European Hematology Association (EHA) oral presentation to report 67% hematological improvement, durable transfusion independence, and no treatment-related serious adverse events in ESA-refractory lower-risk MDS 欧洲血液学协会（EHA）口头报告，指出在ESA难治性低危MDS患者中，67%的患者出现血液学改善，持久的输血独立性，并且没有与治疗相关的严重不良事件。Dr. Myint, a hematology leader and oncology drug-development executive, joins Halia to lead clinical development as ofirnoflast (HT-6184) advances toward pivotal trials Myint博士是一位血液学领域的领军人物，同时也是肿瘤药物开发的高管，他加入Halia公司，将领导ofirnoflast（HT-6184）的临床开发工作，推进其迈向关键试验阶段。LEHI, Utah 犹他州，勒希, ，May 12, 2026 2026年5月12日/PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting the NLRP3 inflammasome and related inflammatory pathways, today announced final Phase 2 results for ofirnoflast (HT-6184) in patients with lower-risk myelodysplastic syndrome (LR-MDS). /PRNewswire/ -- Halia Therapeutics, Inc.是一家临床阶段的生物制药公司，致力于开发针对NLRP3炎症小体及相关炎症通路的首创疗法，今天宣布了ofirnoflast（HT-6184）在低风险骨髓增生异常综合征（LR-MDS）患者中的最终二期试验结果。The data will be presented in an oral session at the European Hematology Association (EHA) 2026 Hybrid Congress, June 11–14, 2026, in Stockholm, Sweden. The accepted abstract is available today on the EHA Congress platform.. 该数据将在 2026 年 6 月 11 日至 14 日于瑞典斯德哥尔摩举行的欧洲血液学协会 (EHA) 2026 混合会议的口头报告环节中展示。已接受的摘要今天可在 EHA 会议平台上查阅。The company also announced the appointment of Han Myint, MD, FACP, as Chief Medical Officer. Dr. Myint will lead Halia's global clinical development, medical affairs, and safety strategy as the company prepares to advance ofirnoflast into pivotal development and progresses its broader pipeline grounded in human genetic resilience and innate immune biology.. 公司还宣布任命韩明特（Han Myint），医学博士、美国内科医师学会会员（FACP），为首席医疗官。明特博士将领导Halia的全球临床开发、医学事务及安全策略，因为公司准备推进ofirnoflast进入关键开发阶段，并推进其基于人类遗传适应力和先天免疫生物学的更广泛产品线。Final Phase 2 Results to Be Presented at EHA2026 最终第二阶段结果将在EHA2026上公布The open-label, single-arm Phase 2 trial enrolled 37 adults with IPSS-R very low- to intermediate-risk MDS (score ≤4.5) who had symptomatic anemia or red blood cell (RBC) transfusion dependence and were refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents (ESAs). Ofirnoflast was administered orally at 2 mg once daily on a 5-days-on/2-days-off schedule for up to 32 weeks. 开放标签、单臂的 2 期试验招募了 37 名 IPSS-R 极低至中危 MDS（评分 ≤4.5）成年患者，这些患者患有症状性贫血或红细胞（RBC）输血依赖，并且对促红细胞生成剂（ESA）无效、不耐受或不符合条件。Ofirnoflast 按照每日一次 2 mg 的剂量口服给药，采用 5 天用药/2 天停药的时间表，持续时间最长为 32 周。The primary endpoint was hematological improvement (HI) per IWG 2018 criteria. Highlights from the accepted abstract include:. 主要终点是根据IWG 2018标准的血液学改善（HI）。接受的摘要亮点包括：。67% overall HI rate among 30 evaluable patients, with multilineage activity: 62% HI-E, 60% HI-P, and 50% HI-N 30名可评估患者中总体HI率为67%，具有多系活性：62% HI-E，60% HI-P，50% HI-N55% RBC transfusion independence for ≥8 weeks among transfusion-dependent patients (10/18), with 39% sustained for ≥16 weeks 55%的依赖输血的患者（10/18）在≥8周内实现红细胞输血独立，其中39%持续≥16周。Median duration of transfusion independence of 28.5 weeks 输血独立性的中位持续时间为28.5周75% HI-E among non-transfusion-dependent patients (9/12) 75%的非输血依赖患者（9/12）患有HI-E。Median hemoglobin rise of 4.5 g/dL in HI-E and transfusion-independence responders (range 0.1–7.1 g/dL) HI-E和输血独立反应者的血红蛋白中位数上升4.5 g/dL（范围0.1–7.1 g/dL）No treatment-related serious adverse events; treatment-related adverse events occurred in 27% of patients, with a single Grade ≥3 event (hypertension) 无治疗相关的严重不良事件；27%的患者发生了治疗相关的不良事件，其中仅有一例≥3级事件（高血压）。