Coya Therapeutics Announces Pipeline Expansion - COYA 303: COYA 301 in Combination with GLP-1 Receptor Agonist for the Treatment of Inflammatory Diseases
2025年1月21日 - 10:15PM
ビジネスワイヤ(英語)
Preclinical study anticipated to be published
in 1H 2025 documenting combination’s additive and/or synergistic
anti-inflammatory signal;
Company will seek to advance asset in
neurodegenerative and autoimmune diseases through the next stages
alongside a strategic partner
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance regulatory T cell (Treg) function,
announces the expansion of its investigational pipeline and
advancement of COYA 303 for the treatment of inflammatory diseases.
Sustained inflammatory responses driven by dysfunctional immune
regulation is a hallmark of serious autoimmune and
neurodegenerative diseases.
COYA 303 is an investigational biologic combination of COYA 301
and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) designed
for subcutaneous administration. In a preclinical study, COYA 303
exhibited a dual immunomodulatory mechanism of action resulting in
an additive/synergistic anti-inflammatory effect, which the Company
believes was due to increased Treg function and suppressed
pro-inflammatory myeloid cells and responder T cells. Coya intends
to publish the results of this study in a peer-reviewed publication
in the first half of 2025 and has filed several patent applications
to protect the compound.
COYA 301 is the Company’s proprietary low-dose IL-2 that serves
as a backbone adjuvant with standard of care agents and other novel
pathways.
Following the positive results of this study, Coya intends to
continue ongoing strategic discussions to advance COYA 303 through
IND-enabling studies and into the clinic. In support of these
efforts, Coya is initiating translational studies in partnership
with a major academic university.
“COYA 303 is the most recent addition to Coya’s investigational
pipeline. We believe that while GLP-1 RAs may have monotherapy
benefits in reducing inflammation, the unique anti-inflammatory
signature of the combination of GLP-1 RA and COYA 301 is supportive
of opportunities that may generate significant shareholder value
for Coya and a potential strategic partner,” stated COYA CEO Arun
Swaminathan.
About Coya Therapeutics, Inc. Headquartered in Houston,
TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage
biotechnology company developing proprietary treatments focused on
the biology and potential therapeutic advantages of regulatory T
cells (“Tregs”) to target systemic inflammation and
neuroinflammation. Dysfunctional Tregs underlie numerous
conditions, including neurodegenerative, metabolic, and autoimmune
diseases, and this cellular dysfunction may lead to sustained
inflammation and oxidative stress resulting in lack of homeostasis
of the immune system.
Coya’s investigational product candidate pipeline leverages
multiple therapeutic modalities aimed at restoring the
anti-inflammatory and immunomodulatory functions of Tregs. Coya’s
therapeutic platforms include Treg-enhancing biologics,
Treg-derived exosomes, and autologous Treg cell therapy.
COYA 302 – the Company’s lead biologic investigational product
or “Pipeline in a Product”– is a proprietary combination of COYA
301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous
administration with a unique dual mechanism of action that is now
being developed for the treatment of Amyotrophic Lateral Sclerosis,
Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s
Disease. Its multi-targeted approach enhances the number and
anti-inflammatory function of Tregs and simultaneously lowers the
expression of activated microglia and the secretion of
pro-inflammatory mediators. This synergistic mechanism may lead to
the re-establishment of immune balance and amelioration of
inflammation in a sustained and durable manner that may not be
achieved by either low-dose IL-2 or CTLA4-Ig alone.
For more information about Coya, please visit
www.coyatherapeutics.com
Forward-Looking Statements
This press release contains “forward-looking” statements that
are based on our management’s beliefs and assumptions and on
information currently available to management. Forward-looking
statements include all statements other than statements of
historical fact contained in this presentation, including
information concerning our current and future financial
performance, business plans and objectives, current and future
clinical and preclinical development activities, timing and success
of our ongoing and planned clinical trials and related data, the
timing of announcements, updates and results of our clinical trials
and related data, our ability to obtain and maintain regulatory
approval, the potential therapeutic benefits and economic value of
our product candidates, competitive position, industry environment
and potential market opportunities. The words “believe,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
and similar expressions are intended to identify forward-looking
statements.
Forward-looking statements are subject to known and unknown
risks, uncertainties, assumptions and other factors including, but
not limited to the success, cost and timing of our product
candidate development activities and ongoing and planned clinical
trials; our plans to develop and commercialize targeted
therapeutics; the progress of patient enrollment and dosing in our
preclinical or clinical trials; the ability of our product
candidates to achieve applicable endpoints in the clinical trials;
the safety profile of our product candidates; the potential for
data from our clinical trials to support a marketing application,
as well as the timing of these events; our ability to obtain
funding for our operations; development and commercialization of
our product candidates; the timing of and our ability to obtain and
maintain regulatory approvals; the rate and degree of market
acceptance and clinical utility of our product candidates; the size
and growth potential of the markets for our product candidates, and
our ability to serve those markets; our commercialization,
marketing and manufacturing capabilities and strategy; future
agreements with third parties in connection with the clinical
development and/or commercialization of our product candidates; our
expectations regarding our ability to obtain and maintain
intellectual property protection; our dependence on third party
manufacturers; the success of competing therapies or products that
are or may become available; our ability to attract and retain key
scientific or management personnel; our ability to identify
additional product candidates with significant commercial potential
consistent with our commercial objectives; ; and our estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. Moreover, we
operate in a very competitive and rapidly changing environment, and
new risks may emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
herein may not occur and actual results could differ materially and
adversely from those anticipated or implied in the forward-looking
statements. Although our management believes that the expectations
reflected in our forward-looking statements are reasonable, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances described in the
forward-looking statements will be achieved or occur. We undertake
no obligation to publicly update any forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20250121304839/en/
Investor David Snyder, CFO
david@coyatherapeutics.com CORE IR Bret Shapiro
brets@coreir.com 561-479-8566 Media For Coya Therapeutics: Kati Waldenburg
media@coyatherapeutics.com 212-655-0924
Coya Therapeutics (NASDAQ:COYA)
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