HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology company today announced successful meetings with the U.S. Food and Drug Administration (FDA) following a pre-IND (Investigational New Drug) meeting and a Type C meeting intended to seek advice from the Agency to reach alignment on multiple aspects of the planned development program in support of an IND application of COYA 302 for the treatment of ALS..

休斯顿——（商业新闻短讯）——Coya Therapeutics，Inc.（“Coya”），一家临床阶段生物技术公司今天宣布，在IND（研究性新药）前会议和C型会议之后，与美国食品和药物管理局（FDA）成功举行了会议，旨在寻求该机构的建议，以就计划开发计划的多个方面达成一致，以支持COYA 302的IND应用治疗ALS。。

COYA 302 is a dual-mechanism investigational biologic combination therapy comprised of proprietary low dose IL-2 and fusion protein CTLA-4 Ig. Low dose IL-2 enhances anti-inflammatory Treg function and numbers while the fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory cell function enabling potentially synergistic mechanisms in modulating inflammatory pathways..

COYA 302是一种双机制研究性生物联合疗法，由专有的低剂量IL-2和融合蛋白CTLA-4 Ig组成。低剂量IL-2增强抗炎Treg功能和数量，而融合蛋白CTLA-4 Ig旨在抑制促炎细胞功能，从而在调节炎症途径中实现潜在的协同机制。。

As a result of the interactions with the FDA, Coya has obtained constructive feedback and has reached alignment on key areas involved in the development of COYA 302, including CMC (chemistry, manufacturing, and controls), preclinical and clinical activities for the IND application. The results of the regulatory meetings constitute a significant step towards the submission of the IND application to the FDA in the second quarter of 2024, and initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND.

由于与FDA的互动，Coya获得了建设性的反馈，并在Coya 302开发的关键领域达成了一致，包括CMC（化学，制造和控制），IND应用的临床前和临床活动。监管会议的结果是在2024年第二季度向FDA提交IND申请以及在接受IND后开始对ALS患者进行COYA 302良好控制的双盲临床试验的重要一步。

Coya plans to continue working closely with the FDA over the course of the COYA 302 development program..

Coya计划在Coya 302开发计划过程中继续与FDA密切合作。。

Dr. Fred Grossman, President and Chief Medical Officer of Coya stated, “This important feedback allows us to advance our development program in ALS with a planned double-blind controlled study, with the potential for bringing forward a much-needed therapy for ALS patients.”

Coya总裁兼首席医疗官弗雷德·格罗斯曼博士表示：“这一重要反馈使我们能够通过计划的双盲对照研究推进ALS的发展计划，并有可能为ALS患者提出急需的治疗方法。”

Howard H. Berman, Ph.D., CEO of Coya stated: “We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in Q2, 2024 is an important next step in advancing the program in patients with ALS. With the recent out-licensing transaction and private placement transaction securing Coya a cash runway into 2026 and through completion of this study, we believe that we are in a position to execute and deliver value to patients and shareholders.”.

霍华德·H·伯曼博士。，Coya首席执行官表示：“我们认为，在2024年第二季度提交IND的道路上，通过多次监管会议与FDA保持一致，是推进ALS患者计划的重要下一步。随着最近的out许可交易和私募交易确保Coya在2026年拥有现金跑道，并且通过完成这项研究，我们相信我们能够执行d为患者和股东提供价值。”。

About COYA 302

关于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.

COYA 302是一种研究性和专有的生物联合疗法，具有双重免疫调节作用机制，旨在增强调节性T细胞（Tregs）的抗炎功能并抑制活化的单核细胞和巨噬细胞产生的炎症。COYA 302由专有的低剂量白细胞介素-2（LD IL-2）和CTLA-4 Ig组成，正在开发用于皮下给药以治疗ALS患者。

These mechanisms may have additive or synergistic effects..

这些机制可能具有累加或协同效应。。

In February of 2023 Coya announced results from a proof-of-concept, open-label clinical study evaluating LD IL-2 and CTLA-4 Ig in small cohort of patients with ALS, conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D.

