Coya Therapeutics, Inc. Announces Preclinical Data Supporting the Role of Expanded Regulatory T Cells (Tregs) as Potential Disease-Modifying Treatment in an Animal Model of Alzheimer’s Disease (AD)

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) announced a publication highlighting the potential of expanded human Tregs to suppress neuroinflammation and mitigate Alzheimer's Disease (AD) pathology in a preclinical mice model. The study demonstrated that Treg administration decreased amyloid burden and neuroinflammatory markers, supporting the development of Treg-enhancing therapies as a potential strategy for AD and other neurodegenerative disorders. Coya plans to initiate Phase I clinical trials for these therapies in 2023, with interim data expected by Q1 2024.

Positive

• Successful suppression of neuroinflammation and alleviation of AD pathology in preclinical studies.
• Reduced amyloid burden and downregulated inflammatory markers in brain.
• Plans to enter Phase I clinical trials for Treg-enhancing biologics in 2023.

Negative

• None.

• Administration of expanded human Tregs with amplified immunomodulatory function suppressed neuroinflammation and alleviated AD pathology in a mice model of AD.
• Expanded human Tregs reduced amyloid burden and downregulated neuroinflammatory markers in the brain including pro-inflammatory cytokines, complement cascade, toll like receptors, and microglia.
• Data provide preclinical support for Treg enhancing therapies as a potential treatment strategy in AD and other neurodegenerative diseases.
• Initiation of Phase I clinical trials for Treg enhancing biologics in neurodegenerative diseases expected in 2023 with interim data readout by or before Q1 2024.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms that enhance Treg function, including biologics and cell therapies, announced the recent publication of an article entitled “Ex vivo expanded human regulatory T cells modify neuroinflammation in a preclinical model of Alzheimer’s Disease” in the peer reviewed journal Acta Neuropathologica Communications. The preclinical study was conducted by Ali Faridar, M.D., of Houston Methodist Hospital (Houston, Texas), under the leadership of Stanley Appel, M.D., the chair of Coya’s Scientific Advisory Board.

“These data further support that enhancing Treg function is a potential strategy to ameliorate neuroinflammation, which may modify Alzheimer’s Disease-associated pathology in the brain. Coya intends to enter a Phase I clinical trial of Treg enhancing biologics for the treatment of neurodegenerative diseases in 2023 with interim data readout anticipated by or before Q1 2024,” stated Howard Berman, Ph.D., Chief Executive Officer of Coya. “We continue advancing our product candidate pipeline including our biologic programs, which are intended to enhance Treg function in vivo and we believe have the potential to address the significant unmet needs of patients with serious neurodegenerative diseases,” stated Dr. Berman.

Stanley Appel, MD., Professor, Houston Methodist Hospital and Chair of Coya’s Scientific Advisory Board, commented, “Dr. Faridar’s transgenic mouse model study provides compelling evidence for the neuroprotective role of Tregs in suppressing neuroinflammation to improve disease pathophysiology and supports the potential role of immunomodulatory therapy for patients with AD and other neurodegenerative diseases.”

The study investigated the therapeutic effects of ex vivo expanded human Tregs on 5xFAD immunodeficient mice (5xFAD-Rag2KO), a well characterized model of AD. Treg administration reduced the levels of both soluble and insoluble Aβ40 and Aβ42 in the dentate gyrus and frontal cortex of treated animals compared to controls. Furthermore, Treg-treated mice showed significant reduction in total and plaque-associated microglia as well as reactive astrocytes in dentate gyrus and frontal cortex versus untreated mice.

Consistent with these findings, proteomic evaluation of the neuroinflammation transcriptome revealed that Treg administration down regulated multiple inflammatory pathways that have been observed to be associated with toxic amyloid beta (Aβ) including pro-inflammatory cytokines (IL1A&B, IL6), complement cascade (C1qa, C1qb, C4a/b), toll like receptors (Tlr3, Tlr4 and Tlr7) and microglial activations markers (CD14, Tyrobp, Trem2). The reduction in the number of plaque-associated glial cells and suppression of pro-inflammatory signaling pathways within these cells following Treg therapy may attenuate the contribution of these toxic glial cells in AD pathology resulting in mitigation of amyloid burden.

The peer reviewed publication can be accessed at https://actaneurocomms.biomedcentral.com/articles/10.1186/s40478-022-01447-z

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 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, and 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.

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Investor Contact

David Snyder

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Source: Coya Therapeutics, Inc.

FAQ

What were the key findings of Coya Therapeutics' recent publication regarding Treg therapy?

The recent publication found that expanded human Tregs suppressed neuroinflammation and alleviated Alzheimer's Disease pathology in a preclinical mice model.

When does Coya Therapeutics plan to start clinical trials for Treg-enhancing therapies?

Coya Therapeutics plans to initiate Phase I clinical trials for Treg-enhancing biologics in 2023.

What is the significance of the reduced amyloid burden in Coya's Treg study?

The reduced amyloid burden indicates the potential effectiveness of Treg therapies in addressing Alzheimer's Disease pathology.

When can investors expect interim data from Coya's upcoming clinical trials?

Investors can expect interim data readout from Coya's clinical trials by or before Q1 2024.