Coya Therapeutics Announces Publication of Potential Novel Blood Biomarker Data in Amyotrophic Lateral Sclerosis (ALS) Patients That Accurately Reflect Therapeutic Responses When Treated with Regulatory T Cell (Treg) Enhancing Therapies
31 8월 2023 - 9:00PM
Business Wire
- Pathological hallmarks of ALS are characterized by alterations
in inflammation and oxidative stress, with oxidative stress playing
a critical role in neuronal damage.
- 4-hydroxy-2-nonenal (4-HNE) is a key mediator of oxidative
stress in cells and tissues.
- Analysis of blood biomarker data from two clinical trials of
Treg-enhancing therapies in patients with ALS demonstrated a strong
correlation between clinical response and levels of 4-HNE and
inflammatory biomarkers monocyte chemoattractant protein-1 (CCL2)
and interleukin (IL-18).
- Coya intends to leverage these correlative biomarkers in its
planned fully powered placebo controlled clinical trial with COYA
302 in patients with ALS.
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, today reported the
publication of a research article entitled “Immunological,
Oxidative, and Structural Factors and Their Responses to Regulatory
T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis” in the
peer-reviewed journal Ageing and Neurodegenerative Diseases. The
publication can be accessed here.
The publication reports the analyses of blood biomarker data
from a cross sectional cohort of sporadic ALS patients (n = 30) and
healthy controls (n=10) and from two investigator-initiated
clinical studies (IIT) (n=11). In the IIT studies, patients were
treated with expanded Treg cell therapy in combination with
low-dose interleukin-2 (IL-2). As previously reported, patients
from these two trials experienced amelioration of disease
progression with corresponding increased Treg numbers and
suppressive function.
Evidence strongly supports the role of inflammation and
oxidative stress in the severity and rate of disease progression in
ALS. These new biomarker data demonstrate that enhancing Treg
function improves clinical outcomes with accompanying changes in
blood levels of oxidative stress markers, such as 4-HNE, and
inflammatory markers, including CCL2 and IL-18, and may have the
potential to serve as objective biomarkers of disease progression
and clinical trial endpoint surrogates to therapies that enhance
Treg function.
Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory
Board, commented, “Our pre-clinical studies have suggested that
oxidative stress results from and promotes neuroinflammation and
neuronal injury in ALS. It is gratifying that biomarkers of
oxidative stress - 4-HNE and ox-LDL - correlated with
responsiveness to therapy in 2 ALS clinical trials of
Treg-enhancing therapies, and may provide an objective confirmation
of clinical benefit in forthcoming trials.”
Following these encouraging results, Coya plans to assess blood
markers of oxidative stress and inflammation systematically and
prospectively in the upcoming well powered placebo controlled
clinical study of COYA 302 (Treg-enhancing biologic combination) in
patients with ALS, aiming to provide a better understanding of the
disease, with the ultimate goal of developing consistent biomarkers
to evaluate treatment response.
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 include 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 cytokine
biologic (proprietary low dose IL-2) for subcutaneous
administration intended to enhance Treg function and expand Treg
numbers in vivo, and COYA 302 is a biologic combination
(proprietary low dose IL-2 and proprietary CTLA4-Ig) 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
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version on businesswire.com: https://www.businesswire.com/news/home/20230831425850/en/
David Snyder, CFO - Coya Therapeutics, Inc.
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
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