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FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS HOUSTON, Aug. 25, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302. This proprietary immunomodulatory biologic combination therapy is being developed for the treatment of patients with amyotrophic lateral sclerosis (ALS). Arun Swaminathan, Chief Executive Officer, added: "The FDA's acceptance of this IND marks a pivotal moment in Coya's journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS. We are grateful to the ALS community for their continued support of this important program." Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy's Laboratories Ltd. ("DRL") stated, "We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS, also known as Lou Gehrig's disease." The approval of the IND by the FDA triggers a $4.2 million milestone payment to Coya from DRL. 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. These mechanisms may have additive or synergistic effects. COYA 302 is an investigational product not yet 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, the nerve cells in the brain and spinal cord that control voluntary muscle movement. About 20,000 people live with ALS in the United States and approximately 5,000 new cases are diagnosed every year. The disease is progressive, meaning the symptoms get worse over time. The functional status of ALS patents declines about 1 point per month on average, as measured by the Revised ALS Function Rating Scale1, or ALSFRS-R, a validated tool to monitor the progression of the disease. ALS has no cure, and the currently approved drug treatments provide limited benefit to patients. ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.2 Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951. National Institutes of Health (NIH) Website (), accessed on January 4, 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. For more information about Coya, please visit About Dr. Reddy's Laboratories Limited Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . 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 press release, 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 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. Investor Contact David Snyder, CFO [email protected] astr partners Matthew Beck [email protected] 917-415-1750 Media Contacts Russo Partners Olipriya Das [email protected] 646-942-5588 Matthew Purcell [email protected] 646-942-5595 SOURCE Coya Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

