Core Insights - Checkpoint Therapeutics has received FDA approval for UNLOXCYT™ (cosibelimab-ipdl), the first PD-L1 blocking antibody approved for treating adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation [1][3][7] - The U.S. market for cSCC treatments is estimated to exceed $1 billion annually, presenting a significant commercial opportunity for Checkpoint [3] - UNLOXCYT offers a differentiated treatment mechanism by binding to PD-L1, potentially inducing antibody-dependent cell-mediated cytotoxicity (ADCC), which may enhance its efficacy compared to existing therapies [3][6] Company Overview - Checkpoint Therapeutics is a commercial-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [25] - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [25] Product Details - UNLOXCYT is administered at a recommended dosage of 1,200 mg via intravenous infusion every three weeks [2] - The drug has shown clinically meaningful objective response rates and durable responses in advanced cSCC, as demonstrated in Study CK-301-101 [3][5] Market Context - Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [5] - Approximately 40,000 cases of cSCC become advanced each year, leading to an estimated 15,000 deaths in the U.S. [5] Clinical Significance - UNLOXCYT addresses a significant unmet need for more effective and tolerable treatment options for patients with advanced cSCC, particularly those with concomitant hematological malignancies or autoimmune disorders [3][5] - The approval of UNLOXCYT marks a transformation for Checkpoint into a commercial-stage company, enhancing its competitive position in the oncology market [3][4]
Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)