EMERYVILLE, Calif.--(BUSINESS WIRE)--Eureka Therapeutics, Inc., a clinical-stage biotechnology company advancing next-generation T-cell therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECT204, a GPC3-targeting ARTEMIS® CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.
The RMAT designation followed the FDA’s review of data from the completed Phase I cohort, together with additional clinical data, from Eureka’s ongoing Phase I/II ARYA-3 trial evaluating ECT204, an autologous ARTEMIS CAR T-cell therapy based on the AbTCR (Antibody-T Cell Receptor) architecture, in adult patients with GPC3-positive advanced HCC. RMAT designation, granted based on preliminary clinical evidence of potential to address unmet medical needs, provides the benefits of Breakthrough Therapy designation for regenerative medicines, including enhanced FDA interaction, alignment on development and manufacturing strategy, discussion of surrogate or intermediate clinical endpoints that may support accelerated approval, and eligibility for priority review of a future biologics license application (BLA).
“This represents an important inflection point for Eureka and for cell therapy in solid tumors,” said Dr. Cheng Liu, Founder and Chief Executive Officer of Eureka Therapeutics. “ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy.”
HCC is among the most biologically resistant solid tumors in oncology, characterized by an immunosuppressive tumor microenvironment that has posed significant challenges to the effectiveness of cell-based therapies. Unlike conventional CAR T cells that rely on a synthetically fused CD3-zeta (ζ) signaling domain linked to co-stimulatory molecules, which may contribute to constitutive activation and limited persistence in solid tumors, ARTEMIS CAR T cells were engineered using the AbTCR architecture and incorporate dual receptors that leverage human gamma delta (γ/δ) T cell receptor (TCR) signaling with co-stimulation delivered through separate receptors. This more natural TCR signaling design combines the precision of antibody-redirected tumor targeting with balanced and sustained T-cell activation, which may explain the improved tumor infiltration, persistence, and functional activity of the engineered T cells in hostile solid tumor environments.
The advantages of ARTEMIS CAR T cells over conventional CAR T cells have been validated by independent research conducted in collaboration with the National Cancer Institute, including NCI-led, peer-reviewed studies published in Cell Reports Medicine. In preclinical solid tumor models, ARTEMIS CAR T cells demonstrated significantly greater tumor infiltration and anti-tumor activity than conventional CAR T cells using the same antigen-binding domain, including in low antigen density settings that typically limit conventional CAR T efficacy.
ECT204 previously received FDA Orphan Drug Designation (ODD) in January 2022, reflecting the significant unmet need in advanced HCC. With RMAT designation in place, Eureka will work closely with the FDA to advance ECT204 through the ongoing ARYA-3 trial while continuing to build on the broader applicability of the ARTEMIS platform across different cancer indications.
About ECT204
ECT204 is an autologous T-cell therapy engineered with Eureka’s proprietary ARTEMIS CAR platform. Unlike conventional CAR T cells, ARTEMIS T cells are designed to mimic the natural biological regulation of T-cell activation, potentially improving safety, tumor infiltration, and persistence in solid tumors. ECT204 targets GPC3 (Glypican-3), an oncofetal antigen found on more than 70% of HCC cells but rarely on healthy tissues. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. 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.
About Eureka Therapeutics, Inc.
Eureka Therapeutics, Inc. is a privately held, clinical-stage biotechnology company developing next-generation T-cell therapies for the treatment of cancer. Its core technologies, the proprietary ARTEMIS® CAR and E-ALPHA® antibody discovery platforms, are designed to create safer and more effective T-cell therapies for solid and hematologic malignancies. The company currently has two ARTEMIS-based clinical programs, ET140203 (ARYA-2) and ECT204 (ARYA-3), in Phase I/II U.S. trials in patients with advanced liver cancer.
Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information, please visit www.eurekatherapeutics.com. ARTEMIS and E-ALPHA are registered trademarks of Eureka Therapeutics, Inc.
Contacts
Eureka Therapeutics, Inc.
Investor Relations
510-318-9215
IR@eurekainc.com
