Hunter Medical Research Institute

Joint effort to leverage existing collaboration and non-dilutive grants to advance development of proprietary Treg exosome technology towards a first-in-human clinical study, continue work on validating biomarkers in a variety of neurodegenerative diseases, and explore novel synergistic drug combinations with COYA 301 (proprietary Low Dose Interleukin-2, or LD IL-2) HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces the expansion of its research collaboration with the Houston Methodist Research Institute (“HMRI”) through a sponsored research agreement (SRA) covering multiple initiatives. The development and production of exosomes from patients’ regulatory T cells will be funded by the Johnson Center for Cellular Therapeutics with participation of the SRA from Coya to Dr. Stanley Appel, Director of the Johnson Center and Chair of Coya’s Scientific Advisory Board. Coya and HMRI will advance the development of multiple patented modalities of exosomes, including full characterization of the nanovesicles, and GMP manufacturing to enable a first-in-human academic clinical study. Furthermore, Coya will continue the characterization and validation of several clinical biomarkers in patients with Amyotrophic Lateral Sclerosis, Alzheimer’s Disease, Frontotemporal Dementia, and Parkinson’s Disease. These proprietary biomarkers will provide valuable tools to better objectively correlate disease status and biological processes, improve the criteria for participation and stratification in clinical studies, and assess treatment response. In addition, Coya and HMRI will continue exploring the potential synergy of COYA 301 (LD IL-2) with other relevant drug products, following the innovative approach of COYA 302 (LD IL-2 + CTLA4-Ig) targeting multiple paths involved in the pathophysiology of severe neurodegenerative and autoimmune diseases. Biologic combinations serve as the cornerstone of Coya’s unique approach in addressing the complex pathophysiology of diseases and offer future opportunities for strategic collaborations. About COYA 301 COYA 301 is the company’s proprietary investigational low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function of regulatory T Cells and is designed for subcutaneous administration. About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and PD. These mechanisms may have additive or synergistic effects. In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported. Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9 ±9.6) and 48 weeks (89.5 ±4.1) were significantly higher compared to baseline (62.1 ±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3 ±8.1 vs. 89.5 ±4.1, p <0.05). The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing. COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. 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 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 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone. For more information about Coya, please visit 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 pro 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.

Working together to understand the factors which could be used to predict outcome following TBI, researchers examined factors related to social support, health, clinical care, biological markers, acute interventions, and longer-term outcomes. A team of Australia's leading health researchers has developed a new 'dictionary' to better predict outcomes for people who have experienced a moderate-severe traumatic brain injury (TBI). The Australian Traumatic Brain Injury Initiative (AUS-TBI) is a consortium of academics, researchers and healthcare professionals from institutions across the country. Working together to understand the factors which could be used to predict outcome following TBI in a study supported by the Australian Medical Research Future Fund Mission for TBI, the team examined factors related to social support, health, clinical care, biological markers, acute interventions, and longer-term outcomes. Published across eight articles in a special edition of the Journal of Neurotrauma, this work culminated in a Single Data Dictionary: a master list of information that if collected would give the best chance at understanding how a person will recover from their brain injury. Consortium lead and Curtin University Deputy Vice-Chancellor, Research Professor Melinda Fitzgerald said predicting each individual's outcome following a TBI was critical -- but also very difficult. "The rate and degree of recovery after moderate-severe TBI varies greatly, due in part to the complex and diverse nature of these injuries," Professor Fitzgerald said. "Despite decades of empirical research, prediction of outcomes after TBI for individual patients remains imprecise: we have only partial understanding of what it is about the person, their injury, their environment, or their care that moderates and/or determines the multiple outcomes that contribute to their quality of life. "At present, there is no indicator or group of indicators that can sufficiently predict treatment outcome or responsiveness to allow for personalised acute care and rehabilitation for patients with TBI." To create the Single Data Dictionary, the AUS-TBI team examined thousands of published research articles reporting factors which may impact a person's recovery, such as their medical history, social contexts, biological markers, level of personal support, effectiveness of treatment and more. The team also consulted extensively with people who have lived experience of TBIs, including an Aboriginal and Torres Strait Islander Advisory Group, to develop the Single Data Dictionary of predictive markers alongside guidelines on how to collect them in a coordinated, culturally sensitive national approach. Co-author Dr Sarah Hellewell, from Curtin's Faculty of Health Sciences, Curtin Health Innovation Research Institute and the Perron Institute, said providing personalised care to ensure the best outcomes for patients was critical, as TBIs are often catastrophic and have lifelong impact on patients, their families, workplaces, the criminal justice system and society as a whole. "Severe TBI has a mortality rate of 30-40 per cent, less than 50 per cent of patients achieve long-term independence and new injuries add $2 billion in lifetime direct costs to the Australian healthcare system each year," Dr Hellewell said. "Between 2006 and 2015, there was no change in survival or functional outcomes following TBI, proving the need for better, targeted management strategies to reduce mortality and improve quality of life for these individuals and reduce negative impacts on families and society." Organisations also involved in the consortium include the Perron Institute, Telethon Kids Institute, Monash University, Griffith University, Deakin University, University of Sydney, University of Queensland, University of Adelaide, University of Melbourne, University of Newcastle, Synapse, Hunter Medical Research Institute, John Hunter Hospital, Brightwater Care Group, The Children's Hospital at Westmead and Epworth HealthCare.

