Yimiao Shenzhou Presents Phase I Data of IM96 CAR-T Therapy at ASCO 2024, Demonstrating a Best ORR of 50% in Metastatic Colorectal Cancer
Imunopharm
Developer of Gene and Cell Therapy Technologies
June 2, 2024 (Central Time), Chicago, USA, Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (hereinafter referred to as "Yimiao Shenzhou" or "the Company") inAt the American Society of Clinical Oncology (ASCO) Annual Meeting, Phase I clinical research data for IM96, a self-developed CAR-T cell therapy product for solid tumors, was announced for the treatment of advanced metastatic colorectal cancer (mCRC).The study was orally presented by Professor Changsong Qi from the Department of Gastrointestinal Oncology, Peking University Cancer Hospital, at the conference.(Abstract No.: 2518). This is the second time that the clinical research data of IM96 for the treatment of mCRC has been selected for a major international oncology conference, following the ESMO 2023 Congress.
IM96 Report Site
ASCO Report Information
Abstract No.:2518
English Title：Phase I Study of GUCY2C CAR-T Therapy IM96 in Metastatic Colorectal Cancer Patients
English Title:Phase I Clinical Study of GUCY2C CAR-T Therapy IM96 in Patients with Metastatic Colorectal Cancer
Sub-venue:Developmental Therapeutics-Immunotherapy
Report Format:Oral Report
Reporter:Professor Changsong Qi, Department of Gastrointestinal Oncology, Peking University Cancer Hospital
Colorectal cancer is the third most common cancer globally and has the second highest mortality rate. Approximately half of the patients are already in the advanced stage at the time of diagnosis, with the liver being the primary organ for colorectal cancer metastasis.Patients with advanced colorectal cancer have very limited drug options for third-line and subsequent treatments, andResponse rate less than 5%, especially the treatment of patients with liver metastases is a challenge.。
Guanylate Cyclase GUCY2C (GCC)Highly expressed on the surface of various gastrointestinal malignant tumor cells with intestinal metaplasia, particularly in colorectal cancer patients.Expression rate as high as 80%，and GCC is expressed in all stages of the occurrence and development of colorectal cancer. This target is restrictively expressed in the tight junctions of small intestine and colon epithelial cells in normal tissues, making it an ideal solid tumor target. IM96 is an autologous CAR-T product targeting GCC. This study is an open-label, dose-escalation and dose-expansion Phase I trial (NCT05287165), aiming to evaluate the safety, efficacy, and pharmacokinetic characteristics of IM96 in patients with advanced metastatic colorectal cancer (mCRC) who are GCC-positive and have failed ≥3 lines of treatment.
As of December 2023, this study has enrolled a total of 20 patients, each at a dose of 3×108（DL1）、6×108（DL2）、12×108(DL3) or 20×108(DL4) CAR-T cell dose for infusion therapy. The follow-up time for all patients was 7 to 19 months, with a median age of 52.5 years. Eleven patients (55%) had liver metastases, and all patients tested positive for pMMR/MSS.
Clinical research data are as follows:
In terms of safety:Only1 case (5.0%)The patient developed neurotoxicity and cytokine release syndrome (CRS) of grade ≥3. CRS of grade 1-2 occurred in 16 patients (80.0%), accompanied by a significant increase in interleukin-6. Additionally, rash of grade 1-3 occurred in 14 patients (70.0%), grade 3 diarrhea occurred in 11 patients (55.0%), and oral mucositis of grade 1-3 occurred in 7 patients (35.0%). These symptoms mainly appeared in the DL2, DL3, and DL4 dose groups. During the study period,All patientsAverageNo dose-limiting toxicity occurred, and the maximum tolerated dose was not reached.
In terms of effectiveness:In all patients,The disease control rate (DCR) reached 73.7%, and the objective response rate (ORR) reached 26.3%.。In the DL3 and DL4 groups,ORR reached 38.5%,Median Progression-Free Survival (mPFS) was 7 months, including patients with liver metastasesORR was 33.3% and mPFS was 7 months., all responding patients did not experience disease progression within 6 months. In the high-dose group, tumor tissueGCC positive rate greater than 20%The patient population showedORR of 50% and mPFS of 10 months。By contrast, the standard chemotherapy drug newly approved by the FDA in 2023 for the treatment of metastatic colorectal cancer, itsORR is only 1.6~4.7%, and mPFS is only 3.7~4.7 months.
