Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance Treg function, announces that Howard
Berman, Ph.D., Chief Executive Officer and Chairman of Coya
Therapeutics, Arun Swaminathan, Ph.D., Chief Business Officer, and
Fred Grossman DO, President and Chief Medical Officer, have been
invited to participate in Chardan Capital Market’s (Chardan’s)
upcoming biotechnology Leadership Call Series on Tuesday, January
30, 2024 at 10:30am ET.
Chardan’s Leadership Call Series features management teams from
leading disruptive biotechnology companies discussing their
business and key industry trends in a fireside chat-style format.
This discussion will be moderated by Chardan Senior Biotechnology
Analyst, Keay Nakae, CFA.
Howard H. Berman, Ph.D., Coya CEO stated: “We appreciate the
opportunity to participate in this event to discuss our pioneering
drug development efforts in Regulatory T Cell (Treg)-enhancing
therapies in neurodegenerative diseases. We will discuss how
combination immunotherapies, such as COYA 302, may overcome the
complex inflammatory environment that is a hallmark in these
conditions and potentially have disease modifying outcomes.”
Interested investors may request attendance to the live virtual
event by emailing Chardan at corpaccess@chardan.com. A replay of
the session will be available on Coya’s website following the
call.
About COYA 302
COYA 302 is an investigational and proprietary biologic
combination therapy 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. These mechanisms may have additive or
synergistic effects.
In February of 2023, Coya announced results from a
proof-of-concept, open-label clinical study evaluating LD IL-2 and
CTLA-4 Ig in a small cohort of patients with ALS conducted at the
Houston Methodist Research Institute (Houston, Texas) by Stanley
Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D.
This study was the first-of-its-kind evaluating this dual-mechanism
immunotherapy for the treatment of ALS. Patients in the study
received investigational treatment for 48 consecutive weeks and
were evaluated for safety and tolerability, Treg function, serum
biomarkers of oxidative stress and inflammation, and clinical
functioning as measured by the ALSFRS-R scale.
During the 48-week treatment period, the therapy was well
tolerated. The most common adverse event was mild injection-site
reactions. No patient discontinued the study, and no deaths or
other serious adverse events were reported.
Patients' disease progression was measured using the ALSFRS-R
scale, a validated rating tool for monitoring the progression of
disability in patients with ALS. The mean (±SD) ALSFRS-R scores at
week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of
treatment were not statistically different compared to the ALSFRS-R
score at baseline (33.5 ±5.9), suggesting significant amelioration
in the progression of the disease over the 48-week treatment
period.
Treg suppressive function, expressed as percentage of inhibition
of proinflammatory T cell proliferation, showed a statistically
significant increase over the course of the treatment period and
was significantly reduced at the end of the 8-week washout
post-treatment period. Treg suppressive function at 24 weeks (79.9
±9.6) and 48 weeks (89.5 ±4.1) were significantly higher compared
to baseline (62.1 ±8.1) (p<0.01), suggesting enhanced and
durable Treg suppressive function over the course of treatment. In
contrast, Treg suppressive function (mean ±SD) was significantly
decreased at the end of the 8-week washout period compared to
end-of-treatment at week 48 (70.3 ±8.1 vs. 89.5 ±4.1, p
<0.05).
The study also evaluated serum biomarkers of inflammation,
oxidative stress, and lipid peroxides. The available data up to 16
weeks after initiation of treatment suggest a decrease in these
biomarker levels, which is consistent with the observed enhancement
of Treg function. The evaluation of the full biomarker data is
ongoing.
Coya recently announced the pipeline expansion of COYA 302 to
include Frontotemporal Dementia (FD) and Parkinson’s Disease (PD)
in addition to ALS.
COYA 302 is an investigational product not yet approved by the
FDA or any other regulatory agency.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's
Disease, is a rare neurological disease that affects motor neurons,
the nerve cells in the brain and spinal cord that control voluntary
muscle movement. About 20,000 people live with ALS in the United
States and approximately 5,000 new cases are diagnosed every year.
The disease is progressive, meaning the symptoms get worse over
time. The functional status of ALS patients declines about 1 point
per month on average, as measured by the Revised ALS Function
Rating Scale1, or ALSFRS-R, a validated tool to monitor the
progression of the disease.
ALS has no cure, and the currently approved drug treatments
provide limited benefit to patients. ALS is a type of motor neuron
disease. As motor neurons degenerate and die, they stop sending
messages to the muscles, which causes the muscles to weaken, start
to twitch (fasciculations), and waste away (atrophy). Eventually,
the brain loses its ability to initiate and control voluntary
movements. Most people with ALS die from respiratory failure,
usually within three to five years from when the symptoms first
appear.2
About Frontotemporal Dementia
Frontotemporal dementia (FTD) is the result of damage to neurons
in the frontal and temporal lobes of the brain. Many possible
symptoms can result, including unusual behaviors, emotional
problems, trouble communicating, difficulty with work, or
difficulty with walking. FTD is rare and tends to occur at a
younger age than other forms of dementia. About 60% of people with
FTD are 45 to 64 years old. FTD is progressive, meaning symptoms
get worse over time. In the early stages, people may have just one
symptom. As the disease progresses, other symptoms appear as more
parts of the brain are affected. It is difficult to predict how
long someone with FTD will live. Some people live more than 10
years after diagnosis, while others live less than two years after
they are diagnosed. There is no cure for FTD, and no treatments
slow or stop the progression of the disease.3
About Parkinson’s Disease
Parkinson’s disease (PD) is a progressive brain disorder that
causes unintended or uncontrollable movements, such as shaking,
stiffness, and difficulty with balance and coordination. The most
prominent manifestations of PD occur when nerve cells in the basal
ganglia, an area of the brain that controls movement, become
impaired or die. As the disease progresses, people may have
difficulty walking and talking. They may also have mental and
behavioral changes, sleep problems, depression, memory
difficulties, and fatigue. Most people with PD first develop the
disease after age 60, but about 10% experience onset before the age
of 50. There is no cure for PD and currently available treatments
are intended to relieve some symptoms.4
References
- Atassi N, et al. The PRO-ACT database: design, initial
analyses, and predictive features. Neurology, 2014;83:1719–1725.
doi: 10.1212/WNL.0000000000000951.
- National Institutes of Health (NIH) Website
(https://www.ninds.nih.gov), accessed on January 8, 2024.
- National Institutes of Health (NIH) Website
(https://www.nia.nih.gov), accessed on January 8, 2024.
- National Institutes of Health (NIH) Website
(https://www.nia.nih.gov), accessed on January 8, 2024.
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’s 300
Series product candidates, COYA 301 and COYA 302, are biologic
therapies intended to enhance Treg function and expand Treg
numbers. COYA 301 is a cytokine biologic for subcutaneous
administration intended to enhance Treg function and expand Treg
numbers in vivo. COYA 302 is a biologic combination for
subcutaneous and/or intravenous administration intended to enhance
Treg function while depleting T effector function and activated
macrophages. 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
capabilities and strategy; future agreements with third parties in
connection with the 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 will 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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Investor Contact David Snyder david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566 Media
Contact Jessica Starman jessica@elev8newmedia.com
818-621-7216
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