Nes-Ziona, Israel, Sept. 23, 2019 — Enlivex Therapeutics Ltd. (Nasdaq:ENLV), a clinical-stage immunotherapy company, today announced the first presentation of its preclinical studies, which were designed to evaluate the combination of Enlivex’s Allocetra-OTS immunotherapy and CAR-T therapy designed for treating solid tumors. The results, detailed in an oral presentation today at the Joint IIS-ISCR Special 2019 Conference – The Cutting Edge of Immunology, Cancer and Immunoncology Research – showed significantly increased duration of survival and overall survival for study subjects who were treated with the combination therapy, as compared to stand-alone solid tumor CAR-T therapy. The results of these preclinical studies showed that the mechanism of action significantly increased the anti-tumor macrophage population surrounding the human solid tumor microenvironment in the subjects who were treated with the combination therapy.
“We believe that these initial findings underscore the potential benefit of the combination of Allocetra-OTS and CAR-T across several solid tumor types,” said Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex. “We believe that a combination regimen which targets two different, complementary, and non-overlapping mechanisms designed to harness the body’s own immune system to fight cancer has the potential to benefit patients and should be the subject of additional research. These findings are expected to be integrated with outcomes from a previous Phase IIa clinical trial of Allocetra in patients post bone-marrow transplantations, demonstrating prevention of cytokine storms – which could serve as a dual benefit to any anti-cancer therapy that induces severe immune reactions. The potential combination of increased efficacy against solid cancers while maintaining a balanced immune system is quite intriguing and planned to be be the focus of additional future studies.”
ALLOCETRATM by Enlivex was designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as “unmet medical needs”, including prevention or treatment of complications associated with bone marrow transplantations (BMT) and/or hematopoietic stem cell transplantations (HSCT); rgan dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.
ABOUT ENLIVEX
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve an out of control immune system (e.g. Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing. For more information, visit http://www.enlivex.com.
ABOUT JOINT IIS-ISCR SPECIAL 2019 CONFERENCE
The Joint IIS-ISCR Special Conference – The Cutting Edge of Immunology, Cancer and Immunoncology Research, is held on September 23-25, 2019 in Tel Aviv, Israel, and hosted by the Israel Immunological Society (IIS) the Israel Society for Cancer Research (ISCR). The conference covers cover a wide collection of topics in contemporary immunology and cancer research ranging from basic principles to translational breakthroughs. Attendees include world-class speakers that will discuss key areas in innate and acquired immunity, immune-oncology and clinical cancer therapy. Special sessions will focus on research hot spots including lymphocyte activation and exhaustion, checkpoint inhibitors, Immunotherapy, Inflammation and immunity, and mechanotransduction in the Immune System.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunitiesfor the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunitiesfor, ALLOCETRATM programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in Enlivex’s most recently filed Annual Report on Form 20-F. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
ENLIVEX CONTACT:
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivex-pharm.com
