Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, announced the Company has initiated a Phase I/II clinical trial of its ET140203 ARTEMIS T cell therapy in adult patients with hepatocellular carcinoma (HCC), the predominant type of liver cancer. The Phase I portion of the ARYA-1 study is now open for enrollment.

ET140203 follows on the experience gained from Eureka’s study of ET140202. ET140202 and ET140203 utilize Eureka’s proprietary ARTEMIS cell receptor platform engineered with a TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on HCC cancer cells. ET140203 ARTEMIS? T cells also incorporate Eureka’s proprietary tumor infiltration technology which has demonstrated a favorable safety profile and enhanced ability to infiltrate solid tumors in animal models – potentially leading to improved efficacy in patients.

“We are very excited to initiate our ET140203 ARYA-1 clinical trial,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “We believe that poor infiltration of T cells into solid tumors is a significant barrier to developing T cell therapies with curative potential. ET140203 can potentially address this limitation associated with the current generation of CAR and TCR therapies, and we are pleased to be able to bring this therapy into the clinic.”

The ARYA-1 study is a multi-center, open-label, dose escalation clinical trial of ARTEMIS T cell therapy to initially assess the safety and tolerability of ET140203 T cells in adult patients with AFP-positive HCC and to determine the recommended phase II dose (RP2D). The first site is at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, based in Duarte, California.

Liver cancer is the fourth leading cause of cancer death worldwide, accounting for an estimated 782,000 deaths in 2018. About 43,000 new cases, and 30,000 deaths from liver cancer are expected to occur in the U.S. in 2020. The rate of liver cancer diagnosis has more than tripled since 1980, according to the American Cancer Society. Patients with advanced HCC have a poor prognosis and limited treatment options.