Longeveron Receives Intent to
Grant Notice from the European Patent Office for Methods to Monitor
Efficacy of Lomecel-B™ Cell Therapy Through Levels of Vascular
Biomarker
Issued claims will protect use of a
biomarker to assess response to Lomecel-B in patients with blood
vessel dysfunction.
Miami, Florida – August 25, 2022
-- InvestorsHub NewsWire -- Longeveron Inc. (NASDAQ:
LGVN), a clinical stage biotechnology company developing
cellular therapies for chronic, aging-related and life-threatening
conditions, today announced that the European Patent Office (EPO)
has issued a notice of its intent to grant the Company a patent (EP
Application No. 15861319.0) related to methods to treat endothelial
dysfunction and monitor the efficacy of allogeneic mesenchymal cell
therapies, also known as medicinal signaling cells (MSCs). The
cells are administered to patients with cardiovascular disease
through the monitoring of a protein, Vascular Endothelial Growth
Factor (VEGF), which is a
signal protein produced by many cells that stimulates the formation
of blood vessels.
"We are extremely pleased to receive
this notice from the European patent office," said Chris Min, M.D.,
Ph.D., Interim Chief Executive Officer and Chief Medical Officer at
Longeveron. "This patent will bolster our robust intellectual
property portfolio and support our goal of delivering effective
cell therapies for a range of aging-related and life-threatening
conditions."
The patent is titled "Methods for
Monitoring Efficacy of Allogeneic Mesenchymal Stem Cell Therapy in
a Subject." Longeveron's lead investigational product is
Lomecel-B™, a cell therapy product derived from MSCs. Many of
Longeveron's clinical studies point to Lomecel-B™ exerting affects
through pro-vascular functions and/or reducing endothelial
dysfunction, a condition where the lining of blood vessels are
abnormal leading to diminished health of blood vessels and blood
flow regulation.
The Company is evaluating the use of
MSCs to treat several indications, including Hypoplastic Left Heart
Syndrome (HLHS), a rare and life-threatening congenital heart
defect that affects approximately 1,000 babies per year. Longeveron
received both a Rare Pediatric Disease
Designation and Orphan Drug
Designation from the Food and Drug Administration in 2021
to test Lomecel-B™ on HLHS infants. Longeveron is currently
evaluating Lomecel-B™ in a Phase 2a trial.
Longeveron is also conducting a trial
of Lomecel-B in patients with Alzheimer's disease in the US and for
aging frailty in Japan.
Now that the European Patent Office
has issued an Intention to Grant, Longeveron will await grant of
the patent and then begin the process of registering the patent in
a number of nation members of the European Patent
Organization. In those jurisdictions where the patent is
registered, the patent is expected to expire in November of
2035.
About Longeveron
Inc.
Longeveron is a clinical stage
biotechnology company developing cellular therapies for specific
aging-related and life-threatening conditions. The Company's lead
investigational product is the Lomecel-B™ cell-based therapy
product, which is derived from culture-expanded medicinal signaling
cells (MSCs) that are sourced from bone marrow of young, healthy
adult donors. Longeveron believes that by using the same cells that
promote tissue repair, organ maintenance, and immune system
function, it can develop safe and effective therapies for some of
the most difficult disorders associated with the aging process and
other medical disorders. Longeveron is currently sponsoring Phase 1
and 2 clinical trials in the following indications: Alzheimer's
disease, hypoplastic left heart syndrome (HLHS), Aging Frailty, and
Acute Respiratory Distress Syndrome (ARDS). Additional information
about the Company is available at www.longeveron.com.
Cautionary Note Regarding
Forward-Looking Statements
Certain statements in this press
release that are not historical facts are forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, which reflect
management's current expectations, assumptions, and estimates of
future performance and economic conditions, and involve risks and
uncertainties that could cause actual results to differ materially
from those anticipated by the statements made herein.
Forward-looking statements are generally identifiable by the use of
forward-looking terminology such as "believe," "expects," "may,"
"looks to," "will," "should," "plan," "intend," "on condition,"
"target," "see," "potential," "estimates," "preliminary," or
"anticipates" or the negative thereof or comparable terminology, or
by discussion of strategy or goals or other future events,
circumstances, or effects. Factors that could cause actual results
to differ materially from those expressed or implied in any
forward-looking statements in this release include, but are not
limited to, statements about the ability of Longeveron's clinical
trials to demonstrate safety and efficacy of the Company's product
candidates, and other positive results; the timing and focus of the
Company's ongoing and future preclinical studies and clinical
trials and the reporting of data from those studies and trials; the
size of the market opportunity for the Company's product
candidates, including its estimates of the number of patients who
suffer from the diseases being targeted; the success of competing
therapies that are or may become available; the beneficial
characteristics, safety, efficacy and therapeutic effects of the
Company's product candidates; the Company's ability to obtain and
maintain regulatory approval of its product candidates; the
Company's plans relating to the further development of its product
candidates, including additional disease states or indications it
may pursue; existing regulations and regulatory developments in the
U.S., Japan and other jurisdictions; the Company's plans and
ability to obtain or protect intellectual property rights,
including extensions of existing patent terms where available and
its ability to avoid infringing the intellectual property rights of
others; the need to hire additional personnel and the Company's
ability to attract and retain such personnel; the Company's
estimates regarding expenses, future revenue, capital requirements
and needs for additional financing; the Company's need to raise
additional capital, and the difficulties it may face in obtaining
access to capital, and the dilutive impact it may have on its
investors; the Company's financial performance, and the period over
which it estimates its existing cash and cash equivalents will be
sufficient to fund its future operating expenses and capital
expenditures requirements. Further information relating to factors
that may impact the Company's results and forward-looking
statements are disclosed in the Company's filings with the
Securities and Exchange Commission, including Longeveron's Annual
Report on Form 10-K for the year ended December 31, 2021, filed
with the SEC on March 11, 2022, and the Company's Quarterly Reports
on Form 10-Q for the periods ended March 31, 2022, and June 30,
2022. The forward-looking statements contained in this press
release are made as of the date of this press release, and the
Company disclaims any intention or obligation, other than imposed
by law, to update or revise any forward-looking statements, whether
as a result of new information, future events, or
otherwise.
Investor
Contact:
Elsie Yau
Stern IR, Inc.
212-698-8700
elsie.yau@sternir.com