Full Press Release Details
Enlivex Announces Dosing of the First Patient in Phase I/II Trial Evaluating
Allocetra Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors
Nes-Ziona, Israel, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics
Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that
the first patient has been dosed in a Phase I/II clinical trial designed to evaluate the safety, tolerability and preliminary efficacy
of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.
Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated
"Our team is continuing to focus on execution of our strategic and operating plan across our various clinical development verticals,
with an ongoing sepsis Phase II clinical trial and two ongoing oncology Phase I/II clinical trials. We believe that AllocetraTM
has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to observing safety and potential
indication of effect in patients, who we expect to enroll in our open-label oncology trials during 2023.
ABOUT THE PHASE I/II TRIAL
The Phase I/II trial is a multicenter, open-label, dose escalation
trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine
escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a week for three consecutive
weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. Patients in
Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1 agent. The primary objective of the
study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra .
Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival.
Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint. The study population encompasses
adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved
therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.
Allocetra is being developed as a universal, off-the-shelf cell
therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram
macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective
diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action
for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination
with leading therapeutic agents.
Enlivex is a clinical stage macrophage reprogramming immunotherapy
company developing Allocetra , a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic
state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of
life-threatening conditions. For more information, visit http://www.enlivex.com.
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", "could,"
"intends," "estimates," "suggests," "has the potential to" and other words of similar
meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical
experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements
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 in the Company's most recent Annual Report on Form 20-F filed with the Securities
and Exchange Commission. 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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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