- Presentation to highlight updated interim data from global trial in patients with metastatic cutaneous squamous cell carcinoma
- Over 50% of enrollment target achieved; full enrollment expected around year-end
- Potential for cosibelimab to be a best-in-class product with market disruptive pricing in a $25 billion PD-(L)1 class
NEW YORK, July 27, 2020 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced 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.
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 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 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 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.