Eureka Announces FDA Allowance Of Investigational New Drug Application For ET190L1 ARTEMIS™ T Cell Therapy In Relapsed And Refractory CD19+ Non-Hodgkin Lymphoma
EMERYVILLE, Calif.–(BUSINESS WIRE)– Eureka Therapeutics, Inc., a clinical stage biotechnology company focused on improving the safety profile of T cell therapies and developing novel T cell therapies for the treatment of solid tumors, today announced U.S. Food and Drug Administration (FDA) allowance of its investigational new drug (IND) application and authorization to commence a Phase I clinical trial for ET190L1 ARTEMIS™ T cells in Relapsed and Refractory CD19+ Non-Hodgkin Lymphoma (NHL), including Chronic Lymphocytic Leukemia (CLL). Eureka expects to enroll the first patient in this trial in the first quarter of 2018.
ET190L1 ARTEMIS™ utilizes Eureka’s proprietary ARTEMIS™ T cell receptor platform and proprietary human anti- CD19 binder to target CD19-positive malignancies. In preclinical studies, ET190L1 ARTEMIS™ matched the cancer killing potency of current CAR-T therapies but with a dramatic reduction in the levels of inflammatory cytokines released. In addition, these studies have shown that ET190L1 ARTEMIS™ T cells are less exhausted and more naive and therefore, expected to have improved persistence in vivo. If confirmed in the clinic, this could result in a longer term therapeutic benefit to patients.
“We designed our ARTEMIS™ T cell receptor platform with the goal of improving upon the efficacy and safety of current T cell therapies” said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. “The agent has a novel receptor that better regulates T cell activation and cytokine release upon engagement with tumor cells, without sacrificing potency. The dangers and costs associated with cytokine release syndrome (CRS) and neurotoxicity are significant. If successful, we hope to apply our ARTEMIS™ T cell technology to a broader class of patients than can be treated with CAR-T therapies, as well as to lower the overall cost of T cell therapies. We are encouraged by the preclinical findings and look forward to quickly moving our therapy into clinical development as we continue to enhance our proprietary ARTEMIS™ platform of innovative T cell therapies for both liquid and solid tumors.”
The Principal Investigator for the Phase I clinical trial is David A. Rizzieri, M.D., Professor of Medicine, Section Chief of Hematologic Malignancies and Associate Director for Clinical Research at the Duke Cancer Institute, Duke University School of Medicine. “My team is excited to work with Eureka Therapeutics in bringing this innovative therapeutic approach to the clinic, which has the potential to reduce the serious side effects that I have seen in patients being treated with current approaches” said Dr. Rizzieri.
About Eureka Therapeutics, Inc.
Eureka Therapeutics, Inc. is a privately held clinical stage biotechnology company, headquartered in the San Francisco Bay area, focused on improving the safety profile of T cell therapies and developing T cell therapies for hematological malignancies and solid tumors. Its core technology platforms center around its proprietary ARTEMIS™ T cell receptor platform and proprietary E-ALPHA® phage display library for the discovery and engineering of human antibodies against intracellular targets via the MHCI complex. The company is developing a pipeline of novel cancer therapeutics targeting intracellular oncogenes as well as cell-surface antigens.
For more information, please visit: www.eurekainc.com
Eureka Therapeutics, Inc.
J.J. Liu, 510-654-7045
Kimberly Ha, 212-850-5612