Checkpoint Therapeutics Announces Presentation of Pivotal Trial Results of Cosibelimab at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

WALTHAM, Mass., June 06, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of data from its pivotal trial of cosibelimab in metastatic cutaneous squamous cell carcinoma (cSCC) during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Positive top-line results were previously announced in January 2022.

Poster Presentation Title: Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma: Results from pivotal cohort

This registration-enabling clinical trial enrolled 78 patients with metastatic cSCC at 24 sites in 8 countries, including Australia/New Zealand (58%), Europe (24%), South Africa (10%), and Thailand (8%), and is being conducted under an Investigational New Drug application with the U.S. Food and Drug Administration. The trial is investigating the safety and efficacy of cosibelimab administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC (lymph nodal or distant metastatic disease). Data from this study is expected to support a Biologics License Application for cosibelimab planned for submission in the fourth quarter of 2022.

Data highlights from the poster include:

Efficacy

• Confirmed objective response rate (ORR) by independent central review in the modified intent to treat population of 48.7% (95% CI, 37.0-60.4)
• 13.2% of patients achieved a complete response in target lesions
• Median duration of response (DOR) had not yet been reached at time of analysis; 76% of responses were ongoing
• The Kaplan-Meier-estimated probability of maintaining a response at six and 24 months was 88.1% and 72.5%, respectively

Safety

• Cosibelimab was generally well tolerated with no unexpected safety signals
• The most common adverse events associated with cosibelimab were fatigue (11.5%) and rash (10.3%)
• Seven patients (9.0%) experienced a grade 3 treatment-related adverse event (TRAE); no grade 4 or 5 TRAEs were reported
  

A copy of the poster can be found on the Publications page of the Checkpoint Therapeutics website.

Cosibelimab was licensed by Checkpoint in 2015 from the Dana-Farber Cancer Institute.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately one million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced and an estimated 15,000 people will die from their disease. 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.

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 (cSCC) intended to support one or more applications for marketing approval. Following positive topline results in metastatic cSCC, Checkpoint intends to submit a Biologics License Application for this indication later this year. Additionally, the global, randomized Phase 3 (CONTERNO) trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer is ongoing. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly 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 Waltham, MA and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com.

Forward‐Looking Statements
This press release contains “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, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements relating to the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy, and projections of publication and regulatory submission timelines. Factors that could cause our actual results to differ materially include the following: our ability to successfully deliver the complete dataset from the clinical trial and complete a BLA submission on schedule as planned; the risk that topline data remains subject to audit and verification procedures that may result in the final data being materially different from the topline data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. 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. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Company Contacts:
Jaclyn Jaffe and Bill 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:
Katie Kennedy
Senior Vice President, Gregory FCA
(610) 731-1045
Checkpoint@gregoryfca.com

Released June 6, 2022