DVX201, a first-ever allogeneic, cord-blood
derived, natural killer (NK) cell therapy, has been administered to
16 patients with no dose limiting toxicities, cytokine release
syndrome or infusion toxicities to date at all dose levels
WEXFORD,
Pa., Sept. 14, 2023 /PRNewswire/ -- Coeptis
Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the
Company"), a biopharmaceutical company developing innovative cell
therapy platforms for cancer, today provided a safety and patient
dosing update from two Phase 1 clinical trials investigating DVX201
for the treatment of relapsed/refractory acute myeloid leukemia
(AML) or high-risk myelodysplastic syndrome (MDS) and patients
hospitalized with COVID-19 infection. DVX201 is a novel allogeneic,
unmodified natural killer (NK) cell therapy generated from pooled
donor CD34+ hematopoietic stem and progenitor cells (HSPC)
cells.
Interim data from both trials involving 16 patients and 23
infusions of DVX201 indicate that the NK cell therapy is
well-tolerated with no dose limiting toxicities (DLTs), cytokine
release syndrome (CRS) or infusion toxicities observed thus far
through the highest dose level. The Phase 1 clinical trial
investigating DVX201 in patients with hospitalized COVID-19
infection (NCT04900454) has completed the three dosing cohorts (3+3
design), enrolling a total of nine patients each receiving a single
infusion. DVX201 was tolerated at all dosing levels.
The Phase 1 trial investigating DVX201 in relapsed/refractory
AML or high-risk MDS (NCT04901416) has safely dosed a total of
seven subjects each receiving two infusions (14 total). The trial
is expected to enroll three to five additional patients who will be
infused at the highest dosing level. Coeptis expects to report
topline safety and efficacy data from the full patient population
in the first quarter of 2024.
"The excellent safety results to date for DVX201 across two
trials with distinct patient populations, including 16 patients and
23 infusions, is extremely encouraging and represents a major step
for this first in-human use of an allogeneic NK cell therapy
derived from pooled donor CD34+ HSPCs," said Colleen Delaney, MD, Chief Scientific and
Medical Officer. "DVX201, a pooled donor product, represents a
truly novel manufacturing platform, and these preliminary safety
results give us confidence as we continue enrolling the highest
dose cohort, which should total seven subjects for 14 infusions for
the remaining portion of the Phase 1 trial in relapsed/refractory
AML and high risk MDS. We anticipate receiving top line data for
this trial in 1Q24."
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
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