Activity observed across WHO MDS subtypes and mutational backgrounds, including patients with and without SF3B1 or del(5q) 观察到的活动跨越了WHO MDS亚型和突变背景，包括有或没有SF3B1或del(5q)的患者。Additional efficacy, safety, biomarker, and quality-of-life data will be presented at the EHA2026 Congress. 将在 EHA2026 大会上展示更多的疗效、安全性、生物标志物和生活质量数据。'These final Phase 2 results validate our approach of targeting upstream innate immune biology in lower-risk MDS,' said David J. Bearss, Ph.D., President, Chief Executive Officer, and co-founder of Halia Therapeutics. 'Ofirnoflast has demonstrated durable transfusion independence, multilineage hematological improvement, and a favorable safety profile in a patient population with significant unmet need.'. “这些最终的第二阶段结果验证了我们针对较低风险MDS的上游先天免疫生物学的方法，”Halia Therapeutics的总裁、首席执行官兼联合创始人David J. Bearss博士说道，“Ofirnoflast在具有显著未满足需求的患者群体中展示了持久的输血独立性、多系造血改善和良好的安全性。”Han Myint, MD, FACP Appointed Chief Medical Officer 韩明特，医学博士，FACP，被任命为首席医疗官Dr. Myint brings more than three decades of experience spanning academic medicine, biotechnology and global pharmaceutical organizations, with deep expertise in hematologic malignancies, oncology drug development and late-stage clinical strategy. Myint博士拥有超过三十年的经验，横跨学术医学、生物技术和全球制药组织，并在血液系统恶性肿瘤、肿瘤药物开发和晚期临床策略方面具有深厚的专业知识。Dr. Myint is an internationally recognized hematologist-oncologist and biopharmaceutical executive with more than three decades of experience spanning academic medicine, biotechnology and large pharmaceutical organizations. Throughout his career, he has led the development of innovative therapies across solid tumors, hematologic cancers and cellular immunotherapy programs, with experience advancing candidates from early-stage research through regulatory approval and commercialization.. Myint博士是一位在国际上享有盛誉的血液肿瘤学家和生物制药高管，拥有超过三十年的经验，涵盖学术医学、生物技术和大型制药组织。在他的职业生涯中，他领导了针对实体瘤、血液癌症和细胞免疫治疗项目的创新疗法开发，并具备将候选药物从早期研究推进到监管审批和商业化的经验。'The addition of Han to our leadership team strengthens our ability to execute the next phase of the ofirnoflast development program with clinical and regulatory execution, as we advance toward pivotal development,' continued Bearss. 'He is one of the rare leaders who has worked across malignant hematology, global drug development, academic medicine, and late-stage commercialization. “韩加入我们的领导团队，增强了我们执行 ofirnoflast 开发计划下一阶段的临床和监管执行能力，因为我们正朝着关键性开发推进，”贝尔继续说道。“他是少数几位在恶性血液学、全球药物开发、学术医学和后期商业化方面都有工作经验的领导者之一。”His experience in myeloid diseases, pivotal trial strategy, and regulatory engagement is directly aligned with where Halia is headed.'. 他在髓系疾病、关键试验策略和监管参与方面的经验与Halia的发展方向完全一致。Commenting on his appointment, Dr. Myint said, 'I am excited to join Halia at such a pivotal moment. The ofirnoflast Phase 2 data support a differentiated therapeutic approach in lower-risk MDS, where patients continue to need new oral options that can improve hematopoiesis and reduce transfusion burden. 对于此次任命，Myint博士表示：“我很高兴能在这样一个关键时期加入Halia。二期试验的最新数据支持了在较低风险的MDS中采用差异化的治疗方法，这类患者仍然需要新的口服药物选择，以改善造血功能并减少输血负担。”