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

Innovative Cellular Therapeutics

  • GCC19CART is an autologous CAR T therapy candidate that has shown promising results in more than 30 R/R mCCR patients in China

  • ICT plans to initiate a Phase 1 trial of GCC19CART in the United States 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 for the treatment of patients with relapsed and refractory mCCR R/R metastatic colorectal cancer.

“We are delighted that GCC19CART has received Fast Track designation from the FDA, underscoring the significant unmet need among patients with relapsed or refractory colorectal cancer,” said Larry (Lei) Xiao, Ph.D., founder and CEO of ICT. “GCC19CART is our lead product candidate for solid tumors from our CoupledCAR® technology platform that has shown promising clinical results in China. We are now focusing our efforts on its development in the USA »

The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of new treatments to treat serious or life-threatening conditions to address an unmet medical need. Once a drug candidate receives Fast Track designation, early and frequent communication between the FDA and sponsor is encouraged throughout the drug development and review process. A drug candidate that receives Fast Track designation is eligible for expedited approval and priority review, if the relevant criteria are met. It is also eligible for rolling review, which means the sponsor can submit completed sections of their Biological License Application (BLA) for FDA review, rather than waiting for each section of the BLA to be completed before that the entire application can be examined.

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

R/R mCRC is a disease with a high unmet medical need. Once a patient fails several standard lines of care (SOC) treatments as defined by the National Comprehensive Cancer Network (NCCN), there are very few effective options. Third-line treatments currently approved in the United States offer an overall response rate (ORR) of 1-1.6% and an overall median survival of 6.4-7.1 months.

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

IRB Approved Clinical Study of GCC19CART

In an IRB-approved clinical study that enrolled 35 patients in China, an overall response rate (ORR) of 50% in the treatment of 3rd more colorectal cancer patients were observed in the 8 patients treated with 2X10^6 GCC19CART cells/kg.

About innovative cell therapies

Innovative Cellular Therapeutics (ICT) is a privately held, clinical-stage biotechnology company with global headquarters in Rockville, MD, and a research and development office in Shanghai, China. ICT focuses on the development of cellular immunotherapies for the treatment of solid tumors. Unique CoupledCAR from ICT® The technology platform is designed to overcome common challenges in the treatment of solid tumors. ICTs have shown promising preclinical and clinical proof-of-concept results in advanced-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 metastatic colorectal cancer and refractory. ICT plans to launch this US-focused clinical trial, called CARAPIA-1, in the summer of 2022. The company has a broad pipeline of CAR-T candidates targeting other solid tumors.

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