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Immunofoco Cleared to Begin CAR T Clinical Trial in US and China

NEW YORK – Immunofoco on Thursday said regulatory authorities in China and the US have approved investigational new drug applications, allowing it to begin a clinical trial of its EpCAM-targeted autologous CAR T-cell therapy IMC001.

The Shanghai-based company is developing IMC001 as a treatment for EpCAM-positive advanced gastrointestinal tumors including gastric cancer and gastroesophageal junction adenocarcinoma.

In an investigator-initiated clinical trial of IMC001, researchers identified a recommended dose and saw partial remissions in two out of five patients treated. One of the patients subsequently had successful surgery for gastric cancer and is alive 85 weeks after treatment. The other responding patient had a 48 percent reduction in tumor size by week 16.

Immunofoco's CAR T-cell therapies incorporate technologies designed to reduce on-target, off-tumor toxicity; effectively target heterogenous tumors; and prolong persistence of the cells in vivo.