FDAnews
www.fdanews.com/articles/209892-eureka-therapeutics-receives-orphan-drug-designation-for-et140203

Eureka Therapeutics Receives Orphan Drug Designation for ET140203

October 21, 2022

Eureka Therapeutics has received an Orphan Drug designation for its investigational therapy ET140203 for the treatment of hepatoblastoma, a rare liver tumor that usually occurs in children under five years old.

The cell therapy involves the collection of a patient’s T cells which are modified to express Eureka’s proprietary ARTEMIS T cells — the acronym stands for antibody redirected T cells with endogenous modular immune signaling — and are then infused back into the patient. The ARTEMIS T cells are designed to target specific types of cancer.

The company is recruiting patients in three phase 1/2 clinical trials to investigate the efficacy and safety of ARTEMIS T cells, including one pediatric study evaluating ET140203.

The FDA grants Orphan Drug status to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States.

View today's stories