Checkpoint Therapeutics, Inc., a company specializing in immunotherapy and targeted oncology, has announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted Biologics License Application (BLA) for cosibelimab. This anti-PD-L1 antibody is under review as a potential treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The resubmission has been accepted as a complete response to the December 2023 Complete Response Letter (CRL), and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.

James F. Oliviero, President and CEO of Checkpoint, expressed satisfaction with the FDA’s acceptance and noted the company’s eagerness to collaborate with the FDA to move forward with the review process. He highlighted the potential of cosibelimab to offer a new treatment option for cSCC patients.

The CRL issued in December 2023 primarily addressed issues related to a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (CMO) and did not raise concerns about the clinical data, safety, or labeling of cosibelimab.

Cosibelimab is a fully-human monoclonal antibody of the IgG1 subtype that targets PD-L1, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting the PD-L1/PD-1 and PD-L1/B7.1 interactions, cosibelimab aims to reverse the suppression of anti-tumor CD8+ T-cells and restore their cytotoxic response. The antibody may offer benefits over existing PD-1 and PD-L1 therapies due to its high tumor target occupancy and the potential for enhanced efficacy through its functional Fc domain, which could facilitate antibody-dependent cellular cytotoxicity (ADCC).

 

Source: globenewswire.com

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