2023年2月，Coya宣布了由Stanley Appel，M.D.，Jason Thonhoff，M.D.，和David Beers，Ph.D.在休斯顿卫理公会研究所（德克萨斯州休斯顿）进行的一项评估ALS患者小群LD IL-2和CTLA-4 Ig的概念验证，开放标签临床研究的结果。

This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale..

这项研究是首次评估这种用于治疗ALS的双重机制免疫疗法。该研究中的患者连续48周接受研究性治疗，并通过ALSFRS-R量表评估其安全性和耐受性，Treg功能，氧化应激和炎症的血清生物标志物以及临床功能。。

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.

在48周的治疗期间，治疗耐受性良好。最常见的不良事件是轻微的注射部位反应。没有患者停止研究，也没有死亡或其他严重不良事件的报告。

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..

使用ALSFRS-R量表测量患者的疾病进展，ALSFRS-R量表是一种经过验证的评估工具，用于监测ALS患者的残疾进展。治疗开始后第24周（33.75±3.3）和第48周（32±7.8）的平均（±SD）ALSFRS-R评分与基线时的ALSFRS-R评分（33.5±5.9）相比无统计学差异，表明48周治疗期间疾病进展显着改善。。

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.

Treg抑制功能表示为促炎性T细胞增殖抑制的百分比，在治疗期间显示出统计学上显着的增加，并且在治疗后8周的清除期结束时显着降低。24周（79.9±9.6）和48周（89.5±4.1）的Treg抑制功能明显高于基线（62.1±8.1）（p＜0.01），表明治疗过程中Treg抑制功能增强且持久。

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)..

相比之下，与第48周治疗结束时相比，8周清除期结束时Treg抑制功能（平均值±SD）显着降低（70.3±8.1比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 of these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing..

该研究还评估了炎症，氧化应激和脂质过氧化物的血清生物标志物。治疗开始后16周的可用数据表明这些生物标志物水平降低，这与观察到的Treg功能增强一致。正在对完整的生物标志物数据进行评估。。

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

COYA 302是一种尚未获得FDA或任何其他监管机构批准的研究产品。

About Amyotrophic Lateral Sclerosis

关于肌萎缩侧索硬化症

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.

肌萎缩侧索硬化症（ALS），也称为Lou Gehrig病，是一种罕见的神经系统疾病，会影响运动神经元，即大脑和脊髓中控制自主肌肉运动的神经细胞。在美国，大约有20000人患有ALS，每年大约有5000例新病例被诊断出来。

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.

这种疾病是进行性的，意味着症状会随着时间的推移而恶化。ALS专利的功能状态平均每月下降约1点，这是通过修订的ALS功能评定量表1或ALSFRS-R（一种经过验证的监测疾病进展的工具）来衡量的。ALS无法治愈，目前批准的药物治疗对患者的益处有限。

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.

ALS是一种运动神经元疾病。当运动神经元退化并死亡时，它们停止向肌肉发送信息，这会导致肌肉衰弱，开始抽搐（束缚），并消耗（萎缩）。最终，大脑失去了启动和控制自主运动的能力。大多数ALS患者死于呼吸衰竭，通常在症状首次出现后的三到五年内。

Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951.

Atassi N等人。PRO-ACT数据库：设计，初步分析和预测特征。神经病学，2014；83:1719-1725。doi:10.1212/WNL.0000000000000951。

National Institutes of Health (NIH) Website (https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als), accessed on January 4, 2023.

美国国立卫生研究院（NIH）网站(https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als)，于2023年1月4日访问。

About Coya Therapeutics, Inc.

关于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 Therapeutics，Inc.（纳斯达克股票代码：Coya）总部位于德克萨斯州休斯顿，是一家临床阶段生物技术公司，开发专有治疗方法，专注于调节性T细胞（“Tregs”）的生物学和潜在治疗优势，以靶向全身炎症和神经炎症。功能失调的Tregs是许多疾病的基础，包括神经退行性疾病，代谢性疾病和自身免疫性疾病，这种细胞功能障碍可能导致持续的炎症和氧化应激，导致免疫系统缺乏稳态。

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’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers.

