Company underscores potential benefits of
low-dose interleukin-2 in Investigator-Initiated Phase 2
Alzheimer’s disease trial as presented at the recent CTAD
Conference
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, as previously disclosed, Arun Swaminathan, Ph.D.,
has been promoted to Chief Executive Officer, effective today,
November 1, 2024. Dr. Swaminathan was instrumental in executing
several significant commercial transactions in his career,
including Coya’s licensing transaction with Dr. Reddy’s Laboratory
in December 2023 that could be worth up to $700 million if all
milestones are met. He brings a wealth of strategic, business
development, operational, and deal-making experience to help guide
Coya in its next phase of corporate growth.
Dr. Swaminathan commented, “I would like to again thank our
board of directors and Executive Chairman Howard Berman for the
opportunity to lead Coya. Our pipeline targets severe
neurodegenerative diseases facing millions of people across the
globe, such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s
disease, Frontotemporal Dementia, and Parkinson’s disease. We
believe our combination therapeutic approach targeting
neuroinflammation can unlock a new paradigm in neurodegenerative
treatment.
“We are encouraged by data from the Phase 2
investigator-initiated trial in patients with mild to moderate
Alzheimer’s disease treated with low-dose interleukin-2 (LD IL-2),
shared at CTAD, validating of our Treg platform. The study
demonstrated stabilization of cognition with statistically
significant CSF biomarker improvement in the lower dose IL-2 arm,
confirming the known biology of the relationship between IL-2 dose
and Treg enhancement. Previous studies have shown that lower IL-2
doses selectively enhance and increase Treg function, while higher
IL-2 doses reduce Treg function via several relevant mechanisms.
This dynamic was observed in this study and helped us identify the
lower dose of LD IL-2 as the right dose that enhances durable Tregs
in patients with Alzheimer’s disease. The data now opens the
potential for a multitude of strategic opportunities involving
biologic combinations that we intend to vigorously pursue,”
concluded Dr. Swaminathan.
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
- Alzheimer’s Association (www.alz.org)
- Centers for Disease Control and Prevention (www.cdc.gov)
About COYA 301
COYA 301 is the company’s proprietary investigational low-dose
interleukin-2 (IL-2) intended to enhance the anti-inflammatory
function of regulatory T cells (Tregs) and is designed for
subcutaneous administration. COYA 301 is an investigational product
not yet approved by the FDA or any other regulatory agency.
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 cytotoxic T
lymphocyte-associated antigen 4 immunoglobulin fusion protein
(CTLA4-Ig) and is being developed for subcutaneous administration
for the treatment of patients with ALS, FTD, and Parkinson’s
Diseases (PD). 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 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 to evaluate
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 Revised
Amyotrophic Lateral Sclerosis Functional Rating Scale (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 a 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 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 a 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 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/20241101815946/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
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