Stemirna Therapeutics Secures Over $40 Million in Series C Financing Led by CDH VGC and Receives FDA IND Approval for Solid Tumor CAR-T Therapy GCC19CART

VCBeat learned immediately that,September 6,Shanghai Si Dan Race BioTechnology Co., Ltd. (hereinafter referred to as "ICT") announced the completion of a Series C financing round exceeding $40 million. The round was led by CDH VGC (CDH Innovation and Growth Fund), with several other investment institutions participating as follow-on investors.

Furthermore, on August 31, the U.S. FDA approved the IND application for GCC19CART, the company’s solid tumor cell therapy product developed based on the CoupledCAR technology platform. This approval supports a Phase I, multicenter clinical study evaluating GCC19CART in patients with relapsed or refractory (R/R) metastatic colorectal cancer. This round of financing will be utilized for the research and development of the innovative CoupledCAR platform technology, advancing the development of cell therapy products for colorectal cancer and other solid tumors, and accelerating clinical trial progress in both the United States and China.

ICT is a global cell therapy company primarily engaged in the research and application of cutting-edge CAR-T and gene editing technologies, dedicated to becoming a leader in the global cell therapy sector. Leveraging its proprietary CoupledCAR technology platform, the company’s novel CAR-T product has achieved significant breakthroughs in investigator-initiated trials (IITs) conducted in China for advanced colorectal, thyroid, and pancreatic cancers, demonstrating an overall response rate (ORR) of 50%. Furthermore, clinical studies for the company’s CAR-T products targeting other solid tumors, including liver and prostate cancers, are progressively being initiated.

Dr. Xiao Lei, Founder of the company, stated: "We sincerely appreciate the continuous support and recognition from CDH VGC and other investors. The approval of the U.S. IND marks a crucial step in validating our platform technology. This round of financing will accelerate the accumulation of additional clinical data for our technology across multiple solid tumor indications. We believe that these CoupledCAR-based^®The solid tumor cell therapy based on this technology will achieve success in clinical trials and commercialization in the future, benefiting a wide range of cancer patients.”

Dr. Victor Lu, former FDA cell therapy reviewer and current Senior Vice President of the company, stated: "The clinical trial authorization granted by the FDA marks a critical step forward in our efforts to treat solid tumors using CAR-T technology."

“Our CAR-T solid tumor product has been validated in dozens of investigator-initiated trials (IITs), demonstrating a significant objective response rate and manageable adverse effects as a monotherapy in patients with advanced colorectal cancer who have received multiple prior lines of therapy,” said Dr. Eugene Kennedy, Chief Medical Officer of the company. “We believe that the clinical trials soon to be launched in the United States will replicate these findings, and the CoupledCAR technology will play a pivotal role in the treatment of solid tumors, curing and saving more patients.”

Gao Jieliang, Partner at CDH VGC, stated, "The application of cell therapy in solid tumors is a globally recognized challenge. The company's independently developed universal CoupleCAR platform technology for solid tumors has achieved breakthrough progress in clinical studies across multiple major cancer types. The U.S. FDA IND approval for the core product, GCC19 CART, further validates the company's technology. These research achievements have advanced the application of cell therapy in solid tumors by another significant step. We will continue to support the company as always, remaining deeply committed to the cell therapy field to benefit more patients."