ET140203 / Eureka Therap, JW (Cayman) Therap - LARVOL DELTA

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Eureka Therapeutics Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • AFP

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Eureka Therapeutics Inc. | N=12 ➔ 6 | Trial completion date: Jun 2026 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2024 ➔ Jun 2023; Directing efforts to the pediatric study (ARYA-2) for this product

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • AFP

Eureka Therapeutics Announces UCSF Benioff Children’s Hospitals as First California Site for ARYA-2 Clinical Trial Targeting Pediatric Liver Cancers (Businesswire) - "Eureka Therapeutics, Inc...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."

Trial status • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Eureka Therapeutics Inc. | Phase classification: P2 ➔ P1/2 | Trial completion date: Jun 2024 ➔ Jun 2026 | Trial primary completion date: Jan 2024 ➔ Apr 2024

Metastases • Phase classification • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • AFP

Eureka Therapeutics Awarded $10.6 Million CIRM Grant to Support Clinical Trial of ARTEMIS T-Cell Therapy in Pediatric Liver Cancer (Businesswire) - "Eureka Therapeutics, Inc...announced that the California Institute for Regenerative Medicine (CIRM) awarded the Company a $10.6 million grant to support its ongoing ARYA-2 Phase I study of ET140203 for the treatment of pediatric patients with refractory/relapsed liver cancer, including hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and hepatocellular carcinoma (HCC)."

Financing • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Eureka Therapeutics Inc. | N=50 ➔ 12 | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • AFP

ARYA-2: ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Eureka Therapeutics Inc. | N=25 ➔ 15 | Trial completion date: Feb 2026 ➔ Jan 2028 | Trial primary completion date: Feb 2024 ➔ Jan 2026

Enrollment change • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pediatrics • Solid Tumor • AFP

ARYA-2: ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Eureka Therapeutics Inc. | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Feb 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pediatrics • Solid Tumor • AFP

"FDA Grants Orphan Drug Designation to ET140203 T Cells for Hepatoblastoma https://t.co/BcQ0CyFU2K via @CancerNetwrk" (@intraccsurvivor)

FDA event • Orphan drug • Gastrointestinal Cancer • Hepatoblastoma • Hepatology • Oncology • Solid Tumor

Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatoblastoma with ET140203 ARTEMIS T cells (Businesswire) - "Eureka Therapeutics...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....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."

Orphan drug • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Oncology • Solid Tumor

Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatocellular Carcinoma (HCC) With ARTEMIS T Cells (Businesswire) - "Eureka Therapeutics...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."

Orphan drug • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

ARYA-2: ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2; N=25; Recruiting; Sponsor: Eureka Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pediatrics • Solid Tumor

Eureka Therapeutics Announces Initiation of Phase I/II ARYA-2 Clinical Trial of ET140203 ARTEMIS T Cells to Treat Pediatric Liver Cancer (Businesswire) - "Eureka Therapeutics, Inc...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 study is now open for enrollment at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center."

Trial status • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Eureka Therapeutics Inc.; Initiation date: Nov 2020 ➔ Feb 2021

Clinical • Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

ARYA-2: ET140203 T-Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2; N=25; Not yet recruiting; Sponsor: Eureka Therapeutics Inc.

Clinical • New P1/2 trial • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pediatrics • Solid Tumor

Eureka Therapeutics Announces Initiation of ARYA-1 Clinical Trial to Evaluate ET140203 ARTEMIS T Cell Therapy in Hepatocellular Carcinoma (Businesswire) - “Eureka Therapeutics, Inc…announced the Company has initiated a Phase I/II clinical trial of its ET140203 ARTEMIS® T cell therapy in adult patients with hepatocellular carcinoma (HCC), the predominant type of liver cancer. The Phase I portion of the ARYA-1 study is now open for enrollment.”

Enrollment open • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology