This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

Start Date01 Feb 2025

Sponsor / Collaborator

Duke University

[+1]

NCT06680661 / Not yet recruitingPhase 2IIT

ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.
Participants will:
* Partake in exams, tests, and procedures as part of usual cancer care.
* Partake in conditioning, which is the treatment that is given before a transplant.
* Have a cord blood transplant.
* Partake in radiation following the transplant.

Start Date15 Nov 2024

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT04344873 / Not yet recruitingEarly Phase 1IIT

Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States and other industrialized societies, and advanced age is the major risk factor for development of CVD. Advancing age appears to exert its pathological influence primarily via adverse functional and structural effects on arteries. Aging is associated with increased stiffness (reduced compliance) of large elastic arteries and impaired arterial endothelial function that is characterized by reductions in nitric oxide (NO)- mediated endothelium-dependent dilation (EDD). While several changes to arteries may contribute to age-associated increases in CVD risk; the development of endothelial dysfunction and stiffening of the large elastic arteries are among the most important contributors. Both are predictors of CV events and clinical CVD with increasing age. Although the importance of endothelial dysfunction and arterial stiffening with age are well established, the initiating events of these deleterious changes are elusive.

Start Date01 Nov 2024

Sponsor / Collaborator

University of Utah

[+1]

100 Clinical Results associated with Abatacept

100 Translational Medicine associated with Abatacept

100 Patents (Medical) associated with Abatacept

2,824

Literatures (Medical) associated with Abatacept

01 Dec 2024·TRANSPLANT IMMUNOLOGY

Smooth muscle cells clonally expand in a murine carotid allograft model complicated by immune reactions to reporter transgenes

Article

Author: Bentzon, Jacob Fog ; Sørensen, Charlotte Brandt ; Pløen, Gro Grunnet

BACKGROUND AND AIMS:

Most experimental studies of allograft vasculopathy (AV) have relied on transplantation between major histocompatibility complex-mismatched inbred mouse strains, but this leads to the complete eradication of donor smooth muscle cells (SMCs) and lesions formed by recipient cells. This is unlike human AV which is thought to form mainly by donor SMCs. Here, we studied sources of neointimal cells in a minor histocompatibility antigen-mismatched AV model by combining male-to-female orthotopic carotid transplantations and lineage tracing by SMC-specific expression of fluorescent proteins.

METHODS:

To track SMC-derived cells in allograft vasculopathy, we used male donor mice with SMC-restricted Cre recombination of the mT/mG reporter transgene, which switches expression of membrane-bound red fluorescent protein (RFP) to green fluorescent protein (GFP), or the stochastically recombining Confetti reporter transgene, which yields a mosaic expression of four fluorescent proteins. Donor carotid segments were harvested and orthotopically allografted to female recipients that were wildtype or had non-recombined reporter transgenes. Inhibition of T cell responses by CTLA4Ig was used in some experiments. Sections of lesions harvested after 4 weeks were analyzed by fluorescence microscopy.

RESULTS:

Donor-derived SMCs survived and gave rise to part of the neointimal cells in experiments where carotid segments from recombined mT/mG male mice were transplanted into wild-type or non-recombined mT/mG female mice. Sex-mismatched transplants developed significant lesions, increasing the intimal and medial area 4.6-fold (p = 0.038) and 2.0-fold (p = 0.024) compared to sex- and fluorescence-matched controls, respectively. Interestingly, sex-matched fluorescence-positive transplants developed intimal lesions in 50% of fluorescence-naïve recipient controls. To study the clonal structure of the neointimal donor-derived SMC lineage cells, we then transplanted male carotids with heterozygous or homozygous recombined Confetti transgenes into female recipients. These transplants developed lesions with few surviving donor SMCs, indicating that expression of the Confetti reporter increased rejection and donor-specific SMC death. Some of the few remaining donor SMCs underwent clonal expansion. CTLA4Ig administration at the time of surgery did not improve SMC survival in mT/mG or Confetti transplants.