Halia's broader platform, rooted in human genetic resilience and innate immune biology, provides a compelling foundation for developing medicines across serious hematologic and inflammatory diseases. I look forward to advancing ofirnoflast and the pipeline through the next stages of clinical development.'. Halia更广泛的平台，根植于人类基因弹性和先天免疫生物学，为开发治疗严重血液病和炎症疾病的药物提供了令人信服的基础。我期待在下一阶段的临床开发中推进ofirnoflast和研发管线。About Han Myint, MD, FACP 关于韩明特，医学博士，FACPDr. Myint is a hematologist-oncologist and drug-development leader with more than 30 years of experience across academia, biotechnology, and global pharmaceutical organizations. Previously, he was Chief Medical Officer of NextCure, Inc., overseeing first-in-human and proof-of-concept oncology trials, and Chief Medical Officer of NexImmune, Inc., a clinical-stage developer of T cell–based immunotherapies.. Myint博士是一位血液肿瘤学家和药物研发领域的领军人物，在学术界、生物技术领域以及全球制药组织拥有超过30年的经验。此前，他曾担任NextCure公司的首席医学官，负责监督首次人体试验和概念验证性肿瘤学试验，并曾担任临床阶段T细胞免疫疗法开发商NexImmune公司的首席医学官。Earlier in his industry career, Dr. Myint held senior leadership roles at Celgene Corporation (now part of Bristol Myers Squibb), including Global Myeloid Disease Lead and Co-Chair of the Global Myeloid Franchise Team, where he contributed to the development, approval, and global launch of therapies for myeloid diseases including Thalassemia, MF, MDS and AML.. 在迈因特博士的行业职业生涯早期，他曾担任新基公司（Celgene Corporation，现为百时美施贵宝的一部分）的高级领导职务，包括全球骨髓疾病主管和全球骨髓专营团队的联合主席。在此职位上，他为包括地中海贫血、骨髓纤维化（MF）、骨髓增生异常综合征（MDS）和急性髓系白血病（AML）在内的骨髓疾病疗法的开发、批准和全球上市做出了贡献。Before transitioning to industry, Dr. Myint was an academic hematologist-oncologist and stem cell transplant physician. He served as Professor of Medicine and Director of Stem Cell Transplantation and the Hematological Malignancies Program at the University of Colorado, Denver, where he built a FACT-accredited and Center of Excellence-designated stem cell transplant program. 在进入工业界之前，Myint博士是一名学术型血液肿瘤学家和干细胞移植医生。他曾在科罗拉多大学丹佛分校担任医学教授以及干细胞移植和血液恶性肿瘤项目的主任，在那里他建立了一个获得FACT认证和卓越中心指定的干细胞移植项目。He previously held academic leadership roles at Rush University Medical Center. Dr. Myint received his MBBS from the Institute of Medicine in Yangon and completed postgraduate training in internal medicine and hematology in the United Kingdom, followed by advanced hematology/oncology and stem cell transplantation training in the United States. 他曾在拉什大学医学中心担任学术领导职务。Myint博士在仰光的医学院获得医学学士学位，并在英国完成内科和血液学研究生培训，随后在美国接受高级血液学/肿瘤学和干细胞移植培训。He is a fellow of the Royal College of Pathologists, London, UK, Royal College of Physicians & Surgeons, Glasgow, Royal College of Physicians of Edinburgh, and American College of Physicians.. 他是英国伦敦皇家病理学院、格拉斯哥皇家内科及外科医学院、爱丁堡皇家内科医学院以及美国医师协会的院士。EHA2026 Presentation Details EHA2026 演讲详情Title: 标题：Ofirnoflast, a First-in-Class NEK7 Inhibitor, Induces Robust Transfusion Independence and Multilineage Hematological Improvement in Lower-Risk Myelodysplastic Syndrome (LR-MDS): Phase 2 Results Ofirnoflast，一种首创的NEK7抑制剂，在较低风险骨髓增生异常综合征（LR-MDS）中诱导显著的输血独立性和多系造血功能改善：2期结果Abstract number: 抽象编号：S174 S174Session: 会话：Oral Session s426 — Myelodysplastic Syndromes – Clinical 口头报告 s426 — 骨髓增生异常综合征 – 临床Presenting author: 报告作者：Varun Bafna, MD 瓦伦·巴夫纳，医学博士Date and time: 日期和时间：Friday, June 12, 2026, 17:15–18:30 CEST 2026年6月12日，星期五，17:15–18:30（欧洲中部夏令时间）Location: 位置：A2-3 Hall, Stockholmsmässan, Stockholm, Sweden, and virtual on the EHA