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HOUSTON, January 18, 2024–(BUSINESS WIRE)–Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, announces that Howard Berman, Ph.D., Chief Executive Officer and Chairman of Coya Therapeutics, Arun Swaminathan, Ph.D., Chief Business Officer, and Fred Grossman DO, President and Chief Medical Officer, have been invited to participate in Chardan Capital Market’s (Chardan’s) upcoming biotechnology Leadership Call Series on Tuesday, January 30, 2024 at 10:30am ET.
Chardan’s leadership call series features leaders from large disruptive biotech corporations discussing their businesses and key industry trends in a casual chat-style format. This discussion will be moderated by Keay Nakae, CFA, Senior Biotechnology Analyst at Chardan.
Howard H. Berman, Ph. D. , CEO of Coya, said, “We appreciate the opportunity to participate on this occasion to discuss our pioneering efforts in drug progression in the realm of regulatory mobile T enhancement (Treg) treatments in neurodegenerative diseases. Immunotreatments, such as COYA 302, can triumph over the complex inflammatory environment that characterizes such situations and potentially have disease-modifying outcomes.
Interested investors may request attendance to the live virtual event by emailing Chardan at [email protected]. A replay of the session will be available on Coya’s website following the call.
About COYA 302
COYA 302 is a patented and investigational biologic combination drug with a dual immunomodulatory mechanism of action aimed at supporting the anti-inflammatory function of regulatory T cells (Tregs) and suppressing inflammation produced by activated monocytes and macrophages. COYA 302 is composed of patented low-dose interleukin-2 (LD IL-2) and Ig CTLA-4 and is being developed for subcutaneous treatment for the treatment of ALS patients. These mechanisms may have additive or synergistic effects.
In February 2023, Coya announced the effects of an open-label, proof-of-concept clinical study comparing LD IL-2 and CTLA-4 Ig in a small cohort of ALS patients conducted at the Houston Methodist Research Institute (Houston, Texas). ) through Stanley Appel, M. D. , Jason Thonhoff, M. D. , Ph. D. and David Beers, Ph. D. This study was the first of its kind to compare this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study gained investigational medicine for 48 consecutive weeks and protection and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured through the ALSFRS-R scale were compared.
During the 48-week treatment period, the remedy was well tolerated. The most common adverse event was mild injection site reactions. No patients 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 assessment tool for monitoring disability progression in patients with ALS. Mean ALSFRS-R scores (± SD) at week 24 (33. 75 ± 3. 3) and week 48 (32 ± 7. 8) after initiation of treatment were not statistically different from the ALSFRS-R score at baseline (33. 5 ± 5. 9), suggesting a significant improvement in disease progression 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. Data available up to 16 weeks after the start of treatment suggest a reduction in the levels of these biomarkers, which is consistent with the observed improvement in Treg function. Assessment of complete knowledge of biomarkers is ongoing.
Coya recently announced the expansion of the COYA 302 pipeline to treat frontotemporal dementia (FD) and Parkinson’s disease (PD), in addition to ALS.
COYA 302 is an investigational product still approved by the FDA or any other regulatory agency.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a rare neurological disease that affects motor neurons, nerve cells in the brain and spinal cord that control voluntary muscle movement. About 20,000 more people are living with ALS in the U. S. About 5,000 new cases are diagnosed each year. The disease is progressive, meaning that symptoms worsen over time. The functional prestige of ALS patients decreases by about 1 point per month on average, as measured by the Revised ALS Function Rating Scale1, or ALSFRS-R, a validated tool for tracking disease progression.
