ROCKVILLE, MARYLAND, August 18, 2022 (GLOBE NEWSWIRE) – Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced that the first patient has been enrolled in its Phase I trial of GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC). The study (NCT05319314) is an open-label, single arm, multicenter Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of GCC19CART in patients with relapsed or refractory metastatic colorectal cancer (R/R mCRC) in the U.S.
“This is an important and exciting milestone for ICT,” said Dr. Larry Lei Xiao, Chief Executive Officer of ICT. “There is a significant unmet medical need for R/R mCRC patients. We believe that GCC19CART has the potential to provide significant clinical benefit to these patients.”
GCC19CART is ICT’s lead product candidate from the Company’s CoupledCAR® technology. It has been tested in 35 patients in an IRB-approved trial in China. The data from the trial has been presented at ASCO, ASGCT, and AACR meetings in 2022.
About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and thyroid cancer. The U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed or refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the summer of 2022. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com.
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