Enters Licensing Agreement with UNeMed Corporation (UNeMed), the Technology Transfer Office of University of Nebraska Medical Center

• Abundant evidence indicates that high levels of inflammation and decreased levels of Regulatory T cells (Tregs) lead to an increased oxidative state in PD, which play a major role in disease progression and possibly etiology

• COYA 301 is a low-dose-IL-2 (ld IL-2) formulation for subcutaneous administration, intended to enhance Treg function in vivo to treat the systemic and neuro-inflammation underlying neurodegenerative and autoimmune diseases

• This agreement grants Coya the exclusive license to patent rights and know-how (IP) related to COYA 301 and combinations for treatment of PD

• IP is based on recently published data documenting that ld IL-2 significantly expands Treg populations and protects nigrostriatal dopaminergic neurons in an animal model of PD

• The license further diversifies Coya’s Treg enhancing biologic portfolio in neurodegenerative disease and expands upon the promising clinical data recently presented in Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s Disease (AD) while opening strategic clinical partnering opportunities in PD 

HOUSTON / Jun 20, 2023 / Business Wire / Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic programs intended to enhance Treg function, today announced expansion of its patent estate for COYA 301, the Company’s low-dose IL-2 (ld IL-2) subcutaneous administration product candidate. Under the terms of the agreement with UNeMed, Coya has been granted the exclusive patent rights and know-how for use of ld IL-2 and ld IL-2 combinations for PD. UNeMed will receive payments upon achievement of certain milestones and will also be eligible to receive tiered low-single digit royalty on net sales.

“We believe that Treg dysfunction is the common thread that binds together many neurodegenerative diseases. This license is based on strong preclinical animal data in PD, builds upon the highly promising clinical data observed in ALS and AD, and expands the optionality that Coya has in strategic partnering discussions to execute on future clinical trials in PD,” said Arun Swaminathan, Ph.D., Chief Business Officer.

The preclinical model published by University of Nebraska Medical Center scientists demonstrated that treatment with ld IL-2 induced a treatment-specific Treg population with overexpression of immunosuppressive Treg cell markers. Furthermore, the treatment had a potent neuroprotective effect on nigral dopaminergic neurons in affected mice. The degeneration of nigral dopaminergic neurons is considered the hallmark of PD suggesting that this interventional strategy may lead to sustained suppressive immune responses and neuroprotection in PD. The paper is titled Interleukin-2 expands neuroprotective regulatory T cells in Parkinson’s disease and can be accessed here:

“We are incredibility excited about this partnership,” UNeMed President and CEO Michael Dixon, Ph.D., said. “Coya is in a great position to develop this new therapy, and bring it to the market where it can have a significantly positive impact on healthcare.”

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’ lead 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

About UNeMed Corporation

UNeMed Corporation is the technology transfer and commercialization office for the University of Nebraska Medical Center. UNeMed serves all UNMC researchers, faculty and staff who develop new biomedical technology and inventions, and strives to help bring those innovations to the marketplace. Learn more at UNeMed.com, or contact them at This email address is being protected from spambots. You need JavaScript enabled to view it. or 402-559-2468.

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