CONCLUSION:

Male-to-female transplant models feature donor-derived SMCs, some of which undergo clonal expansion, but immune rejection to fluorescence reporters appears to bias results in lineage tracing models. Overcoming these challenges with alternative reporter transgenes or tolerant recipients is necessary to study the mechanisms by which donor SMCs contribute to allograft vasculopathy.

01 Dec 2024·Journal of Translational Autoimmunity

To switch or to swap? Evidence from a meta-analysis for the best treatment approach in childhood chronic uveitis resistant to the I anti-TNF

Review

Author: Pagnini, Ilaria ; Soldovieri, Sara ; Marrani, Edoardo ; Oliverio, Teodoro ; de Masi, Salvatore ; Maccora, Ilaria ; Simonini, Gabriele ; Mastrolia, Maria Vincenza

Objective:

Since adalimumab approval in childhood chronic non-infectious uveitis (cNIU), the prognosis has been dramatically changed, but the 25 % failed to achieve inactivity. There is not accordance if it is better to switch to another anti-TNF or to swap to another category of biologic. Thus, we aim to summarize evidence regarding the best treatment of cNIU refractory to the first anti-TNF.

Methods:

A systematic literature review and meta-analysis, according to PRISMA Guidelines, was performed(Jan2000-Aug2023). Studies investigating the efficacy of treatment in cNIU refractory to the first anti-TNF were considered for inclusion. The primary outcome was the improvement of intraocular inflammation according to SUN. A combined estimation of the proportion of children responding to switch or swap and for each drug was performed.

Results:

23 articles were eligible, reporting 150 children of whom 109 switched anti-TNF (45 adalimumab, 49 infliximab, 9 golimumab) and 41 swapped to another biologics (31 abatacept, 8 tocilizumab and 1 rituximab). The proportion of responding children was 46 %(95 % CI 23-70) for switch and 38 %(95 % CI 8-73) for swap (χ²0.02, p = 0.86). Instead analysing for each drug, the proportion of responding children was the 24 %(95 % CI 2-55) for adalimumab, 43 %(95 % CI 2-80) for abatacept, 79 %(95 % CI 61-93) for infliximab, 56 %(95 % CI 14-95) for golimumab and 96 %(95 % CI 58-100) for tocilizumab. We evaluated a superiority of tocilizumab and infliximab compared to the other drugs(χ² 27.5 p < 0.0001).

Conclusion:

Although non-conclusive, this meta-analysis suggests that, after the first anti-TNF failure, tocilizumab and infliximab are the best available treatment for the management of cNIU.

01 Dec 2024·JOINT BONE SPINE

2024 update of the recommendations of the French Society of Rheumatology for the diagnosis and management of patients with rheumatoid arthritis

Article

Author: Salmon, Jean-Hugues ; Kedra, Joanna ; Alegria, Guillermo Carvajal ; Vittecoq, Olivier ; Seror, Raphaèle ; Vacher, Danielle ; Fautrel, Bruno ; Goëb, Vincent ; Marotte, Hubert ; Drouet, Juliette ; Tournadre, Anne ; Goff, Benoit Le ; Gaujoux-Viala, Cécile ; Escaffre, Pascale ; Daien, Claire ; Baillet, Athan ; Rempenault, Claire ; Brocq, Olivier ; Dieudé, Philippe ; Le Goff, Benoit ; Senbel, Eric ; Dernis, Emmanuelle ; Avouac, Jérôme ; Constantin, Arnaud ; Richez, Christophe ; Juge, Pierre-Antoine ; Saraux, Alain ; Gottenberg, Jacques-Eric

The French Society of Rheumatology recommendations for managing rheumatoid arthritis (RA) has been updated by a working group of 21 rheumatology experts, 4 young rheumatologists and 2 patient association representatives on the basis of the 2023 version of the European Alliance of Associations for Rheumatology (EULAR) recommendations and systematic literature reviews. Two additional topics were addressed: people at risk of RA development and RA-related interstitial lung disease (RA-ILD). Four general principles and 19 recommendations were issued. The general principles emphasize the importance of a shared decision between the rheumatologist and patient and the need for comprehensive management, both drug and non-drug, for people with RA or at risk of RA development. In terms of diagnosis, the recommendations stress the importance of clinical arthritis and in its absence, the risk factors for progression to RA. In terms of treatment, the recommendations incorporate recent data on the cardiovascular and neoplastic risk profile of Janus kinase inhibitors. With regard to RA-ILD, the recommendations highlight the importance of clinical screening and the need for high-resolution CT scan in the presence of pulmonary symptoms. RA-ILD management requires collaboration between rheumatologists and pulmonologists. The treatment strategy is based on controlling disease activity with methotrexate or targeted therapies (mainly abatacept or rituximab). The prescription for anti-fibrotic treatment should be discussed with a pulmonologist with expertise in RA-ILD.

