All three conditions share common hallmark of
complex inflammatory pathways underlying disease pathophysiology
that involve dysfunctional regulatory T cell (Treg) biology which
may limit efficacy of monotherapy approaches;
COYA 302 is a proprietary biologic combination
immunotherapy that targets multiple pathways which may successfully
overcome the complex immune environment driving these diseases;
Cash runway guidance remains into 2026;
Company also provides strong and productive
milestone and catalyst update for 2024
Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance Treg function, announces that it is
expanding its pipeline in neurodegenerative conditions for COYA 302
beyond ALS to include frontotemporal dementia (FTD) and Parkinson’s
disease (PD). The Company’s updated pipeline can be viewed
here.
FTD and PD share a similar disease pathogenesis to ALS that is
associated with a heightened proinflammatory cascade involving
dysfunctional Tregs and proinflammatory microglia and macrophages.
The biological redundancies in molecular immune pathways in these
complex diseases limit the efficacy of many single drug therapies,
requiring the development of novel therapeutics that can address
this pathophysiologic complexity.
Dr. Fred Grossman, Coya’s President and Chief Medical Officer
stated, “ALS, FTD, and PD are driven by a similar, yet complex,
proinflammatory environment that requires targeting more than a
single pathway. COYA 302 has been designed to target multiple
pathways, such as restoring dysfunctional Tregs and inhibiting
proinflammatory microglia and macrophages, and may have disease
modifying potential in these severe diseases with high unmet
need.”
COYA 302 is a dual-mechanism investigational biologic
combination immunotherapy comprised of proprietary low dose IL-2
and fusion protein CTLA-4 Ig. Low dose IL-2 enhances
anti-inflammatory Treg function and numbers while the fusion
protein CTLA-4 Ig suppress proinflammatory cell function, enabling
potentially synergistic mechanisms in modulating inflammatory
pathways and restoring immune balance. COYA 302 has the potential
to be disease modifying by targeting multiple dysregulated immune
pathways while restoring function in anti-inflammatory Treg
function.
Coya intends to file an IND for COYA 302 for the treatment of
ALS in the first half of 2024 and an IND for COYA 302 for the
treatment of FTD before the end of 2024. In addition, studies in
animal models of PD are planned in 2024, and based on those
studies, a subsequent IND filing is anticipated for the treatment
of PD.
Howard H. Berman, Ph.D., Coya’s CEO stated: “Our vision has
always been to leverage the potential of Tregs in neurodegenerative
diseases. With COYA 302, we have taken a page from the playbook of
oncology and viral disease where combination therapies have been
transformational. We believe that the complementary and possibly
synergistic multi-mechanism mode of action of COYA 302 in targeting
the complex immune environment will lead to promising clinical
outcomes in patients with neurodegenerative diseases.”
The Company also announces its key milestones and catalysts
anticipated in 2024, including:
H1 2024:
- COYA 302 File IND and Initiate Phase 2 Trial in ALS
Patients
- COYA 302 Publication of Phase 1 Investigator Initiated Trial
clinical data in ALS Patients
- COYA 302 Publication of Longitudinal Biomarker study with
correlation to patient survival in ALS Patients
- COYA 302 Presentation on Longitudinal Biomarker Data in ALS
Patients at Conference
- COYA 301 Presentation of Phase 1 Investigator Initiated Trial
data in AD Patients at 18th annual AD + PD Conference
H2 2024:
- COYA 302 First patient dosed in Phase 2 Trial in ALS
Patients
- COYA 302 File IND and Initiate Phase 2 Trial in FTD
Patients
- COYA 302 Animal data released in PD model
- COYA 301 Proof of Concept combination data with Drug X in AD
mouse model
- COYA 301 Phase 2 Investigator Initiated Trial Topline AD
data Presented (Summer)
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 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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version on businesswire.com: https://www.businesswire.com/news/home/20240116826337/en/
Investor David Snyder david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566
Media Jessica Starman jessica@elev8newmedia.com
818-621-7216
Coya Therapeutics (NASDAQ:COYA)
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