RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF)

开始日期2022-05-31

申办/合作机构

Blade Therapeutics, Inc.

NCT04814472 / Completed临床1期

A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers

开始日期2021-05-16

申办/合作机构

Blade Therapeutics, Inc.

NCT04814498 / Completed临床1期

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers

开始日期2021-05-03

申办/合作机构

Blade Therapeutics, Inc.

100 项与 Cudetaxestat 相关的临床结果

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100 项与 Cudetaxestat 相关的转化医学

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100 项与 Cudetaxestat 相关的专利（医药）

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项与 Cudetaxestat 相关的文献（医药）

2022-07-03·Expert opinion on therapeutic patents2区 · 医学

Nucleotide pyrophosphatase/phosphodiesterases (NPPs) including NPP1 and NPP2/ ATX as important drug targets: A patent review (2015-2020)

2区 · 医学

Review

作者: Khan, Imtiaz Ali ; Al-Rashida, Mariya ; Iqbal, Jamshed ; Bano, Sehrish ; Alharthy, Rima D

INTRODUCTION:

Ectobucleotidases are a broad class of extracellular nucleotide and nucleoside hydrolyzing enzymes. Since they play a crucial role in mediating purinergic cell signalling, they are promising therapeutic targets for treatment of a range of disorders, including fibrosis, tumor metastasis, inflammation, multiple sclerosis, and autoimmune diseases. Hence selective inhibtors of ectonulceotidases are of great interest for therapeutic intervention.

AREA COVERED:

Many compounds have demonstrated promising inhibitory potential against ecto-nucleotide pyrophosphatase/phosphodiesterases (NPPs). The chemistry and clinical applications of NPP inhibitors patented between 2015 and 2020 are discussed in this review.

EXPERT OPINION:

In recent years, there has been a lot of effort towards finding effective and selective inhibitors of NPPs. Even though a number of inhibitors are known, only a few in vivo investigations have been published. In addition to IOA-289, which has passed Phase Ia clinical trials, potent NPP2/ATX inhibitor compounds such as BLD-0409, IPF and BBT-877 have been placed in phase I clinical studies. Some of the most promising NPP2/ATX inhibitors in recent years are closely related analogs of previously known inhibitors, such as PF-8380. Knowledge of the structure activity relationship of such promising inhibitors can potentially translate into the discovery of more potent and effective inhibitors of NPP.

2021-05-04·Expert opinion on therapeutic patents2区 · 医学

An updated patent review of autotaxin inhibitors (2017–present)

2区 · 医学

Review

作者: Tan, Zehui ; Chen, Yuxiang ; Zhai, Xin ; Lei, Hongrui ; Guo, Ming

INTRODUCTION:

The ATX-LPA axis is an attractive target for therapeutic intervention in a variety of diseases, such as tumor metastasis, fibrosis, pruritus, multiple sclerosis, inflammation, autoimmune conditions, metabolic syndrome, and so on. Accordingly, considerable efforts have been devoted to the development of new chemical entities capable of modulating the ATX-LPA axis.

AREAS COVERED:

This review aims to provide an overview of novel ATX inhibitors reported in patents from September 2016 to August 2020, discussing their structural characteristics and inhibitory potency in vitro and in vivo.

EXPERT OPINION:

In the past four years, the classification of ATX inhibitors based on binding modes has brought great benefits to the discovery of more efficacious inhibitors. In addition to GLPG1690 currently in phase III clinical studies for IPF, BBT-877, and BLD-0409 as potent ATX inhibitors have been enrolled in phase I clinical evaluation; meanwhile, many effective molecules were also reported successively. However, most emerging ATX inhibitors in the last four years are closely analogs of previous entities, such as GLPG1690 and PF-8380, which translate into the urgently identification of ATX inhibitors with diverse structural features and promising properties in the near future.

