On November 17, 2021 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported the initiation of ARYA-2, a Phase I/II open-label, dose escalation clinical trial of ET140203 ARTEMIS T-cell therapy in pediatric patients with relapsed or refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC) (Press release, Eureka Therapeutics, NOV 17, 2021, View Source [SID1234595745]). The Phase I portion of the ARYA-2 study is now open for enrollment at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center.
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"Relapsed or refractory pediatric liver cancers are rare, have limited treatment options, and remain difficult to treat," said Dr. Allison F. O’Neill, Clinical Director of the Solid Tumor Program, Director of Medical Therapies of the Liver Tumor Center of Excellence at Dana-Farber/Boston Children’s, and principal investigator of the clinical trial. "Engineered T-cell therapies have the potential to transform the outcome of patients with difficult-to-treat liver cancers. We are thrilled to work with Eureka Therapeutics and initiate a trial of ET140203 T-cell therapy for pediatric and adolescent patients with relapsed or refractory liver tumors."
The ARYA-2 trial is part of Eureka’s liver cancer program portfolio and is being run in parallel with Eureka’s ongoing ARYA-1 and ARYA-3 trials to evaluate ARTEMIS T cells in adult patients with HCC. With ARYA-1, ET140203 ARTEMIS T cells target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. With ARYA-3, ECT204 ARTEMIS T cells target the Glypican 3 (GPC3) protein found on liver cancer cells.
"Eureka recognizes the highly unmet medical need in treating pediatric patients with advanced liver cancers," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "We are pleased to be working with Dana-Farber to address it by bringing ARTEMIS T-cell therapies to patients in the clinics."
The US. Food and Drug Administration (FDA) has granted ET140203 Fast Track Designation for the treatment of HB and HCC in pediatric patients, and Rare Pediatric Disease Designation (RPDD) for the treatment of HB.
ABOUT THE FDA FAST TRACK AND RPDD DESIGNATIONS
The FDA’s Fast Track Designation facilitates and expedites the development and review of new drugs intended to treat serious or life-threatening diseases or conditions with unmet medical needs. Fast Track Designation allows early and frequent communication between the FDA and the company to expedite development, review, and potential marketing application of ET140203.
The FDA’s Rare pediatric disease designation is designed to encourage the development of drug candidates addressing serious or life-threatening rare diseases or conditions in children. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval for a drug candidate of such designation may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
ABOUT THE CLINICAL TRIAL AND ET140203
The ARYA-2 study is an open-label, dose escalation, multi-center, Phase I/II clinical trial designed to assess the safety/tolerability and preliminary efficacy of ET140203 T cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory HB, HCN-NOS, or HCC. Additional information about Eureka’s Phase I/II study may be found at ClinicalTrials.gov, using Identifier NCT: NCT04634357.
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.