Novel NK cell therapy approach is
designed to bolster and replenish the immune system during severe
viral infection, which can severely reduce immune cells leading to
hospitalization and death
WEXFORD,
Pa., Feb. 7, 2024 /PRNewswire/ -- Coeptis
Therapeutics Holdings, Inc. (Nasdaq: COEP) (the "Company" or
"Coeptis"), a biopharmaceutical company developing innovative cell
therapy platforms for cancer and infectious diseases, today
announced plans to pursue DVX201, its proprietary allogeneic stem
cell expansion and directed differentiation platform of unmodified
natural killer (NK) cell therapy, as an antiviral treatment
addressing various respiratory viral infections that lead to
hospitalization, including the "tripledemic" of influenza, COVID-19
and respiratory syncytial virus (RSV).
DVX201, the first-ever allogeneic, cord-blood derived NK cell
therapy generated from pooled donor CD34+ hematopoietic stem and
progenitor cells (HSPC) cells, is designed to supply a boost of
healthy immune cells to potentially help fight the infection by
directly infusing them into the patient's body.
DVX201 NK cells are generated from cord blood cells (from birth
tissue), a well understood and FDA regulated source of cells, that
has been infused into patients for over 20 years. DVX201 is
produced by pooling CD34+ cells isolated from multiple cord blood
donations to increase lot size and immune system diversity.
Importantly, doses undergo stringent testing including a potency
assay before treatment, to assess their ability to kill virally
infected cells. Additionally, DVX201 does not contain T-cells,
which significantly reduces the possibility for major rejection by
patients, which is a major concern for some cell therapy
products.
"We're excited to progress the clinical development of this
therapy to test a truly novel approach, treating severe viral
infections with live cells to replenish and bolster patients'
immune systems," said Colleen
Delaney, MD, MSc, Chief Scientific and Medical Officer. "An
important aspect of viral infections that are often observed in
patients hospitalized with viruses like the flu, COVID-19, and RSV,
often referred to as the tripledemic, is the challenges they
present to immune cells. The immune system works hard to kill
virally infected cells but, in many cases, struggle to keep up and
become depleted, leading to severe infection, worsening symptoms,
hospitalizations, and even death."
Dr. Delaney added: "Our first step is to fully explore key
safety measures because this is a very novel approach to treating
hospitalized viral infections with a first-in-class universal
therapy. We have started dosing DVX201 at low doses and escalated
upwards to almost 1 billion cells in a single infusion. For
context, the body normally has around two billion NK cells at any
given moment."
In two Phase 1 clinical trials for the treatment of
relapsed/refractory acute myeloid leukemia (AML) or high-risk
myelodysplastic syndrome (MDS) and patients hospitalized with
COVID-19 infection, interim data for a total of 17 patients and 25
infusions of DVX201 have indicated that the NK cell therapy is
well-tolerated with no dose limiting toxicities (DLTs). Further,
there have been no observed cytokine release syndrome (CRS) or
infusion toxicities thus far, even through the highest dose
level.
"Based on these favorable Phase 1 results to date, we are
excited to advance plans for a Phase 2 clinical program
investigating DVX201 as an anti-viral therapy in high-risk patients
hospitalized with viral respiratory infections," said Dave Mehalick, President and CEO of Coeptis
Therapeutics. "The tripledemic of flu, RSV, and COVID represents a
serious challenge for our healthcare system for the foreseeable
future. When vaccinations aren't sufficient and/or when vaccination
rates are below levels necessary to stave off future epidemics, we
believe this NK cell therapy approach has the potential to be an
important treatment, either as monotherapy or in a complementary
approach for severe infections. DVX201, the first-ever allogeneic,
cord-blood derived NK cell therapy generated from pooled donor
CD34+ HSPC cells, has the potential to offer significant support to
patients and to our strained healthcare system."
Since the COVID-19 pandemic, seasonal infections for the three
viral infections have been elevated, and the CDC highlights last
year's 2022-2023 "tripledemic" in which weekly hospitalization
rates exceeded 20 per 100,000. If this season follows with a severe
flu and RSV, and with a moderate overlapping COVID-19 wave, the CDC
warns that it expects similar impacts and hospitalizations placing
a severe strain on the healthcare system. A truly global concern,
The World Health Organization estimates that nearly 7 million
people have died from COVID-19 worldwide since the 2020 pandemic.
