Checkpoint Therapeutics Announces Completion of Enrollment in the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma

On May 12, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported 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 (Press release, Checkpoint Therapeutics, MAY 12, 2021, View Source [SID1234579815]).

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In January 2020, Checkpoint announced that the U.S. Food and Drug Administration 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, stated, "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." Mr. Oliviero continued, "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) (Free SITC Whitepaper) ("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."

About Cutaneous Squamous Cell Carcinoma
cSCC is the second most common human cancer in the United States, 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.

About Cosibelimab
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.