FDA has granted Investigational New Drug (IND) approval to Immunofoco’s investigational chimeric antigen receptor (CAR-T-cell therapy), IMC001, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).
This marks a significant step forward with promising results from the phase 1 clinical trial (NCT05028933) in developing CAR-T for solid tumors.
Immunofoco’s CEO, Dr. Crystal Sun, expressed her gratitude to the entire team, highlighting the significance of the company’s achievement: securing dual IND approval for a second CAR-T product targeting solid tumors in both the US and China.
Dr. Sun acknowledged the potential of EpCAM as a target for CAR-T therapy due to its widespread presence in various tumor types, including primary, metastatic, and circulating cells.
She emphasized the broader clinical need addressed by CAR-T therapy, as nearly 90% of patients with gastrointestinal tumors express EpCAM.
With the US and Chinese IND approvals, IMC001 is now poised for further clinical trials and international collaborations, potentially establishing itself as a promising new treatment option for patients with advanced GI and solid tumors worldwide.
Source: Immunofoco Announces the Dual Approval of IND Applications by the US FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors
https://www.prnewswire.com/news-releases/immunofoco-announces-the-dual-approval-of-ind-applications-by-the-us-fda-and-china-cde-for-the-first-epcam-car-t-targeted-at-advanced-solid-tumors-302069603.html
