Abatacept

Preclinical study anticipated to be published in 1H 2025 documenting combination’s additive and/or synergistic anti-inflammatory signal; Company will seek to advance asset in neurodegenerative and autoimmune diseases through the next stages alongside a strategic partner 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, announces the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases. Sustained inflammatory responses driven by dysfunctional immune regulation is a hallmark of serious autoimmune and neurodegenerative diseases. COYA 303 is an investigational biologic combination of COYA 301 and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) designed for subcutaneous administration. In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells. Coya intends to publish the results of this study in a peer-reviewed publication in the first half of 2025 and has filed several patent applications to protect the compound. COYA 301 is the Company’s proprietary low-dose IL-2 that serves as a backbone adjuvant with standard of care agents and other novel pathways. Following the positive results of this study, Coya intends to continue ongoing strategic discussions to advance COYA 303 through IND-enabling studies and into the clinic. In support of these efforts, Coya is initiating translational studies in partnership with a major academic university. “COYA 303 is the most recent addition to Coya’s investigational pipeline. We believe that while GLP-1 RAs may have monotherapy benefits in reducing inflammation, the unique anti-inflammatory signature of the combination of GLP-1 RA and COYA 301 is supportive of opportunities that may generate significant shareholder value for Coya and a potential strategic partner,” stated COYA CEO Arun Swaminathan. 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 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 clinical development and/or 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. Investor David Snyder, CFO david@coyatherapeutics.com CORE IR Bret Shapiro brets@coreir.com 561-479-8566 Media For Coya Therapeutics: Kati Waldenburg media@coyatherapeutics.com 212-655-0924

来源：药渡 撰文：balabala     编辑：维他命 免疫药物市场是一个由创新、扩展适应症和竞争战略驱动的动态格局。从生物制剂到生物仿制药，该领域表现最好的药物不仅为患者提供改变生活的疗法，还为制药公司创造了数十亿美元的收入。 表1. 2023年自免药销售额TOP10 在这里，我们根据2023年的销售数据向大家介绍前10名最畅销的免疫学药物，了解这些药物如何塑造免疫学市场、进行临床突破和面对竞争挑战。 NO.1 Humira（阿达木单抗） 2023年销售额：144.04亿美元 公司：艾伯维 FDA首批日期：2002年12月31日 适应症：类风湿性关节炎、幼年特发性关节炎、银屑病关节炎、强直性脊柱炎、克罗恩病、溃疡性结肠炎、斑块状银屑病、化脓性汗腺炎和葡萄膜炎。 图1. Humira作用机制示意图 畅销原因：Humira的统治地位以2023年的销售额大幅下降而告终，比2022年的212亿美元下降了32%。生物仿制药竞争的影响在2023年Q4最为严重，全球销售额暴跌近41%至33亿美元。 基于此，艾伯维正在转向更新的免疫学药物Rinvoq和Skyrizi，以抵消Humira的损失。据艾伯维预计，这些药物将在2024年产生160亿美元的收入，到2027年将超过270亿美元。 NO.2 Dupixent（杜普利尤单抗） 2023年销售额：115.88亿美元 公司：再生元和赛诺菲 FDA首批日期：2017年3月28日 适应症：湿疹、嗜酸性粒细胞性或口服类固醇依赖性哮喘、其他药物一起用于成人慢性鼻-鼻窦炎伴鼻息肉病（CRSwNP）、嗜酸性粒细胞性食管炎（EoE）、结节性瘙痒症（PN）。 图2. Dupixent作用机制示意图 畅销原因：Dupixent在2023年实现了强劲增长，全球净销售额同比增长33%，达到 115.88亿美元。与2022年同期相比，仅Q4的销售额就飙升了31%，达32.2亿美元。自2017年FDA批准以来，再生元和赛诺菲的Dupixent一直被誉为特应性皮炎患者的创新疗法。多年来，再生元不断拓展Dupixent的适应症，推动年销售额稳步增长，从2019年的23亿美元增加到2020年的40亿美元、2021年的62亿美元和2022年的98亿美元。展望未来，Dupixent的销售额将会继续增长。 此外，再生元和赛诺菲正在积极寻求FDA批准其用于慢性阻塞性肺病（COPD），这将使其有望成为第一个获批用于该病症的生物疗法。这一适应症获批可能会使再生元在美国的峰值销售额增加25亿美元，并为赛诺菲在国际市场的峰值销售额增加10亿美元。 NO.3 Stelara（乌司奴单抗） 2023销售额：108.58亿美元 公司：强生 FDA首批日期：2009年9月25日 适应症：斑块状银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎。 图3. Stelara作用机制示意图 畅销原因：Stelara在2023年表现强劲，贡献了强生当年总收入的约12.8%。根据强生2023年年报，Stelara仍然是其最畅销的产品。然而，由于Stellara的专利到期，强生正在为生物仿制药竞争做准备。据强生与生物仿制药制造商达成的协议，首批生物仿制药到2025年1月1日已经进入市场。尽管存在预期的竞争，但强生有信心其免疫药物市场份额的下降将被25种潜在重磅产品所抵消。与此同时，生物仿制药已经进入欧洲市场，这影响了Stellara在2024年下半年的销售。 NO.4 Skyrizi（利生奇珠单抗） 2023销售额：77.63亿美元 公司：艾伯维 FDA首批日期：2019年4月23日 适应症：斑块状银屑病、活动性银屑病关节炎、克罗恩病。 图4. Skyrizi作用机制示意图 畅销原因：Skyrizi是一种白细胞介素23（IL-23）抑制剂，在治疗中度至重度斑块状银屑病和活动性银屑病关节炎方面显示出临床疗效。Skyrizi的靶向作用机制和持久疗效使其成为皮肤病学现代生物制剂的首选。2023年，Skyrizi的全球收入为77.63 亿美元，同比增长高达50%，使其成为艾伯维免疫学产品组合的基石。 NO.5 Entyvio（维得利珠单抗） 2023销售额：52.80亿美元 公司：武田 FDA首批日期：2014年5月20日 适应症：成人溃疡性结肠炎和成人克罗恩病。 图5. Entyvio作用机制示意图 畅销原因：Entyvio最初获得FDA批准用于治疗和维持溃疡性结肠炎。皮下给药的方式给患者提供了极大的灵活性。迄今为止，Entyvio已在全球范围内累积了超过100 万患者/年的使用，凸显了其广泛的应用和临床价值。 NO.6 Cosentyx（司库奇尤单抗） 2023年销售额：49.80亿美元 公司：诺华 FDA首批日期：2015年1月21日 适应症：斑块状银屑病、银屑病关节炎、活动性强直性脊柱炎、附着点炎相关关节炎、非放射学中轴型脊柱关节炎、化脓性汗腺炎。 图6. Cosentyx作用机制示意图 畅销原因：自2015年推出以来，Cosentyx在五种全身炎症中始终显示出长期疗效和可靠的安全性。全球治疗超过100万患者，其扩展到银屑病以外的炎症性疾病，为其不断增长的销售额做出了重大贡献。 NO.7 Enbrel（依那西普） 2023年销售额：45.27亿美元 公司：安进 FDA首批日期：1998年11月2日 适应症：类风湿性关节炎、多关节幼年特发性关节炎（pJIA）、银屑病关节炎、强直性脊柱炎和斑块状银屑病。 图7. Enbrel作用机制示意图 畅销原因：在美国，FDA已经批准了Enbrel的生物仿制药版本，越来越多的公司宣布计划开发其他生物仿制药版本，这表明Enbrel的竞争日益激烈。 NO.8 Xolair（奥马珠单抗） 2023年销售额：39.87亿美元 公司：基因泰克和诺华 FDA首批日期：2003年6月20日 适应症：持续性哮喘、慢性鼻-鼻窦炎伴鼻息肉、食物过敏、荨麻疹。 图8. Xolair作用机制示意图 畅销原因：2024年2月16日，FDA批准奥马珠单抗用于减少成人和一岁及以上食物过敏儿童因意外接触食物而导致的过敏反应。临床试验表明，接受 Xolair治疗16至20周的患者中，有68%可以耐受至少600mg花生蛋白而没有中度至重度过敏症状，而安慰剂组只有5%。此外，与安慰剂相比，接受Xolair治疗的患者耐受牛奶（66%：11%）、鸡蛋（67%：0%）或腰果（42%：3%）至少1,000毫克蛋白质的比例明显更高，而没有中度至重度过敏反应。 NO.9 Rinvoq（乌帕替尼） 2023销售额：39.69亿美元 公司：艾伯维 FDA首批日期：2019年8月16日 适应症：类风湿性关节炎、银屑病关节炎、特应性皮炎、溃疡性结肠炎、克罗恩病、强直性脊柱炎、非放射学中轴型脊柱关节炎等。 图9. Rinvoq的结构 畅销原因：2023年，FDA批准Rinvoq作为中度至重度活动性克罗恩病的首个口服治疗药物。临床试验表明，与接受安慰剂的患者相比，接受45毫克Rinvoq的患者达到临床缓解的比例更高。此外，与安慰剂组相比，经结肠镜检查评估，接受45毫克Rinvoq治疗的患者在肠道炎症方面表现出更大的改善。预计到2027年，Rinvoq的销售额将超过100亿美元，这得益于其在风湿病学、炎症性肠病（IBD）和特应性皮炎方面的适应症。 NO.10 Orencia（阿巴西普） 2023年销售额：36.01亿美元 公司：百时美施贵宝 FDA首批日期：2005年12月23日 适应症：类风湿性关节炎、活动性银屑病关节炎、急性移植物抗宿主病 （aGVHD）。 图10. Orencia的结构 畅销原因：2023年，Orencia的美国收入增长了4%，主要是由于需求增加。在需求增长的推动下，国际收入增长了3%，但部分被外汇波动3%的负面影响所抵消。在没有外汇影响的情况下，全球收入增长了6%。百时美施贵宝公司报告称，在美国、欧盟（EU）和日本没有Orencia生物仿制药，该配方和其他相关专利预计将于2026年后到期。 参考资料： [1]药渡数据 https://data.pharmacodia.com/ [2]https://xtalks.com/ [3]https://sites.arizona.edu/njardarson-lab/top200-posters/ *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！ 版权声明：本文内容及图片，如有侵权请联系删除。 免责声明：本文内容仅作信息交流学习，并不反映任何意见及观点。 往期推荐 乐威医药荣获2024年度EcoVadis承诺奖牌 乐威医药再获三项国家专利知识产权 乐威医药入选服务业创新发展星锐企业名单