Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ET140203 for the treatment of hepatoblastoma (HB), a rare childhood tumor in the liver that typically occurs in children under the age of 5.
“We are pleased to receive ODD for ET140203 following the FDA’s earlier grant of Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) designations to ET140203 for the treatment of HB,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “These designations highlight the significant unmet medical need for better pediatric liver cancer treatment options.”
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 (adult) and ARYA-2 (pediatric) studies use ET140203 ARTEMIS T cells directed with a TCR mimic antibody 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.
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.
About ARYA-2 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 hepatoblastoma (HB), hepatocellular malignant neoplasm, not otherwise specified (HCN-NOS), or hepatocellular carcinoma (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.
About Eureka Therapeutics, Inc.
Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA1 and ARYA2) and ECT204 (ARYA3), in Phase I/II US trials in patients with advanced liver cancer.
Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com.
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Source: Eureka Therapeutics, Inc.
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