Checkpoint Therapeutics to Present Cosibelimab Interim Results from Registration-Enabling Trial at ESMO Virtual Congress 2020
Checkpoint Therapeutics (CKPT) announced updated interim data on cosibelimab for metastatic cutaneous squamous cell carcinoma (mCSCC) ahead of its presentation at the ESMO Virtual Congress 2020. Over 50% of the enrollment target has been achieved, with completion expected by year-end. Cosibelimab, a high-affinity anti-PD-L1 antibody, aims to disrupt the $25 billion PD-(L)1 therapy market with competitive pricing. The company expects to share full top-line results next year for this promising therapy, which currently has a 50% objective response rate among initial patients.
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- Presentation to highlight updated interim data from global trial in patients with metastatic cutaneous squamous cell carcinoma
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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
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
Previously released interim results for cosibelimab were presented in a poster presentation at the ESMO Congress 2019. Results included a
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
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 >
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) 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.
Forward‐Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our plans to submit one or more applications for marketing approval for cosibelimab, statements regarding the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, statements relating to the functional Fc domain of cosibelimab translating into potential enhanced efficacy, statements relating to the timing of the completion of enrollment and full top-line results, statements relating to how long we believe our cash will fund our operations, any statements relating to our growth strategy and product development programs, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the ongoing Phase 1 study; risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Company Contacts:
Jaclyn Jaffe and William Begien
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com
Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
arr@lifesciadvisors.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
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