115

News (Medical) associated with Abatacept

19 Nov 2024

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Coya Therapeutics CEO Dr. Arun Swaminathan Issues Letter to Stockholders

HOUSTON--( BUSINESS WIRE )-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, releases the following letter to stockholders from Chief Executive Officer Dr. Arun Swaminathan. Dear Fellow Stockholder, Given my recent transition to the role of CEO, I wanted to share my thoughts on Coya and our future and to express my gratitude to our founder and Executive Chair, Dr. Howard Berman, whose bold vision has instilled the “innovation and get-it-done” culture in Coya’s DNA. We have made tremendous strides in 2024, repeatedly executing on our promises. As I look to 2025, I am confident that our nimble and highly experienced team will continue to exceed expectations. I have spent my entire 25-year career in the biotech space, and I believe that Coya has the most promise of any company that I have represented. I truly believe our novel science, strong clinical proof of concept data, pharmaceutical partnership validation, cash runway, and clear path to a commercial drug differentiates us. Prior to serving at Coya, I helped spearhead and lead pharmaceutical transactions worth billions of dollars that led to significant value creation. I believe the opportunities ahead of us in 2025 and beyond are what investors, stockholders, and patients should be most excited about. Our science and approach of regulating Tregs is now validated in multiple trials across multiple neurodegenerative diseases, we have a track record of executing value-creating non-dilutive deals, and our strong cash position allows us to be prudent in our decisions. Year Ahead We expect our activities in 2025 to be focused on the following indications: ALS (Amyotrophic Lateral Sclerosis) Program: We have alignment with the FDA on the data required to initiate our potentially pivotal COYA 302 Phase 2 double-blind randomized study in patients with ALS. We are targeting the submission of the requested data package by 2Q 2025 and initiation of the clinical trial upon FDA clearance. The roadmap to topline results is now clear with reduced uncertainty. In late 2023, we partnered with Dr. Reddy’s Laboratories, a multi-billion-dollar drug developer, to license COYA 302 in ALS in a deal that is worth up to $700 million. We still retain the rights to COYA 302 in ALS in Japan and South/Central America and Mexico, thus providing us direct upside and optionality in this indication alone. FTD (Frontotemporal Dementia) Program: We expect to see topline results in 2H 2025 from the investigator-initiated, open-label study of Low Dose IL-2 (LD IL-2) + CTLA4-Ig in FTD. Study endpoints will measure safety, peripheral and central inflammation, FTD progression, and pharmacodynamic effects on Treg cell populations. The data are expected to guide our planned COYA 302 Phase 2 double-blind randomized study (which will be funded by the Alzheimer’s Drug Discovery Foundation) and further optimize the design for success. The guidance from the FDA on the ALS IND reduces uncertainty on the planned IND filing for FTD in 2H of 2025. We have retained full commercial rights on this program thus far, providing us optionality to develop the program to BLA approval ourselves and capture the full potential upside or partner at a later stage once we obtain additional clinical data. AD (Alzheimer’s disease) Program: Complementing the promising data that was presented at CTAD in Madrid for LD IL-2 in mild to moderate AD, the investigators will disclose additional data in 1H 2025 that summarizes the changes in inflammation in the peripheral system (blood) and central nervous system (CSF and brain) and other molecular measurements for the two IL-2 dosing arms vs. placebo. These important data will help to further address the basic science associated with the promising clinical response observed in the lower dose IL-2 arm and its association with better Treg enhancement. We retain full rights to the AD indication for COYA 302 and are already in the process of exploring non-dilutive and strategic partnering opportunities. While the CTAD data was based on LD IL-2 alone and proved highly promising in and of itself, COYA 302, which is a proprietary combination of LD IL-2 and CTLA4-Ig, targets multiple pathways and is developed to more significantly and durably enhance Treg function, which we believe will be highly attractive to potential partners. Strategic Partnerships Dr. Reddy’s Partnership: Our partnership with Dr. Reddy’s Laboratories is approaching its one-year anniversary, and our collaboration could not be stronger. We have a reliable partner for ALS, and leveraging its resources and expertise has created value beyond the milestone payments. In 2025, we anticipate receiving $8.4 million upon initiation of the Phase 2 ALS clinical trial and will continue to evaluate opportunities to further deepen the relationship. Other Strategic Possibilities: As I have described, my background is one of deal-making, and I intend to leverage my network and capabilities to maximize opportunities for Coya in 2025. We have only partnered COYA 302 in ALS, and the optionality to partner, co-develop, or license the asset in other indications exists. Any potential transaction will be evaluated based on maximizing stockholder value. The positive data from the investigator-initiated trial of LD IL-2 in patients with Alzheimer’s disease increases our confidence in obtaining value-creating pharma partnerships that combine our proprietary LD IL-2, COYA 301, with other modalities. I can envision multiple opportunities with LD IL-2 serving as a backbone adjuvant with standard of care agents and other novel pathways. Moreover, the opportunity for grant funding and financial support from foundations exists and will be vigorously pursued. We believe the data emerging on Tregs in autoimmune disease (such as lupus, rheumatoid arthritis, and scleroderma) and, in particular, treatment with LD IL-2 is compelling and may strengthen the role of COYA 302 and LD IL-2 combinations in this space. I intend to actively pursue partnerships in this arena that would further place us in a strong position to pursue value-creating deals. Value-Creating Pipeline Like many experts in the scientific community, we believe combination strategies are the future to address devastating neurodegenerative diseases. We believe targeting one mechanism or pathway is likely insufficient to achieve maximal effect - hence our approach with COYA 302. COYA 302 is a “Pipeline within a Product” and has strong potential in ALS, FTD, AD, Parkinson’s disease, and other indications. We are continuously building our intellectual property to further enhance the value of Coya. One recent development is the combination of COYA 301 and GLP-1 agonists. Data suggests that the mechanism of action appears additive and/or synergistic in ameliorating inflammation. This is yet another opportunity for value-creating strategic partnerships. We intend to publish more detailed data in 1Q 2025. Conclusion As you can see from our past performance, our entire management team is committed to the success of Coya. We expect to recognize a number of clinical, regulatory, and/or commercial milestones in 2025 that will help us advance the treatment of neurodegenerative diseases. On behalf of the entire Coya team, please accept our sincere gratitude for both your support and belief in our science, our story, and our team. We look forward to presenting additional clinical data and updating you on our additional corporate developments as they unfold. Onwards and upwards! 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 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 will 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 because of new information, future developments or otherwise.