Pharmaceuticals (Basel, Switzerland)3区 · 医学

Design and Development of Autotaxin Inhibitors

3区 · 医学

ReviewOA

作者: Xu, Xu-Dong ; Li, Yan ; Shang, Hai ; Jia, Yi ; Tian, Yu

Autotaxin (ATX) is the only enzyme of the ecto-nucleotide pyrophosphatase/phosphodiesterase (ENPP2) family with lysophospholipase D (lysoPLD) activity, which is mainly responsible for the hydrolysis of extracellular lysophosphatidylcholine (LPC) into lysophosphatidic acid (LPA). LPA can induce various responses, such as cell proliferation, migration, and cytokine production, through six G protein-coupled receptors (LPA1-6). This signaling pathway is associated with metabolic and inflammatory disorder, and inhibiting this pathway has a positive effect on the treatment of related diseases, while ATX, as an important role in the production of LPA, has been shown to be associated with the occurrence and metastasis of tumors, fibrosis and cardiovascular diseases. From mimics of ATX natural lipid substrates to the rational design of small molecule inhibitors, ATX inhibitors have made rapid progress in structural diversity and design over the past 20 years, and three drugs, GLPG1690, BBT-877, and BLD-0409, have entered clinical trials. In this paper, we will review the structure of ATX inhibitors from the perspective of the transformation of design ideas, discuss the advantages and disadvantages of each inhibitor type, and put forward prospects for the development of ATX inhibitors in the future.

项与 Cudetaxestat 相关的新闻（医药）

2022-09-10

·药明康德

一周盘点 | 新药进展大爆发，10项创新疗法公布积极早期临床数据...