This study demonstrates that IM96 exhibits favorable safety and sustained efficacy in the last-line treatment of patients with advanced metastatic colorectal cancer, particularly showing high therapeutic potential in patients with liver metastases.
He TingPh.D.
Founder & CEO of Yimiao Shenzhou
It is a great honor to announce the latest clinical research findings of IM96 in treating advanced metastatic colorectal cancer (mCRC) at the 2024 ASCO Annual Meeting, addressing the global clinical oncology community. mCRC has always been a significant challenge in the field of malignant tumor treatment. Currently, among the globally approved standard third-line treatments, the overall response rate (ORR) is extremely low, with the highest ORR being less than 5%. Additionally, the median progression-free survival (PFS) is relatively short, lasting only 3 to 4 months. Such efficacy rates and benefit durations clearly do not meet the treatment needs of the vast majority of patients.
As the company's self-developed CAR-T cell therapy product targeting GUCY2C for solid tumors, IM96 has demonstrated excellent safety and groundbreaking efficacy in clinical research. It provides a new and effective treatment option for patients with advanced metastatic colorectal cancer and brings hope for CAR-T cell drugs to overcome solid tumors. The next step for our team is to accelerate the clinical development of this drug, so that a large number of patients with advanced metastatic colorectal cancer worldwide can benefit as soon as possible.
Data shows that colorectal cancer has an annual global incidence of over 1.93 million new cases and more than 930,000 deaths, ranking third in incidence and second in mortality among major malignant tumors worldwide. It has become one of the most serious cancer threats to human health. Although there have been significant improvements in understanding the pathogenesis, prevention, and clinical management of colorectal cancer in recent years, its incidence and mortality rates have not shown a significant decreasing trend. Treatment outcomes remain unsatisfactory, especially for advanced metastatic colorectal cancer, where treatment options are limited and efficacy is poor. There is an urgent need for new therapeutic approaches to meet clinical demands.
It is reported that the 2024 ASCO Annual Meeting was grandly held in Chicago from May 31 to June 4. During the meeting, a series of wonderful academic reports, special seminars, and interactive activities were held, covering many hot topics such as the latest advances in the field of oncology, innovative drug development, and personalized treatment. During the 5-day conference, participants will have in-depth discussions on various aspects of cancer prevention and treatment, share innovative ideas and practical experience, and jointly contribute wisdom to solving the problem of cancer, a major health challenge for humanity.
// 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 drug 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 proprietary gene and cell drug R&D and industrialization platform, holding multiple core technologies. It has won the top prize in the finals of China’s Disruptive Technology Innovation Competition, received clinical trial approvals for 5 Class 1 new drugs, and obtained Beijing's first Drug Manufacturing License for gene and cell therapy products. Its R&D pipeline covers hematological cancers including lymphoma, leukemia, and myeloma, as well as solid tumors such as liver cancer, colorectal cancer, gastric cancer, and pancreatic cancer, positioning it as a leader in the gene and cell drug industry.
The company has undertaken more than 10 national and provincial-level scientific research projects, including the Special Research Project of the Ministry of Science and Technology's Key R&D Program, the "Challenge Leader" technical project for cell therapy by the National Innovation Center, and the Beijing Municipal Science and Technology Major Special Project. It is a National High-tech Enterprise, a Beijing-based specialized, refined, distinctive, and innovative enterprise, a Zhongguancun Frontier Technology Enterprise, a Zhongguancun High-tech Enterprise, as well as a postdoctoral research workstation. The team has been honored with awards such as Beijing Science and Technology Nova, Zhongguancun High-end Leading Talent, Beijing Haidian Haiying Talent, Xinguomen Leading Talent, the Gold Award (First Place) in 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.
