Yimiao Shenzhou Receives China's First IND Approval for IM96 CAR-T Therapy Targeting Metastatic Colorectal Cancer

Professor Shen Lin stated：Congratulations on the official approval of IM96 for clinical registration! Metastatic colorectal cancer in its advanced stage represents a significant challenge in global cancer treatment, with a vast patient population and very slow progress in drug therapies over the past 20 years, leaving many patients' treatment needs unmet. As a self-developed CAR-T drug targeting GCC for solid tumors, preliminary clinical studies have shown that IM96 holds promising prospects for significant clinical benefits in treating advanced metastatic colorectal cancer. We look forward to initiating the IM96 clinical trial as soon as possible, advancing the product’s market entry at the earliest opportunity, and benefiting a broader patient population.

Dr. He Ting said:The approval of IM96 for clinical trials marks a significant milestone in the development of CAR-T drugs for solid tumors by Beijing Yimiaoshenzhou Medical Techology Co., Ltd. It also signifies that CAR-T drug treatment for metastatic colorectal cancer in China has entered a new phase of development, offering hope to address the significant unmet needs in the clinical treatment of this disease. Next, we will accelerate the clinical trial process of IM96 and expedite the drug’s submission for market approval, aiming to benefit late-stage metastatic colorectal cancer patients in China and around the world as soon as possible.

Colorectal cancer is one of the most common malignant tumors worldwide, with more than 1.93 million new cases and over 930,000 deaths annually. Its incidence and mortality rank third and second, respectively, among major malignant tumors globally. Data released by China’s National Cancer Center (NCC) shows that in 2022, there were 517,100 new cases of colorectal cancer in China, with 240,000 deaths, making it the second most prevalent malignant tumor in the country. The treatment of colorectal cancer has always faced significant challenges, especially for patients with advanced metastatic disease, where treatment options are extremely limited and often ineffective, making it difficult to achieve satisfactory outcomes.

As a solid tumor CAR-T cell therapy product independently developed and owned by Beijing Yimiaoshenzhou Medical Technology Co., Ltd., IM96 was successively selected for presentation at the 2023 ESMO Annual Meeting and the 2024 ASCO Annual Meeting, among other international oncology academic conferences. With its groundbreaking efficacy and excellent safety data, it has garnered widespread attention from the global medical community. Previously,Not long after, the preclinical research paper of IM96 was published in the top international journal in the field of cancer immunotherapy.《Journal for ImmunoTherapy of Cancer》The journal has been accepted and will be officially published soon.