513(g) request will help initiate dialogue
with FDA and guide regulatory pathway
WEXFORD,
Pa., Aug. 1, 2023 /PRNewswire/ -- Coeptis
Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the
Company"), a biopharmaceutical company developing innovative cell
therapy platforms for cancer, announced that it has submitted a
513(g) request to the U.S. Food and Drug Administration (FDA) for
an in vitro companion diagnostic test designed to be used
with anti-CD38 monoclonal antibody therapies. The 513(g) request
serves to introduce Coeptis' diagnostic technology to the FDA and
to request guidance in determining the appropriate classification
and regulatory pathway.
The companion diagnostic test is intended to guide clinicians'
decisions in difficult to treat oncology indications. Treatments
for complicated oncology indications that target CD38 can have
significant impact on the immune system including increased risk
for infectious complications, autoimmune disorders, and secondary
malignancies, so in vitro companion diagnostics could be a
valuable tool in guiding treatment decisions.
"With this 513(g) submission, we now look forward to initiating
a dialogue with the FDA to advance the regulatory development of
our CD38 diagnostics technology, which we believe has potential to
significantly improve the treatment of severe and complicated
oncology indications," said Dave
Mehalick, President and CEO of Coeptis Therapeutics. "For
patients living with these very severe and difficult to treat
conditions, this companion diagnostic could potentially relieve
substantial burdens and cost of treatments to those individuals who
likely won't respond to treatment. Importantly, predicting
treatment could provide clinicians with the opportunity to choose a
different, possibly more effective treatment plan, rather than
losing time with an ineffective therapy as the disease
progresses."
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 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
Global Market; (2) the risk that, if the Deverra transaction closes
it will disrupt current plans and operations of the Company; (3)
the inability to recognize the anticipated benefits of the proposed
transaction, 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 targeted Deverra
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 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
504-416-6965
andy.galy@coeptistx.com
Tiberend Strategic Advisors, Inc.
Investors
Daniel
Kontoh-Boateng
862-213-1398
dboateng@tiberend.com
Media
David
Schemelia
609-468-9325
dschemelia@tiberend.com
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SOURCE Coeptis Therapeutics