Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra™ in Patients with Osteoarthritis
October 30 2024 - 8:00AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a
clinical-stage macrophage reprogramming immunotherapy company,
today announced that the Japanese Patent Office issued a notice of
allowance for patent application number 2022-512861 titled
“THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. Once
issued, the resulting patent will provide Enlivex with added
intellectual property (IP) protection through at least 2040. The
Company expects that this new patent will be formally issued in
Japan by the end of the second quarter of 2025.
Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex,
commented, “this notice of allowance demonstrates our commitment to
protecting Allocetra’s™ commercial opportunities in key geographies
around the world. We also believe that it highlights the successful
execution of our global IP strategy. Going forward, we will
continue to pursue multiple layers of patent protection in key
global markets as we work to develop Allocetra™ as a next
generation cell therapy for osteoarthritis, which is an unmet
medical need that currently has poor treatment alternatives.”
ABOUT KNEE OSTEOARTHRITIS1
Osteoarthritis is by far the most common form of arthritis,
affecting more than 32.5 million Americans and more than 300
million individuals worldwide. About half of knees with ACL
injuries develop osteoarthritis within 5 to 15 years. 78 million
Americans are projected to have osteoarthritis by the year 2040.
Symptomatic knee osteoarthritis is particularly prevalent and
disabling, with 40% of men and 47% of women developing knee
osteoarthritis in their lifetimes. Osteoarthritis accounts for over
one million hospitalizations annually in the United States,
primarily for total joint replacement. The burden of osteoarthritis
is enormous, and the need for treatments that reduce pain and
attendant disability for persons with osteoarthritis is critical.
There are currently no medications approved by either the U.S. Food
and Drug Administration (FDA) or the European Medicines Agency
(EMA) that have been demonstrated to arrest, slow or reverse
progression of structural damage in the joint.
ABOUT ENLIVEX
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 https://enlivex.com/.
ENLIVEX CONTACT Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd. shachar@enlivexpharm.com
INVESTOR RELATIONS CONTACT Dave Gentry, CEO
RedChip Companies Inc. 1-407-644-4256
ENLV@redchip.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 the timing and receipt of
intellectual property protection for ALLOCETRATM programs 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.
1 Source: The Arthritis Foundation; Disease modification in
osteoarthritis; pathways to drug approval, Katz et. Al.,
Osteoarthritis and Cartilage Open (2) (2020)
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