▎药明康德内容团队编辑本期看点可以同时结合HER2上两个不同位点的双特异性抗体偶联药物zanidatamab zovodotin的1期临床试验公布初步数据，疾病控制率（DCR）达72%。潜在的“first-in-class”在研非竞争性自分泌运动因子（autotaxin）抑制剂cudetaxestat用于治疗特发性肺纤维化的临床前及1期临床试验数据积极。溶瘤腺病毒新药VCN-01联用PD-L1抑制剂durvalumab治疗头颈部鳞状细胞癌的1期临床试验初步数据显示出了可接受的安全性和令人鼓舞的生物活性。双环肽偶联毒素BT5528在晚期实体肿瘤患者中的1/2期临床试验公布初步数据，EphA2阳性的卵巢癌及尿路上皮癌患者中，DCR达67%。用于治疗射血分数降低的心力衰竭（HFrEF）患者的新药JK07在1b期临床试验中展现积极的中期数据。药明康德内容团队整理Zanidatamab zovodotin（ZW49）：公布1期临床试验的初步数据Zymeworks于近日宣布，将在欧洲肿瘤内科学会（ESMO）年会报告其新药zanidatamab zovodotin（ZW49）的1期临床试验数据。ZW49是一款使用Zymeworks专有的Azymetric和ZymeLink平台开发的靶向HER2的双特异性抗体偶联药物，由可以同时结合HER2上两个不同位点的双特异性抗体zanidatamab通过可切割的接头与其专有的细胞毒素连接。该1期临床试验纳入了76例HER2阳性癌症患者（胃癌患者占28%，乳腺癌患者占22%）。初步结果显示，zanidatamab zovodotin在HER2+的癌症患者中显示出可控的安全性，且具有令人鼓舞的单药抗肿瘤活性。在29例接受了2剂治疗的患者中，客观缓解率（ORR）为28%，DCR为72%。大多数与治疗相关的不良事件（TRAE）为1级或2级，包括角膜炎（42%)、脱发（25%）和腹泻（21%）。在经历3级或更高级别TRAE的7例患者中，2例是4级事件，包括输液相关反应和中性粒细胞计数减少。有3例患者因TRAE停药，没有报告与治疗相关的患者死亡或间质性肺病病例。Cudetaxestat：公布临床前及1期临床试验的数据Blade Therapeutics在2022年欧洲呼吸学会国际大会上展示了其用于治疗特发性肺纤维化（IPF）患者的新药cudetaxestat的临床前研究和1期临床试验的数据。新闻稿指出，cudetaxestat是一种潜在的“first-in-class”在研非竞争性自分泌运动因子抑制剂，对许多纤维化标志物表现出强大的临床前活性，并能调节关键的纤维化基因。临床前研究表明，非竞争性的自分泌运动因子抑制能够提供差异化的特性，即使在自分泌运动因子的底物水平高的情况下依然能在体内/外模型中显示出显著的抗纤维化活性。在1期研究中，cudetaxestat的耐受性良好，未发现与药物相关的严重不良事件（SAE）。与其他常用的已批准的药物疗法一起使用时，cudetaxestat出现药物间相互作用的可能性较低。Blade公司计划将cudetaxestat作为单一疗法或与pirfenidone/nintedanib联用推进到针对IPF患者的2期临床试验中。VCN-01：公布1期临床试验的初步数据Synthetic Biologics于近日宣布了一项1期临床试验的初步数据，该试验评估了其溶瘤腺病毒新药VCN-01联用PD-L1抑制剂durvalumab治疗头颈部复发性/转移性鳞状细胞癌（R/M HNSCC）患者的安全性、药代动力学、药效学和生物活性。VCN-01是一种基于Ad5的溶瘤腺病毒，旨在在具有功能失调的RB1通路的癌细胞中复制，然后表达透明质酸酶以增强病毒在肿瘤内扩散，促进化疗和免疫细胞渗透到肿瘤中。临床试验结果显示，VCN-01与durvalumab的联合治疗显示出了可接受的安全性和令人鼓舞的生物活性。VCN-01给药后血液中病毒基因组的水平和增加的血清透明质酸酶水平维持了超过6周，肿瘤炎症标志物CD8阳性T细胞增加，肿瘤PD-L1上调，并观察到了肿瘤基因表达谱的改变和相关通路的下调。安全性方面，在序贯方案中与durvalumab一起给药时，VCN-01的安全性良好，最常见的TRAE是发热、流感样症状和肝转氨酶增加。观察到的TRAEs具有剂量依赖性和可逆性，并且与先前描述的其他基于腺病毒的产品的TRAEs一致。BT5528：公布1/2期临床试验的初步数据Bicycle Therapeutics于近日公布了其靶向EphA2的双环肽偶联毒素BT5528在晚期实体瘤患者中的1/2期临床试验的初步数据。EphA2在多种难以治疗的肿瘤中过度表达，调节细胞的迁移、增殖和分化。此前针对这一靶点的抗体偶联药物开发并没有获得理想的结果。此次公布数据的临床试验中，在尿路上皮癌和卵巢癌患者中观察到抗肿瘤活性。除尿路上皮癌和卵巢癌患者以外，该篮子试验中还纳入了患有非小细胞肺癌、三阴性乳腺癌、头颈癌和食道癌的患者。在9例EphA2阳性的反应可评估的卵巢癌患者中，观察到6例患者的靶病灶缩小，其中1例患者实现了CR，1例患者在缓解评估标准下达到PR，DCR为67%，总缓解率为22%。在3例EphA2阳性的反应可评估的尿路上皮癌患者中，观察到2例患者的肿瘤缩小，ORR和DCR为67%。安全性方面，BT5528在研究剂量下具有良好的耐受性，没有观察到治疗相关的出血和低级别、低发生率的周围神经病变、皮疹和眼部疾病。JK07：公布1b期临床试验数据Salubris Biotherapeutics于近日公布了其新药JK07在射血分数降低的心力衰竭患者中进行1b期临床试验的积极中期数据。JK07是一种重组融合蛋白，由完全人免疫球蛋白IgG1单克隆抗体和人生长因子神经调节蛋白（NRG-1）的活性多肽片段组成。NRG-1是一种经过临床验证的生长因子，在射血分数降低的心力衰竭中显示出有希望的活性，但也有不良副作用。研究表明，NRG-1通过与两种不同的受体HER3/ErbB3和HER4/ErbB4相互作用来诱导信号传导。HER4/ErbB4通路被认为能够负责心脏的再生作用，而HER3/ErbB3通路被认为主要负责重组NRG-1的安全性和耐受性限制。通过用抗体融合设计阻HER3/ErbB3信号传导，JK07可以选择性地刺激HER4/ErbB4通路，具有良好的药代动力学特征。中期数据包括三个单次递增剂量组的11例受试者。在前两个队列完成入组后，JK07显示出剂量依赖性地改善了射血分数（EF）。在队列2中，单次给药JK07后的第90天观察到相对EF平均改善30%。在队列3中，前哨受试者在第30天时的相对EF改善超70%。JK07在该研究中总体上具有良好的耐受性，迄今为止未报告严重不良事件。LUT014：公布1/2期临床试验数据Lutris Pharma于近日公布了其新型小分子BRAF抑制剂LUT014治疗乳腺癌患者放射性皮炎的1/2期临床试验的积极顶线结果。BRAF抑制剂具有矛盾效应，阻断肿瘤细胞中的该通路会导致细胞凋亡和肿瘤缩小，但阻断正常细胞中的该通路会导致MAPK通路激活，细胞开始生长。LUT014利用的正是这种矛盾效应来增强细胞增殖、平衡细胞破坏，这也是放射性皮炎的典型特征。LUT014是一种可局部外用的凝胶，在该试验的第一部分中，75%的患者的放射性皮炎获得了完全消退。第二部分的研究结果显示，LUT014相比于安慰剂具有更好的疗效，皮炎严重程度改善率分别为100%和73%，患者的生活质量也得到了改善。TCR-T细胞疗法：公布1/2期临床试验的初步数据Alaunos Therapeutics于近日公布了其正在进行的1/2期临床试验TCR-T Library的早期临床研究结果。这是一项开放标签、剂量递增研究，招募的实体肿瘤患者包括非小细胞肺癌、结直肠癌、子宫内膜癌、胰腺癌、卵巢癌和胆管癌的患者。首位接受治疗的是一例携带KRAS G12D突变的非小细胞肺癌患者，已观察到该患者获得了客观的部分缓解。第二位接受治疗的是一例结肠癌患者，已接受了第二剂量水平都给药，目前已确认了28天的安全窗口。LY3471851（NKTR-358）：公布1b期临床试验数据LY3471851（NKTR-358）是Nektar Therapeutics公司开发的一种潜在“first-in-class”疗法，它靶向体内的白介素2（IL-2）受体复合物，可以刺激抑制性免疫细胞调节性T 细胞（Treg）增殖。通过激活这些细胞，LY3471851可以使免疫系统恢复平衡，有望解决许多自身免疫性疾病患者潜在的免疫系统失衡问题。此次公布的两项1b期临床试验分别探索了LY3471851在特应性皮炎和银屑病患者中的疗效和安全性。结果显示，LY3471851在研究剂量下的安全性良好，并观察到了关键疗效指标剂量依赖性的改善。NGM120：公布1a期临床试验前列腺癌亚组的初步数据NGM Biopharmaceuticals在2022 ESMO大会上更新了其新药NGM120的1a期临床试验中针对晚期前列腺癌患者部分的初步结果。生长分化因子-15（GDF-15）被认为是抗肿瘤T细胞活性的负调节因子，可阻止T细胞招募到肿瘤微环境中，并对标准护理和当前的免疫治疗方法（如检查点抑制剂）产生抗药性。NGM120是一种新型拮抗抗体，可结合胶质细胞源性神经营养因子α样受体（GFRAL）并抑制GDF-15的信号传导，具有治疗癌症的潜力。该1a期试验的初步结果显示，NGM120的耐受性良好，没有剂量限制性毒性，并为晚期前列腺癌患者提供了令人鼓舞的抗癌活性信号。在62周时，5例前列腺癌患者中有2例实现了疾病控制，其中1例实现了部分缓解。ERAS-601和ERAS-007：公布1/1b期临床试验的初步数据Erasca于近日宣布了其ERK1/2抑制剂ERAS-007和SHP2抑制剂ERAS-601在BRAF驱动和RAS/MAPK改变的实体肿瘤中积极的初步1/1b期临床试验数据。23%（6/26）RAS/MAPK改变的非结直肠癌（CRC）实体肿瘤患者和44%（4/9）BRAF驱动的非CRC实体肿瘤患者对单药ERAS-007或ERAS-601有反应（包括已确认和未确认的PR）。此外，这两种药物具有良好的安全性和耐受性，且与治疗相关的不良事件基本不重叠，支持药物联用的开发。TAC01-HER2：1/2期临床试验中期数据即将公布Triumvira Immunologics于近日宣布，其TAC-T细胞疗法TAC01-HER2的1/2期临床试验的中期数据将在2022 ESMO大会上进行公布。TAC01-HER2是一种新型的细胞疗法，由基因工程自体T细胞组成，该T细胞表达T细胞抗原偶联剂（TAC），并可识别人类表皮生长因子受体2（HER2）。该疗法使用了Triumvira Immunologics专有的TAC平台技术，能以不同于CAR-T和TCR-T细胞疗法的方式激活天然T细胞功能。NVL-520：1/2期临床试验初步数据即将公布Nuvalent于近日宣布，其新型ROS1选择性抑制剂NVL-520的1/2期ARROS-1研究剂量递增部分的初步安全性和临床活动数据即将公布。该临床试验针对晚期ROS1阳性非小细胞肺癌和其他实体肿瘤患者展开。NVL-520被设计为在对目前可用的ROS1抑制剂产生耐药性的肿瘤中保持活性，并优化了脑渗透性，旨在解决目前可用的ROS1激酶抑制剂存在的临床挑战，包括耐药性、脱靶中枢神经系统（CNS）不良事件和脑转移等。Visugromab（CTL-002）：1期临床试验数据即将公布CatalYm于近日宣布，其人源化的单克隆抗体visugromab（CTL-002）的1期临床试验GDFATHER-1的成熟结果将在2022 ESMO大会上进行口头报告。该试验评估了visugromab与PD-1抑制剂nivolumab联合用于治疗最后一线抗PD-1/PD-L1复发/难治性患者的安全性、耐受性，并有希望获得药代动力学数据。Visugromab旨在中和肿瘤产生的GDF-15来抵消这些免疫抑制机制，增强免疫细胞对肿瘤的浸润，改善树突状细胞对T细胞的启动，增强T细胞和NK细胞的肿瘤杀伤作用。BI-1808：完成1/2a期临床试验计划的剂量递增部分BioInvent International于近日宣布，已按计划完成其抗TNFR2抗体BI-1808的1/2a期试验的剂量升级部分。正在进行的研究数据显示，BI-1808的安全性和耐受性良好，在剂量递增期间未观察到严重的不良事件或剂量限制性毒性。鉴于这些积极的数据，将探索更高剂量的BI-1808作为单一药物的影响。TNFR2在肿瘤微环境的Treg细胞表面高表达，已被证明对肿瘤的生长和存活很重要，是癌症免疫疗法的一个新的有前途的靶点。随后的2a期试验将评估BI-1808作为单一药物以及与pembrolizumab联用在肺癌和卵巢癌患者中的疗效，以及BI-1808作为单一药物在皮肤T细胞淋巴瘤患者中的疗效。Darovasertib：首位患者入组1期临床试验IDEAYA Biosciences于近日宣布，其潜在的“first-in-class”小分子蛋白激酶C（PKC）抑制剂darovasertib作为单一疗法用于原发性非转移性葡萄膜黑色素瘤（UM）患者的新辅助/辅助治疗的1期临床试验已完成了首位患者入组。2022年4月，FDA指定darovasertib为葡萄膜黑色素瘤的孤儿药。此前，在一项评估darovasertib和克唑替尼（crizotinib）合成致死组合的1/2期临床试验中，所有16例接受该治疗组合给药的可评估转移性UM患者均显示出肿瘤缩小，获得100%的DCR，与31%的ORR。EBS-LASV：启动1期临床试验Emergent BioSolutions于近日宣布，其开发的用于预防由拉沙病毒感染引起的疾病的重组VSV载体拉沙病毒候选疫苗EBS-LASV已启动1期临床试验，以评估其安全性和免疫原性。拉沙热病毒每年会引起急性病毒性人畜共患病拉沙热的大爆发，该病在西非许多地区流行或持续存在。MRT-2359：IND申请获得FDA许可Monte Rosa Therapeutics于近日宣布，其靶向GSPT1的分子胶降解剂（MGD）MRT-2359的IND申请已获得FDA的许可，有望在2022年第四季度针对MYC驱动的实体瘤患者启动1/2期临床试验。MRT-2359是一种有效的、选择性的口服生物可利用的MGD。MYC转录因子是公认的癌症驱动因素，通过维持高水平的蛋白质翻译影响肿瘤细胞的增殖和生长。临床前研究表明，依赖于MYC诱导的蛋白质翻译受翻译终止因子GSPT1影响。MRT-2359可诱导E3泛素连接酶的组件cereblon与GSPT1之间的相互作用，从而导致GSPT1蛋白的靶向降解，优先破坏MYC驱动的细胞中的蛋白质合成，发挥抗肿瘤活性。TN-301：IND申请获得FDA许可Tenaya Therapeutics于近日宣布其高选择性组蛋白去乙酰化酶6（HDAC6）小分子抑制剂TN-301的IND申请获得FDA许可，并获准开展1期临床试验。TN-301最初被开发用于治疗射血分数保留型心力衰竭（HFpEF），这类患者的左室射血分数（LVEF）值为50%或以上。在HFpEF临床前模型中，TN-301通过改善左心室舒张和充盈显示出了令人信服的潜力。IMM-1-104：向FDA递交IND申请Immuneering于近日宣布，已向FDA递交了其高选择性第三代小分子MEK抑制剂IMM-1-104的IND申请，以开展针对携带RAS突变的晚期实体瘤患者的1/2a期临床试验。IMM-1-104旨在实现泛RAS活性，通过驱动深度循环抑制来调节MAPK通路的信号传导动力学，能在剥夺肿瘤细胞快速生长所需的持续增殖信号转导的同时，为健康细胞提供富有节律的、标准化的信号水平，选择性地影响癌细胞的程度大于健康细胞。在包括KRAS突变的胰腺癌，NRAS突变的黑色素瘤，KRAS突变的结直肠癌和KRAS突变的肺癌的动物模型中，无论MEK上游驱动MAPK通路激活的特定突变如何，IMM-1-104均显示出强大的单药抗肿瘤活性，同时具有良好的耐受性和安全性。药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息参考资料：[1] Zymeworks Announces Release Of ESMO Abstract For Phase 1 Study Of Zanidatamab Zovodotin (ZW49) In Solid Cancers. Retrieved September 4, 2022, from https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-release-esmo-abstract-phase-1-study[2] Blade Therapeutics Presents Analyses from Phase 1 and Preclinical Studies of Cudetaxestat at the European Respiratory Society International Congress 2022. Retrieved September 4, 2022, from https://www.blademed.com/news/september-4-2022/[3] Synthetic Biologics Announces Presentation at ESMO Congress 2022 Describing Phase 1 Investigator-sponsored Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck. Retrieved September 4, 2022, from https://www.syntheticbiologics.com/news-media/press-releases/detail/334/synthetic-biologics-announces-presentation-at-esmo-congress[4] Garcia-Carbonero R, Bazan-Peregrino M, Gil-Martín M, et al. Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. J Immunother Cancer. 2022;10(3):e003255. Doi:10.1136/jitc-2021-003255 [5] Immuneering Announces Submission of IND Application to the FDA for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations. Retrieved September 2, 2022, from https://ir.immuneering.com/news-releases/news-release-details/immuneering-announces-submission-ind-application-fda-phase-12a[6] CatalYm to Present Complete Phase 1 Safety and Efficacy Data on GDF-15 Neutralizing Antibody Visugromab (CTL-002) at the 2022 ESMO Congress. Retrieved September 5, 2022, from https://www.catalym.com/catalym-to-present-complete-phase-1-safety-and-efficacy-data-on-gdf-15-neutralizing-antibody-visugromab-ctl-002-at-the-2022-esmo-congress/[7] BioInvent completes the planned dose-escalation in Phase 1/2a trial of BI-1808 in advanced malignancies. Retrieved September 6, 2022, from https://bioinvent.com/media/press-releases/mfnsingle/?slug=bioinvent-completes-the-planned-dose-escalation-in-phase-1-2a-trial-of-bi-1808-in-advanced-malignancies[8] Nektar Therapeutics Presents Data for Rezpegaldesleukin (LY3471851) in Patients with Atopic Dermatitis and Psoriasis from Two Separate Clinical Studies at 2022 European Academy of Dermatology (EADV) Congress. Retrieved September 7, 2022, from https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-presents-data-rezpegaldesleukin-ly3471851[9] Monte Rosa Therapeutics Announces FDA Clearance of Investigational New Drug Application for MRT-2359, a GSPT1-directed Molecular Glue Degrader. Retrieved September 6, 2022, from https://ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-fda-clearance-investigational[10] Tenaya Therapeutics Announces FDA Clearance of Investigational New Drug Application and Initiation of Phase 1 Safety Study for TN-301, an HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction. Retrieved September 6, 2022, from https://investors.tenayatherapeutics.com/news-releases/news-release-details/tenaya-therapeutics-announces-fda-clearance-investigational-new[11] Alaunos Therapeutics Announces Early Clinical Data Showing Objective Clinical Response Using its TCR-T Cell Therapy. Retrieved September 6, 2022, from https://ir.alaunos.com/news-releases/news-release-details/alaunos-therapeutics-announces-early-clinical-data-showing[12] IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy in (Neo)Adjuvant Uveal Melanoma. Retrieved September 6, 2022, from https://media.ideayabio.com/2022-09-06-IDEAYA-Announces-First-Patient-In-for-Phase-I-Clinical-Trial-to-Evaluate-Darovasertib-Monotherapy-in-Neo-Adjuvant-Uveal-Melanoma[13] Triumvira Immunologics to Present Interim Clinical Data from Ongoing Phase 1/2 Trial with T Cell Therapy TAC01-HER2 at European Society for Medical Oncology 2022 Congress. Retrieved September 6, 2022, from https://triumvira.com/triumvira-immunologics-to-present-interim-clinical-data-from-ongoing-phase-1-2-trial-with-t-cell-therapy-tac01-her2-at-european-society-for-medical-oncology-2022-congress/[14] NGM Bio Presents Updated Preliminary Findings for a Subgroup of Patients with Advanced Prostate Cancer from the Ongoing Phase 1a Dose Escalation Trial of NGM120 in Patients with Advanced Solid Tumors at the ESMO Annual Congress. Retrieved September 6, 2022, from https://ir.ngmbio.com/news-releases/news-release-details/ngm-bio-presents-updated-preliminary-findings-subgroup-patients[15] Bicycle Therapeutics Announces BT5528 Phase I Dose Escalation Results in Patients with Advanced Solid Tumors. Retrieved September 7, 2022, from https://www.businesswire.com/news/home/20220907005284/en/Bicycle-Therapeutics-Announces-BT5528-Phase-I-Dose-Escalation-Results-in-Patients-with-Advanced-Solid-Tumors[16] Salubris Biotherapeutics Announces Updated Phase 1b Data Demonstrating that JK07, the First Investigational Antibody Fusion Protein for Heart Failure, Resulted in Clinically Meaningful Improvements in Ejection Fraction. Retrieved September 7, 2022, from https://www.businesswire.com/news/home/20220907005352/en/Salubris-Biotherapeutics-Announces-Updated-Phase-1b-Data-Demonstrating-that-JK07-the-First-Investigational-Antibody-Fusion-Protein-for-Heart-Failure-Resulted-in-Clinically-Meaningful-Improvements-in-Ejection-Fraction[17] Lutris Pharma Reports Positive Top-Line Results From the Open Label Part 1 and Double Blinded Part 2 of Its Phase 1/2 Trial of LUT014 to Treat Radiation Dermatitis in Patients with Breast Cancer. Retrieved September 7, 2022, from https://www.prnewswire.com/news-releases/lutris-pharma-reports-positive-top-line-results-from-the-open-label-part-1-and-double-blinded-part-2-of-its-phase-12-trial-of-lut014-to-treat-radiation-dermatitis-in-patients-with-breast-cancer-301619283.html[18] Nuvalent to Present Preliminary Phase 1 Data from ARROS-1 Clinical Trial of NVL-520 at 34th EORTC-NCI-AACR Symposium and Announces Pipeline Updates. Retrieved September 7, 2022, from https://investors.nuvalent.com/2022-09-07-Nuvalent-to-Present-Preliminary-Phase-1-Data-from-ARROS-1-Clinical-Trial-of-NVL-520-at-34th-EORTC-NCI-AACR-Symposium-and-Announces-Pipeline-Updates[19] Erasca Presents Promising Preliminary Phase 1/1b Monotherapy Data for ERAS-007 ERK and ERAS-601 SHP2 Inhibitors Supporting Ongoing and Future Combination Trials. Retrieved September 7, 2022, from https://investors.erasca.com/news-releases/news-release-details/erasca-presents-promising-preliminary-phase-11b-monotherapy-data[20] Emergent BioSolutions Initiates Phase 1 Study Evaluating Lassa Virus Vaccine Candidate . Retrieved September 6, 2022, from https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-initiates-phase-1-study-evaluating-lassa免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

免疫疗法抗体创新药First in Class细胞疗法

2022-08-01

·BioSpace

Blade Therapeutics to Participate in “Drug Development in Pulmonary Medicine” Panel Discussion at 2022 BTIG Biotechnology Conference

Aug. 1, 2022 12:00 UTC SAN FRANCISCO--(BUSINESS WIRE)-- Blade Therapeutics, Inc., a clinical-stage biopharmaceutical company developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced that Wendye Robbins, M.D., president and CEO, will participate in the “Drug Development in Pulmonary Medicine: Emerging Trends and a Review of the Unmet Need” panel discussion on Tuesday, August 9, 2022, 1:00 pm (ET), during the 2022 BTIG Biotechnology Conference, August 8 – 9, in New York City. Blade’s lead investigational medicine is cudetaxestat, a non-competitive autotaxin inhibitor with direct anti-fibrotic activity and differentiating characteristics that is expected to enter a planned phase 2 clinical trial in patients with idiopathic pulmonary fibrosis. This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate, and technology sectors. To join the conference, email info@btig.com. About Blade Therapeutics Blade Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing cutting-edge treatments for debilitating, incurable fibrotic and neurodegenerative diseases. The company has deep expertise in novel biological pathways – including autotaxin / LPA and calpain biology – that are foundational to cell- and tissue-damage responses associated with fibrosis and neurodegeneration. Blade’s focused approach offers the potential to produce disease-modifying, life-saving therapies. Blade expects to advance a differentiated pipeline of oral, small-molecule therapies that include a non-competitive autotaxin inhibitor and an inhibitor of dimeric calpains. Visit for more information and follow Blade on LinkedIn.

