ICT Receives FDA Clearance of IND Application to Initiate a Phase 1 Clinical Trial for GCC19CART

ICT Receives FDA Clearance of IND Application to Initiate a Phase 1 Clinical Trial for GCC19CART 1366 911 Innovative Cellular Therapeutics

Innovative Cellular Therapeutics Receives FDA Clearance of IND Application to Initiate a Phase 1 Clinical Trial for GCC19CART, a CoupledCAR® Platform Product Candidate for Relapsed or Refractory Metastatic Colorectal Cancer

ROCKVILLE, Md., Sept. 01, 2021 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a Maryland based clinical stage biotechnology company developing the CoupledCAR® platform of chimeric antigen receptor (CAR) T-cell therapies for solid tumors, today announced that 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 and refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the first half of 2022.

“We believe that the Study-May-Proceed letter from FDA for our IND represents a critical step forward and clearance of the last significant regulatory barrier before we can start working toward generating potentially compelling clinical data for patients with solid tumors with our CoupledCAR T-cell therapies in the U.S.,” said Victor Lu, Ph.D., Senior Vice President of Regulatory Affairs of ICT.

“This IND clearance builds upon the promising clinical data generated by our team in Shanghai demonstrating objective responses with manageable expected toxicity when administered to heavily pretreated colorectal cancer patients as single-agent experimental therapy,” said Eugene Kennedy, M.D., Chief Medical Officer of ICT. “I look forward to advancing this program in the U.S. while we continue to develop proof-of-concept data for additional solid tumor indications.”

“Because GCC19CART and all future product candidates from our CoupledCAR platform share key aspects of technology and manufacturing, we believe the IND clearance is a first step towards validation of not only GCC19CART, but the potential of the entire platform,” said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. “Indeed, we are advancing an extensive product candidate pipeline individually targeting multiple solid tumor indications. We are excited by the potential of our CoupledCAR platform based therapeutic candidates to address the significant unmet need of patients with advanced colorectal cancer and other solid tumors.”

Based on ICT’s proprietary solid tumor CoupledCAR® technology platform, GCC19CART is a CAR T-cell therapy intended to treat refractory or relapsed metastatic colorectal cancer that expresses the target antigen guanylate cyclase 2C (GCC or GUCY2C). GCC-CART has already demonstrated encouraging results in proof-of-concept human trials in China. ICT is moving GCC19CART into a U.S. clinical trial.

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 Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com.

Investor Relations Contacts:
Julie Savage
Innovative Cellular Therapeutics

Irina Koffler
LifeSci Advisors

Media Relations Contact:
Kate L. Barrette
RooneyPartners LLC