.

In a maturing Phase 1 dataset, CRB-701 used alone produced an objective response rate of about 43% in previously treated patients with oropharyngeal cancer, Cohen said. He characterized levels of peripheral neuropathy and skin effects as minimal. Corbus is also studying the drug in cervical cancer, where Phase 1 data are maturing, he said.

The company is exploring CRB-701 in combination with pembrolizumab as an initial treatment for oropharyngeal cancer. Cohen said he would like the dataset to include roughly one to two dozen patients and that the update would focus on response rates, rather than durability.

Asked about Genmab’s positive topline results in frontline head and neck cancer, Cohen said changes in initial treatment would have a relatively limited effect on Corbus’ second-line program because patients whose disease progresses would still need other options. He also said he was interested in seeing a breakdown of Genmab’s results by HPV status, which he said had not been disclosed.

Obesity study showed weight loss, CEO says

Corbus’ other main program, CRB-913, is a CB1 inverse agonist being developed for obesity. Cohen said the drug is designed to remain largely outside the brain, an approach intended to address psychiatric safety concerns that affected an earlier drug in the class, rimonabant.

In a double-blind, placebo-controlled study involving about 250 patients, CRB-913 produced approximately 5% placebo-adjusted weight loss after three months of dosing, Cohen said. He compared the early result with other oral obesity treatments, while noting that the Corbus data were at an early stage.

Cohen said there were no reports of suicidality in the study and that depression and anxiety events were mild, transient and occurred without a difference between the active and placebo groups. He also described lower rates of several gastrointestinal side effects relative to GLP-1 treatments. The trial’s three-month dosing period leaves longer-term outcomes to be assessed.

Corbus sees potential for CRB-913 both as a standalone treatment and in combination with a GLP-1 drug, Cohen said. He noted that the combination approach has been studied preclinically but described testing it in patients as a future opportunity.

At ObesityWeek, Corbus expects to present additional measures from the study, including waist circumference and body mass index, Cohen said. The company is also working on a publication with further details.

About Corbus Pharmaceuticals (NASDAQ:CRBP)

Corbus Pharmaceuticals Holdings, Inc is a biopharmaceutical company focused on developing medicines for serious diseases in oncology and immunology. The company's research is centered on therapies designed to modulate immune-cell activity and target biological pathways involved in cancer and inflammatory disease.

Corbus' oncology pipeline has included soquelitinib, formerly known as CPI-818, an oral, selective inhibitor of interleukin-2-inducible T-cell kinase (ITK) being evaluated for its potential to treat T-cell lymphomas and other cancers.

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