Eureka Therapeutics Announces FDA Clearance of IND Application for Phase 1/2 Trial of ET140202 Artemis T-Cell Therapy

Eureka Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ET140202 ARTEMIS T-cell therapy in AFP-positive patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer.

The Company plans to initiate its Phase 1/2 US multicenter clinical trial in the first half of 2019. The Phase 1 dose escalation portion of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ET140202. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose.

As previously reported in September 2018, Eureka presented data from a first-in-human study of ET140202 in China. The findings from the First Affiliated Hospital of Xi’An Jiaotong University demonstrated a favorable safety profile of ET140202 T-cell therapy in six patients with no observed cytokine release syndrome (CRS) or drug-related neurotoxicity. In addition, one patient in the i.v. arm of the study had a complete response. Overall, tumor regression was observed in three out of six patients.

“This is an exciting time for Eureka as we prepare to initiate our US clinical trial in patients with hepatocellular carcinoma,” said Cheng Liu, Ph.D., President and Chief Executive Officer of Eureka Therapeutics. “HCC is an area of significant unmet medical need and patient options are currently limited. We intend to advance ET140202 as rapidly as possible in the US and to build upon the experience from our promising proof-of-concept study in China.”