April 06, 2023
Immunofoco Announces U.S. FDA and China CDE's Dual Approval of its IND Applications for CLDN18.2 CAR-T for the Treatment of Solid Tumors
China CDE recently approved the IND application for CLDN18.2 CAR-T (IMC002) following the previous approval by the U.S. FDA
MC002, the first CAR-T product based on a highly specific VHH nanobody, is an autologous CAR-T product targeting CLDN18.2
MC002 has showed good safety and efficacy in preclinical research and IITs with an excellent tolerance and preliminary efficacy in humans
Shanghai, China -- Immunofoco, a clinical-stage biotech company devoted to bringing revolutionary immune cell drugs to patients with solid tumors, announced that China Centre for Drug Evaluation (China CDE) recently approved the IND application for CLDN18.2 CAR-T (IMC002) following the previous approval of the same CAR-T by the U.S. FDA in March of 2023.
IMC002, the first CAR-T product based on a highly specific VHH nanobody, is an autologous CAR-T product targeting CLDN18.2 and has showed good safety and efficacy in preclinical research and investigator-initiated clinical trials (IITs) with an excellent tolerance and preliminary efficacy in humans. The highly specific VHH antibodies have equipped the CAR-T with a better safety and wider clinical dose window and range of clinical indications, including CLDN18.2-positive advanced digestive malignancies (gastric cancer/esophagogastric junction adenocarcinoma, advanced pancreatic cancer, etc.).
"The IND applications have been approved by both Chinese and the U.S. regulatory authorities, which fully reflects the team's industrialization and efficient execution capabilities, making IMC002 the first high-specificity nanobody-based CAR-T product targeting CLDN 18.2", said by Crystal Sun, the founder and CEO of Immunofoco, thanks to the professional and hard work, I believe we will develop more and better cell therapy products for patients with solid tumors and improve their survival quality."
Dr. Jianming Xu, a well-known physician scientist specialized in immunology in China, and the principal investigator of the IMC002 phase I clinical trial said: "as a kind of very promising treatment, CAR-T product targeting CLDN18.2 is also prone to serious adverse reactions. However, the nanobody of IMC002 has a high sequence specificity, and previous data has already shown that the CAR-T is well tolerated in humans. It is expected to balance the safety and efficacy well. I am highly looking forward to advancing the registration trial of IMC002 as soon as possible."
About Immunofoco
Founded by scientists and industry elites in September 2020 in Zhangjiang, Shanghai, Immunofoco is a clinical-stage biotech company committed to bringing long-term survival benefits to patients with solid tumors by developing revolutionary immune cell drugs, and its executive committees have the experience of successfully advancing the regulatory approval of the first CAR-T drug in China.
We focus on CAR-T clinical treatment barriers of the solid tumors and have adopted the strategy of “curing the solid tumors by treating them as hematologic malignancies”. Our product pipeline includes Peri Cruiser®, SNR, T-Booster and other innovative platforms to further reduce CAR-T cells’ toxicities, improve their expansions, tumor infiltrations and treatment efficacy. Immunofoco’s mission is to bring survival benefits to cancer patients by leveraging internal and external resources to pursue effective CAR-T therapy for solid tumors.
