Checkpoint Smart Endpoint: A Major Milestone in Cosibelimab Development

WALTHAM, Mass. - Checkpoint Therapeutics, Inc., a clinical-stage immunotherapy and targeted oncology company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for cosibelimab, an investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation.

The BLA filing acceptance marks a significant milestone in Checkpoint's promising cosibelimab development program. Cosibelimab has shown a unique mechanism of action and an impressive safety profile, making it an important new treatment option for cSCC patients who are currently underserved by available therapies.

According to prescription claims data, approximately 11,000 cSCC patients were treated with systemic therapies in 2021, highlighting the need for more effective and tolerable treatment options. The FDA's acceptance of Checkpoint's BLA filing is a testament to the company's dedication to bringing cosibelimab to patients in need as quickly as possible.

'We believe that cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients,' said James Oliviero, President and Chief Executive Officer of Checkpoint. 'We are thrilled to have reached this major milestone and look forward to continuing to work closely with the FDA as we move closer to bringing cosibelimab to patients.'

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2024, indicating that it does not currently plan to hold an advisory committee meeting. Checkpoint would like to thank the patients and physicians who participated in the cosibelimab clinical studies, as well as its team for their hard work and dedication in achieving this important milestone.

With its acceptance of Checkpoint's BLA filing, the FDA has indicated that no potential filing review issues have been identified. The company is eager to bring cosibelimab to patients who need it most and looks forward to continuing to advance its promising development program.

Checkpoint smart endpoint