CR Therapeutics completes nearly RMB 100 million financing to accelerate advancement of core pipelines including in vivo CAR-T

Recently, CR Therapeutics completed a financing round of nearly RMB 100 million. The round was jointly led by Chengdu Future Industry Fund and Yuanbio Venture Capital, with participation from Renyou Investment, Peakview Capital, and other institutions. Existing shareholder Legend Capital also made an additional investment. The proceeds will be primarily used to advance the clinical development of the company's core pipeline.

Individualized gene-modified immune cell therapies have been clinically validated, but their widespread use in patients in urgent need of treatment is limited by challenges such as long manufacturing lead times and high costs.

With years of scientific research and clinical accumulation in the cell therapy field, the CR Therapeutics team has focused on the development of next-generation off-the-shelf cell therapy products since its establishment in July 2023. The company has established two platform technologies: in vivo CAR-T and therapeutic vaccines as a novel drug modality, aiming to address the challenges of traditional cell therapy applications. Products developed from both platforms of CR Therapeutics combine efficacy, safety, and accessibility, holding the potential to achieve a true breakthrough in next-generation immune cell therapies and to become representative products in their respective fields.

The in vivo CAR-T field has formed two major technology routes: viral vectors and mRNA-LNP, each with its own advantages and disadvantages in terms of efficacy and safety. The industry appears to have entered a new bottleneck: must there be a trade-off between safety and potent efficacy?

Based on in-depth consideration and comprehensive comparison of the entire lifecycle of in vivo CAR-T products, CR Therapeutics has chosen the mRNA-LNP route, which offers a higher safety profile. Through modular parallel research and development, the company has carried out a series of internationally competitive innovations in cell-targeted delivery systems, mRNA sequence optimization, and CAR molecular design. These efforts have achieved comprehensive improvements in delivery efficiency, expression duration, cytotoxic activity, and solid tumor penetration, holding the potential to deliver products that are both safe and potent, thereby breaking through the industry bottleneck. The core pipeline has been advanced into multiple clinical studies, demonstrating low toxicity and efficient CAR-T generation in clinical settings.

The highly innovative TCR-T in vivo platform is based on the therapeutic vaccine technology route as a novel drug modality, capable of achieving comprehensive and durable T cell immune activation and generating high-fold expansion of multiple TCR clones in vivo (TCR-T in vivo).

EBV is the first human tumor-associated virus. Ninety-five percent of the global adult population is infected and carries the virus for life. Long-term infection can lead to various tumors, including nasopharyngeal carcinoma, lymphoma, and EBV-associated gastric cancer. The lead pipeline candidate of CR Therapeutics' TCR-T in vivo platform, CR101, has demonstrated excellent efficacy in clinical studies of patients with advanced EBV-associated tumors who have failed multiple lines of therapy, have multiple metastases throughout the body, and are resistant to PD-1 antibodies. Some patients have achieved complete remission (CR) and have survived for more than three years. CR101 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of nasopharyngeal carcinoma.

In addition, this technology has been approved for clinical translational application at West China Lecheng Hospital in Hainan Boao. All treated patients have achieved rapid seroconversion of EBV-DNA to negative, representing a major clinical breakthrough.

CR Therapeutics is located at the Frontier Medical Center in Chengdu High-tech Zone. Leveraging the robust biomedical ecosystem of Chengdu High-tech Zone, the efficient full-chain incubation and support from West China Hospital of Sichuan University and the Chengdu Minshan Cell Therapy Technology Research Institute, and the efficient execution of its founder and team, the company has achieved multiple milestones in less than three years since its establishment, including advancing in vivo CAR-T candidates into clinical studies, generating product sales revenue, and receiving Orphan Drug Designation from the FDA for its therapeutic vaccine.

Professor Yang Hanshuo, founder, chairman, and chief scientist of CR Therapeutics, has years of scientific research experience at West China Hospital of Sichuan University. He possesses strong clinical, scientific, and commercial insights and has proactively advanced the translation of scientific and technological achievements, pioneering a new model for the transformation of research outcomes.

CR Therapeutics received strategic investments in its early stages from institutions including Legend Capital and Chengdu High-tech Biocity Jingchuang Capital. In the recent financing round, the investing institutions have demonstrated a clear synergy and empowering effect, which will further accelerate the clinical development and industrialization of the company's core pipeline.