▎WuXi AppTec Content Team ReportOn February 23, Immunofoco announced its independently developedAutologous CAR-T Cell Injection Targeting EpCAMFollowing the approval of IMC001's clinical trial application by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, it has recently received clinical research authorization from the U.S. FDA for the treatment ofEpCAM-Positive Advanced Digestive System Tumors，Including but not limited to advanced gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJ).
Immunofoco is dedicated to breakthrough therapies for solid tumors, providing patients with immune cell treatment drugs that offer long-term survival benefits.. Starting from the pain points of solid tumor treatment and clinical benefits, the company proposed"Transforming Solid Tumors into Hematological Tumors"Clinical Strategy.According to Sun Yiping, founder, chairman and CEO of ImmunofocoDr. Sun Minmin"In an interview with the WuXi AppTec content team, we introduced: 'Drawing on the treatment experience of cell therapy in hematological tumors, we propose a combination treatment plan of ‘transforming solid tumors into hematological tumors.’That is, using surgical, interventional, and ablation methods to remove solid tumors, and using cell therapies such as CAR-T products to eliminate CTCs (circulating tumor cells) and micrometastases, combining both approaches to achieve a clinical effect of ‘1+1>2’.。”IMC001 is preciselyImmunofocoConducting Investigator-Initiated Trials (IIT) under the strategy of "Transforming Solid Tumors into Hematological Tumors"CAR-T Products。EpCAM is a biomarker of circulating tumor cells. It is highly expressed in both metastatic and primary sites of digestive system tumors, while its expression is low in normal tissues. Therefore, it is considered a promising therapeutic target for digestive system tumors, with a wide range of potential indications.IMC001 PreviouslyAwarded Orphan Drug Designation by the FDA in August 2023。Immunofoco's EpCAM CAR-T Clinical Research Progress Has Been Featured Multiple Times at International Conferences. At the 2022 European Society for Medical Oncology (ESMO) Annual Meeting, Immunofoco's EpCAM CAR-T Therapy Was Used forAdvanced Malignant Tumors of the Digestive SystemClinical Research Progress Debuts at the 2023 AmericanAmerican Society of Clinical Oncology (ASCO)During this period, Immunofoco also updated the clinical data of EpCAM CAR-T (IMC001).According to the Immunofoco press release, as of January 31, 2024, the IIT clinical trial for advanced gastric cancer has been confirmed.IMC001'sThe recommended dose is safe and effective,This dose groupTwo out of five patients were confirmed to have partial response (PR),Objective Response Rate (ORR）Up to 40%。One of the PR patients successfully converted to being eligible for surgery 30 weeks after a single infusion of IMC001 monotherapy and underwent radical gastrectomy.Survival Beyond 85 Weeks；Another PR patient had a 48% reduction in tumor size at week 16.The survival time of patients has significantly increased compared to historical data.Founder, Chairman and CEO of ImmunofocoDr. Sun MinminIndicates:"First of all, I would like to congratulate and thank the entire team,This is Immunofoco's second CAR-T product for solid tumors to receive IND approval in both China and the U.S.。EpCAM, as a target, shows great potential in CAR-T therapy for solid tumors because it is highly expressed in primary tumors, metastases, and circulating tumor cells. Approximately 90% of the population with gastrointestinal tumors express EpCAM, which can meet broader clinical needs.The FDA's approval of this IND means that IMC001 will be able to conduct broader clinical trials and collaborations on an international scale, and is expected to become a new option for patients with advanced gastrointestinal tumors worldwide.”
References:
[1] Approved Again! Immunofoco's Another Cell Therapy Product, EpCAM CAR-T IND, Granted Approval in Both China and the U.S. Retrieved Feb 23, 2024, From https://mp.weixin.qq.com/s/MeBR9yO7-Ap5p9xSTQ4mBw
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