Checkpoint Therapeutics Announces Completion of Enrollment in the Registration-Enabling Trial of Cosibelimab

Checkpoint Therapeutics, Inc. recently announced the completion of enrollment for the metastatic cutaneous squamous cell carcinoma (cSCC) cohort in its registration-enabling clinical trial of anti-PD-L1 antibody, cosibelimab.

In January 2020, Checkpoint announced that the US FDA had confirmed the registration submission pathway for cosibelimab in metastatic cSCC based on the ongoing clinical trial, which has a target enrollment of approximately 75 patients and a primary efficacy endpoint of confirmed objective response rate assessed by independent central review. Top-line results are expected in the fourth quarter of 2021 and, upon a successful outcome, Checkpoint intends to submit a Biologics License Application (BLA) for cosibelimab in the first half of 2022, followed shortly thereafter by a Marketing Authorization Application submission in Europe. Additionally, Checkpoint continues to enroll a registration-enabling cohort of patients with locally advanced cSCC and anticipates that this second indication will also be included in the planned BLA and MAA submissions next year.

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said “We are pleased to report the completion of enrollment for our metastatic cSCC cohort, with over 75 patients enrolled, which we expect will enable a readout of top-line results in the fourth quarter of this year. Based on the interim data presented last year at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, we believe cosibelimab has the potential to be a best-in-class anti-PD-L1 antibody, which we intend to commercialize at a substantially lower price in comparison to currently marketed anti-PD-(L)1 therapies. With a compelling safety and efficacy profile, as well as our market disruptive pricing strategy, we believe cosibelimab can achieve meaningful and rapid market share in the $25 billion and growing PD-(L)1 class.”

cSCC is the second most common human cancer in the US, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types.

Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to support one or more applications for marketing approval. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (EGFR) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com.