Congress platform 瑞典斯德哥尔摩Stockholmsmässan会展中心A2-3大厅，以及EHA大会平台线上虚拟会议About Ofirnoflast (HT-6184) 关于Ofirnoflast（HT-6184）Ofirnoflast is Halia's first-in-class, oral, allosteric NEK7 inhibitor designed to modulate NLRP3 inflammasome activation upstream of inflammatory signaling. By targeting NEK7 before NLRP3 assembly, ofirnoflast prevents inflammasome formation and disrupts a key pathway implicated in ineffective hematopoiesis. Ofirnoflast 是 Halia 公司首创的口服别构 NEK7 抑制剂，旨在调节炎症信号上游的 NLRP3 炎性体激活。通过在 NLRP3 组装之前靶向 NEK7，ofirnoflast 阻止炎性体形成并破坏与无效造血相关的关键途径。Halia is advancing ofirnoflast as a potential disease-modifying therapy for lower-risk MDS, with broader development opportunities across inflammasome-driven diseases.. Halia公司正在推进ofirnoflast作为一种潜在的疾病修饰疗法，用于较低风险的MDS，并在炎症小体驱动的疾病中拥有更广泛的开发机会。About Halia Therapeutics 关于Halia TherapeuticsHalia Therapeutics is a clinical-stage biotechnology company headquartered in Lehi, Utah, developing first-in-class therapies that target inflammasome-driven disease biology. The company is focused on addressing significant unmet medical needs in hematologic diseases through novel mechanisms of action designed to target the root causes of inflammation-driven pathology. Halia Therapeutics是一家总部位于犹他州莱希的临床阶段生物技术公司，致力于开发针对炎症小体驱动疾病生物学的首创疗法。该公司专注于通过设计针对炎症驱动病理根本原因的全新作用机制，满足血液疾病领域未被满足的重大医疗需求。Halia's lead program, ofirnoflast, is being developed for lower-risk MDS and other hematologic diseases driven by NLRP3 inflammasome biology. Its broader pipeline is grounded in human genetic resilience and precision medicine. For more information, visit . Halia的主导项目ofirnoflast正在被开发用于低风险的MDS及其他由NLRP3炎性体生物学驱动的血液疾病。其更广泛的管线立足于人类遗传适应力和精准医学。欲了解更多信息，请访问。www.haliatx.com www.haliatx.com. 。Forward-Looking Statements 前瞻性声明This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the potential clinical, therapeutic, and commercial benefits of ofirnoflast (HT-6184); the timing and content of upcoming scientific presentations; the design, timing, and outcomes of current and future clinical trials; regulatory plans and interactions; the appointment and expected contributions of Halia's Chief Medical Officer; and the company's pipeline and development strategy. 本新闻稿包含适用证券法意义上的前瞻性声明，包括关于ofirnoflast（HT-6184）潜在临床、治疗和商业效益的声明；即将发布的科学报告的时间与内容；当前及未来临床试验的设计、时间与结果；监管计划与互动；Halia首席医学官的任命及其预期贡献；以及公司的产品管线与开发策略。Words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend,' and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based on Halia's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to clinical development, regulatory review, manufacturing, financing, competition, intellectual property, personnel, and general business conditions. 诸如“可能”、“将”、“预期”、“计划”、“预计”、“估计”、“意图”等词语及类似表述旨在识别前瞻性陈述。前瞻性陈述基于哈利亚当前的预期和假设，并受可能导致实际结果产生重大差异的风险和不确定性影响，包括与临床开发、监管审查、生产、融资、竞争、知识产权、人员及一般商业状况相关的风险。Halia undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.. Halia 不承担更新任何前瞻性声明的义务，无论是由于新信息、未来事件或其他原因，除非法律要求。Contacts 联系人Media: 媒体：Taylor Avei 泰勒·艾维Director of Business Development 商务拓展总监 [email protected] 电子邮件地址+1 (385) 355-4315 +1 (385) 355-4315Investor Relations: 投资者关系： Leigh Salvo 莉·萨尔沃New Street Investor Relations 新街投资者关系[email protected] 电子邮件地址SOURCE Halia Therapeutics 来源：哈利亚治疗公司21 21% %more press release views with 更多新闻发布视图与 Request a Demo 请求演示
