**Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT for Treatment of Advanced Cutaneous Squamous Cell Carcinoma**

On December 13, 2024, Checkpoint Therapeutics, Inc. disclosed in an 8-K filing that the U.S. Food and Drug Administration (FDA) has given the green light to UNLOXCYT (cosibelimab-ipdl) for addressing adults contending with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). Patients who are not suitable for curative surgery or radiation treatment can now benefit from this approved therapy.

UNLOXCYT marks a significant achievement for Checkpoint Therapeutics, as it is the organization’s first FDA-approved product. This milestone paves the way for Checkpoint to enter the commercial landscape, particularly in the U.S. market segment with an estimated annual value exceeding $1 billion. UNLOXCYT aims to provide a distinct treatment option by targeting the programmed death ligand-1 (PD-L1) and activating the anti-tumor immune response.

James Oliviero, President and Chief Executive Officer of Checkpoint, expressed, “Today’s FDA approval of UNLOXCYT is a significant milestone both for Checkpoint and for patients with advanced cSCC.” By binding to PD-L1 rather than programmed death receptor-1 (PD-1), UNLOXCYT appears to offer a new approach in treating advanced cSCC. Moreover, the drug has shown promise with antibody-dependent cell-mediated cytotoxicity, setting it apart from existing therapies for cSCC.

With cSCC as the second most common skin cancer type, the FDA’s approval of UNLOXCYT offers patients a promising treatment avenue. Emily Ruiz, M.D., M.P.H., highlighted the critical need for effective and well-tolerated treatment options, especially for individuals battling advanced cSCC with underlying health conditions. UNLOXCYT, with its dual mechanisms and favorable safety profile, stands as a valuable immunotherapy option for oncologists treating cSCC patients.

The FDA based its approval of UNLOXCYT on data from Study CK-301-101 (NCT03212404), which demonstrated clinically meaningful response rates and response durations. Checkpoint Therapeutics is gearing up for the commercial launch of UNLOXCYT and acknowledges the crucial role played by patients, healthcare providers, and the FDA throughout the drug’s development and approval process.

Checkpoint Therapeutics anticipates initiating a robust commercial launch plan for UNLOXCYT and looks forward to serving patients in need.

**About Checkpoint Therapeutics**
Checkpoint Therapeutics, Inc. is a company specializing in immunotherapy and targeted oncology solutions for solid tumor cancers. The recent FDA approval of UNLOXCYT sets the stage for offering novel treatments for patients with metastatic or locally advanced cSCC. Additionally, the organization is exploring olafertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor, as a potential therapy for EGFR mutation-positive non-small cell lung cancer. Headquarters are based in Waltham, MA, and the company was established by Fortress Biotech, Inc.

This press release contains forward-looking statements, reflecting the organization’s perspectives regarding future events. Interested parties are encouraged to refer to the official documentation for detailed information and disclosures.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Checkpoint Therapeutics’s 8K filing here.

Checkpoint Therapeutics Company Profile

Checkpoint Therapeutics, Inc, a clinical-stage immunotherapy and targeted oncology company, focuses on the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers in the United States and internationally. The company's lead antibody product candidate is Cosibelimab, which is in Phase 1 clinical trial to treat patients with selected recurrent or metastatic cancers; and CK-302, a product candidate in preclinical trials for hematological malignancies and solid tumors.