Yimiao Shenzhou Unveils Promising Phase I Clinical Data of Novel BCMA-Targeted CAR-T Therapy INS21 for Relapsed/Refractory Multiple Myeloma at IMS 2023
Imunopharm
Developer of Gene and Cell Therapy Technologies
In recent years, China has made rapid progress in the research and treatment of myeloma,MoreMore and more中China Voice登上国际学术舞台，其中New technologies represented by CAR-T are rapidly emerging, gradually reaching the international forefront or leading standards, and are contributing Chinese wisdom to the improvement of myeloma treatment worldwide.
September 29, 2023, Mid-Autumn Festival, Athens, Greece,Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (referred to as "Yimiao Shenzhou" or "the Company") successfully unveiled globally the Phase I clinical research data of its self-developed CAR-T product INS21, based on the InstanCART rapid and efficient preparation process platform, for the treatment of relapsed/refractory multiple myeloma (r/r MM), at the 20th Annual Meeting of the International Myeloma Society (IMS) (one of the largest international conferences in the field of hematology worldwide). The data received widespread attention from both academia and industry in the global myeloma community.The study data were orally presented by Professor Liu Hui, Director of the Hematology Department at Beijing Hospital, in the form of a report at the Practical Aspects of Immunotherapy session (Abstract Number: OA-07). This is also one of only two Chinese myeloma treatment research achievements selected for the General Session at this conference.
Conference Venue (Photo from the IMS official website)
As of May 2023, the Phase I clinical trial (NCT04537442) evaluating the safety and efficacy of a single infusion of InstanCART cell product for r/r MM enrolled 22 patients. All patients completed at least one month of follow-up after receiving CAR-T infusion, with 15 patients treated at a dose of 1.0×10.6Patients were enrolled in the conventional CAR-T cell group at a dose of CAR-T cells/kg, with 7 patients receiving 2×107T cells (per person) dosing enrolled in the InstanCART cell group.
The data from this clinical trial study shows:
In terms of safety:No ≥3 grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or Cytokine Release Syndrome (CRS) was observed in either the InstanCART group or the conventional CAR-T group, and all toxicities were fully reversible. InstanCART demonstrated excellent safety comparable to conventional CAR-T.
In terms of effectiveness:The best objective remission rate (ORR) of the traditional CAR-T group was 93% (14/15), including 8 cases of sCR, 2 cases of CR, 2 cases of VGPR, 2 cases of PR, and 1 case of SD. In contrast, the best ORR of the InstanCART group reached 100% (7/7), including 3 cases of sCR, 1 case of VGPR, and 3 cases of PR, demonstrating superior treatment efficacy compared to the traditional CAR-T group. Moreover, patients in the InstanCART group had a higher probability of converting to sCR three months after CAR-T infusion, indicating better long-term efficacy compared to traditional CAR-T.
Pharmacokinetics:InstanCART Cell Group: Maximum Cell Count (Cmax) in Peripheral Blood and AUC from 0 to 28 Days (Cmax=297×107/L, AUC0-28d=2854×107/L) Much higher than the traditional CAR-T cell group (Cmax=59.1×107/L, AUC0-28d=708.6×107/L). InstanCART cells transfer the in vitro culture expansion phase into the patient's body, allowing CAR-T cells with stronger stemness to better exert their anti-tumor effects. As a result, InstanCART cells achieve comparable clinical therapeutic effects at significantly lower doses than traditional CAR-T cells.
In summary, the research shows that,InstanCART CellsCompared with traditional CAR-T cells, it has shown promise in treating relapsed or refractory multiple myeloma (r/r MM).Good safety, effectiveness, and anti-tumor efficiency, with stronger tumor suppression and in vivo expansion efficiency at lower doses, showing promising clinical application prospects.
He TingPh.D.
Founder & CEO of Yimiao Shenzhou
It is a great honor to orally share the latest research findings of Beijing Yimiaoshenzhou Medical Techology Co., Ltd.'s new CAR-T product, INS21, with the global myeloma academic community at the IMS 2023 Annual Meeting. As a highly disruptive and revolutionary CAR-T therapeutic product, the safety and efficacy data demonstrated by INS21 are highly anticipated. It is expected to break through the traditional pain points of long production cycles and high production costs for CAR-T cell therapies, significantly improving patient access to treatment. Moving forward, we will accelerate the pace of clinical development to bring this novel CAR-T therapy to a broad population of myeloma patients as soon as possible, making domestically developed CAR-T drugs accessible to households across China.
INS21 is a next-generation CAR-T cell therapy product independently developed by Beijing Yimiaoshenzhou Medical Technology Co., Ltd., targeting BCMA for the treatment of r/r MM. It employs the 4th generation CAR-T design and the highly efficient and rapid InstanCART cell preparation process, significantly reducing the production time of autologous CAR-T cells from the industry standard of 9 to 14 days to within 3 days.
Previously, the research data of this product had beenGlobally announced at the 64th ASH Annual Meeting in 2022, attracting attention within the industry.. At the same time, the product has also demonstrated disruptive and revolutionary application potential in the treatment of r/r MM, winning several government and industry awards, includingThe First Prize Winner of the 2022 China Disruptive Technology Innovation Competition Finals, Hosted by the Ministry of Science and TechnologyTop 100 Most Innovative Medical Technology Products & Solutions in 20222023 Zhongguancun Forum International Technology Trade Conference "Top 100 New Technologies and Products List"。
// About Yimiao Shenzhou //
Founded in 2015 and headquartered in Beijing, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. is driven by the mission of "making cancer no longer an incurable disease." It is a leading innovative biopharmaceutical company at the clinical stage, focusing on applying cutting-edge gene and cell drug technologies to treat major diseases (such as cancer and autoimmune diseases). To date, the company has completed nine rounds of strategic financing. It owns a one-stop, self-developed gene and cell drug R&D and industrialization platform, mastering several core technologies. It was awarded the top prize for disruptive technological innovation in the national finals competition, received four clinical trial approvals for Class I new drugs, and obtained Beijing’s first-ever Manufacturing License for gene and cell drugs. Its R&D pipeline covers hematological cancers such as lymphoma, leukemia, and myeloma, as well as solid tumors like 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/ministerial-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 Stars, Zhongguancun High-end Leading Talents, Beijing Haiying Talents, Xinguomen Leading Talents, the Gold Award (First Place) at Tsinghua University President’s Cup Innovation Challenge, MIT Technology Review’s 35 Innovators Under 35, and Fortune magazine’s 40 Under 40 Business Elites.
