- Using proprietary exosome tethering modification technology,
Treg derived exosomes were engineered with a surface protein,
cytotoxic T lymphocyte associated protein 4 (CTLA-4) to increase
selective targeting to immune cells;
- This patented technology requires no genetic modifications,
overcomes known limitations of exosome manipulation, and enables
tethering of multiple potential proteins to an exosome surface and
loading of therapeutic cargo in the exosome interior;
- CTLA-4-engineered Treg exosomes (CTLA-4-Treg exosomes)
dramatically increased targeting of, binding to, internalization
of, and uptake into immune cells including macrophages and T
cells;
- This technology can serve as a platform to engineer the exosome
surface with proteins of interest to target specific cell and
tissue types to potentially treat epitope driven autoimmune
diseases and cancer
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
multiple therapeutic platforms intended to enhance Treg function,
including biologics and cell therapies, announced that Dr. Phil
Campbell, Professor of Biomedical Engineering at CMU, presented his
talk, “Rapid Functionalization of Treg Exosomes for Targeted
Immunotherapy” at the 5th Exosome Based Therapeutic Development
Summit in Boston, MA this morning (September 7, 2023). The
presentation can be accessed here.
Coya and CMU entered into a Research Collaboration Agreement and
Option Agreement in 2022 to develop a unique patented technology
intended to advance the potential use of exosomes for the treatment
of diseases of unmet need.
In this study, it was demonstrated that by using a proprietary
cholesterol DNA tether technology, 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. It was also demonstrated that
CTLA-4-Treg exosomes exhibited far better cell uptake then
non-modified Treg EVs in representative immune cells, macrophages
(J7774 murine cell line) and T-cells (human Jurket cell line).
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). The results demonstrate that targeted delivery of
FASL-exosomes substantially increases its therapeutic effect with
enhanced apoptosis in tumor cells and suppression of alloreactive T
cells in mice, while minimizing potential off target effects. This
publication is available here.
Tregs are important immunomodulatory cells, with a key role
controlling inflammation, enabling self-tolerance, and promoting
regenerative processes. Treg-derived exosomes share many of the
properties of the parent Treg cells making them able to modulate
physiological and pathophysiological processes. The proprietary
technology generates Exosome Polymer Hybrids (EPHs) which allow for
efficient and versatile method of engineering and customizing
cargos of Treg-derived exosomes using oligonucleotide tethers.
Delivering EPHs to sites of inflammation or epitopes that drive
specific diseases, while delivering customized loads, enables the
next generation of selectively targeted and potent Treg-derived
exosomes.
Engineered exosomes may have multiple advantages, including low
immunogenicity, improved stability, increased plasma retention
after systemic delivery and increased residence time following
local delivery, enhanced biodistribution, improved cell binding and
uptake, and enhanced targeted therapeutic response.
Dr. Fred Grossman, President and Chief Medical Officer of Coya
stated, “This proprietary technology expands Coya’s pipeline to
include autoimmune disorders and cancer. These engineered exosomes
are a cell - free drug delivery system without genetic modification
that can travel throughout the body unimpeded, including through
the blood brain barrier, to provide specific targeted
therapies.”
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 proprietary 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230907917969/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara (646)-755-7412
James@haydenir.com
Media Contact Anna Marie Imbordino
annamarie@quantum-corp.com 917-680-8765
Coya Therapeutics (NASDAQ:COYA)
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