Immunofoco Gets Approval to Begin Trials for IMC001

Immunofoco Gets Approval to Begin Trials for IMC001

By, Admin 27 February 2024

Immunofoco gets US FDA & China CDE approvals to begin clinical trial of IMC001 for EpCAM CAR-T targeted advanced solid tumours

Overview

Immunofoco, a company dedicated to developing cell therapy products for solid tumours, 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 US FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumours, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

About EpCAM

  • EpCAM serves as a biomarker for circulating tumour cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumours, while its expression in normal tissues is low. 
  • t has been identified as a promising therapeutic target for GI tumours with a wide range of expandable indications. 
  • MC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of ""curing the solid tumours by treating them as hematologic malignancies "". 
  • In August 2023, the product was granted Orphan Drug Designation (ODD) by the US FDA.

Trial Results

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.

Future Process

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 tumour size by week 16.

Words From Immunofoco

  • 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 tumours in both the US and China. 
  • Targeting EpCAM shows great potential for CAR-T treatment of solid tumours as it is highly expressed in primary, metastatic and circulating tumour cells. 
  • About 90% of the patients with gastrointestinal tumours 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 tumours on a global scale.

About Immunofoco

Immunofoco has pioneered a clinical strategy focused on “curing the solid tumours by treating them as hematologic malignancies”, addressing the challenges in solid tumour treatment, and the clinical advantages of treating hematologic malignancies.

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