It also estimates the impact of seasonal flu, killing approximately
290,000 to 650,000 people per year, while RSV may be responsible
for 29,000 deaths per year.
About Coeptis Therapeutics Holdings, Inc.
Coeptis Therapeutics Holdings,
Inc., together with its
subsidiaries including Coeptis Therapeutics,
Inc. and Coeptis Pharmaceuticals,
Inc., (collectively "Coeptis"), is a biopharmaceutical
company developing innovative cell therapy platforms for cancer and
infectious diseases that have the potential to disrupt conventional
treatment paradigms and improve patient outcomes. Coeptis' product
portfolio and rights are highlighted by assets licensed from
Deverra Therapeutics, including an allogeneic cellular
immunotherapy platform and DVX201, a clinical-stage, unmodified
natural killer cell therapy technology. Additionally, Coeptis is
developing a universal, multi-antigen CAR T technology licensed
from the University of Pittsburgh
(SNAP-CAR), and the GEAR™ cell therapy and companion
diagnostic platforms, which Coeptis is developing with
VyGen-Bio and leading medical researchers at the Karolinska
Institutet. Coeptis' business model is designed around maximizing
the value of its current product portfolio and rights through
in-license agreements, out-license agreements and co-development
relationships, as well as entering into strategic partnerships to
expand its product rights and offerings, specifically those
targeting cancer and infectious diseases. The Company is
headquartered in Wexford, PA. For more information on Coeptis
visit https://coeptistx.com/.
Cautionary Note Regarding Forward-Looking
Statements
This press release and statements of our
management made in connection therewith contain or may contain
"forward-looking statements" (as defined in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended). Forward-looking
statements include statements concerning our plans, objectives,
goals, strategies, future events or performance, and underlying
assumptions, and other statements that are other than statements of
historical facts. When we use words such as "may," "will,"
"intend," "should," "believe," "expect," "anticipate," "project,"
"estimate" or similar expressions that do not relate solely to
historical matters, we are making forward-looking statements.
Forward-looking statements are not a guarantee of future
performance and involve significant risks and uncertainties that
may cause the actual results to differ materially and perhaps
substantially from our expectations discussed in the
forward-looking statements. Factors that may cause such differences
include but are not limited to: (1) the inability to maintain the
listing of the Company's securities on the Nasdaq Capital Market;
(2) the risk that the integration of the Deverra licensed assets
will disrupt current plans and operations of the Company; (3) the
inability to recognize the anticipated benefits of the
newly-licensed assets, which may be affected by, among other
things, competition, the ability of the Company to grow and manage
growth economically and hire and retain key employees; (4) the
risks that the Company's products in development or the
newly-licensed assets fail clinical trials or are not approved by
the U.S. Food and Drug Administration or other applicable
regulatory authorities; (5) costs related to integrating the
newly-licensed Deverra assets and pursuing the contemplated asset
development paths; (6) changes in applicable laws or regulations;
(7) the possibility that the Company may be adversely affected by
other economic, business, and/or competitive factors; and (8) the
impact of the global COVID-19 pandemic on any of the foregoing
risks and other risks and uncertainties identified in the Company's
filings with the Securities and Exchange Commission (the "SEC").
The foregoing list of factors is not exclusive. All forward-looking
statements are subject to significant uncertainties and risks
including, but not limited, to those risks contained or to be
contained in reports and other filings filed by the Company with
the SEC. For these reasons, among others, investors are cautioned
not to place undue reliance upon any forward-looking statements in
this press release. Additional factors are discussed in the
Company's filings made or to be made with the SEC, which are
available for review at www.sec.gov. We undertake no obligation to
publicly revise these forward-looking statements to reflect events
or circumstances that arise after the date hereof unless required
by applicable laws, regulations, or rules.
CONTACTS:
Coeptis Therapeutics, Inc.
Andy Galy, Sr. VP of Communications
andy.galy@coeptistx.com
Tiberend Strategic Advisors, Inc.
Investors
Daniel
Kontoh-Boateng
dboateng@tiberend.com
Media
David
Schemelia
dschemelia@tiberend.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/coeptis-therapeutics-to-pursue-phase-2-program-using-proprietary-first-in-class-allogeneic-nk-cell-therapy-for-the-treatment-of-viral-infections-302055678.html
SOURCE Coeptis Therapeutics, Inc.