Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

- The first EpCAM targeted CAR-T product obtained US/CN IND approval.

- Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001.

SHANGHAI, Feb. 23, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA.

The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) in 2022 and updated during the American Society of Clinical Oncology (ASCO) in 2023.

As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after  a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16.

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale.

About Immunofoco

Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser^®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) product obtained ODD from the U.S. FDA in July 2022, and its IND application has been approved in both the U.S. and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, with its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.