Funds will help support the development of COYA
302 for the treatment of Frontotemporal Dementia (FTD)
COYA 302’s combination therapeutic approach
aligns with ADDF’s belief in combination therapy being the future
of Alzheimer’s and related dementia treatments
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 that the Alzheimer’s Drug Discovery Foundation (“ADDF”)
has purchased 603,136 shares of the Company’s common stock at a
purchase price of $8.29 per share for an aggregate investment of $5
million.
The ADDF’s mission is to rapidly accelerate the development of
drugs to prevent, treat, and cure Alzheimer’s disease (AD) and
related dementias, including FTD. Coya’s lead therapeutic
candidate, COYA 302, is being evaluated in multiple
neurodegenerative diseases, including FTD, and the Company intends
for this equity investment to help fund the development of COYA 302
in a planned Phase 2 trial in FTD.
“Inflammation has emerged as a promising novel pathway for
chronic neurological diseases like FTD. A combination drug, like
COYA 302, is an innovative approach being developed to suppress
neuroinflammation by targeting multiple inflammatory pathways,”
said Howard Fillit, M.D., Co-Founder and Chief Science Officer of
the ADDF. “Combination therapy will be integral to slowing – and
eventually halting – cognitive decline for a disease as complex as
FTD, and exploring combined therapeutic modalities is an important
advancement in the development of future care regimens.”
“We are grateful that a world-renowned organization like the
ADDF has chosen to support our corporate mission as well as the
clinical development of COYA 302 through this equity investment,”
said Howard Berman, Ph.D., Chief Executive Officer of Coya. “The
ADDF’s scientists have extensively vetted COYA 302 for the
treatment of FTD, a disease that is driven by a pronounced
peripheral and central nervous system inflammatory response. Like
Coya, the ADDF believes that combination therapies are the future
of Alzheimer’s and related dementia treatments, including FTD,
aligning our strategic approach to combatting such a complex
disease that has no current treatment options. We look forward to
working with the ADDF to potentially bring a new treatment paradigm
to these patients,” continued Dr. Berman.
Dr. Berman added, “Research has shown that neurodegenerative
diseases, such as AD, FTD, Parkinson’s disease, and ALS, aka ‘Lou
Gehrig’s disease,’ share common disease pathways, including
neuroinflammation and catastrophic neuronal loss that leads to
cognitive or motor dysfunction through the complex interplay of the
body’s immune system and dysfunctional anti-inflammatory regulatory
Tregs. Thus, the traditional ‘one disease – one target – one drug’
approach may be ineffective for such neurodegenerative diseases,
which may at least partially explain why there are limited
effective treatments for these conditions. However, we believe the
results thus far from studies involving COYA 302 indicate the
potential to provide a sustained and lasting effect on these
neurodegenerative diseases through the targeting of multiple immune
pathways.”
The offer and sale of the securities described above were
offered in a private placement under Section 4(a)(2) of the
Securities Act of 1933, as amended (the “Act”), and/or Regulation D
promulgated thereunder and have not been registered under the Act,
or applicable state securities laws. Accordingly, the securities
issued in the private placement may not be offered or sold in the
United States except pursuant to an effective registration
statement or an applicable exemption from the registration
requirements of the Act and such applicable state securities
laws.
The Company has agreed to file a registration statement with the
Securities and Exchange Commission (“SEC”) covering the resale of
the securities issued to ADDF no later than 30 days following the
date of the definitive agreements and to have the registration
statement declared effective no later than 75 days following the
date of the definitive agreements in the event of a “full review”
by the SEC.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or other jurisdiction in which such an offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such state or other jurisdiction.
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 CTLA4-Ig
(abatacept) and is being developed for subcutaneous administration
for the treatment of patients with ALS, FTD, PD, and AD. 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 commercially
available LD IL-2 and CTLA4-Ig in a small cohort of patients with
ALS conducted at the Houston Methodist Hospital 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 302 is an investigational product not yet approved by the
FDA or any other regulatory agency.
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.1
References
1. National Institutes of Health (NIH) Website
(https://www.nia.nih.gov), accessed on January 8, 2024
About Alzheimer’s Disease
Alzheimer's disease is the most common cause of dementia, a
general term for memory loss and other cognitive abilities serious
enough to interfere with daily life. Alzheimer's disease accounts
for up to 80% of dementia cases, affecting an estimated 5.7 million
Americans. In more than 90% of people with Alzheimer’s, symptoms do
not appear until after age 60. The incidence of the disease
increases with age and doubles every 5 years beyond age 65.
Alzheimer's is a progressive disease, where dementia symptoms
gradually worsen over a number of years. In its early stages,
memory loss is mild, but with late-stage Alzheimer's, individuals
lose the ability to carry on a conversation and respond to their
environment. It is the sixth leading cause of death among all
adults and the fifth leading cause for those aged 65 or older. On
average, a person with Alzheimer's lives 4 to 8 years after
diagnosis but can live as long as 20 years, depending on other
factors. 1, 2
References
- Alzheimer’s Association (www.alz.org).
- Centers for Disease Control and Prevention (www.cdc.gov).
About The Alzheimer’s Drug Discovery Foundation
(ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the
Alzheimer's Drug Discovery Foundation is dedicated to rapidly
accelerating the discovery of drugs to prevent, treat and cure
Alzheimer's disease. The ADDF is the only public charity solely
focused on funding the development of drugs for Alzheimer's,
employing a venture philanthropy model to support research in
academia and the biotech industry. The ADDF's leadership and
contributions to the field have played a pivotal role in bringing
the first Alzheimer's PET scan (Amyvid®) and blood test
(PrecivityAD®) to market, as well as fueling the current robust and
diverse drug pipeline. Through the generosity of its donors, the
ADDF has awarded more than $290 million to fund over 750
Alzheimer's drug discovery programs, biomarker programs and
clinical trials in 20 countries. To learn more, please visit:
http://www.alzdiscovery.org/.
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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20240520242949/en/
Investor Contact David
Snyder, CFO david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566
Media Contacts For Coya
Therapeutics: Kati Waldenburg media@coyatherapeutics.com
212-655-0924
For ADDF: Jackie Trudeau Jtrudeau@alzdiscovery.org
646-452-3360
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