PASADENA, Calif., May 15, 2024 /PRNewswire/ -- Huntington Medical Research Institutes (HMRI), a pioneer in scientific research dedicated to unraveling diseases of the heart and brain, gains new insights into dementia among American Indians for the first time through a landmark study led by renowned epidemiologist Astrid Suchy-Dicey, PhD, Associate Professor, and Scientific Director, Clinical and Translational Neurosciences. Continue Reading "Overall, our findings emphasize the importance of inclusive Alzheimer's disease and dementia research, representing all populations." Post this Renowned epidemiologist Astrid Suchy-Dicey, PhD, Associate Professor, and Scientific Director, Clinical and Translational Neurosciences, HMRI. This is the first large, prospective, population-based study to estimate the prevalence of vascular and Alzheimer's dementias in American Indians, using a gold-standard method of cognitive determination consistent with protocols used by National Alzheimer's Coordinating Center Alzheimer's Disease Research Centers and as recommended by National Institute on Aging and Alzheimer's Association. This report, "Epidemiology and prevalence of dementia and Alzheimer's disease in American Indians: data from the Strong Heart Study," was published today in Alzheimer's and Dementia: The Journal of the Alzheimer's Association. Until recently, the epidemiology of Alzheimer's disease and related dementias among American Indians and other Indigenous peoples has been critically underrepresented in mainstream dementia research. Disparities in socioeconomics, historical, and sociological factors increase risk, resulting in disparate prevalence and incidence of disease. American Indians endure a high prevalence of contributing comorbidities, such as hypertension, diabetes, and depression, exacerbated by relatively poorer access to socioeconomic resources. Suchy-Dicey cautions, "interpretation of race-based differences [in health disparities research] should be done with caution; such differences probably have more to do with social determinants than with biological differences." Previous data using administrative and health records estimated dementia prevalence in American Indians and Alaska Natives as similar to that of non-Hispanic Whites. However, this prospectively conducted, population-based study detected higher prevalence -- with approximately half of American Indians over age 65 affected by some cognitive impairment, and approximately 10% with dementia. These epidemiologic findings are thought to be an improvement on prior research because they are not limited by underreporting of cases in the clinical context. Records-based research may be prone to data or information bias, due to inadequate or late care, poor specialty access in rural regions, and poor cultural sensitivity in some contexts. It is estimated that up to 50% of those with dementia may be missing notations in their medical records, further increasing disparities for those who experience barriers to care, and compounding problems for research on racial-ethnic disparities using such data. Thus, prior studies that are not population-based, with prospectively collected, objective, and sensitive methods for case identification may represent underestimates of true prevalence and incidence in these populations. So far, the data in this report is the closest to gold-standard epidemiologic estimates of dementia prevalence for American Indians. Additionally, this study reported novel findings that vascular brain injury was equally important to Alzheimer's disease in etiology, both as independent contributors but also with substantive overlap between them. This suggests a continued need for vascular prevention in this population, which may be lagging behind the majority population in reduction and prevention of cardiovascular disease (CVD) and cerebrovascular disease (CBVD). Future studies will investigate whether primary prevention of vascular disease could result in decreased prevalence and incidence of dementia in this population. Finally, traumatic head injury was found to be a significant contributor among "other" impairments, perhaps representing acute cognitive changes. These findings echo prior research on blood biomarker findings, which detected higher prevalence of markers for neuronal remodeling in this population than expected. More follow-up is needed, but this may be an important factor to consider in future dementia research, especially in American Indians and other minoritized groups. "Overall, our findings emphasize the importance of inclusive Alzheimer's disease and dementia research, representing all populations, and especially with data gathering that is sensitive and knowledgeable to that particular group," said Suchy-Dicey. "We hope these findings will be useful to clinicians and researchers, especially those interested in health disparities." Suchy-Dicey collaborated with University of Washington School of Medicine colleagues Kimiko Domoto-Reilly, MD, Suman Jayadev, MD, Thomas J Grabowski, MD, and Kristoffer Rhodas, PhD, and with Dedra S. Buchwald, MD and Lonnie Nelson, PhD, of Washington State University. Data and participants are from the Strong Heart Study, and part of a growing body of work on Alzheimer's disease and vascular dementias in this otherwise critically-understudied population. This study has been funded in whole or in part with federal funds from the National Institutes of Health, including the National Heart, Lung, and Blood Institute and National Institute on Aging, including R01HL093086 (Buchwald), P50AG005136 (Grabowski), K01AG057821 (Suchy-Dicey). More information: Astrid M. Suchy-Dicey et al, Epidemiology and prevalence of dementia and Alzheimer's disease in American Indians: data from the Strong Heart Study, Alzheimer's and Dementia: The Journal of the Alzheimer's Association (2024). About HMRI Based in Pasadena, California, Huntington Medical Research Institutes (HMRI) is a pioneer in scientific research with a 70-year track record of groundbreaking discoveries that have changed the world – from seatbelts to lifesaving diagnostic technology like the MRI. Today, HRMI is laser-focused on biomedical research that investigates diseases of the heart and brain, and it is committed to inspiring and educating the next generation of scientists. SOURCE Huntington Medical Research Institutes