Phase 2Executive ChangeCell Therapy

18 Nov 2024

·www.businesswire.com

Aqtual Presents New Data on Development of RA Therapy Selection Test at ACR Convergence 2024

HAYWARD, Calif.--( BUSINESS WIRE )--Aqtual, Inc., a precision medicine company using its novel active chromatin cell-free DNA platform to develop products for chronic diseases and oncology, today announced the presentation of new data supporting its innovative blood-based test for rheumatoid arthritis (RA) therapy selection. Presented at the American College of Rheumatology (ACR) Convergence 2024, the data highlights significant clinical trial progress and reinforces the company's plans to commercialize the test in 2025. The first poster demonstrates proof-of-concept data that Aqtual's therapy selection test can predict treatment response in patients with RA. The second poster provides an interim analysis from PRIMA-102, Aqtual's prospective observational clinical trial that has enrolled more than 1000 patients to date, with more than 500 patients having completed the study follow-up period. “PRIMA-102 represents a significant step toward personalized treatment strategies for RA patients experiencing inadequate response or intolerance to current disease-modifying antirheumatic drug therapies,” said Gordon K. Lam, M.D., F.A.C.R., Arthritis & Osteoporosis Consultants of the Carolinas. “The study has enrolled an impressive number of patients from across the U.S., representing a diverse range of treatment histories, making its results broadly applicable to real-world patient populations.” Many patients with RA try at least two or three different therapies before finding one that works for them. 1 It is estimated that annual healthcare costs of RA patients in the United States total more than $19B, not including intangible costs like quality of life, premature mortality, and societal costs. 2 “The PRIMA-102 data we are sharing today supports our 2025 plan to deliver the first RA therapy selection test that provides a positive prediction of drug-class specific therapy response for both biologic and targeted synthetic DMARDs,” said Diana Abdueva, Ph.D., co-founder and CEO of Aqtual. “By providing information on the likelihood of response to the TNFi, anti-T cell and JAKi drug classes, we will empower clinicians to improve outcomes for their patients and the health system as a whole.” Posters are available on the Aqtual website: A Novel Blood-based Assay That Predicts Clinical Response to TNFα Inhibitors or Janus Kinase Inhibitors in Patients with Rheumatoid Arthritis Development of a Blood-based Cell-free DNA Classifier Assay to Predict Biologic and Targeted Synthetic DMARDs Response in Rheumatoid Arthritis Patients (PRIMA-102) About Aqtual, Inc. Aqtual, Inc. is a precision medicine company developing products for chronic disease management and oncology utilizing a novel cell-free DNA-based platform. Aqtual’s proprietary platform evaluates protein regulation, epigenetics, and transcriptomics solely using cell-free DNA fragments found in the blood. The platform yields efficient and robust real-time analysis of disease and treatment while overcoming the limitations of previous cell-free DNA methodologies. 1 Lauper K, Iudici M, Mongin D, Bergstra SA, Choquette D, Codreanu C, Cordtz R, De Cock D, Dreyer L, Elkayam O, Hauge EM, Huschek D, Hyrich KL, Iannone F, Inanc N, Kearsley-Fleet L, Kristianslund EK, Kvien TK, Leeb BF, Lukina G, Nordström DC, Pavelka K, Pombo-Suarez M, Rotar Z, Santos MJ, Strangfeld A, Verschueren P, Courvoisier DS, Finckh A. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the 'JAK-pot' collaboration. Ann Rheum Dis. 2022 Oct;81(10):1358-1366. doi: 10.1136/annrheumdis-2022-222586. Epub 2022 Jun 15. PMID: 35705376; PMCID: PMC9484385. 2 Birnbaum H, Pike C, Kaufman R, Marynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010 Jan;26(1):77-90. doi: 10.1185/03007990903422307. PMID: 19908947

Clinical Study

06 Nov 2024

·www.businesswire.com

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Third Quarter 2024 Financial Results

