Eureka Therapeutics Announces US FDS Clearance of IND Application for Phase 1/2 Trial of ET140202 Artemis T-Cell Therapy, for the Treatment of Liver Cancer
EMERYVILLE, Calif.--(BUSINESS WIRE)--Jan 30, 2019--Eureka Therapeutics, Inc., a clinical stage biotechnology company developing antibody-TCR (AbTCR) T-cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ET140202 ARTEMIS™ T-cell therapy in AFP-positive patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer.
The Company plans to initiate its Phase 1/2 US multicenter clinical trial in the first half of 2019. The Phase 1 dose escalation portion of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ET140202. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose.
As previously reported in September 2018, Eureka presented data from a first-in-human study of ET140202 in China. The findings from the First Affiliated Hospital of Xi’An Jiaotong University demonstrated a favorable safety profile of ET140202 T-cell therapy in six patients with no observed cytokine release syndrome (CRS) or drug-related neurotoxicity. In addition, one patient in the i.v. arm of the study had a complete response. Overall, tumor regression was observed in three out of six patients.
“This is an exciting time for Eureka as we prepare to initiate our US clinical trial in patients with hepatocellular carcinoma,” said Cheng Liu, Ph.D., President and Chief Executive Officer of Eureka Therapeutics. “HCC is an area of significant unmet medical need and patient options are currently limited. We intend to advance ET140202 as rapidly as possible in the US and to build upon the experience from our promising proof-of-concept study in China.”
ABOUT LIVER CANCER
A highly unmet medical need, liver cancer is the second most common cause of cancer-related deaths, with roughly 600,000 patient deaths every year worldwide. Hepatocellular carcinoma (HCC) is the predominant type of liver cancer that occurs in approximately 31,500 newly diagnosed patients per year in the United States. General 5-year survival rate of liver and intrahepatic bile duct cancer in the United States is only 18%.
ET140202 utilizes Eureka’s proprietary ARTEMIS™ T-cell receptor platform engineered with a proprietary human TCR-mimic (TCRm) antibody to target an AFP-peptide/HLA-A2 complex on HCC cancer cells. Using its proprietary E-ALPHA® antibody discovery platform, Eureka developed a TCRm antibody to selectively bind an AFP peptide displayed on the cell surface by the HLA-A2 major histocompatibility complex (MHC).
ABOUT EUREKA THERAPEUTICS, INC.
Eureka Therapeutics, Inc. is a privately held clinical stage biotechnology company developing antibody-TCR (AbTCR) T-Cell Therapies for solid and hematological malignancies. Its core technology centers around its proprietary ARTEMIS™ AbTCR T-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 multiple solid and hematologic tumors.
Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com.
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CONTACT: Eureka Therapeutics, Inc.
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH OTHER SCIENCE FDA SCIENCE
SOURCE: Eureka Therapeutics, Inc.
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PUB: 01/30/2019 08:00 AM/DISC: 01/30/2019 08:01 AM