Innovative Cellular Therapeutics (ICT) Receives FDA Fast Track Designation for GCC19CART, its Lead Solid Tumor Candidate, in the Treatment of Patients with Relapsed or Refractory Metastatic Colorectal Cancer

• GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 R/R mCRC patients in China
• ICT plans to initiate a Phase 1 Trial of GCC19CART in the U.S. for the Treatment of R/R mCRC in mid-2022

ROCKVILLE, Md., April 19, 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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to GCC19CART, the Company’s lead solid tumor therapy candidate in treating patients with relapsed and refractory metastatic colorectal cancer R/R mCRC.

“We are pleased that GCC19CART has received FDA Fast Track Designation highlighting the large unmet need in patients with relapsed or refractory colorectal cancer,” said Larry (Lei) Xiao, Ph.D., ICT’s founder and Chief Executive Officer. “GCC19CART is our lead solid tumor product candidate from our CoupledCAR^® platform technology that has shown early promising clinical results in China. We are now focusing our efforts on its development in the U.S.”

The FDA’s Fast Track Designation aims to facilitate development and expedite the review of new therapeutics to treat serious or life-threatening conditions in order to fill an unmet medical need. Once a drug candidate receives Fast Track Designation, early and frequent communication between the FDA and the sponsor is encouraged throughout the entire drug development and review process. A drug candidate that receives Fast Track Designation is eligible for Accelerated Approval and Priority Review, if relevant criteria are met. It is also eligible for Rolling Review which means that the sponsor can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed.

GCC19CART for R/R mCRC
GCC19CART is the lead solid tumor candidate from ICT’s proprietary CoupledCAR^® technology platform, which has been specifically designed to target and eliminate cancer cells expressing guanylyl cyclase C (“GCC”), a marker for colorectal cancer. The FDA has granted Fast Track Designation to GCC19CART based on its potential to address the unmet need for patients with R/R mCRC who have failed standard therapies.

R/R mCRC is a disease with a large unmet medical need. Once a patient fails multiple lines of standard of care (SOC) treatments as defined by the National Comprehensive Cancer Network (NCCN), there are very few effective options. The currently approved third line treatments in the U.S. provide an overall response rate (ORR) of 1 to 1.6% and overall median survival of 6.4 to 7.1 months.

ICT plans to initiate a Phase 1 study designed to evaluate the safety, tolerability, and activity of GCC19CART in patients with R/R mCRC in the U.S. in mid-2022.

IRB-approved clinical study of GCC19CART

In an IRB-approved clinical study that enrolled 35 patients in China, a 50% Overall Response Rate (ORR) in the treatment of 3^rd plus line colorectal cancer patients was seen in the 8 patients who are treated with 2X10^6 GCC19CART cells/kg.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company with a global headquarter in Rockville, MD, and a research and development office in Shanghai, China. 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 and 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.

Investor Relations Contacts:

Innovative Cellular Therapeutics:
ir@ictbioinc.com

Kevin Gardner
LifeSci Advisors
617-283-2856
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
917-680-5608
ccalabrese@lifesciadvisors.com