Press Release

Checkpoint Therapeutics Announces Issuance of Two New Patents for EGFR Inhibitor CK-101

U.S. and European patent protections through at least August 2034

Company Release - 3/13/2019 8:30 AM ET

NEW YORK, March 13, 2019 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced that the European Patent Office (EPO) has issued a composition of matter patent for CK-101 (also known as RX518). CK-101 is Checkpoint’s third-generation epidermal growth factor receptor (EGFR) inhibitor that is under development for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC).

European Patent No. 3035936 specifically covers the compound CK-101 and a broad range of related compounds, salts and pharmaceutical compositions, including various dosage forms of such pharmaceutical compositions. It also covers certain uses of such compounds or salts in treating cancer or a disorder mediated by EGFR or NSCLC, either alone or in combination with an additional anti-cancer and/or cytotoxic agent.

The U.S. Patent and Trademark Office previously issued a U.S. counterpart composition of matter patent for CK-101 (U.S. Patent No. 9,550,770). Together, the patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extension in the U.S. under the Hatch-Waxman Act. 

Additionally, in January 2019 the U.S. Patent and Trademark Office issued U.S. Patent No. 10,172,868, which claims a method of treating a patient diagnosed with NSCLC, metastatic NSCLC or NSCLC with EGFR mutations that is comprised of administering a therapeutically effective amount of CK-101. This U.S. patent is scheduled to expire in August 2034, not including any potential patent term extension.  

"We are very pleased by the issuance of a European composition of matter patent for CK-101, in addition to a second U.S. patent, as they represent important milestones in our intellectual property strategy," said James F. Oliviero, President and CEO of Checkpoint. “We plan to continue to expand and fortify our intellectual property estate for CK-101 in the U.S. and abroad as we advance CK-101 toward Phase 3 trial initiation, which we expect later this year.”

Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc. in 2015.

About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation EGFR inhibitor, in a Phase 1/2 clinical trial for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In addition, Checkpoint is currently evaluating its lead antibody product candidate, CK-301, an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts intended to support one or more Biologics License Application submissions. Checkpoint is headquartered in New York City. 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, 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 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; risks relating to our ability to seek accelerated approvals for our drug candidates; 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:
Jeremy Feffer
Managing Director, LifeSci Advisors, LLC
(212) 915-2568
jeremy@lifesciadvisors.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 940-0135
tplohoros@6degreespr.com

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Source: Checkpoint Therapeutics, Inc