On July 27, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that an abstract highlighting updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma ("mCSCC") has been accepted for e-poster presentation at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020, to be held September 19-21, 2020 (Press release, Checkpoint Therapeutics, JUL 27, 2020, View Source [SID1234562393]).
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Cosibelimab is a potential best-in-class, high affinity, fully-human IgG1 monoclonal antibody 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 to reactivate an antitumor immune response. Cosibelimab is currently being studied in a global, open-label, registration-enabling Phase 1 clinical trial intended to support U.S., EU and other foreign marketing approval applications worldwide. Enrollment in the mCSCC trial has surpassed 50% of the enrollment target, with completion of enrollment expected around year-end and full top-line results anticipated next year. Checkpoint is also enrolling patients with locally advanced cutaneous squamous cell carcinoma to support a potential second indication for cosibelimab.
James F. Oliviero, President and CEO of Checkpoint stated, "We believe cosibelimab is a best-in-class anti-PD-L1 antibody, which we plan to commercialize at a substantially lower price in comparison to currently marketed anti-PD-(L)1 therapies. Through our market disruptive pricing strategy, we believe cosibelimab will obtain meaningful and rapid market share in the $25 billion PD-(L)1 class, while significantly lowering the barrier of high out-of-pocket costs patients endure worldwide to access premium-priced cancer therapies." Mr. Oliviero continued, "We are excited to present updated interim data from our pivotal mCSCC trial at the upcoming ESMO (Free ESMO Whitepaper) Congress, as we continue to make significant progress towards completing enrollment around year-end. We recently enhanced our enrollment efforts through the opening of clinical sites in two additional countries and intend to open sites in other western European countries this quarter to further accelerate enrollment in mCSCC and additional potential indications for cosibelimab."
Previously released interim results for cosibelimab were presented in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress 2019. Results included a 50% objective response rate by investigator assessment in the first 14 mCSCC patients, including one complete response. All responses (100%) were confirmed and ongoing at the time of analysis. A copy of the ESMO (Free ESMO Whitepaper) Congress 2019 poster presentation is available on the Publications page of the Pipeline section of Checkpoint’s website, www.checkpointtx.com.
In January 2020, Checkpoint announced that the U.S. Food and Drug Administration had confirmed the registration submission pathway for cosibelimab in mCSCC 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.
About Cutaneous Squamous Cell Carcinoma
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. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. 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.