ROCKVILLE, Md., December 4, 2019 — 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.”
The U.S. Food and Drug Administration (FDA) has cleared ICT’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 is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an “armored” CAR-T cell therapy, has already demonstrated encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.
About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead candidate in the U.S., ICTCAR014, is a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. ICT’s lead candidate in China, ICTCAR003, is a CD19-targeting CAR-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid tumors. For more information, please visit www.ictbio.com.
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