Full Press Release Details
Enlivex Receives Allocetra IND Clearance
From The U.S. Food And Drug Administration For Treatment Of Patients with Advanced Solid Malignancies
Israel, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage
reprogramming immunotherapy company, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational
New Drug (IND) application to study Allocetra in patients with advanced solid malignancies. The FDA's Phase I/II clearance
follows a recent announcement by the Company that the first patient has been dosed in a Phase I/II multi-center clinical trial in Israel
designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra stand-alone, and in combination with a PD1 checkpoint
inhibitor, in patients with advanced solid tumors.
Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated "We are pleased with the FDA's regulatory clearance for our
IND. The formal initiation of clinical development of AllocetraTM for oncology indications in the United States represents
a significant milestone for Enlivex. We believe that AllocetraTM has the potential to provide a paradigm shift in the 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 several open-label Company-sponsored and investigator-initiated oncology trials during 2023."
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.
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.
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.