Coya Therapeutics Expands Sponsored Research Collaboration with Houston Methodist Research Institute Along with Funding from the Johnson Center for Cellular Therapeutics to Advance Regulatory T Cell Exosome Platform into the Clinic
Coya Therapeutics has expanded its research collaboration with the Houston Methodist Research Institute (HMRI) to advance the development of regenerative T cell (Treg) exosome technology. This initiative is funded by the Johnson Center for Cellular Therapeutics and aims to progress towards a first-in-human clinical study. The collaboration will also focus on validating clinical biomarkers for neurodegenerative diseases and exploring drug combinations, particularly COYA 301 (low dose interleukin-2) and COYA 302 (LD IL-2 + CTLA4-Ig). These efforts could offer new therapeutic avenues for conditions like ALS, Alzheimer's, and Parkinson's Disease.
- Coya is expanding its research collaboration with Houston Methodist Research Institute.
- Funding from the Johnson Center for Cellular Therapeutics supports the project.
- Focus on advancing Treg exosome technology towards first-in-human clinical studies.
- Validation of clinical biomarkers in neurodegenerative diseases such as ALS, Alzheimer's, and Parkinson's Disease.
- Exploration of synergistic drug combinations, notably COYA 301 and COYA 302.
- Potential new therapeutic avenues for severe neurodegenerative and autoimmune diseases.
- None.
Insights
The expanded collaboration between Coya Therapeutics and Houston Methodist Research Institute primarily aims to advance the development of Treg exosome technology. This form of therapy focuses on utilizing regulatory T cells to modulate the immune response, often targeting neurodegenerative conditions. The commitment to develop multiple patented modalities of exosomes and their full characterization indicates a strong inclination towards precision and tailored treatments.
Biomarkers play a important role in enhancing the accuracy of clinical studies. By validating biomarkers specific to diseases like Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s and Parkinson’s, the collaboration is poised to improve patient stratification and treatment response evaluation. This can lead to more effective and targeted therapies, addressing unmet medical needs and potentially creating significant advancements in neurodegenerative disease treatment.
The focus on clinical biomarkers and exosome technology represents cutting-edge science, which, if successful, could revolutionize treatment approaches in neurodegenerative diseases.
From a financial standpoint, the announcement is indicative of Coya Therapeutics' strategic efforts to leverage non-dilutive funding from the Johnson Center for Cellular Therapeutics. Non-dilutive grants are significant as they provide financing without diluting shareholder equity, which can be favorable for existing investors. Additionally, the collaborative nature of the agreement could reduce the financial burden on Coya while accelerating the pace of their research and development.
Operationally, the involvement in developing proprietary biomarkers and exploring novel drug combinations could diversify Coya's product pipeline, reducing the risk associated with single-product dependency. The emphasis on multiple patented modalities could also open up future revenue streams through licensing or strategic partnerships, enhancing Coya's long-term financial stability and growth potential.
Investors should note the forward-looking nature of these projects, which could entail significant future expenditures before any commercial returns are realized. However, successful breakthroughs could position Coya strongly within the biotech industry, potentially leading to substantial financial gains.
Market-wise, the collaboration and advancements in Treg exosome technology place Coya Therapeutics in a promising position within the rapidly evolving biotechnology sector. The focus on neurodegenerative diseases, which affect millions globally, taps into a market with significant demand for innovative treatments. Currently, available therapies for disorders like ALS and Alzheimer’s offer limited efficacy, underlining the need for novel approaches.
By advancing proprietary biomarkers, Coya could enhance the precision of clinical trials and therapies, potentially setting new industry standards. The synergy exploration with COYA 301 and other drug products hints at a strategic approach to combination therapies, which could address the complex nature of neurodegenerative diseases more effectively than monotherapies.
This could not only boost Coya's market presence but also attract potential partners or acquirers keen on innovative treatment modalities in high-need therapeutic areas.
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)
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 (
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
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 www.coyatherapeutics.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 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 profile of 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240620465914/en/
Investor Contact
David
david@coyatherapeutics.com
CORE IR
Bret Shapiro
brets@coreir.com
561-479-8566
Media Contacts
Kati Waldenburg
media@coyatherapeutics.com
212-655-0924
Source: Coya Therapeutics, Inc.
FAQ
What is the focus of Coya Therapeutics' expanded collaboration with Houston Methodist Research Institute?
Which diseases are targeted by Coya Therapeutics' biomarker validation efforts?
Which drug combinations are being explored by Coya Therapeutics?
How is the Johnson Center for Cellular Therapeutics involved in the collaboration with Coya Therapeutics?
What is the significance of Coya Therapeutics' research on regulatory T cell exosome technology?
