IRF5 program strengthens Kymera’s oral immunology pipeline with a complementary mechanism to expand into rheumatic and other autoimmune diseases with a potential best-in-class oral drug

IRF5项目通过一种互补机制加强了Kymera的口服免疫学管线，拓展至风湿病及其他自身免疫疾病，有望成为同类最佳的口服药物。

IRF5, a historically undrugged transcription factor and master regulator of immunity, has strong genetic and clinical pathway validation across multiple diseases including RA, SLE, IBD and others

IRF5，一个历史上未被药物靶向的转录因子和免疫主调节因子，在包括RA、SLE、IBD等多种疾病中具有强大的遗传和临床通路验证。

KT-579, a potent, selective, oral degrader of IRF5 with an excellent profile in preclinical safety studies, has demonstrated activity comparable or superior to approved and clinically active drugs in multiple efficacy animal models of lupus and RA

KT-579是一种有效、选择性高、口服的IRF5降解剂，在临床前安全性研究中表现出优异的特性，并在多个狼疮和类风湿性关节炎的动物模型中显示出与已批准和临床有效的药物相当或更优的活性。

IND-enabling studies are ongoing with Phase 1 testing expected to begin in early 2026

IND相关研究正在进行中，预计一期测试将在2026年初开始。

Company to hold video webcast today at 10:00 a.m. ET as part of the release of first quarter 2025 results

公司将于东部时间今天上午10:00举行视频网络直播，作为发布2025年第一季度业绩的一部分。

WATERTOWN, Mass., May 09, 2025 (GLOBE NEWSWIRE) --

马萨诸塞州沃特敦，2025年5月9日（环球新闻社）--

Kymera Therapeutics, Inc.

基梅拉治疗学公司

(NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today unveiled a new wholly-owned program within its industry-leading oral immunology pipeline. KT-579, a highly potent, selective, first-in-class development candidate, targets IRF5, an essential signaling node in genetically and clinically validated immune pathways driving inflammation in many diseases with no or suboptimal oral options. The new program serves as a valuable addition to the Company's current portfolio, positioned to target multiple common immuno-inflammatory diseases with the potential to expand access to oral systemic advanced therapies for broader patient populations.

(NASDAQ: KYMR)，一家处于临床阶段的生物制药公司，致力于推进一类新型口服小分子降解药物用于免疫疾病治疗，今天在其行业领先的口服免疫学管线中公布了一个全新的全资项目。KT-579 是一种高效、选择性强、首创新药的开发候选药物，靶向 IRF5，这是在基因和临床上已被验证的免疫通路中的关键信号节点，可驱动多种目前尚无或仅有次优口服治疗选择的疾病的炎症反应。这个新项目为公司的现有产品组合增添了重要价值，有望针对多种常见的免疫炎症疾病，并扩大更广泛患者群体获得口服系统性先进疗法的机会。

Kymera will share preclinical data and outline upcoming milestones for KT-579 during a video webcast this morning..

凯米拉将在今天上午的视频网络直播中分享KT-579的临床前数据，并概述即将到来的里程碑。

“We’re excited to unveil KT-579 as the latest addition to our paradigm-shifting oral immunology portfolio, providing a complementary immunoregulatory mechanism to our existing pipeline. IRF5 is a master regulator of immunity, and we believe blocking its activity with our degrader has the potential to deliver a transformative oral option in multiple chronic, debilitating rheumatic and autoimmune diseases,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics.

“我们很高兴推出KT-579，作为我们开创性口服免疫学产品组合的最新成员，为现有管线提供了一种互补的免疫调节机制。IRF5是免疫系统的关键调控因子，我们相信通过我们的降解剂阻断其活性，有望在多种慢性、致残性风湿病和自身免疫疾病中提供一种变革性的口服治疗选择。”Kymera Therapeutics创始人、总裁兼首席执行官Nello Mainolfi博士表示。

“The compelling data we have generated demonstrating activity in human primary cells, patient cell samples, and preclinical animal models showcases, for the first time in industry, that targeting IRF5 can lead to correcting immune dysregulation in a disease specific way while generally sparing normal cells.”.

“我们生成的引人注目的数据表明，在人类原代细胞、患者细胞样本和临床前动物模型中具有活性，这首次在行业内展示了靶向IRF5可以以疾病特异性方式纠正免疫失调，同时通常不影响正常细胞。”

Historically an undrugged transcription factor, IRF5 is a master regulator of innate and adaptive immune response pathways involving pro-inflammatory cytokines (TNFα, IL-6, IL-12, IL-23), B cell activation (autoantibody production), and Type I Interferon (IFN). IRF5 is selectively expressed and activated in specific cell types such as dendritic cells, monocytes, macrophages, and B cells.

历史上，IRF5作为一种未被药物靶向的转录因子，是调控先天性和适应性免疫反应通路的主要调控因子，涉及促炎细胞因子（TNFα、IL-6、IL-12、IL-23）、B细胞活化（自身抗体生成）以及I型干扰素（IFN）。IRF5在特定细胞类型中选择性表达和激活，例如树突状细胞、单核细胞、巨噬细胞和B细胞。

Its cell- and disease activation-specific profile has the potential to block cell-specific immune dysregulation while sparing normal cell function. IRF5 has been challenging to drug using traditional small molecule inhibitors due to multiple complex activation steps and the high degree of IRF family member homology..

其细胞和疾病激活特异性特征有潜力在不影响正常细胞功能的情况下，阻止特定细胞的免疫失调。由于涉及多个复杂的激活步骤以及IRF家族成员的高度同源性，使用传统的小分子抑制剂对IRF5进行药物开发一直具有挑战性。

KT-579, a potent, selective and oral degrader has the potential to be the first IRF5-targeted therapy to deliver a completely novel and potentially transformative treatment option, in many cases superior to pathway biologics, in rheumatic and autoimmune diseases such as lupus, Sjögren’s, RA, IBD, among others.

KT-579是一种强效、选择性且可口服的降解剂，有潜力成为首个针对IRF5的治疗方法，为风湿病和自身免疫疾病（如狼疮、干燥综合症、类风湿关节炎、炎症性肠病等）提供一种全新的、可能具有变革性的治疗选择，在许多情况下优于通路生物制剂。

Currently in IND-enabling studies, the Company intends to advance KT-579 into Phase 1 clinical testing in early 2026..

目前正在进行IND支持性研究，公司计划在2026年初将KT-579推进到1期临床试验。

In preclinical studies, KT-579 demonstrated an encouraging profile in human primary cells, patient derived cells, and

在临床前研究中，KT-579 在人类原代细胞和患者来源的细胞中表现出令人鼓舞的特性，

in vivo

体内

disease models generally superior to existing standards of care:

疾病模型通常优于现有的护理标准：

Selectivity and Potency:

选择性与效力：

KT-579 was highly selective for IRF5 over all other proteins in the detectable proteome including other IRF family proteins. KT-579 also demonstrated picomolar to nanomolar potencies across all relevant human cell types evaluated, including B cells, dendritic cells, macrophages, and monocytes. KT-579 demonstrated potent inhibition of proinflammatory cytokines downstream of TLR4, TLR7, TLR8 and TLR9 activation in cellular assays and blocked Type I IFN production and response..

KT-579对IRF5的选择性高于可检测蛋白质组中的所有其他蛋白，包括其他IRF家族蛋白。KT-579在所有相关的人类细胞类型中均表现出皮摩尔到纳摩尔级别的效力，这些细胞类型包括B细胞、树突细胞、巨噬细胞和单核细胞。KT-579在细胞实验中显示出对TLR4、TLR7、TLR8和TLR9激活下游的促炎性细胞因子的强大抑制作用，并阻断了I型干扰素的产生和反应。

In Vivo

体内

Profile:

个人资料：

KT-579 achieved robust degradation (>90%) across multiple preclinical species

KT-579在多种临床前物种中实现了强大的降解效果（>90%）

in vivo

体内

and in all disease-relevant tissues with low oral doses. In preclinical safety studies, KT-579 did not show any adverse effects at concentrations up to 200-fold the projected human efficacious levels, demonstrating a favorable safety profile.

并且在所有与疾病相关的组织中，低口服剂量即可生效。在临床前安全性研究中，KT-579 在高达预计人类有效水平 200 倍的浓度下未显示任何不良反应，展现出良好的安全性。

Efficacy Models:

疗效模型：

In several preclinical efficacy models of lupus and RA, KT-579 was generally more efficacious than clinically active or marketed small molecule inhibitors and injectable biologics, phenocopying IRF5 knockout studies. In a lupus model, KT-579 demonstrated sustained and near complete reduction of proteinuria and circulating autoantibodies superior to the current standard of care.

在多个狼疮和类风湿关节炎的临床前疗效模型中，KT-579 通常比临床上活跃或已上市的小分子抑制剂和可注射生物制剂更有效，并且与 IRF5 基因敲除研究结果一致。在狼疮模型中，KT-579 展现了持续且近乎完全的蛋白尿和循环自身抗体减少效果，优于目前的标准治疗方案。

Additionally, in lupus patient PBMC samples, KT-579 effectively blocked TLR7- and TLR8-induced pro-inflammatory cytokines and IFNβ production and TLR9-induced IgG levels. In a mouse RA model, treatment with KT-579 led to significant reduction in joint swelling..

此外，在狼疮患者PBMC样本中，KT-579有效阻断了TLR7和TLR8诱导的促炎性细胞因子和IFNβ的产生，以及TLR9诱导的IgG水平。在小鼠RA模型中，使用KT-579治疗显著减轻了关节肿胀。

Event Details

事件详情

Kymera will host a video webcast today, May 9, 2025, at 10:00 a.m. ET. To join the video call or view the livestreamed webcast please register via this

Kymera 将于 2025 年 5 月 9 日东部时间上午 10:00 举办视频网络直播。要加入视频通话或观看直播的网络广播，请通过此链接注册。

link

链接

or visit “

或访问“

News and Events

新闻与事件

” in the Investors section of the Company’s website at

“在公司网站的投资者部分 tại

www.kymeratx.com

www.kymeratx.com

. A replay of the webcast and the presentation will be available following the event.

活动结束后，网络直播和演示文稿将提供回放。

About Kymera Therapeutics

关于凯米拉疗法

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics.

Kymera是一家处于临床阶段的生物技术公司，率先在靶向蛋白质降解（TPD）领域开展研究，致力于开发解决关键健康问题并有潜力显著改善患者生活的药物。Kymera正在利用TPD技术应对传统疗法无法触及的疾病靶点和通路。

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years.

Kymera 已将首个降解剂推进至免疫疾病领域的临床阶段，目前正专注于构建一条行业领先的口服小分子降解剂管线，旨在为这些疾病的患者提供新一代便捷且高效的治疗方案。自2016年成立以来，Kymera 连续多年被评为波士顿最佳工作场所之一。

For more information about our science, pipeline and people, please visit .

如需更多关于我们科学、研发进展和团队的信息，请访问。

www.kymeratx.com

www.kymeratx.com

or follow us on

或关注我们

X

X

or

或

LinkedIn

领英

.

。

Availability of Other Information About Kymera Therapeutics

关于Kymera Therapeutics的其他信息的可用性

For more information, please visit the Kymera website at

欲了解更多信息，请访问 Kymera 网站：

https://www.kymeratx.com/

https://www.kymeratx.com/

or follow Kymera on

或关注 Kymera 的

X (@KymeraTx)

X (@KymeraTx)

and

和

LinkedIn (Kymera Therapeutics

LinkedIn (凯米拉治疗学

). Investors and others should note that Kymera communicates with its investors and the public using the Company website, including, but not limited to, corporate disclosures, investor presentations, FAQs, Securities and Exchange Commission (SEC) filings, and press releases, as well as on

). 投资者及其他人士应注意，Kymera通过公司网站与投资者和公众进行沟通，包括但不限于公司披露、投资者简报、常见问题解答、美国证券交易委员会（SEC）文件以及新闻稿，也包括在

X

X

and

和

LinkedIn

领英

. The information that Kymera posts on its website or on

。Kymera在其网站上发布的信息或

X

X

or

或

LinkedIn

领英

could be deemed to be material information. As a result, the Company encourages investors, the media and others interested to review the information that Kymera posts there on a regular basis. The contents of Kymera’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended..

可能被视为重要信息。因此，公司鼓励投资者、媒体及其他感兴趣的人士定期查阅 Kymera 在该处发布的信息。Kymera 网站或社交媒体的内容不应被视为以引用方式并入依据修订后的《1933年证券法》提交的任何文件中。

Cautionary Note Regarding Forward-Looking Statements

前瞻性声明的警告性说明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, and the advancement of KT-579 into Phase 1 clinical testing in early 2026.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性声明，包括但不限于关于我们对战略、业务计划和发展目标的预期的明示和暗示声明，涉及我们临床和临床前管线的开发，包括其治疗潜力、临床益处和安全性，以及KT-579在2026年初进入第一阶段临床试验的进展。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target,' “upcoming” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”、“也许”、“将”、“可以”、“会”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“寻求”、“预测”、“未来”、“项目”、“潜力”、“继续”、“目标”、“即将”等词语或类似表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词语。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future trials and the results of such trials, whether preclinical results will be indicative of the results of clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors.

本新闻稿中的任何前瞻性声明均基于管理层的当前预期和信念，并受多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性声明存在重大差异，包括但不限于：与以下方面相关的风险：未来临床试验的启动、时间和设计固有的不确定性，正在进行和未来试验的数据的可用性和时间以及这些试验的结果，临床前结果是否预示临床试验的结果，成功证明候选药物安全性和有效性的能力，与监管机构计划互动的时间和结果，足以满足我们运营费用和资本支出需求的资金的可用性以及其他因素。

These.

这些。

Investor and Media Contact:

投资者和媒体联系：

Justine Koenigsberg

朱斯汀·科尼格斯伯格

Vice President, Investor Relations

投资者关系副总裁

investors@kymeratx.com

投资者@凯米拉公司.com

media@kymeratx.com

媒体@凯默拉tx.com

857-285-5300

857-285-5300