WEXFORD,
Pa., Jan. 4, 2024 /PRNewswire/ -- Coeptis
Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or
"Coeptis"), a biopharmaceutical company developing innovative cell
therapy platforms for cancer, today announced that Dave Mehalick, President and CEO of Coeptis
Therapeutics Holdings, has issued a Letter to Shareholders
providing a review of its 2023 achievements and anticipated
milestones for 2024. The full text of the letter follows.
A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE
OFFICER
To my fellow shareholders,
2023 was nothing short of transformative for Coeptis with the
highlight of the year being the exclusive licensing agreement with
Deverra Therapeutics Inc. With this single transaction, we gained
access to a proprietary allogeneic stem cell expansion and directed
differentiation platform, a clinical-stage, unmodified natural
killer (NK) cell therapy, DVX201, and a team of visionary
scientists led by Colleen Delaney,
MD, MSc, who joined Coeptis as our Chief Scientific and Medical
Officer.
Since completing the agreement in August, we have been working
diligently with Dr. Delaney and her team to advance the DVX201
clinical programs, while integrating SNAP-CAR, our universal,
multi-antigen CAR technology that we licensed from the University of Pittsburgh into the Deverra
allogeneic immune effector cell generation platform. Our strategy
is to leverage these innovative and complementary platforms to
develop powerful, personalized cell-based treatments to improve
outcomes for patients with cancer. Importantly, these cell-based
therapies are universal products enabling greater patient access to
these medical breakthroughs. It is a bold vision, and I believe we
now have under one roof the technological assets and scientific
expertise to fully pursue the opportunity. As we look to 2024, we
see enormous potential to advance our pipeline and achieve
meaningful growth milestones.
DVX201 – Rapidly Advancing Clinical Programs; Expected,
Near-Term Milestones
DVX201 is a first-ever allogeneic, cord-blood derived NK cell
therapy generated from pooled donor CD34+ hematopoietic stem and
progenitor cells (HSPC) cells. This product is being investigated
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 from both trials involving 17
patients and 25 infusions of DVX201 indicated that the NK cell
therapy is well-tolerated with no dose limiting toxicities (DLTs),
and with no cytokine release syndrome (CRS) or infusion toxicities
observed thus far through the highest dose level.
Drilling down further, the Phase 1 clinical trial investigating
DVX201 in patients with hospitalized COVID-19 infection completed
the three dosing cohorts, enrolling a total of nine patients each
receiving a single infusion. DVX201 was tolerated at all dosing
levels, an important observation for this first-in-human allogeneic
cell therapy derived from pooled donor manufacturing. Based on
these favorable results, Coeptis plans to pursue a Phase 2 clinical
program investigating DVX201 as an anti-viral therapy in high-risk
patients hospitalized with viral respiratory infections, allowing
us to expand beyond COVID-19 related infection and into a
substantially larger patient population.
Meanwhile, the Phase 1 trial investigating DVX201 in
relapsed/refractory AML or high-risk MDS has now safely dosed a
total of eight subjects each receiving two infusions. The trial is
expected to enroll two additional patients who will be infused at
the highest dosing level, with completion of dosing expected to
occur in Q1 2024. This timeline is also expected to enable us to
report topline safety and efficacy data from the full patient
population in the first half of 2024.
An Emerging Leader in Natural Killer Cell Therapy
Our DVX201 programs represent an important value driver for
Coeptis, but we believe they are the tip of the iceberg considering
our expectations regarding the greater potential of our assembled
technologies. The assets from Deverra along with SNAP-CAR out of
the University of Pittsburgh and the
GEAR platform developed at the Karolinska
Institute provide Coeptis with a foundation for us to pursue
one of our primary goals, which is to change the paradigm of how
engineered allogeneic NK and other immune effector cell therapies
are developed and administered.
CAR-T cell therapies have been transformative and curative for
some, however challenges with starting material, costs and
accessibility continue to persist. NK cell therapies, on the other
hand, offer several key advantages compared to CAR-T. For example,
NK cells have been shown to be able to target cancer through
multiple broadly expressed activating ligands and can be used
allogeneically without the risk of graft versus host disease (GVHD)
and cytokine release syndrome (CRS) that is associated with T cell
therapies.
Coeptis sees significant potential to integrate our technology
platforms to develop next-generation therapies for cancer. The team
at Deverra has pioneered advances in donor selection and
manufacturing approaches, including pooled donor approaches, that
have made it possible to generate significant numbers of unmodified
NK cells reproducibly and at scale with minimal lot to lot
variability and with low cost of goods, addressing major hurdles in
the allogeneic cell therapy development space. These generated
unmodified NK cells can also be engineered to vastly enhance the
accessibility, versatility and potential enhanced efficacy of NK
cell derived therapies for a host of cancers and infectious
diseases.
Research is underway at Coeptis to bring together Deverra's
novel stem cell expansion and differentiation technology, which we
have accessed through our exclusive license deal with Deverra, with
our existing SNAP-CAR and GEAR technologies. Importantly, in
October 2023 and with this strategy
in mind, we expanded our licensing agreement with the University of Pittsburgh to include SNAP-CAR NK,
adding a third NK-focused technology to Coeptis' development
portfolio.
SNAP-CAR, combined with Deverra's proprietary allogeneic stem
cell expansion and differentiation platform for the generation of
NK cells from pooled donor cord blood CD34+ cells, has us focused
on continued development efforts towards a first-in-class fully
universal (no HLA matching and antigen agnostic) targeted cell
therapy. Our vision is that the combination of technologies offers
Coeptis the opportunity to develop cell therapies that can be
engineered with off-the-shelf convenience and can target multiple
antigens simultaneously while also offering greater control over
toxicity.
In what I believe to be an extremely informative and visionary
talk, Dr. Delaney previewed this vision at the 2023 Cell & Gene
Meeting on the Mesa, which is one of the most prestigious
conferences in cell therapy industry. I encourage all shareholders
to view this video. Interest during her presentation and in
one-on-one meetings was exceptionally strong, and we are eager to
build on the momentum in 2024.
For our shareholders…
This is a very exciting time in
the growth and evolution of Coeptis Therapeutics, and we are
working diligently to advance our assets to become a leader in the
development of next-generation cell therapy technologies for cancer
and infectious diseases. I would like to thank our employees for
their dedication and loyalty, and our shareholders for their
ongoing support as we pursue our vision to become a leader in the
cell therapy industry.
On behalf of the entire Coeptis team, I wish you all a happy and
healthy 2024.
Best Regards,
Dave Mehalick
President and CEO
Coeptis Therapeutics Holdings, Inc.
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. 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
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SOURCE Coeptis Therapeutics, Inc.
