Coya Therapeutics Presents New Experimental Data Supporting the Mechanism of Action of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting
2023年10月5日 - 10:00PM
ビジネスワイヤ(英語)
- COYA 302 is an investigational and proprietary biologic
combination with a dual immunomodulatory mechanism of action
intended to enhance the anti-inflammatory function of regulatory T
cells (Tregs) and suppress the inflammation produced by activated
monocytes and macrophages;
- COYA 302 is comprised of proprietary low dose interleukin-2 (LD
IL-2) and CTLA-4 Ig, and is being developed for subcutaneous
administration for the treatment of patients with ALS;
- The experimental data generated in cell samples from ALS
patients highlight the significant positive effect of LD
IL-2/CTLA4-Ig and other Treg-enhancing therapies in reducing the
inflammatory environment observed in ALS. It is known that the
degree of neuroinflammation directly correlates with the severity
and rate of progression observed in ALS;
- Coya is actively planning its next clinical study to evaluate
the efficacy and safety of COYA 302 in patients with ALS.
Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics and cell therapies intended to enhance the function of
Tregs, announced new experimental data presented at the 22nd Annual
Northeast ALS (NEALS) Consortium Meeting on October 4th, 2023.
Details of the study can be found here.
Results of the in vitro study in samples from ALS patients
highlight the deleterious role of M1 pro-inflammatory monocytes and
macrophages in the ability of Tregs to maintain their
immunomodulatory anti-inflammatory function and achieve immune
homeostasis. Tregs are often dysfunctional in ALS, exhibiting low
anti-inflammatory suppressive function. The degree of impaired Treg
function has been shown to directly correlate with the severity and
rate of progression of this life-threatening disease.
Prior studies conducted by Dr. Appel and his team at the Houston
Methodist Hospital demonstrated that dysfunctional Tregs from ALS
patients can be successfully expanded ex vivo restoring their
suppressive function, but when Tregs were infused back to the
patients the anti-inflammatory function had limited duration.
Subsequent studies have identified that the inflammatory
environment created by myeloid cells could be a key contributor to
the loss of Treg suppressive function.
The present in vitro research work studied the interactions
between expanded Tregs and activated monocytes and macrophages, and
the ability of immunomodulatory drugs and other Treg-enhancing
therapies to increase Treg anti-inflammatory function and suppress
the pro-inflammatory function of the M1 phenotype of activated
monocytes and macrophages.
Main results of the study are summarized below:
- M1 activated monocytes and macrophages reduce Treg viability
and upregulate apoptosis markers.
- Immunomodulatory drugs known to suppress the M1 phenotype
significantly decreased the production of inflammatory cytokines
involved in tissue damage.
- The combination of LD IL-2/CTLA4-Ig significantly decreased the
M1 phenotype and cytokine production and maintained Treg
viability.
Results of this study further support the potential of COYA 302
(LD IL-2 and CTLA4-Ig) to address the multiple pathways involved in
the progression and severity of ALS. Coya is working expeditiously
in the planning and execution of its next clinical study to
evaluate the efficacy and safety of COYA 302 in patients with
ALS.
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 a 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 lead therapeutic
programs includes Treg-enhancing biologics (COYA 300 Series product
candidates) COYA 301 and COYA 302, which are intended to enhance
Treg function and expand Treg numbers. COYA 301 is a proprietary
investigational recombinant human low dose IL-2 biologic for
subcutaneous administration intended to enhance Treg function and
expand Treg numbers in vivo, and COYA 302 is a dual-mechanism
investigational biologic combination comprised of proprietary low
dose IL-2 and CTLA-4 Ig. The low dose IL-2 is intended to enhance
anti-inflammatory regulatory T cell function and numbers while the
fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory
cell function. These two mechanisms may be additive or synergistic
in suppressing inflammation. 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, those related to risks associated with the impact
of COVID-19; 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
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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.
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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
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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/20231005620023/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara 646-755-7412
James@haydenir.com
Media Contact Anna Marie Imbordino
annamarie@quantum-corp.com 917-680-8765
Coya Therapeutics (NASDAQ:COYA)
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Coya Therapeutics (NASDAQ:COYA)
過去 株価チャート
から 6 2023 まで 6 2024