On August 11, 2016 Checkpoint Therapeutics, Inc. ("Checkpoint"), a Fortress Biotech (NASDAQ:FBIO) company, reported 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 (Press release, Fortress Biotech, AUG 11, 2016, View Source [SID:1234514509]). 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. Schedule your 30 min Free 1stOncology Demo! "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."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. ("Checkpoint"), a Fortress Biotech company, is an innovative, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel, non-chemotherapy, immune-enhanced combination treatments for patients with solid tumor cancers. Checkpoint aims to acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. Currently, Checkpoint is developing a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a professor in the Department of Cancer Immunology and AIDS at the Dana-Farber Cancer Institute. The portfolio of antibodies Checkpoint licensed from Dana-Farber includes antibodies targeting Programmed death-ligand 1 ("PD-L1"), Glucocorticoid-induced TNFR related protein ("GITR") and carbonic anhydrase IX ("CAIX"). Checkpoint plans to develop these novel immuno-oncology and checkpoint inhibitor antibodies on their own and in combination with each other, as data suggests that combinations of these targets may work synergistically together. Checkpoint has also licensed and is developing three oral, small molecule, targeted anti-cancer agents, consisting of an inhibitor of epidermal growth factor receptor ("EGFR") mutations, an inhibitor of the bromodomain and extra-terminal ("BET") protein, BRD4, and an inhibitor of poly (ADP-ribose) polymerase ("PARP"). Checkpoint will also seek to add additional immuno-oncology drugs and other targeted therapies in order to create wholly-owned proprietary combinations that leverage the immune system and complimentary mechanisms. Checkpoint is headquartered in New York City. For more information, visit www.checkpointtx.com.