Coya的研究产品候选管道利用多种治疗方式，旨在恢复Tregs的抗炎和免疫调节功能。Coya的治疗平台包括Treg增强生物制剂，Treg衍生的外泌体和自体Treg细胞疗法。Coya的300系列候选产品Coya 301和Coya 302是旨在增强Treg功能和扩大Treg数量的生物疗法。

COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages.

COYA 301是一种用于皮下给药的细胞因子生物制剂，旨在增强Treg功能并扩大体内Treg数量，COYA 302是一种用于皮下和/或静脉内给药的生物组合，旨在增强Treg功能，同时消耗T效应子功能和活化的巨噬细胞。

These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com.

这两种机制在抑制炎症方面可能是相加的或协同的。有关Coya的更多信息，请访问www.coyatherapeutics.com。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含基于管理层的信念和假设以及管理层目前可获得的信息的“前瞻性”声明。前瞻性陈述包括除本演示文稿中包含的历史事实陈述以外的所有陈述，包括有关我们当前和未来财务业绩、业务计划和目标、当前和未来临床和临床前开发活动、我们正在进行和计划中的临床试验的时间和成功以及相关数据的信息，我们临床试验和相关数据的发布时间、更新和结果，我们获得和维持监管批准的能力，我们候选产品的潜在治疗效益和经济价值，竞争地位，行业环境和潜在市场机会。

The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements..

“相信”、“可能”、“会”、“估计”、“继续”、“预期”、“打算”、“预期”等词语以及类似的表达旨在识别前瞻性陈述。。

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 .

前瞻性陈述受到已知和未知风险、不确定性、假设和其他因素的影响，包括但不限于与新型冠状病毒影响相关的风险；我们的产品候选开发活动以及正在进行和计划进行的临床试验的成功，成本和时间安排；我们计划开发和商业化靶向治疗药物；我们的临床前或临床试验中患者登记和给药的进展；我们的候选产品在临床试验中达到适用终点的能力；我们候选产品的安全概况；我们的临床试验数据支持营销应用的潜力，以及这些事件的时间安排；我们获得运营资金的能力；我们候选产品的开发和商业化；获得和维持监管批准的时间和能力；我们候选产品的市场接受率和程度以及临床实用性；我们候选产品的市场规模和增长潜力，以及我们服务这些市场的能力；我们的商业化、营销和制造能力和战略；与第三方就我们候选产品的商业化达成的未来协议；我们对获得和维持知识产权保护能力的期望；我们对第三方制造商的依赖；已经或可能获得的竞争疗法或产品的成功；我们吸引和留住关键科学或管理人员的能力；我们能够确定与我们的商业目标一致的具有重大商业潜力的其他候选产品；以及我们对费用、未来收入和资本的估计。

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.

我们的这些前瞻性陈述主要基于我们目前对未来事件和趋势的预期和预测，我们认为这些事件和趋势可能会影响我们的财务状况、运营结果、业务战略、短期和长期业务运营和目标以及财务需求。

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.

此外，我们的经营环境竞争激烈，变化迅速，新的风险可能会不时出现。我们的管理层不可能预测所有风险，也不可能评估所有因素对我们业务的影响，也不可能评估任何因素或因素组合可能导致实际结果与我们可能做出的任何前瞻性陈述中所包含的结果存在重大差异的程度。

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.

鉴于这些风险、不确定性和假设，本文讨论的前瞻性事件和情况可能不会发生，实际结果可能与前瞻性声明中预期或暗示的结果存在重大不利差异。虽然我们的管理层认为我们的前瞻性声明中反映的期望是合理的，但我们不能保证前瞻性声明中描述的未来结果、活动水平、绩效或事件和情况能够实现或发生。

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..

我们没有义务公开更新任何前瞻性声明，无论是书面的还是口头的，无论是由于新信息、未来发展还是其他原因。。