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, provides a corporate update and announces its financial results for the quarter ended September 30, 2024. Recent Corporate Highlights Announced positive results from an investigator initiated double-blind study of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer’s Disease (AD) at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid Filed patents for COYA 301 in combination with Glucagon-Like Peptide-1 (GLP-1) receptor agonists Promoted Arun Swaminathan, Ph.D. to Chief Executive Officer, effective November 1, 2024, while Howard Berman has transitioned from CEO to Executive Chairman Announced anti-inflammatory effects of COYA 302 in the brain from a preclinical inflammatory mouse model of Parkinson’s disease (PD) Aligned with FDA on the non-clinical data needed to support the planned randomized, double-blind, placebo-controlled, Phase 2b trial of COYA-302 in patients with Amyotrophic Lateral Sclerosis (ALS). A Phase 1 investigator-initiated trial (IIT) combining LD IL-2 + CTLA4-Ig began in patients with Frontotemporal Dementia (FTD) Upcoming Expected Catalysts for 2025 Q1 2025: Additional clinical data to be released in the Phase 2 LD IL-2 investigator-initiated trial (IIT) study in patients with AD. Publication and release of additional and comprehensive blood immune panels and inflammatory cerebrospinal fluid (CSF) biomarkers comparing LD IL-2 arms to placebo arm Q1/Q2 2025: COYA 301/GLP-1 combination data submission for publication and additional intellectual property filings Q2 2025: Submission of additional data to support the start of the COYA-302 Phase 2 trial in patients with ALS Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL) Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS 2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD* (*Clinical trial initiated upon FDA IND approval) “We are pleased with the constructive discussion we have had with the FDA,” said Coya CMO, Dr. Fred Grossman. “We have clarity on the non-clinical data needed to support the start of our Phase 2 study of COYA-302 in patients with ALS and we are fully aligned with the FDA. We are confident in the path forward towards the completion of this important potential pivotal trial. Following FDA acceptance of the Coya 302 IND in ALS, we expect to submit the IND for COYA 302 in FTD, likely in the second half of 2025.” Coya CEO Arun Swaminathan, Ph.D. said: “As the new CEO of Coya, I am very encouraged by our progress in 2024. I believe our progress opens a wide array of strategic opportunities in 2025, both with existing and new partners. I will be keenly focused on delivering shareholder value over the next year. “During the third quarter of 2024 we continued to advance our pipeline of neurodegenerative treatments, all aimed at neurodegenerative diseases with high unmet need, including AD, PD, and ALS. “Our drug candidates all target neuroinflammation, which we see as a major contributing factor towards disease progression in the neurological conditions we are addressing. Moreover, our approach to potential combination therapies for treatment of these neurodegenerative diseases differentiates us from other companies and offers, what we believe, a new treatment paradigm that could lead to the creation of meaningful shareholder value. “We anticipate 2025 will be a busy and productive year filled with multiple milestones, clinical data and catalysts. In Q1 of 2025, we will be presenting additional clinical data from the investigator-initiated phase 2 trial in AD and later in the year clinical data from another investigator-initiated clinical trial in FTD, this time with the combination of LD IL-2 and CTLA-4 Ig. We are also excited to begin our Coya sponsored phase 2 trials for our combination biologic COYA 302 in both ALS and FTD. “During the CTAD conference in Madrid at the end of October, encouraging Phase 2 data was presented from an investigator-initiated trial that highlighted the benefits of LD IL-2 in treating patients with mild to moderate Alzheimer’s disease. This data increased our confidence in our combination drug candidate, COYA 302, which combines COYA 301, our proprietary LD IL-2 candidate, with the fusion protein CTLA4-Ig, or Abatacept for the potential treatment of neurodegenerative diseases, such as ALS and FTD. We believe LD IL-2 enhances and restores Treg function, lowering inflammation, while CTLA4-Ig inhibits other inflammatory cell types and so may sustain and create more durable Treg functionality. While we were encouraged with the promising LD IL-2 monotherapy data in AD, we believe that our combination approach with CTLA-4 Ig provides numerous advantages by targeting multiple immune pathways which are critical in these complex diseases. “We also believe there is potential for strategic opportunities combining COYA-301 with other therapeutic agents as potential therapeutics for patients with AD or other neurodegenerative and autoimmune diseases. “Finally, our recent capital raise provides additional flexibility and cushion for us to execute on our corporate, clinical, and regulatory goals. As of October 31, 2024, our interim cash and cash equivalents (unaudited) was $39.8 million. We continue to be in discussions with our partners and potential partners looking for opportunities to reach our goals quicker and in the best way possible. I look forward to sharing additional corporate, clinical, and regulatory progress as appropriate,” concluded Swaminathan. Unaudited Financial Results As of September 30, 2024, Coya had cash and cash equivalents of $31.1 million. Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $1.6 million for the three months ended September 30, 2023. The increase was due to a $0.3 million increase in our preclinical expenses primarily due to our preclinical advancement of COYA 302 in ALS and a $0.3 million increase in internal research and development expenses. General and administrative expenses were $2.2 million for the three months ended September 30, 2024, and $2.0 million for the three months ended September 30, 2023, a change of approximately $0.2 million. The increase was primarily due to a $0.4 million increase in stock-based compensation and employee headcount, partially offset by a $0.2 million decrease in corporate fees. Net loss was $4.0 million for the three months ended September 30, 2024, compared to net loss of $3.4 million for the three months ended September 30, 2023. 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 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 will 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. CONDENSED BALANCE SHEETS September 30, December 31, 2024 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 31,057,395 $ 32,626,768 Collaboration receivable - 7,500,000 Prepaids and other current assets 4,449,006 1,069,557 Total current assets 35,506,401 41,196,325 Fixed assets, net 45,429 65,949 Total assets $ 35,551,830 $ 41,262,274 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 336,722 $ 1,155,656 Accrued expenses 1,409,235 2,973,215 Deferred collaboration revenue 573,089 923,109 Total current liabilities 2,319,046 5,051,980 Deferred collaboration revenue 1,222,596 574,685 Total liabilities 3,541,642 5,626,665 Stockholders' equity: Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued or outstanding as of September 30, 2024 or December 31, 2023 - - Common stock, $0.0001 par value; 200,000,000 shares authorized; 15,221,308 and 14,405,325 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 1,523 1,441 Additional paid-in capital 69,830,059 61,501,801 Subscription receivable - (11,250 ) Accumulated deficit (37,821,394 ) (25,856,383 ) Total stockholders' equity 32,010,188 35,635,609 Total liabilities and stockholders' equity $ 35,551,830 $ 41,262,274 CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Collaboration revenue $ — $ — $ 3,552,109 $ — Operating expenses: Research and development 2,223,903 1,592,232 9,928,214 3,891,896 In-process research and development — — 25,000 350,000 General and administrative 2,219,545 1,964,990 6,747,790 5,456,087 Depreciation 6,841 6,841 20,521 20,521 Total operating expenses 4,450,289 3,564,063 16,721,525 9,718,504 Loss from operations (4,450,289 ) (3,564,063 ) (13,169,416 ) (9,718,504 ) Other income: Other income 428,871 142,089 1,204,405 464,693 Net loss $ (4,021,418 ) $ (3,421,974 ) $ (11,965,011 ) $ (9,253,811 ) Per share information: Net loss per share of common stock, basic and diluted $ (0.26 ) $ (0.34 ) $ (0.80 ) $ (0.94 ) Weighted-average shares of common stock outstanding, basic and diluted 15,221,308 9,947,915 14,866,089 9,873,387 CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS Nine Months Ended September 30, 2024 2023 Cash flows from operating activities: Net loss $ (11,965,011 ) $ (9,253,811 ) Adjustment to reconcile net loss to net cash used in operating activities: Depreciation 20,521 20,521 Stock-based compensation, including the issuance of restricted stock 1,872,990 634,249 Acquired in-process research and development assets 25,000 350,000 Changes in operating assets and liabilities: Collaboration receivable 7,500,000 - Prepaids and other current assets (3,379,449 ) 314,910 Accounts payable (773,956 ) (177,911 ) Accrued expenses (1,477,041 ) (835,689 ) Deferred collaboration revenue 297,891 - Net cash used in operating activities (7,879,055 ) (8,947,731 ) Cash flows from investing activities: Purchase of in-process research and development assets (25,000 ) (350,000 ) Net cash used in investing activities (25,000 ) (350,000 ) Cash flows from financing activities: Proceeds from sale of common stock upon initial public offering, net of offering costs - 14,250,311 Proceeds from sale of common stock, net of offering costs 4,943,668 - Proceeds from subscription receivable 11,250 - Payment of financing costs related to the 2023 Private Placement (131,918 ) - Proceeds from the exercise of stock options 1,975 - Proceeds from the exercise of warrants 1,509,707 - Net cash provided by financing activities 6,334,682 14,250,311 Net increase in cash and cash equivalents (1,569,373 ) 4,952,580 Cash and cash equivalents as of beginning of the period 32,626,768 5,933,702 Cash and cash equivalents as of end of the period $ 31,057,395 $ 10,886,282 Supplemental disclosures of non-cash financing activities: Conversion of convertible preferred stock upon initial public offering $ - $ 8,793,637 Conversion of convertible promissory notes upon initial public offering $ - $ 12,965,480

