On March 13, 2019 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, reported that the European Patent Office (EPO) has issued a composition of matter patent for CK-101 (also known as RX518) (Press release, Checkpoint Therapeutics, MAR 13, 2019, View Source [SID1234534318]). 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).

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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.