Phase I Study of GCC CAR-T Therapy IM96 in Patients With Advanced Colorectal Cancer
Imunopharm
Developer of Gene and Cell Therapy Technologies
On October 23, 2023, in Madrid, Spain, Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (referred to as "Yimiao Shenzhou" or "the Company")At the 2023 European Society for Medical Oncology (ESMO) Annual Meeting, a world-leading oncology event, the Phase I clinical study data of IM96, a self-developed CAR-T cell therapy product targeting GUCY2C (GCC) for the treatment of advanced metastatic colorectal cancer (mCRC), was disclosed for the first time.The research data were orally presented by Professor Changsong Qi from the Department of Gastrointestinal Oncology, Peking University Cancer Hospital (Abstract Number: 1018O).
Number：1018O
English Title：Phase I Study of GCC CAR-T therapy IM96 in Patients With Advanced Colorectal Cancer
English Title：Phase I Clinical Study of GCC CAR-T Therapy IM96 in Patients with Advanced Colorectal Cancer
Speaker: Professor Changsong Qi (Department of Gastrointestinal Oncology, Peking University Cancer Hospital)
Report Time: October 23, 10:55 - 11:05, CEST
Professor Qi Changsong Delivers Oral Report at the Conference
As of December 2022, in the Phase I clinical trial (NCT05287165) evaluating the safety, efficacy, and pharmacokinetic characteristics of IM96 CAR-T therapy for GCC-positive advanced metastatic colorectal cancer (mCRC) that failed ≥3 lines of treatment, a total of 9 patients were enrolled and infused with 3×10.8（DL1）、6×108（DL2）、12×108(DL3) or 20×108(DL4) dose of CAR-T cells. The enrolled patients included 5 males and 4 females, with a median age of 52.6 years.
Clinical research data are as follows:
No neurotoxicity syndrome (ICANS) or cytokine release syndrome (CRS) of grade ≥3 was observed in all enrolled patients.
The disease control rate (DCR) was 66.7%, and the objective response rate (ORR) was 11.1%., one patient achieved partial remission (PR) and has continued to show remission for 11 months to date.；
After CAR-T infusion, among the 9 patients, 5 (55.6%) showed a significant decrease in CEA levels, while all patients had abnormally high CEA levels at baseline. CAR-T cells expanded in all patients and peaked 7 to 10 days after infusion. In 2 patients, the tumors continuously shrank, with CEA levels decreasing within 3 months while CAR-T cells expanded to 10 times.8/L. When the dose of IM96 is ≥6×108，When the moderate to high intensity GCC expression rate in tumor tissue was greater than 30%, all patients achieved tumor shrinkage.
In summary, IM96 in the treatment of ≥3 lines of therapy failure in GCC-positive advanced metastatic colorectal cancer (mCRC)Well-tolerated, with encouraging safety and efficacy, and significant treatment benefits for patients., laying the foundation for further clinical research.
Currently, colorectal cancer is the third most common malignant tumor globally and ranks second among the causes of death from malignant tumors. It has become one of the cancer types that seriously threaten human health. Although there have been significant improvements in recent years in understanding the pathogenesis, prevention, and clinical management of colorectal cancer, its incidence and mortality rates have not shown a significant decreasing trend. The treatment outcomes remain unsatisfactory, especially for advanced metastatic colorectal cancer, where the available treatment options are limited and the efficacy is poor. There is an urgent need for new treatment approaches to meet clinical demands.
He Ting Ph.D.
Founder & CEO of Yimiao Shenzhou
Very excited to announce the latest research findings of IM96 in treating advanced metastatic colorectal cancer on the international academic stage of the ESMO Annual Congress. Colorectal cancer tends to recur and metastasize easily after multiple lines of treatment, and effective treatment options are very limited. IM96 has demonstrated encouraging safety and efficacy in clinical studies, providing not only a new and effective treatment option for patients with advanced metastatic colorectal cancer but also confidence in CAR-T cell therapy for solid tumors. Beijing Yimiaoshenzhou Medical Technology Co., Ltd. will further deepen its research and accelerate the clinical development of this drug to benefit a wide range of patients with advanced metastatic colorectal cancer as soon as possible.
It is reported that the ESMO (European Society for Medical Oncology) Annual Congress is one of the most influential academic conferences in the field of oncology worldwide. It focuses on delivering cutting-edge information on the latest cancer research and treatment, providing high-quality learning and exchange opportunities in oncology for oncologists and industry-related professionals from around the globe.
// About Yimiao Shenzhou //
Founded in 2015, Beijing Yimiaoshenzhou Medical Technology Co., Ltd., headquartered in Beijing, 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. It has a one-stop, self-developed gene and cell therapy R&D and industrialization platform, mastering multiple core technologies. The company was awarded the top prize in the finals of China's Disruptive Technology Innovation Competition, received clinical trial approvals for four Class 1 new drugs, and obtained Beijing's first Drug Manufacturing License for gene and cell therapies. Its R&D pipeline covers hematological malignancies such as lymphoma, leukemia, and myeloma, as well as solid tumors including liver cancer, colorectal cancer, gastric cancer, and pancreatic cancer, establishing itself as a leader in the gene and cell therapy field.
The company has undertaken more than 10 national and provincial-level scientific research projects, including the special project of the Ministry of Science and Technology's Key R&D Program and Beijing's major science and technology special projects. It is a national high-tech enterprise, a Beijing "Specialized, Precise, Unique, and Innovative" enterprise, a Zhongguancun Frontier Technology enterprise, a Zhongguancun High-tech enterprise, and a postdoctoral research workstation. The team has been honored with awards such as Beijing Science and Technology Nova, Zhongguancun High-end Leading Talent, Beijing Haiying Talent, Xinguomen Leading Talent, the Gold Award (First Place) in Tsinghua University President’s Cup Innovation Challenge, MIT Technology Review’s 35 Innovators Under 35, and Fortune magazine’s 40 Under 40 Business Elites.
