Eureka Therapeutics Announces Initiation of Phase I/II ARYA-2 Clinical Trial of ET140203 ARTEMIS® T Cells to Treat Pediatric Liver Cancer

EMERYVILLE, Calif.–(BUSINESS WIRE)–Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies for the treatment of solid tumors, today announced 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). The Phase I portion of the ARYA-2 trial is now open for enrollment at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center.

“Recurring or refractory pediatric liver cancers are rare, have limited treatment options, and remain difficult to treat,” says Dr. Allison F. O’Neill, clinical director of the Solid Tumor Program, director of medical therapies for 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 change the outcome of patients with difficult-to-treat liver cancers. We are excited to partner 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 study is part of Eureka’s portfolio of liver cancer programs and is being conducted in parallel with Eureka’s ongoing ARYA-1 and ARYA-3 studies 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 protein (GPC3) found on liver cancer cells.

“Eureka recognizes the highly unmet medical need in the treatment of pediatric patients with advanced liver cancer,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “We are excited to partner with Dana-Farber to address this by bringing ARTEMIS® T-cell therapies to patients in the clinics.”

The United States. 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 INDICATIONS

The FDA’s Fast Track Designation facilitates and accelerates the development and evaluation of new drugs intended to treat serious or life-threatening diseases or conditions with unmet medical needs. Fast Track Designation enables early and frequent communication between the FDA and the company to accelerate the development, review and potential marketing application of ET140203.

The FDA’s Rare Pediatric Disease designation is intended to encourage the development of drug candidates for the treatment of serious or life-threatening rare diseases or conditions in children. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor receiving approval for a drug candidate with such a designation may be eligible for a voucher that can be redeemed to receive a priority review from a next marketing request for another product.

ABOUT THE CLINICAL TRIAL AND ET140203

The ARYA-2 trial is an open-label, dose-escalation, multicenter, Phase I/II clinical trial designed to evaluate the safety/tolerability and preliminary efficacy of ET140203 T cells in pediatric subjects who are AFP-positive/ be HLA-A2. -positive and with relapsed/refractory HB, HCN-NOS or HCC. Additional information about Eureka’s Phase I/II trial can be found at ClinicalTrials.gov, using Identifier NCT: NCT04634357.

ET140203 is an investigational therapy that collects a patient’s T cells, designed to express Eureka’s proprietary ARTEMIS® cell receptor and infuse it back into the patient. Engineered ET140203 T cells express a TCR-mimicking antibody to target an alpha-fetoprotein (AFP) peptide/HLA-A2 complex to liver cancer cells. In addition, ET140203 ARTEMIS® T cells also contain Eureka’s patented tumor infiltration technology that demonstrates an improved 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 for the treatment of cancer. The core technology is based on the patented ARTEMIS® cell receptor platform and the 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 (ARYA-1 and ARYA-2) and ECT204 (ARYA-3), in Phase I/II US studies in patients with advanced liver cancer.

Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information about Eureka, visit www.eurekatherapeutics.com.

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