Hepatocellular Malignant Neoplasm, NOS

Emeryville, California, April 2nd, 2024 – Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced the activation of UCSF Benioff Children’s Hospitals as the first California site to join the ARYA-2 clinical trial (NCT04634357). The ARYA-2 trial is evaluating Eureka’s investigational ARTEMIS® ET140203 T-cell therapy which targets the alpha-fetoprotein (AFP)-peptide/HLA-A2 complex. This therapy is designed to treat pediatric subjects (1 to 21 years) with relapsed or refractory liver cancer, including hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and hepatocellular carcinoma (HCC). “Multiply relapsed or refractory liver cancers in children and adolescents are highly complex and lack effective treatment options, especially given the rarity of these conditions,” said Dr. Arun Rangaswami, MD, Professor of Clinical Pediatrics and a senior solid tumor faculty member at UCSF. “We are excited to collaborate with Eureka to bring the promise of next-generation engineered T-cell therapy to this pediatric population with high unmet medical needs.” “We are proud to contribute to the collaborative effort aimed at developing cutting edge therapies for treating pediatric cancer ,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development, at the California Institute for Regenerative Medicine (CIRM). “Our recent $10.6 million grant towards Eureka’s ARYA-2 program underscores our commitment to improving the lives of young patients battling cancer.” “Our ARTEMIS T-cells are designed to overcome challenges in safely and effectively treating solid tumors,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “UCSF’s participation significantly accelerates progress in bringing this potentially life-saving therapy to young patients with liver cancer.” This expansion builds upon Eureka’s ongoing efforts with the ARYA-2 trial, which is also actively recruiting patients at the Dana-Farber Cancer Institute. For more information on the ARYA-2 trial, Eureka’s T-cell therapy platform, and the potential of this treatment, please visit eurekaconnectme.com. 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 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), 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. ARTEMIS and E-ALPHA are registered trademarks owned by Eureka. About the California Institute for Regenerative Medicine (CIRM) At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov CONTACTS: Eureka Therapeutics, Inc. Natalie Liu Investor Relations 510-318-9215 IR@eurekainc.com

EMERYVILLE, Calif.--(BUSINESS WIRE)-- Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced the activation of UCSF Benioff Children’s Hospitals as the first California site to join the ARYA-2 clinical trial (NCT04634357). The ARYA-2 trial is evaluating Eureka’s investigational ARTEMIS® ET140203 T-cell therapy which targets the alpha-fetoprotein (AFP)-peptide/HLA-A2 complex. This therapy is designed to treat pediatric subjects (1 to 21 years) with relapsed or refractory liver cancer, including hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and hepatocellular carcinoma (HCC). “Multiply relapsed or refractory liver cancers in children and adolescents are highly complex and lack effective treatment options, especially given the rarity of these conditions,” said Dr. Arun Rangaswami, MD, Professor of Clinical Pediatrics and a senior solid tumor faculty member at UCSF. “We are excited to collaborate with Eureka to bring the promise of next-generation engineered T-cell therapy to this pediatric population with high unmet medical needs.” “We are proud to contribute to the collaborative effort aimed at developing cutting edge therapies for treating pediatric cancer,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development, at the California Institute for Regenerative Medicine (CIRM). “Our recent $10.6 million grant towards Eureka’s ARYA-2 program underscores our commitment to improving the lives of young patients battling cancer.” “Our ARTEMIS T-cells are designed to overcome challenges in safely and effectively treating solid tumors,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “UCSF’s participation significantly accelerates progress in bringing this potentially life-saving therapy to young patients with liver cancer.” This expansion builds upon Eureka’s ongoing efforts with the ARYA-2 trial, which is also actively recruiting patients at the Dana-Farber Cancer Institute. For more information on the ARYA-2 trial, Eureka’s T-cell therapy platform, and the potential of this treatment, please visit eurekaconnectme.com. 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 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), 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 . ARTEMIS and E-ALPHA are registered trademarks owned by Eureka. About the California Institute for Regenerative Medicine (CIRM) At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to

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 and ECT204 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. 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 , using Identifier NCT: NCT04502082, NCT04634357 and NCT04864054. 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.