Core Viewpoint - Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) for cosibelimab to the FDA, aiming to address previous approvability deficiencies and seeking approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation [5][4]. Company Overview - Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [2]. - The company is evaluating cosibelimab, an anti-PD-L1 antibody, and olafertinib, a third-generation EGFR inhibitor, for various cancer treatments [2]. Product Details - Cosibelimab is a fully-human monoclonal antibody that inhibits the interaction between PD-L1 and its receptors, potentially enhancing anti-tumor immune responses [6]. - The drug has shown promising results in pivotal studies, with a 55% objective response rate and a 26% complete response rate in locally advanced cSCC, and a 50% objective response rate and a 13% complete response rate in metastatic cSCC [1]. Regulatory Progress - The BLA resubmission follows alignment with the FDA on addressing issues raised in a previous complete response letter (CRL), which did not express concerns about the clinical data package [4]. - The resubmission is supported by recent study results published in October 2023, indicating the efficacy and safety of cosibelimab in treating selected recurrent or metastatic cancers [9].
Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab