FDA Grants Fast Track Designation to SteadyCell's GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer

Shanghai Si Dan Race BioTechnology Co., Ltd. (referred to as "ICT"), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GCC19CART, the company’s leading solid tumor therapy developed for the treatment of relapsed or refractory metastatic colorectal cancer (R/R mCRC).

Dr. Leo Xiao, CEO and founder of ICT, said: "We are delighted that GCC19CART has been granted Fast Track designation by the FDA, which highlights the large number of patients with metastatic colorectal cancer who have relapsed or refractory disease and for whom current therapies are not meeting treatment needs." "GCC19CART is an advanced solid tumor product developed based on our proprietary CoupledCAR platform technology and has achieved outstanding results in clinical trials in China. We are committed to initiating registration clinical trials for this product in the United States."

"The FDA's Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious or life-threatening diseases in order to address unmet medical needs," said Dr. Victor Lu, Head of Regulatory Affairs at ICT. "The candidate drug GCC19CART receiving Fast Track designation means that ICT can hold more frequent meetings with the FDA to discuss the drug’s development plan and ensure that the appropriate data needed to support drug approval is collected. It also allows for more frequent written communication with the FDA regarding the design of proposed clinical trials and makes the drug eligible for Accelerated Approval and Priority Review. These benefits will significantly advance the approval and market launch of our product to benefit patients."

GCC19CART for the Treatment of Relapsed, Refractory, and Metastatic Colorectal Cancer

GCC19CART is the leading solid tumor product in ICT's proprietary CoupledCAR® technology platform, specifically designed to target and eliminate cancer cells expressing the colorectal cancer tumor marker guanylate cyclase C (GCC). The FDA has granted it Fast Track designation based on GCC19CART’s significant potential demonstrated in treating recurrent, refractory, metastatic colorectal cancer patients who are unresponsive to conventional therapies.

Refractory and relapsed colorectal cancer recognized by the National Comprehensive Cancer Network (NCCN) is defined as patients who have failed multiple lines of standard-of-care (SOC) treatments or have developed metastases. These patients have significant unmet medical needs. Currently, there are very few effective treatment options for patients with refractory and relapsed colorectal cancer, and it can be said that there is almost no possibility of a cure. The latest statistics from the United States show that the objective response rate for third-line treatment of patients with refractory, relapsed, and metastatic colorectal cancer is only 1%-1.6%, with an overall median survival of just 6.4-7.1 months.

GCC19CART IRB Clinical Progress

In the early clinical trial (IRB) initiated by the researchers in China, a total of 35 patients with advanced colorectal cancer were enrolled. Among the 8 patients who received a dose of 2X10^6 GCC19CART cells/kilogram in the dose escalation experiment, we observed an objective response rate of 50%. Next, ICT plans to launch a Phase I clinical trial in the United States in mid-2022 to evaluate the safety, tolerability, and efficacy of GCC19CART in patients with relapsed or refractory metastatic colorectal cancer.

About ICT

Shanghai Si Dan Race BioTechnology Co., Ltd. (ICT) focuses on developing cellular immunotherapies for the treatment of solid tumors. ICT's unique CoupledCAR® technology platform aims to overcome common challenges in treating solid tumors. CART products developed based on this platform have already achieved promising clinical outcomes in the treatment of advanced solid tumors. The company’s CAR-T cell therapy product for advanced colorectal cancer, GCC19CART, received clinical trial approval from the U.S. Food and Drug Administration (FDA) in August 2021, and the trial, named CARAPIA-1, is expected to launch in the U.S. by the summer of 2022. ICT is also advancing a rich pipeline of CAR-T candidates targeting other solid tumors, including prostate cancer and ovarian cancer. For more information, please visit www.ictbio.com.