ET1402L1-ARTEMIS T cells / Eureka Therap - LARVOL DELTA

ET-109: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2; N=2; Terminated; Sponsor: Eureka Therapeutics Inc.; Completed ➔ Terminated; Reallocation of resources to new HCC study.

Clinical • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Clinical • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Neutropenia • Oncology • Solid Tumor • IFNG • IL10 • IL2 • IL4 • IL6 • TNFA

ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: First Affiliated Hospital Xi'an Jiaotong University; Recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Neutropenia • Oncology • Solid Tumor • IFNG • IL10 • IL2 • IL4 • IL6 • TNFA

ET-109: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2; N=2; Completed; Sponsor: Eureka Therapeutics Inc.; Active, not recruiting ➔ Completed; N=50 ➔ 2; Trial completion date: Oct 2022 ➔ Dec 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

ET-109: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eureka Therapeutics Inc.; Trial primary completion date: Jul 2022 ➔ Jan 2021

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

ET-109: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eureka Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Eureka Therapeutics completes $45 million series E financing and enters into strategic collaboration with Lyell Immunopharma (Businesswire) - “Eureka Therapeutics, Inc…announced that it has closed a $45 million Series E financing…In addition to the financing, Eureka and Lyell have entered into a strategic collaboration to develop therapies against several undisclosed solid tumor targets expressed across multiple cancer types…The Company will use proceeds from the Series E round to advance its proprietary TCR-mimic and antibody-TCR ARTEMIS® programs, including Eureka’s anti-AFP ARTEMIS® Phase I/II clinical trial in the United States for the treatment of hepatocellular carcinoma (HCC), the predominant type of liver cancer.”

Financing • Licensing / partnership • Trial status

Eureka Therapeutics to present at the CAR-TCR Summit Europe (Businesswire) - "Eureka Therapeutics, Inc...announced that its Director of Strategy and Business Development, Dr. Jingyi Xiang, will be presenting at CAR-TCR Summit Europe being held at the Novotel London West, London, United Kingdom on February 25, 2020...Title:...Novel Antibody-TCR Platform (ARTEMIS® T cells) Combines Fab-based Antigen Recognition with gamma/delta-TCR Signalling for Favorable Safety and Efficacy Profile in T Cell Immunotherapy....ET140202, the Company’s lead asset, is currently in a Phase I/II US multicenter clinical trial in patients with advanced hepatocellular carcinoma (HCC)."

Preclinical

ET140202 T-cell therapy for the treatment of liver cancer is built upon a novel antibody-T cell receptor (AbTCR) ARTEMIS™ T-cell platform (SITC 2019) - "ET140202 is built upon our novel AbTCR ARTEMIS(tm) T-cell platform, which was designed to harness the natural biology of T cells to fight cancer. Both in vitro cellular assays and in vivo mouse studies support the safety and efficacy of ET140202 T cells. Whether these pre-clinical findings for AbTCR-based ET140202 T-cell therapy translate into the clinical setting is currently being tested (clinicaltrial.gov, NCT0399803)."

IO Biomarker • PD(L)-1 Biomarker

Eureka Therapeutics to present at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (Businesswire) - "Eureka Therapeutics, Inc...announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, November 6-10, 2019, in National Harbor, Maryland. The presentation will highlight the company’s proprietary ARTEMIS™ antibody T-cell receptor (AbTCR) platform used to develop ET140202 for the treatment of hepatocellular carcinoma (HCC), the most predominant type of liver cancer."

Preclinical

ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: First Affiliated Hospital Xi'an Jiaotong University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Eureka Therapeutics announces initiation of phase 1/2 clinical trial of ET140202 ARTEMIS T-cell therapy in liver cancer (Businesswire) - "Eureka Therapeutics, Inc....announced initiation of Phase 1/2 clinical trial of ET140202 ARTEMIS™ T-Cell therapy in liver cancer at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, based in Duarte, California."

Trial status

ET-109: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma Who Are Not Candidates for Standard-Of-Care Therapy (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Eureka Therapeutics Inc.

Clinical • New P2 trial

ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Clinical • New P1 trial

ET140202 t-cells: A novel therapy targeting AFP/MHC complex, that is both safe and effective in treating metastatic hepatocellular carcinoma. (ASCO 2019) - "Herein we report a case study of ET140202 for a male subject with 3 liver HCC lesions, multiple lung metastases and with no response to sorafenib and regorafenib. ET140202 T cells has the potential to be used safely and effectively in AFP+/HLA-A2+ HCC to induce regression of primary and metastatic lesions."

Safety and efficacy of repeated intra-hepatic artery and intravenous infusion of ET140202, a novel anti-AFP/MHC complex T-cell, in advanced hepatocellular carcinoma. (ASCO 2019) - "Repeated infusion of ET140202 T cells via i.a. and i.v. routes is safe and shows early sign of efficacy 4 months post initiation of the treatment in AFP+/HLA-A2+ HCC subject."

Clinical