蛋白质的糖基化是指寡糖链通过共价键与肽链结合，是蛋白质重要的翻译后加工修饰之一。对蛋白质的结构稳定性、血清半衰期、生物活性及溶解度等关键属性都可能具有重要影响，通常是重组蛋白/抗体类生物制品的关键质量属性（CQA）。 酸性单糖唾液酸通常位于修饰蛋白的寡糖链末端，唾液酸化对重组蛋白类药物的药代动力学具有重要影响，可降低蛋白质在体内被清除的速率，还参与细胞识别、信号传导等生物过程。 今天为大家介绍一种增强CHO细胞培养物中Fc融合蛋白的唾液酸化的有效方法。 人类蛋白质糖链的唾液酸通常为α2,6-唾液酸和α2,3-唾液酸。由于编码α2,6- ST的st6gal1基因启动子被甲基化失活，做为重组蛋白类药物生产重要宿主的CHO细胞无法产生α2,6-唾液酸，因此仅能对其表达的蛋白质进行α2,3-唾液酸化修饰。 对CHO细胞来源的重组蛋白唾液酸连接进行双重处理可使其更接近人类的蛋白质，从而减少或避免治疗性蛋白引发的机体的免疫反应。 目前许多研究聚焦于通过上调唾液酸转移酶活性和下调唾液酸酶活性来最大化唾液酸含量。其中最直接的方法是通过调整培养基组分来实现唾液酸水平的提升。 糖皮质激素（GCs）一类类固醇激素。因与糖皮质激素受体（GRs）可特异性结合并激活其功能，常被用来调控细胞代谢、增殖、分泌以及糖蛋白糖基化等生理过程。 今天挑选常见的六种GCs（图1），分别是氢化可的松（Hyd）、皮质酮（Ccs）、地塞米松（Dex）、 倍他米松（Bet）、 泼尼松龙（Prl） 和 泼尼松（Prd），评估GCs作为培养基添加剂在提升CHO细胞培养中重组蛋白质量方面的应用价值。 图1：用作CHO细胞培养物添加剂的GCs的化学结构 1 材料与方法 细胞：CHO DUKX-B11，在ST6Gal1中过表达并表达α2,6-ST的CTLA4-Ig 测试添加剂：Hyd、Ccs、Dex、Bet、Prl和Prd 浓度范围：0、0.5、1、10 和 20 mg/L 培养模式：CHO细胞以3×106个细胞/mL的密度接种至工作体积为20 mL的125 mL锥形瓶中，置于在 37 ℃、100 rpm 、 5% CO2 摇床中培养。从第1天到第8天，每24小时取样一次。监测活细胞密度（VCD）和活率。 2 结果 GCs对CHO细胞培养性能的影响 图2：补充GC培养物的活细胞密度（VCD）分布曲线 除20 mg/L浓度外，添加GC对VCD的影响与对照组相比无显著差异。 图3：补充GC培养物的细胞活力曲线 在所有测试的GC浓度下，CHO细胞培养物的活率均未受影响。 图4：GC对CHO细胞培养中（A） IVCD和（B）滴度的影响 通过ELISA定量检测CTLA4-Ig水平发现，GCs对CTLA4-Ig的产生具有浓度相关性的负面影响（图4B）。20 mg/L Ccs下CTLA4-Ig的产量降低了47%，但10 mg/L Ccs培养的CTLA4-Ig滴度则与对照相当。 这些数据表明，糖皮质激素的使用会导致CTLA4-Ig的生成减少，但在CHO细胞培养体系中，糖皮质激素的使用浓度可达到10 mg/L。 结合此前研究报道指出，糖皮质激素会抑制哺乳动物细胞的葡萄糖转运和谷氨酰胺摄取功能。CHO细胞培养物中添加GC后，细胞生长和重组蛋白产量降低与葡萄糖和谷氨酰胺摄取受抑制有关。 盐酸水解α2,3-和α2,6-唾液酸，而唾液酸酶S仅能水解α2,3-唾液酸。如图5所示，添加10 mg/L浓度的Ccs可显著提升总唾液酸含量。与对照组相比，含量变化幅度为1.16倍。实验数据表明，在CHO细胞培养体系中添加Ccs等某些糖基化辅酶， 能有效提升唾液酸化水平。 CTLA4-Ig中唾液酸的相对丰度   图5：α2,3-唾液酸含量（A）与总唾液酸含量（B）的分析结果 细胞内唾液酸转移酶在将CMP-唾液酸递送至糖链残基的过程中起着关键作用。因此，提高该酶的活性可有效调控重组蛋白的唾液酸化水平。如图6所示，与对照组相比，添加10 mg/L Ccs后，细胞内唾液酸转移酶活性显著增加。 细胞内唾液酸转移酶活性 图6：第6天的相对细胞内唾液酸转移酶活性 CHO 细胞的内源性唾液酸酶，可在细胞培养过程中在培养上清液中积累，导致分泌至培养上清中糖蛋白糖链末端唾液酸被移除。因此，唾液酸酶的下调可提高糖蛋白的唾液酸化程度。如图7所示，在培养第6天，补充有10 mg/L Ccs 的细胞外唾液酸酶活性比对照组降低了25%。 细胞外唾液酸酶活性 图7：第6天细胞外唾液酸酶活性分析 3 结论 本文描述了在表达α2,3和α2,6-ST的CHO细胞培养液中，添加不同种类的GCs对细胞培养性能和Fc-融合蛋白唾液酸化的影响。尽管额外添加GCs可对生产效率产生负面影响，但可提升重组蛋白的唾液酸总量。其中，Ccs对提升Fc融合蛋白总唾液酸化水平最为显著，包括具有类人唾液酸化特征的α2,6-唾液酸。 唾液酸含量的增加主要归因于两个因素：细胞内唾液酸转移酶活性上调与细胞外唾液酸酶活性下调。唾液酸转移酶活性增强后，能更有效地将唾液酸转移到末端半乳糖残基上。此外，在Ccs处理条件下，由于唾液酸酶活性降低，Fc融合蛋白上的唾液酸裂解过程受到抑制。 本文介绍了一种提高CHO细胞培养物中重组蛋白质量的有效策略，通过将Ccs作为细胞培养添加剂，可有效增强细胞内唾液酸转移酶活性，并抑制细胞外唾液酸酶活性，从而提高唾液酸化水平，最终实现提升CHO细胞重组蛋白质量的目标。 参考文献： Utilization of Glucocorticoids as Additives for Enhanced Sialylation of Fc-fusion Protein in CHO Cell Cultures[J]. Biotechnology and Bioprocess Engineering 26: 286-293