NEW YORK & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced the first patient has been dosed in its Phase 1 clinical trial evaluating AJ1‑11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis..

纽约和剑桥，马萨诸塞州。-（商业新闻短讯）--Ajax Therapeutics，Inc.，一家为骨髓增生性肿瘤（MPNs）患者开发下一代JAK抑制剂的生物制药公司，今天宣布第一名患者已在其第一阶段临床试验中服用AJ1-11095，这是一种一流的II型JAK2抑制剂，用于治疗骨髓纤维化患者。。

“We’re excited to announce dosing of the first patient enrolled in our first-in-human study with AJ1-11095” said David Steensma, MD, FACP, Chief Medical Officer at Ajax. “As a first-in-class therapy with a unique mechanism of action as a Type II inhibitor of JAK2, AJ1-11095 was developed to provide a much-needed new treatment for patients with myeloproliferative neoplasms by offering the potential for improved efficacy compared to existing therapies.”.

阿贾克斯首席医疗官、FACP医学博士DavidSteensma说：“我们很高兴宣布我们首次使用AJ1-11095进行人体研究的第一名患者的剂量。”。“作为具有作为JAK2 II型抑制剂的独特作用机制的一流疗法，AJ1-11095的开发旨在为骨髓增生性肿瘤患者提供急需的新疗法，与现有疗法相比，它具有改善疗效的潜力。”。

AJ1-11095 is the first JAK2 inhibitor to enter the clinic that binds the Type II conformation of the JAK2 kinase as opposed to all the other approved JAK2 inhibitors, including ruxolitinib, that bind the Type I conformation. The advancement of AJ1-11095 into this Phase 1 clinical trial was based on preclinical studies in which AJ1-11095 showed superior efficacy when compared to Type I JAK2 inhibitors with significant disease modifying effects on mutant allele burden and fibrosis, two of the main hallmarks of myelofibrosis..

AJ1-11095是第一个进入临床的结合JAK2激酶II型构象的JAK2抑制剂，而不是所有其他批准的结合I型构象的JAK2抑制剂，包括ruxolitinib。AJ1-11095进入这一1期临床试验的进展是基于临床前研究，其中AJ1-11095与I型JAK2抑制剂相比具有优越的疗效，对突变等位基因负荷和纤维化具有显着的疾病缓解作用，这是骨髓纤维化的两个主要标志。。

John Mascarenhas, MD, Professor of Medicine, Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence in Blood Cancers and Myeloid Disorders at Tisch Cancer Institute and principal investigator of the Phase 1 Study added, “There continues to be a significant unmet need for myelofibrosis patients who lose or lack response to existing therapies.

西奈山伊坎医学院医学教授、医学博士约翰·马斯卡伦哈斯（John Mascarenhas）和蒂希癌症研究所（Tisch Cancer Institute）血癌和髓系疾病卓越中心主任兼第一阶段研究的首席研究员补充道：“对于对现有疗法失去或缺乏反应的骨髓纤维化患者，仍然存在严重的未满足需求。

AJ1-11095 is a promising new therapeutic option for these patients and we look forward to the clinical results from the Phase 1 study.”.

AJ1-11095对于这些患者来说是一种有前途的新治疗选择，我们期待着第一阶段研究的临床结果。”。

The Phase 1 clinical trial is an open-label, multi-center, dose escalation and dose expansion study designed to evaluate the safety, tolerability and preliminary efficacy of AJ1-11095. The study will enroll patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) who have been failed by a Type I JAK2 Inhibitor.

第一阶段临床试验是一项开放标签，多中心，剂量递增和剂量扩展研究，旨在评估AJ1-11095的安全性，耐受性和初步疗效。该研究将招募I型JAK2抑制剂失败的原发性骨髓纤维化（PMF），真性红细胞增多症后骨髓纤维化（PPV-MF）或原发性血小板增多症后骨髓纤维化（PET-MF）患者。

Further details about the study can be found at www.clinicaltrials.gov under the NCT identifier: NCT06343805..

有关该研究的更多详细信息，请访问www.clinicaltrials.gov，网址为NCT标识符：NCT06343805。。

About AJ1-11095

关于AJ1-11095

AJ1-11095 was designed by Ajax, through an exclusive collaboration with Schrödinger, using structure-based drug design and computational methods at scale to selectively bind the Type II conformation of the JAK2 kinase in order to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the Type I conformation of JAK2.

AJ1-11095由Ajax通过与Schrödinger的独家合作设计，使用基于结构的药物设计和大规模计算方法，选择性结合JAK2激酶的II型构象，以便与所有目前批准的JAK2抑制剂（包括结合JAK2 I型构象的ruxolitinib）相比，提供更大的疾病修饰功效。

Additionally, AJ1-11095 has been shown in preclinical studies to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic Type I JAK2 inhibition..

此外，临床前研究表明，AJ1-11095可逆转骨髓纤维化，减少突变等位基因负担，并维持对慢性I型JAK2抑制产生抗性的MPN细胞的功效。。

About Myelofibrosis

关于骨髓纤维化

Myelofibrosis (MF) is a rare blood cancer that affects approximately 20,000 patients in the United States. The disease is characterized by spleen enlargement, scarring (fibrosis) in the bone marrow, progressive anemia, and debilitating symptoms, such as fatigue, night sweats, itching, and abdominal discomfort, which can impair a patient’s’ quality of life.

骨髓纤维化（MF）是一种罕见的血癌，在美国约有20000名患者受到影响。该疾病的特征是脾肿大，骨髓瘢痕形成（纤维化），进行性贫血和虚弱症状，如疲劳，盗汗，瘙痒和腹部不适，这可能会损害患者的生活质量。

The most widely used treatment for MF patients are Type I JAK2 inhibitors which can reduce spleen size and provide symptomatic improvement but have little effect on the underlying cause of disease. Over time, most MF patients stop Type I JAK2 inhibitor therapy. The most common causes for treatment discontinuation include a lack of benefit or loss of response, adverse events, and disease progression, leaving significant unmet treatment needs for these patients..

MF患者最广泛使用的治疗方法是I型JAK2抑制剂，它可以减少脾脏大小并提供症状改善，但对疾病的根本原因几乎没有影响。随着时间的推移，大多数MF患者停止I型JAK2抑制剂治疗。停止治疗的最常见原因包括缺乏益处或失去反应，不良事件和疾病进展，这些患者的治疗需求严重未得到满足。。

About Ajax Therapeutics

关于Ajax Therapeutics

Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel next generation therapies for myeloproliferative neoplasms (MPNs), including myelofibrosis. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms, we aim to discover and develop more precisely designed therapies to address the significant unmet needs for patients with MPNs..

Ajax Therapeutics，Inc.正在寻求独特的选择性方法，以开发针对骨髓增生性肿瘤（MPN）（包括骨髓纤维化）的新一代疗法。通过将我们创始科学家的深层癌症和结构生物学见解与业界最先进的计算药物发现和蛋白质结构平台相结合，我们旨在发现和开发更精确设计的疗法，以解决MPN患者的重大未满足需求。。

Please find more information at www.ajaxtherapeutics.com.

请访问www.ajaxtrapeutics.com了解更多信息。