ImmunoFocu's Global First-in-Class EpCAM-Targeted CAR-T Therapy IMC001 Receives CDE Acceptance for New IND Application in Advanced Epithelial Solid Tumors
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
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On December 25, Immunofoco announced that the clinical trial application for a new indication of its self-developed EpCAM-targeted autologous CAR-T cell injection product (IMC001) has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Acceptance No.: CXSL2400901).Intended for the treatment of advanced epithelial solid tumorsPreviously, IMC001 received IND approval in both China and the US in February 2024 for the treatment of advanced digestive system tumors with positive EpCAM expression, marking it as the world's first CAR-T targeting EpCAM to be approved for IND.
EpCAM is a type I transmembrane glycoprotein that is uniformly and highly expressed on the membranes of various human epithelial-derived tumors, such as esophageal cancer, colorectal cancer, pancreatic cancer, ovarian cancer, lung cancer, gastric cancer, and breast cancer, while its expression in normal tissues is relatively low. In one study, EpCAM expression was not observed in 129 cases of normal gastric mucosa, but EpCAM expression was detected in 77% of gastric cancers, with 56% showing moderate to high expression. Another study showed that 100% of patients with metastatic breast cancer expressed EpCAM.Since EpCAM shifts from the basolateral surface to the cell membrane surface after malignant transformation of tumors, and is highly expressed in primary lesions, metastatic lesions, and circulating tumor cells, it has become a potential target for CAR-T cell therapy, showing potential application value in the treatment of various epithelial-derived tumors.。
In the poster presentations at the 2024 ASCO and CSCO meetings, the IIT clinical research data for IMC001 showed that, as of the cutoff date (March 31, 2024), among 10 late-line gastric cancer patients who had undergone at least one efficacy evaluation, IMC001 infusion demonstrated good safety and a 90% disease control rate (DCR). One patient in the low-dose group (1/3, 33.3%) and two patients in the medium-dose group (2/5, 40%) achieved PR. The median OS in the medium-dose group exceeded 55 weeks, with one patient confirmed to have achieved PR at week 24, successfully converted to receive surgical opportunity at week 27, and underwent radical gastrectomy; this patient had survived for over 22 months as of the cutoff date.
Dr. Sun Minmin, Founder, Chairman and CEO of ImmunofocoStated: "IMC001 is the first solid tumor CAR-T product initiated under the company’s 'Transform Solid Tumors into Hematological Tumors' strategy proposed during its early establishment. Since EpCAM is a biomarker of circulating tumor cells (CTC), and CTCs are the seeds of recurrence and metastasis, cutting off CTCs can prevent recurrence and metastasis, potentially offering long-term survival benefits for cancer patients. The new IND application for extended indications is based on its demonstrated safety and efficacy in the IIT study targeting advanced gastrointestinal tumors, as well as showing excellent anti-tumor effects in various animal tumor models such as triple-negative breast cancer. The high expression of EpCAM in multiple epithelial-derived tumors makes it a promising therapeutic target. IMC001 is expected to provide a new treatment option for patients with advanced epithelial solid tumors, addressing the urgent clinical need for effective therapies."
About Immunofoco
Immunofoco is a biotechnology company dedicated to breaking through solid tumor treatments and bringing long-term survival benefits to patients worldwide. The company, formed through the collaboration of scientists and industry elites, commenced operations in September 2020. Its core team successfully advanced the first CAR-T drug in China to the marketing application stage, boasting extensive experience in cell drug development and industrialization.
Immunofoco, starting from the pain points of solid tumor treatment and clinical benefits, has proposed the clinical strategy of "transforming solid tumors into hematological tumors" for the first time globally. Based on this, it developed the Peri Cruiser® technology platform and also created other platforms such as SNR and T-Booster, aiming to enhance the safety of CAR-T products, combat tumor heterogeneity, and improve their expansion and tumor infiltration capabilities.
The company has always been oriented towards clinical value, with a rich product pipeline. Among them, IMC002 (CLDN18.2 CAR-T) has been granted Fast Track designation by the U.S. FDA, as well as two Orphan Drug Designations (ODD) for gastric cancer and pancreatic cancer. Its IND application received dual approval in China and the U.S. in April 2023; IMC001 (EpCAM CAR-T) has conducted two IIT clinical studies, demonstrating good tolerable safety and preliminary efficacy. It received ODD designation from the U.S. FDA in August 2023, and its IND application received dual approval in China and the U.S. in February 2024; IMC008 (SNR CAR-T) has rapidly advanced to the IIT clinical research stage, receiving two ODD designations from the U.S. FDA in August 2023 for the treatment of gastric cancer and pancreatic cancer, respectively.
R&D Pipeline
Source: Immunofoco