Checkpoint Therapeutics Aligns with FDA for Cosibelimab BLA Resubmission

Checkpoint Therapeutics, Inc. (Nasdaq: CKPT), a clinical-stage company specializing in immunotherapy and oncology, has announced a significant development with the Food and Drug Administration (FDA). The company has reached an agreement with the FDA on the strategy for resubmitting its biologics license application (BLA) for cosibelimab. This resubmission is planned for mid-year and seeks approval for cosibelimab as a new treatment option for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are unsuitable for curative surgery or radiation.

James F. Oliviero, the President and CEO of Checkpoint Therapeutics, expressed satisfaction with the alignment reached with the FDA. He emphasized that the company is eager to resubmit the BLA, aiming to potentially offer a new and differentiated immunotherapy treatment for patients suffering from advanced cSCC.

In December 2023, the FDA had issued a complete response letter (CRL) for the cosibelimab BLA. This letter highlighted issues found during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization (CMO). Importantly, the CRL did not raise concerns about the clinical data, safety, or labeling pertaining to cosibelimab's approval.

Checkpoint Therapeutics is a company at the forefront of immunotherapy and targeted oncology, focusing on developing innovative treatments for solid tumor cancers. The company's leading product candidate, cosibelimab, is an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute. It is being evaluated as a potential treatment for specific recurrent or metastatic cancers, including both metastatic and locally advanced cSCC.

Checkpoint is also developing a small-molecule cancer treatment known as olafertinib (formerly CK-101). Olafertinib is a third-generation inhibitor of the epidermal growth factor receptor (EGFR) and is being studied as a potential treatment for patients with EGFR mutation-positive non-small cell lung cancer. Headquartered in Waltham, Massachusetts, Checkpoint Therapeutics was founded by Fortress Biotech, Inc.

The collaboration with the FDA is a critical step for Checkpoint Therapeutics as it pursues approval for cosibelimab. The company's approach focuses on addressing the deficiencies outlined in the CRL, particularly those related to the third-party CMO. By resubmitting the BLA, Checkpoint aims to overcome these hurdles and introduce a new immunotherapy option to the market.

Checkpoint Therapeutics' commitment to developing new cancer treatments is evident in its ongoing efforts to evaluate and commercialize novel products like cosibelimab and olafertinib. The company's strategy includes addressing regulatory challenges and ensuring that their products meet FDA standards for approval.

With this alignment on the resubmission strategy, Checkpoint Therapeutics is poised to advance its mission of providing innovative treatments for cancer patients. The anticipated resubmission of the BLA for cosibelimab marks a pivotal moment in the company's efforts to bring new and effective therapies to those in need.