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Innovative Cellular Therapeutics Announces FDA Clearance of IND for its Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy | ||||||||||||||
By: GlobeNewswire - 04 Dec 2019 | Back to overview list |
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ROCKVILLE, Md., Dec. 04, 2019 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics (ICT), a biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for blood cancers and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT expects to initiate a U.S. clinical trial evaluating ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients whose tumors are PD-L1 positive, in the first part of 2020. Dr. David L. Porter of the Abramson Cancer Center of the University of Pennsylvania will be the Lead Principal Investigator for the clinical trial. “The clearance of our first U.S. IND is a significant step as we expand our U.S. activities,” said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. “Building upon the encouraging data presented in November at the Society for Immunotherapy of Cancer (SITC), which showed objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. Our development strategy translates rapid clinical proof-of-concept trials in China into U.S. and global development programs with the goal of regulatory approval through expedited review pathways. We look forward to advancing ICTCAR014 into our first U.S. clinical trial.” About ICTCAR014 About Innovative Cellular Therapeutics
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