Core Viewpoint - The FDA has accepted Checkpoint Therapeutics' resubmission of the Biologics License Application (BLA) for cosibelimab, indicating a positive step towards potential approval for treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) [7]. Group 1: Company Overview - Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [3]. - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [3]. - Checkpoint is evaluating cosibelimab, an anti-PD-L1 antibody, and olafertinib, a third-generation EGFR inhibitor, for potential treatments in specific cancer types [3]. Group 2: Product Details - Cosibelimab is a fully-human monoclonal antibody that binds to PD-L1, blocking its interaction with PD-1 and B7.1 receptors, thereby enhancing the anti-tumor response of CD8+ T-cells [2]. - The antibody is differentiated from existing PD-1 and PD-L1 therapies due to its sustained high tumor target occupancy and potential for enhanced efficacy through antibody-dependent cellular cytotoxicity (ADCC) [2]. Group 3: Regulatory Update - The FDA issued a Complete Response Letter (CRL) in December 2023, citing issues related to a third-party contract manufacturing organization, but did not express concerns regarding the clinical data package or safety [1]. - The resubmission of the BLA has been accepted as a complete response, with a Prescription Drug User Fee Act (PDUFA) goal date set for December 28, 2024 [7].
Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma