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KT-621 BROADEN2 Phase 2b trial in AD ongoing, with data expected by mid-2027
KT-621 BROADEN2 第二阶段b试验在阿尔茨海默病中进行,预计2027年中期获得数据。
KT-621 BREADTH Phase 2b trial in asthma initiated, with data expected in late-2027
KT-621 BREADTH 哮喘二期b阶段试验启动,预计2027年底获得数据。
KT-579 Phase 1 HV clinical trial expected to start in 1Q26, with data expected in 2H26
KT-579 第一阶段高压临床试验预计于2026年第一季度开始,数据预计在2026年下半年公布。
Advancing at least one new development candidate towards IND for a first-in-class, oral immunology program in 2026
在2026年之前,将至少一个新型开发候选药物推进到IND,用于首创的口服免疫学项目。
Well-capitalized with $1.6 billion
资本充足,达16亿美元
1
1
in cash and runway into 2029
现金和跑道延长至 2029 年
Kymera to present its 2026 objectives at the J.P. Morgan 44
凯米拉将在摩根大通第44届会议上展示其2026年目标
th
th
Annual Healthcare Conference today at 9:00 a.m. PT/12:00 p.m. ET
年度医疗保健会议今天上午9:00(太平洋时间)/中午12:00(东部时间)
WATERTOWN, Mass., Jan. 13, 2026 (GLOBE NEWSWIRE) --
马萨诸塞州沃特敦,2026年1月13日(环球新闻社)--
Kymera Therapeutics, Inc.
奇美拉治疗公司
(NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced its anticipated 2026 preclinical and clinical milestones across its industry leading oral immunology pipeline.
(纳斯达克: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,近日宣布了其预计在2026年实现的临床前和临床里程碑,涵盖其行业领先的口服免疫学研发管线。
“Kymera enters 2026 from a position of exceptional strength, driven by significant progress in the clinic and the consistent execution of our strategy,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Across our programs, we delivered upon and, in many cases, exceeded expectations in 2025, best exemplified by the first-in-industry STAT6 data in healthy volunteers and AD patients with our novel oral degrader, KT-621.
“Kymera在2026年将从一个极具优势的地位出发,这得益于我们在临床方面取得的重大进展以及我们战略的持续执行,”Kymera Therapeutics创始人、总裁兼首席执行官Nello Mainolfi博士说道。“在我们的各项计划中,2025年我们不仅实现了目标,并且在许多情况下超越了预期,最有力的例证是我们针对健康志愿者和AD患者使用新型口服降解剂KT-621获得了业界首个STAT6数据。”
We have built a powerful engine for innovation, paired with the scientific expertise and strong execution required to translate novel ideas into first-in-class medicines that address the limitations of today’s immunology treatments. Our growing portfolio of oral programs reflects our ability to develop medicines with the potential to combine biologics-like efficacy and safety profiles with the improved convenience and patient access of oral drugs.”.
我们已经建立了一个强大的创新引擎,结合了将新颖创意转化为一流药物所需的科学专业知识和强大执行力,以解决当今免疫学治疗的局限性。我们不断增长的口服药物项目组合反映了我们有能力开发出具有生物制品类似疗效和安全性,同时兼具口服药物便利性和患者可及性改善的药物。
Dr. Mainolfi continued, “With multiple clinical readouts ahead, an early pipeline of undisclosed first-in-class programs, and an exceptionally strong cash balance, we have the foundation to shape the future of immunology. By reimagining how many common immuno-inflammatory diseases are treated, we aim to expand the reach of advanced therapies and deliver oral medicines that fundamentally can change the standard of care for patients.”.
Mainolfi博士继续说道:“随着多个临床结果即将公布,一条早期的、尚未公开的首创项目管线,以及非常雄厚的现金余额,我们有能力建立起塑造免疫学未来的基础。通过重新构想许多常见的免疫炎症性疾病如何被治疗,我们的目标是扩大先进疗法的覆盖范围,并提供可以从根本上改变患者护理标准的口服药物。”
Additional details on Kymera's pipeline and progress will be presented today at the J.P. Morgan Healthcare Conference.
Kymera 的产品线和进展的更多细节将在今天举行的摩根大通医疗保健会议上公布。
STAT6 Degrader Program
STAT6降解程序
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation, and currently in Phase 2 clinical testing. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment paradigms for more than 140 million patients around the world, including children and adults, suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and bullous pemphigoid (BP), among others..
KT-621 是一种研究性、首创的、每日一次的口服 STAT6 降解剂,STAT6 是负责 IL-4/IL-13 信号传导的特异性转录因子,也是 2 型炎症的核心驱动因素,目前正处于二期临床试验阶段。KT-621 是首个进入临床评估的针对 STAT6 的药物,有望改变全球超过 1.4 亿患者(包括儿童和成人)的治疗模式,这些患者患有 2 型疾病,如特应性皮炎 (AD)、哮喘、慢性阻塞性肺病 (COPD)、嗜酸性粒细胞性食管炎 (EoE)、伴鼻息肉的慢性鼻窦炎 (CRSwNP)、慢性自发性荨麻疹 (CSU)、结节性瘙痒症 (PN) 和大疱性类天疱疮 (BP) 等。
Recent KT-621
最近的KT-621
Updates
更新
In December 2025, the Company reported positive results from the KT-621 BroADen Phase 1b clinical trial in moderate to severe AD patients. After 28 days of daily dosing, KT-621 demonstrated deep STAT6 degradation in blood and skin, robust reductions in disease-relevant Type 2 inflammatory biomarkers in blood, skin and lungs, and meaningful improvements in clinical endpoints and patient-reported outcomes on signs and symptoms in atopic dermatitis as well as comorbid asthma and allergic rhinitis, with a favorable safety and tolerability profile.
2025年12月,公司报告了KT-621 BroADen 1b期临床试验在中重度特应性皮炎(AD)患者中的积极结果。经过28天的每日给药,KT-621在血液和皮肤中显示出深度的STAT6降解,显著降低了与疾病相关的2型炎症生物标志物在血液、皮肤和肺部的水平,并在特应性皮炎的症状和体征以及共病哮喘和过敏性鼻炎的临床终点和患者报告结果方面表现出有意义的改善,同时具备良好的安全性和耐受性。
The impact on biomarkers and clinical endpoints was in line or numerically exceeded data reported from dupilumab studies after 4 weeks of treatment. .
对生物标志物和临床终点的影响与度普利尤单抗研究报道的数据一致或在数值上超过了四周治疗后的数据。
FDA Fast Track designation was granted to KT-621 in December 2025 for the treatment of moderate to severe AD.
2025年12月,KT-621获得了FDA快速通道资格,用于治疗中度至重度AD。
Dosing commenced in November 2025 for the KT-621 BROADEN2 Phase 2b trial, a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of three doses of KT-621 in approximately 200 patients with moderate to severe AD over 16 weeks. BROADEN2 was recently expanded to include adolescents (ages 12-18) in addition to adults.
2025年11月开始进行KT-621 BROADEN2二期b阶段试验的给药,这是一项全球性、随机、双盲、安慰剂对照、剂量范围研究,评估三种剂量的KT-621在约200名中度至重度AD患者中为期16周的疗效、安全性和耐受性。BROADEN2最近扩展至包括青少年(12-18岁)在内,而不仅限于成人。
The primary endpoint is the percent change from baseline in Eczema Area and Severity Index (EASI) score at week 16. Secondary endpoints will evaluate a range of additional safety, efficacy, and quality of life measures..
主要终点是第16周时湿疹面积和严重程度指数(EASI)评分相对于基线的百分比变化。次要终点将评估一系列额外的安全性、有效性和生活质量指标。
In January 2026, the Company initiated the BREADTH Phase 2b clinical trial, a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of three doses of KT-621 in approximately 264 adult patients with moderate to severe eosinophilic asthma over 12 weeks.
2026年1月,公司启动了BREADTH二期b阶段临床试验,这是一项全球性、随机、双盲、安慰剂对照、剂量范围研究,评估三种剂量的KT-621在约264名中重度嗜酸性粒细胞哮喘成年患者中为期12周的疗效、安全性和耐受性。
The primary endpoint is the percent change from baseline in pre-bronchodilator of forced expiratory volume in one second (FEV1). Secondary endpoints will evaluate a range of additional safety, efficacy, and quality of life measures..
主要终点是从基线开始的一秒钟用力呼气量 (FEV1) 支气管扩张剂前的百分比变化。次要终点将评估一系列额外的安全性、有效性和生活质量指标。
Key Upcoming KT-621 Milestones:
关键的即将到来的KT-621里程碑:
Complete enrollment of the BROADEN2 Phase 2b AD trial in 2026, with data expected to be reported by mid-2027.
2026年完成BROADEN2二期b阶段AD试验的全面招募,预计数据将在2027年年中公布。
Commence dosing in the BREADTH Phase 2b asthma trial in the first quarter of 2026, with data expected to be reported in late-2027.
2026年第一季度开始在BREADTH二期哮喘试验中进行给药,预计数据将在2027年底公布。
IRF5 Degrader Program
IRF5降解剂项目
KT-579 is an investigational, first-in-class, oral degrader of IRF5, a genetically validated transcription factor and master regulator of immunity. KT-579 has the potential to selectively block inflammation and restore immune regulation by inhibiting pro-inflammatory cytokines, Type I IFN, and autoantibody production while sparing normal cell function.
KT-579 是一种研究性、首创的口服 IRF5 降解剂,IRF5 是一种经过基因验证的转录因子,也是免疫系统的关键调控因子。KT-579 有潜力通过抑制促炎细胞因子、I 型干扰素和自身抗体的产生,选择性地阻断炎症并恢复免疫调节,同时保留正常细胞功能。
KT-579 has the potential to be the first novel mechanism with broad utility in diseases where effective and well tolerated oral therapies are needed, such as lupus, Sjögren's, inflammatory bowel disease (IBD), and rheumatoid arthritis (RA), among others..
KT-579 有潜力成为首个具有广泛用途的新机制,适用于需要有效且耐受性良好的口服疗法的疾病,如狼疮、干燥综合征、炎症性肠病 (IBD) 和类风湿性关节炎 (RA) 等。
Recent KT-579 Updates
最近的KT-579更新
The Company has completed IND-enabling studies for the program. In preclinical studies, KT-579 degraded IRF5 across multiple preclinical species and in all disease-relevant tissues. In preclinical models of lupus and RA, KT-579 was equal or more efficacious than small molecule inhibitors and biologics currently marketed or in the clinic.
公司已经完成了该计划的IND支持性研究。在临床前研究中,KT-579在多种临床前物种和所有疾病相关组织中降解了IRF5。在狼疮和类风湿性关节炎的临床前模型中,KT-579的效果与目前市场上或临床中的小分子抑制剂和生物制剂相当或更优。
In preclinical safety studies, KT-579 did not show any adverse effects of any type at all doses and concentrations tested..
在临床前安全性研究中,KT-579 在所有测试剂量和浓度下均未显示任何类型的不良反应。
Key Upcoming KT-579 Milestones:
关键的即将到来的KT-579里程碑:
Initiate the first-in-human Phase 1 healthy volunteer trial in the first quarter of 2026, with data expected to be reported in the second half of 2026.
在2026年第一季度启动首次人体一期健康志愿者试验,预计将在2026年下半年报告数据。
Partnered Programs
合作伙伴计划
KT-485/SAR447971, a selective, potent, oral IRAK4 degrader, is being advanced in collaboration with Sanofi for immuno-inflammatory diseases, with a Phase 1 clinical trial expected to initiate in 2026
KT-485/SAR447971是一种选择性、强效的口服IRAK4降解剂,正与赛诺菲合作开发用于免疫炎症性疾病,预计将于2026年启动一期临床试验。
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Preclinical activities are ongoing under an exclusive option and license agreement with Gilead Sciences to advance the Company's oral CDK2 molecular glue program for the potential treatment of breast cancer and other solid tumors. Upon exercise of Gilead’s option, which would result in an option exercise payment to Kymera, Gilead would assume all responsibility to develop, manufacture and commercialize all products resulting from the collaboration..
根据与吉利德科学公司(Gilead Sciences)的独家选择权和许可协议,公司正在推进其口服CDK2分子胶项目,用于潜在治疗乳腺癌及其他实体瘤的临床前工作正在进行中。在吉利德行使选择权后,将向凯米拉(Kymera)支付选择权行使费用,此后吉利德将全权负责开发、生产和商业化所有源自该合作的产品。
Research
研究
Leveraging its unique target selection strategy, proven small molecule discovery capabilities, and deep development expertise, Kymera is building an industry leading portfolio of innovative oral immunology medicines addressing high value undrugged targets for areas of significant patient need.
利用其独特的目标选择策略、经过验证的小分子发现能力以及深厚的研发专长,Kymera 正在构建一个行业领先的创新口服免疫药物组合,针对高价值的未开发靶点,满足患者需求显著的领域。
Key Upcoming Milestones:
关键的即将到来的里程碑:
The Company intends to advance at least one new development candidate towards IND for a first-in-class, oral immunology program in 2026.
公司计划在2026年为首个一流的口服免疫学项目推进至少一个新开发候选药物进入IND。
J.P. Morgan Healthcare Conference
摩根大通医疗保健会议
Kymera will present its 2026 objectives at the 44
凯米拉将在第44届会议上提出其2026年目标。
th
th
Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PT (12:00 p.m. ET). A live webcast of the presentation and Q&A session will be available under “
2026年1月13日星期二上午9:00(太平洋时间)/中午12:00(东部时间)举行的年度摩根大通医疗保健会议。演讲和问答环节的现场网络直播将在“
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 archived on Kymera’s website following the event.
网络广播和演示文稿的重播将在活动结束后存档于Kymera的网站上。
1
1
Unaudited, estimated cash as of December 31, 2025.
截至2025年12月31日的未经审计的估计现金。
About Kymera Therapeutics
关于Kymera Therapeutics
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,率先在靶向蛋白降解(TPD)领域开展工作,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到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、研发管线和人员的信息,请访问。
www.kymeratx.com
www.kymeratx.com
or follow us on
或关注我们
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X
or
或
领英
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。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性陈述的谨慎声明
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, including for the Phase 1b data readout of KT-621 in AD patients in December 2025, the initiation of Phase 2b studies of KT-621 in patients with AD and asthma in the fourth quarter of 2025 and first quarter of 2026, respectively, the effect of initial parallel development of Phase 2b studies in AD and asthma patients on acceleration of late parallel development across multiple indications, and the preliminary cross-study assessments comparing non-head-to-head clinical data of KT-621 to published data for dupilumab, the advancement of KT-579 into Phase 1 clinical testing in early 2026, the KT-485/SAR447971 program, objectives on the development of CDK2 degraders, and Kymera’s financial condition and expected cash runway into 2029.
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、业务计划及开发临床和临床前管线的目标的隐含和明确声明,包括其治疗潜力、临床益处和安全性,特别是关于KT-621在阿尔茨海默病患者中的1b期数据读取(预计在2025年12月)、针对AD和哮喘患者的KT-621的2b期研究分别于2025年第四季度和2026年第一季度启动、AD和哮喘患者中初步并行开发2b期研究对加速多适应症晚期并行开发的影响,以及将KT-621的非头对头临床数据与dupilumab的已发表数据进行初步跨研究评估、KT-579在2026年初进入1期临床试验的进展、KT-485/SAR447971项目、CDK2降解剂开发目标,以及Kymera的财务状况和预计现金跑道至2029年。
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”、“即将到来”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。
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 forw.
本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念,并受到许多风险、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任何前瞻性陈述中所述的情况存在重大差异。
Investor and Media Contact:
投资者和媒体联系人:
Justine Koenigsberg
朱斯廷·科尼格斯伯格
Vice President, Investor Relations
投资者关系副总裁
investors@kymeratx.com
投资者@凯美拉医药公司.com
media@kymeratx.com
媒体@凯默拉tx.com
857-285-5300
857-285-5300