There is no cure for ALS, and recently approved medications offer limited benefits to patients. ALS is a type of motor neuron disease. As motor neurons degenerate and die, they prevent messages from being sent to the muscles, causing the muscles to weaken, contract (fasciculation), and die (atrophy). Over time, the brain loses its ability to initiate and perform voluntary movements. Most people with ALS die from respiratory failure, usually within 3 to five years of the onset of symptoms. 2
About Frontotemporal Dementia
Frontotemporal dementia (FTD) is the result of damage to neurons in the frontal and temporal lobes of the brain. Many possible symptoms can result, including unusual behaviors, emotional problems, trouble communicating, difficulty with work, or difficulty with walking. FTD is rare and tends to occur at a younger age than other forms of dementia. About 60% of people with FTD are 45 to 64 years old. FTD is progressive, meaning symptoms get worse over time. In the early stages, people may have just one symptom. As the disease progresses, other symptoms appear as more parts of the brain are affected. It is difficult to predict how long someone with FTD will live. Some people live more than 10 years after diagnosis, while others live less than two years after they are diagnosed. There is no cure for FTD, and no treatments slow or stop the progression of the disease.3
About Parkinson’s Disease
Parkinson’s disease (PD) is a progressive brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. The most prominent manifestations of PD occur when nerve cells in the basal ganglia, an area of the brain that controls movement, become impaired or die. As the disease progresses, people may have difficulty walking and talking. They may also have mental and behavioral changes, sleep problems, depression, memory difficulties, and fatigue. Most people with PD first develop the disease after age 60, but about 10% experience onset before the age of 50. There is no cure for PD and currently available treatments are intended to relieve some symptoms.4
References
Atassi N, et al. The PRO-ACT Database: Design, Analysis, and Predictive Features. Neurology, 2014; 83: 1719-1725. es what I have: 10. 1212/WNL. 0000000000000000000951.
National Institutes of Health (NIH) (https://www. ninds. nih. gov), accessed January 8, 2024.
National Institutes of Health (NIH) (https://www. nia. nih. gov), accessed January 8, 2024.
National Institutes of Health (NIH) (https://www. nia. nih. gov), accessed January 8, 2024.
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 pipeline of investigational product applicants leverages multiple healing modalities aimed at restoring the anti-inflammatory and immunomodulatory effect of Tregs. Coya’s healing platforms come with Treg-enhancing biologics, Treg-derived exosomes, and Treg’s autologous mobile therapy. The three hundred product applicants in the Coya series, COYA 301 and COYA 302, are biological treatments designed for Treg to act and increase the Treg count. COYA 301 is a cytokine biologic for subcutaneous treatment aimed at Treg and increase Treg count in vivo. COYA 302 is a biological blend for subcutaneous and/or intravenous treatment intended for Tregs to serve as a function of the depleting T-effector and activated macrophages. These two mechanisms can be additive or synergistic in suppressing inflammation. To learn more about Coya, visit www. coyahealings. 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 effect of COVID-19; the good fortune, pace and timing of our ongoing and planned product candidate progression activities and clinical trials; our plans to expand and advertise specific healing products; progress of patient recruitment and dosing in our preclinical or clinical trials; the ability of our product applicants to achieve applicable endpoints in clinical trials; the protection profile of our product applicants; the prospect of our knowledge of clinical trials to assist in a commercialization application, as well as the timing of such events; our ability to download financing for our operations; the progression and advertising of our product applicants; the timing and our ability to discharge and maintain regulatory approvals; the rate and degree of market acceptance and clinical application of our product applicants; the extent and prospect of expansion of the markets for our product applicants, as well as our ability to serve those markets; our sales, marketing and production functions and strategy; long-term agreements with third parties in connection with the advertising of our product applicants; our expectations related to our ability to download and maintain protection of intellectual assets; our dependence on third-party manufacturers; the good fortune of competing treatments or products that are or are likely to become available; our ability to attract and retain key clinical or management personnel; our ability to identify other product applicants with significant advertising prospects consistent with our business objectives; ; and our estimates related to expenses, long-term revenues, capital needs and additional financing needs.
We have based such forward-looking statements largely on our existing expectations and projections regarding long-term events and trends that we believe would likely have an effect on our monetary condition, effects of operations, business strategy, operations and business objectives in the near term. and close to the long term. in the long term, as well as our finances. needs. Additionally, we operate in a highly competitive and rapidly changing environment, and new hazards may arise from time to time. It is not possible for our control to anticipate all risks, nor can we evaluate the effect of all aspects on our business or the extent to which any factor, or combination of factors, could have an effect on our business. such that the actual effects differ materially from those contained in long-term contracts. – any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and events discussed herein would likely not occur and actual effects could differ materially and adversely from those expected or implied by the forward-looking statements. Although our control believes that the expectations reflected in our forward-looking statements are reasonable, we cannot assure you that the long-term effects, degrees of activity, functionality or occasions and events described in the forward-looking statements will be achieved or occur. We undertake no legal responsibility 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, long-term developments or otherwise.
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Contacts
Investor Contact David Snyderdavid@coyatherapeutics. com CORE GO Bret Shapirobrets@coreir. com 561-479-8566Media Contact Jessica Starmanjessica@elev8newmedia. com 818-621-7216