Yimiao Shenzhou's IM83 CAR-T Therapy for Advanced Liver Cancer Enters Phase I Clinical Trial with Investigator Meeting Successfully Held
Imunopharm
Developer of Gene and Cell Therapy Technologies
On December 4, 2023, the first investigator meeting for Beijing Yimiao Shenzhou Pharmaceutical Technology Co., Ltd. ("Yimiao Shenzhou") Phase I clinical study evaluating the safety and efficacy of IM83 CAR-T cell therapy for advanced liver cancer was held at Beijing Tsinghua Changgung Hospital, affiliated with Tsinghua University ("Beijing Tsinghua Changgung Hospital"), announcing the upcoming Phase I registrational clinical study of IM83 CAR-T cell injection ("IM83").
Beijing Tsinghua Changgung Hospital serves asThis studyThe lead organization, in collaboration with Peking University Cancer Hospital and the Cancer Institute & Hospital, Chinese Academy of Medical Sciences, will serve as the research center. Academician Dong Jiahong, President of Beijing Tsinghua Changgung Hospital, Professor Shen Lin from Peking University Cancer Hospital, and Professor Zhao Hong from the Cancer Institute & Hospital, Chinese Academy of Medical Sciences, will act as the Principal Investigators (PIs).
The meeting was chaired by Professor Chen Xiaoyuan, Director of the Drug Clinical Research Institution at Beijing Tsinghua Changgung Hospital. Members of the project teams from three research centers thoroughly discussed the study protocol and subsequent implementation plans. Academician Dong Jiahong stated that this project is the first CAR-T study in the registration phase at Beijing Tsinghua Changgung Hospital, and the hospital highly values the project's progress. In the field of CAR-T therapy for solid tumors, we have already seen excellent results in gastrointestinal cancers, and we also anticipate breakthroughs in CAR-T treatment for liver cancer. Professor Shen Lin expressed that IM83 features innovative molecular design, and she hopes that the product’s characteristics can be fully evaluated through a scientifically designed study protocol. She believes that with the collaboration of the three institutions, the project will surely be successful. Professor Zhao Hong stated that he is very pleased to participate in the clinical research of such an innovative product as IM83. He hopes that during the research process, sufficient data on target expression and biomarker screening will be gathered to lay a solid foundation for further studies.
As the first self-developed next-generation solid tumor CAR-T drug by Beijing Yimiaoshenzhou Medical Techology Co., Ltd. targeting GPC3 for the treatment of advanced liver cancer, IM83 officially received clinical trial approval (application number: CXSL2300249) from the National Medical Products Administration in June 2023. The drug innovatively adopts a new molecular design to address challenges such as the strong immunosuppressive properties of liver cancer and the weak expansion ability of CAR-T cells. This enables CAR-T cells to accurately recognize GPC3 antigens on the surface of liver cancer cells while simultaneously targeting GPC3-negative tumor cells through an innovative design, allowing for more precise elimination of liver cancer cells.In investigator-initiated clinical studies, IM83 demonstrated encouraging efficacy and favorable safety, proving effective in killing target-positive liver cancer cells, with significant clinical potential and promising applications.
According to data from the National Cancer Center, in 2020, there were 410,000 new cases of liver cancer in China, accounting for 55% of the global new cases. There were 390,000 deaths, with a five-year survival rate of less than 20%, making it the third leading cause of cancer-related deaths in China. Currently, the large number of liver cancer patients, high mortality rate, and limited treatment options are the main challenges faced in the prevention and treatment of liver cancer in China. Developing safe, effective treatments that can significantly extend patient survival has become an urgent priority in the pharmaceutical industry.
Next, Beijing Yimiaoshenzhou Medical Techology Co., Ltd. will closely collaborate with Beijing Tsinghua Changgung Hospital, Peking University Cancer Hospital, and the Cancer Hospital of the Chinese Academy of Medical Sciences to actively carry out Phase I registrational clinical trials for IM83. The aim is to bring safe and effective treatment options to China's large population of advanced liver cancer patients as soon as possible, making a positive contribution to the development of clinical oncology and healthcare in China!
// About Yimiao Shenzhou //
Founded in 2015 and headquartered in Beijing, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. is a leading innovative biopharmaceutical company at the clinical stage. With the mission of "making cancer no longer an incurable disease," the company focuses on applying cutting-edge gene and cell therapy technologies to treat major diseases such as cancer and autoimmune disorders. To date, the company has completed 9 rounds of strategic financing and owns a one-stop, self-developed gene and cell therapy R&D and industrialization platform. It possesses multiple core technologies, won the top prize in the finals of China’s Disruptive Technology Innovation Competition, obtained four clinical trial approvals for Class I new drugs, and received Beijing's first-ever Manufacturing License for gene and cell-based pharmaceuticals. Its R&D pipeline covers hematological cancers like lymphoma, leukemia, and myeloma, as well as solid tumors such as liver, colorectal, gastric, and pancreatic cancers, making it a leader in the field of gene and cell therapies.
The company has undertaken more than 10 national and provincial-level scientific research projects, such as the special project of the Ministry of Science and Technology's key R&D plan and Beijing's major science and technology special project. It is a national high-tech enterprise, a specialized and innovative enterprise in Beijing, a frontier technology enterprise in Zhongguancun, a high-tech enterprise in Zhongguancun, and a postdoctoral research workstation. The team has been honored with awards such as Beijing's New Science and Technology Star, Zhongguancun High-end Leading Talent, Beijing Haiying Talent, Xinguomen Leading Talent, the Gold Award (First Place) at Tsinghua University’s President's Cup Innovation Challenge, MIT Technology Review's 35 Innovators Under 35, and Fortune Magazine’s 40 Under 40 Business Elites.
