On February 8, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ET140203 and ECT204 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Eureka Therapeutics, FEB 8, 2022, View Source [SID1234607861]).
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Eureka is currently recruiting patients in three Phase I/II clinical trials to investigate the safety and potential efficacy of ARTEMIS T cells that have been engineered to target specific liver cancer antigens. The ARYA-1 and ARYA-2 studies use ET140203 ARTEMIS T cells to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. The ARYA-3 study uses ECT204 T cells to target the Glypican 3 (GPC3) protein expressed on the surface of liver cancer cells.
"We are pleased to have received ODD for ET140203 and ECT204 just months after receiving FDA Fast Track Designation (FTD) for the treatment of hepatoblastoma (HB) and HCC in pediatric patients, and Rare Pediatric Disease Designation (RPDD) for the treatment of HB," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "These designations for Eureka’s clinical candidates underscore the significant unmet medical need for more effective liver cancer treatment options. We are committed to working closely with regulators, clinical investigators, patients and their families to advance these programs in the clinics."
Under the Orphan Drug Act, orphan drug status provides incentives, including tax credits, grants and waiver of certain administrative fees for clinical trials, and seven years of market exclusivity following drug approval.
ABOUT ET140203
ET140203 is an investigational therapy during which a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptor and infused back into the patient. Engineered ET140203 T cells express a TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on liver cancer cells. In addition, ET140203 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients.
ET140203 is currently being investigated in two of Eureka’s ongoing clinical studies, ARYA-1 and ARYA-2: The ARYA-1 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with AFP-positive HCC; the ARYA-2 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in pediatric subjects who are AFP-positive and have relapsed/refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and HCC.
ABOUT ECT204
ECT204 is an investigational ARTEMIS T-cell therapy targeting Glypican 3 (GPC3), a promising HCC antigen found in more than 70% of HCC cells. ECT204 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.
Additional information about the above studies may be found at www.clinicaltrials.gov, using Identifier NCT: NCT04502082, NCT04634357 and NCT04864054.