Full Press Release Details
Enlivex Announces Issuance of Israeli Patent
Covering the Use of Allocetra to
Prevent Cytokine Release Syndrome (CRS) Resulting
from CAR T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS
Nes-Ziona, Israel, Feb 15, 2023 (GLOBE NEWSWIRE) - Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced
the issuance of an Israeli patent, numbered 284985, entitled, "Combination Immune Therapy and Cytokine Control Therapy for Cancer
Treatment." The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use
of for Allocetra for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients
whose cytokine storms result from infectious diseases or non-infectious sources.
Oren Hershkovitz, PhD, CEO of Enlivex commented, "We are pleased
with the continued buildup of our comprehensive intellectual property portfolio for Allocetra ."
Infectious diseases covered by this patent include influenza, bird
flu, severe acute respiratory syndrome (SARS), Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis (HLH), sepsis, gram-negative
sepsis, malaria, an Ebola virus, a variola virus, a systemic Gram-negative bacterial infection, or Jarisch-Herxheimer syndrome, or wherein
said non-infectious stimuli, condition, or syndrome comprises is hemophagocytic lymphohistiocytosis (HLH), sporadic HLH, macrophage activation
syndrome (MAS), chronic arthritis, systemic Juvenile Idiopathic Arthritis (sJIA), Still's Disease, a Cryopyrin-associated Periodic
Syndrome (CAPS), Familial Cold Auto-inflammatory Syndrome (FCAS), Familial Cold Urticaria (FCU), Muckle-Well Syndrome (MWS), Chronic Infantile
Neurological Cutaneous and Articular (CINCA) Syndrome, a cryopyrinopathy comprising inherited or de novo gain of function mutations in
the NLRP3 gene, a hereditary auto-inflammatory disorder, acute pancreatitis, severe burns, a trauma, an acute respiratory distress syndrome,
an immunotherapy, a monoclonal antibody therapy, secondary to drug use, is secondary to inhalation of toxins, a lipopolysaccharide (LPS),
a Gram-positive toxins, fungal toxins, glycosylphosphatidylinositol (GPI), or modulation of RIG-1 gene expression.
CAR T-cells are T-cells that have been genetically modified to include
a receptor that allows them to specifically target and destroy cancer cells. While certain CAR T-cell treatments were recently approved
by the FDA in several cancer indications, such treatments have been associated in many patients with a side effect named cytokine release
syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways.
Preclinical data indicate that Allocetra has the potential to prevent or ameliorate cytokine release syndrome associated with CAR
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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