Phase 2Phase 1Financial StatementIND

100 Deals associated with Abatacept

External Link

KEGG	Wiki	ATC	Drug Bank
D03203	Abatacept	L04AA24	DB01281

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Graft Versus Host Disease	US	Bristol Myers Squibb Co.	15 Dec 2021
Juvenile Idiopathic Arthritis	US	Bristol Myers Squibb Co.	25 Aug 2009
Arthritis, Psoriatic	EU	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	IS	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	LI	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	NO	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	EU	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	IS	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	LI	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	NO	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Rheumatoid Arthritis	US	Bristol Myers Squibb Co.	23 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocarditis	Phase 3	US	Bristol Myers Squibb Co.	22 Jun 2022
Myocarditis	Phase 3	CA	Bristol Myers Squibb Co.	22 Jun 2022
Polymyalgia Rheumatica	Phase 3	FR	Bristol Myers Squibb Co.	13 Dec 2018
Giant Cell Arteritis	Phase 3	US	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	AU	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	AT	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	BE	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	BG	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	CA	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	DK	Bristol Myers Squibb Co.	15 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03680092 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia \| Hematologic Neoplasms \| acute leukemia ... View more	43	Cyclophosphamide+Abatacept (Cyclophosphamide and Abatacept)	aewfdmzdpn(hlqeawgrmo) = fuqodljvnn czeftbjzrw (szbajovnpb, hpmkpeykje - oibmljhsog) View more	-	02 Oct 2024
				Tacrolimus+Methotrexate (Methotrexate and Tacrolimus)	aewfdmzdpn(hlqeawgrmo) = wotnmximvi czeftbjzrw (szbajovnpb, hpqwkbybsx - vyghgrxrzr) View more
NCT03882008 (CTgov)	Phase 4	Rheumatoid Arthritis	25	Abatacept	opvfvbalck(hpztvzqtpx) = ymcujdbcef nzihvtvbcm (xygytgzyuc, enimwtldxr - ottofbbbmu) View more	-	30 Jul 2024
EULAR2024	Not Applicable	Idiopathic Inflammatory Myopathies	-	Abatacept 125mg weekly subcutaneous	ndvbiifwqo(afngafftqz) = txrappeebj taejbqtmzs (qtiqzphvyy )	-	05 Jun 2024
				Placebo+SOC	ndvbiifwqo(afngafftqz) = eybzdejukw taejbqtmzs (qtiqzphvyy )
EULAR2024	Not Applicable	ACPA-positive	92	ABT	hlbqtacswf(jritmhnfrd) = cgsqxvwdpp jkqdbsiwru (julezusexq ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Neoplasms	-	Abatacept	ycvsjyqyym(ugebfnizxx) = highlighted an increased risk of non-melanoma skin cancer (NMSC) with abatacept, compared with conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) ruychotmxx (yzkmqphnxw )	Negative	05 Jun 2024
				Placebo
EULAR2024	Not Applicable	Progressive pulmonary fibrosis	526	Abatacept	qekmjlcavn(ylzhbvfbep) = haneduomny lvfvcrlkvz (wwjhqlflej )	Positive	05 Jun 2024
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Abatacept	mjeavebvnh(fgwtrqbrou) = zpdkuhiiav lnbmmnejyq (kfcpnvajye ) View more	Positive	05 Jun 2024
				Methotrexate	mjeavebvnh(fgwtrqbrou) = cesarsggcm lnbmmnejyq (kfcpnvajye ) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Methotrexate + Abatacept	orrijjtdeh(uirhclrtrg) = aygumlxtka sxmlnididn (sedftcoswl, 346 - 1719) View more	-	05 Jun 2024
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	rituximab	qwcrhditna(pbmmphemps) = xdqjlidpsg gdlkxcmira (cjdupcomoi, -4.5 to 6.7)	Positive	05 Jun 2024
				abatacept	qwcrhditna(pbmmphemps) = phpcrbgtnr gdlkxcmira (cjdupcomoi, -2.6 to 9.2)
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Biologic and targeted synthetic DMARDs	kqnaulprtf(fwycixjozu) = hmqtighqeg yflyituiqs (edqcusalok ) View more	-	05 Jun 2024

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