Coya Therapeutics, Inc., a clinical-stage biotechnology company developing biologics and
cell therapies intended to enhance the function of Tregs, today announced licensing of the
exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU
with potential applications across multiple indications, including neurodegeneration,
autoimmune, and oncology.
This technology is versatile, permitting the modification of exosomes from different
biological sources while overcoming several of the scale-up and manufacturing challenges
encountered with exosomes, including not requiring genetic manipulation. In addition, the
ability to customize the surface of the exosome with a protein of interest while loading the
interior of the exosome with cargo opens possibilities across multiple therapeutic areas
beyond neurodegenerative diseases.
Data was recently presented at the 5th Exosome Based Therapeutic Development Summit
in Boston, MA on September 7, 2023, demonstrating that Treg exosome membranes could
be engineered to controllably immobilize CTLA-4, a membrane surface active protein, onto
the Treg exosome surface resulting in stable CTLA-4-Treg exosomes. CTLA-4-Treg
exosomes dramatically increased targeting of, binding to, internalization of, and uptake
into immune cells including macrophages and T cells. Previously, using the same
technology, CMU demonstrated applications in Oncology by engineering mesenchymal
derived exosomes with an immunomodulatory apoptotic inducing protein, Fas Ligand
(FAS-L).
This novel proprietary EET platform extends Coya’s pipeline beyond Neurodegenerative
disorders to include autoimmune disorders and cancer while expanding Coya’s optionality
for potential non-dilutive business development and strategic partnerships with companies
seeking novel ways to deliver cargo/drugs in a targeted fashion.
Fred Grossman, President and CMO said “The science behind the technology is strong
and has focused on overcoming the limitations of exosomes. We believe this technology
can shape the future of targeted delivery of desired agents to address multiple conditions.”
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 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.