ICT Bio's GCC19CART Achieves Breakthrough in Solid Tumor Treatment, Highlighted by First-Ever Publication in JAMA Oncology

On September 19, 2024, JAMA Oncology, a prestigious journal in the field of international oncology, published clinical research findings on GCC19CART, an independently developed product by Stance Biotechnology Co., Ltd. (hereinafter referred to as “Stance”). The study was conducted in collaboration with the research team led by Professor Cui Jiuwei from the Cancer Center of the First Hospital of Jilin University, with Dr. Chen Naifei, Associate Chief Physician, serving as the first author. This study represents a significant milestone in the application of CAR-T cell therapy for solid tumors, particularly in the treatment of metastatic colorectal cancer (mCRC).

The published results highlight the successful application of GCC19 CAR-T therapy in patients with metastatic colorectal cancer (mCRC) who had received multiple lines of standard treatment. At a dose level of 2×10⁶ CAR-T cells per kilogram of body weight, the therapy achieved an objective response rate (ORR) of 57% and a median overall survival (mOS) of 26.1 months. In addition to the 57% ORR, approximately 75% of responding patients remained alive two years later. This therapy was administered as a monotherapy, without combination with other drugs or treatment modalities.

“To the best of our knowledge, this is the first report demonstrating significant efficacy of CAR-T cell therapy as a monotherapy in the treatment of advanced colorectal cancer,” stated Dr. Xiao Lei, CEO of Stance Therapeutics. “This product is built on the CoupledCAR platform technology, which integrates multiple functional genes and activates their expression in a spatiotemporal sequence. Unlike other attempts at CAR-T therapies for solid tumors, CoupledCAR enables CAR-T cells targeting solid tumors to expand and activate within the immune system without requiring binding to solid tumor antigens. These CAR-T cells then effectively migrate from the immune system into the tumor microenvironment beyond the bloodstream, achieving potent killing of tumor cells. Since the expansion and activation of CAR-T cells against solid tumors are independent of solid tumor antigens, the CoupledCAR platform technology not only demonstrates efficacy in metastatic colorectal cancer but also shows potential for application in other types of tumors.”

Stanse’s Phase I clinical trial conducted in the United States has also demonstrated encouraging progress. At the first dose level of 1×10⁶ CAR-T cells per kilogram of body weight, 2 out of 4 patients achieved partial response (PR), resulting in an objective response rate (ORR) of 50%. At the second dose level of 2×10⁶ CAR-T cells per kilogram of body weight, 4 out of 5 patients achieved PR, yielding an ORR of 80%. Although these findings are preliminary, they closely replicate the data from China and suggest that the therapeutic efficacy may exceed expectations. Dr. Eric Rowinsky, Chief Medical Officer at Stanse, commented on the U.S. results: “In the field of third-line treatment for colorectal cancer, the objective response rates (ORR) of the three approved standard therapies are only 1–6%. In contrast, GCC19CART demonstrates significant potential to deliver breakthrough therapeutic outcomes for patients with heavily pretreated colorectal cancer. Even more promising is the prospect that, if applied in the first-line setting in the future, GCC19CART could have a profound and transformative impact on halting the progression of early-stage colorectal cancer, thereby ushering in a new era of treatment.”

Stanse Biotechnology Co., Ltd. is a clinical-stage biotechnology company focused on the development of CAR-T cell therapy products for solid tumors. Stanse’s proprietary CoupledCAR platform technology is designed to overcome key challenges in treating solid tumors, and CAR-T products developed based on this platform have achieved promising clinical results in the treatment of advanced solid tumors, such as colorectal cancer and prostate cancer. The company’s CAR-T cell therapy product GCC19CART for advanced colorectal cancer has received Investigational New Drug (IND) approval and Fast Track designation from the U.S. Food and Drug Administration (FDA). The U.S. clinical trial CARAPIA-1 is currently underway (ClinicalTrials.gov Identifier: NCT05319314). Stanse is also building a robust pipeline of CAR-T candidate drugs targeting other solid tumors, including prostate cancer and pancreatic cancer. For more information, please visitwww.ictbio.com。