Checkpoint Therapeutics Reports Acceptance of IND Application for CK-101 (FBIO)

August 11, 2016 8:03 AM EDT
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Checkpoint Therapeutics, Inc. (“Checkpoint”), a Fortress Biotech (NASDAQ: FBIO) company, announced today that its Investigational New Drug (“IND”) application for CK-101, its novel, oral, third generation EGFR inhibitor product candidate, has been accepted by the U.S. Food and Drug Administration (“FDA”) and is now active. The IND acceptance enables Checkpoint to begin a Phase 1/2 clinical trial of CK-101. The trial, expected to begin in September, is designed to assess the safety, tolerability and efficacy of CK-101 in EGFR T790M mutation-positive non-small cell lung cancer patients.

“The acceptance of this IND marks an important milestone for Checkpoint and the CK-101 program,” said James F. Oliviero, III, President and CEO of Checkpoint Therapeutics. “We look forward to commencing clinical trials for CK-101, which we plan to develop as both a monotherapy and in combination with our portfolio of immuno-oncology agents.”

Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK-101 (also known as RX518), which it acquired from NeuPharma, Inc. in 2015.

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