FDA approves Checkpoint Therapeutics’ Unloxcyt for advanced cSCC

Shares of Checkpoint Therapeutics, Inc. rose 4.6% to $3.84 in post-market trading after the US Food and Drug Administration (FDA) approved Unloxcyt (cosibelimab-ipdl) treatment for advanced cutaneous squamous cell carcinoma (cSCC). This approval is the first for Checkpoint and represents a major Checkpoint Therapeutics milestone, positioning the drug to compete in a U.S. market estimated at over $1 billion annually.

FDA Approval After Manufacturing Setbacks

The Checkpoint Therapeutics approval came after an earlier setback in December 2023 when the FDA issued a Complete Response Letter regarding issues with the company’s third-party manufacturer. Despite this, the FDA-approved Unloxcyt treatment proceeded smoothly following a resubmission in July 2024. The approval, granted just ahead of the December 28 Prescription Drug User Fee Act goal date, underscores the drug’s strong clinical profile.

Unloxcyt: A Differentiated Option in Advanced Cutaneous SCC

Unloxcyt is a PD-L1 blocking antibody, designed to interrupt the interaction between PD-L1 and T-cell receptors such as PD-1, thereby enhancing the anti-tumor immune response. Additionally, it induces antibody-dependent cell-mediated cytotoxicity (ADCC), a distinguishing feature compared to other therapies.

Checkpoint highlighted Unloxcyt as a monoclonal antibody therapy that binds directly to PD-L1 rather than PD-1, potentially offering a differentiated treatment option. The drug is indicated for patients with advanced cutaneous SCC, specifically those ineligible for curative surgery or radiation. Its recommended dosage is 1,200 mg administered intravenously every three weeks.

Clinical Validation for FDA-Approved Unloxcyt Treatment

The Checkpoint Therapeutics approval relied on robust data from Study CK-301-101, which demonstrated durable response rates in patients with advanced cSCC. The trial results validated Unloxcyt’s efficacy, paving the way for regulatory success.

Dr. Emily Ruiz, a leading dermatologist and academic director at Brigham and Women’s Hospital, described Unloxcyt as a critical advancement for advanced cutaneous SCC. She noted that the drug provides an effective and tolerable option for high-risk patients, particularly those with comorbidities such as autoimmune disorders or organ transplants.

Unloxcyt Commercial Launch and Market Opportunity

Checkpoint is now focusing on the Unloxcyt commercial launch, with CEO James Oliviero calling the approval a transformative Checkpoint Therapeutics milestone. The company aims to position the drug as a leader in the U.S. market for advanced cutaneous SCC, a field with significant unmet need.

Checkpoint also continues to develop Olafertinib, a potential treatment for EGFR mutation-positive lung cancer, as part of its broader oncology strategy. Meanwhile, the approval of Unloxcyt places the firm firmly in the spotlight, with its monoclonal antibody therapy showcasing innovative mechanisms like PD-L1 inhibition and ADCC induction.

Industry Implications for Checkpoint Therapeutics Approval

The FDA’s decision highlights the potential for smaller biotech companies to make significant contributions to oncology. With its FDA-approved Unloxcyt treatment, Checkpoint Therapeutics is poised to address gaps in the immunotherapy landscape, particularly for advanced cutaneous SCC.