合作

2022-06-13

·BioSpace

Biotech Acquisition Company and Blade Therapeutics Mutually Agree to Terminate Business Combination Agreement

NEW YORK and SOUTH SAN FRANCISCO, Calif., June 13, 2022 /PRNewswire/ -- Biotech Acquisition Company (NASDAQ: BIOT) ("BAC"), a publicly traded special purpose acquisition company affiliated with SPRIM Global Investments, and Blade Therapeutics Inc. ("Blade"), a biopharmaceutical company based in South San Francisco, Calif., today announced that they have mutually agreed to terminate the previously announced Agreement and Plan of Merger (the "Merger Agreement"), effective immediately. As required by Cayman Islands law, BAC will convene the previously postponed extraordinary general meeting of shareholders on Tuesday, June 14, 2022, at 9:00 AM Eastern Time. As previously announced, the extraordinary general meeting will occur at the offices of Ellenoff Grossman and Schole LLP located at 1345 Avenue of the Americas, 11th Floor, New York, New York, 10105 and virtually via live webcast at . As a result of the termination of the Merger Agreement, at the extraordinary general meeting, BAC intends that none of the proposed resolutions to approve the Merger Agreement and the related resolutions will be put forward for consideration and approval by BAC's shareholders and that the extraordinary general meeting will be adjourned indefinitely. In light of the termination of the Merger Agreement, the proposed business combination will not be concluded and any ordinary shares submitted for redemption will not be redeemed at this time and will be returned to the respective holder, broker or bank in the manner described in the definitive proxy statement for the extraordinary general meeting. BAC intends to continue to pursue the consummation of a business combination with an appropriate target. Additional information about the termination of the Business Combination will be provided in a Current Report on Form 8-K to be filed by BAC with the SEC and available at . Michael Shleifer, Ph.D., chairman and CEO of BAC, co-founder and managing partner of SPRIM Global Investments said, "We wish Blade continued success as they continue to develop cutting-edge science and a clinical-stage pipeline targeting diseases that remain undertreated. BAC remains committed to finding a life-sciences partner that can deliver value for our shareholders." Wendye Robbins, M.D., president and CEO of Blade said, "Blade remains focused on our development plans, particularly for our company's differentiated lead asset, cudetaxestat, a non-competitive autotaxin inhibitor which is expected to enter a planned phase 2 clinical study in patients with idiopathic pulmonary fibrosis." About Biotech Acquisition Company Biotech Acquisition Company raised $230 million in its initial public offering in January 2021. BAC's Class A ordinary shares and warrants trade on the Nasdaq Capital Market under the symbols "BIOT" and "BIOTW," respectively. BAC is a blank check company, incorporated as a Cayman Islands exempted company, formed for the purpose of effecting a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or other similar business combination with one or more businesses. BAC believes that a business combination with a company focused on the healthcare sector will complement the background and expertise of SPRIM Global Investments, a global investment firm in the life sciences and healthcare industries, which is an affiliate of BAC and of several members of BAC's management team. BAC is led by Dr. Michael Shleifer, its CEO and chairman. About Blade Therapeutics Blade Therapeutics, Inc. is a biopharmaceutical company focused on developing cutting-edge treatments for debilitating, incurable fibrotic and neurodegenerative diseases that impact millions of people worldwide. The company has deep expertise in novel biological pathways – including autotaxin / LPA and calpain biology – that are foundational to cell- and tissue-damage responses associated with fibrotic and neurodegenerative diseases. Blade expects to advance a differentiated pipeline of oral, small-molecule therapies that include a non-competitive autotaxin inhibitor and inhibitors of dimeric calpains designed for the potential treatment of lung, liver and cardiac fibrosis or neurodegenerative diseases. The company's focused approach offers the potential to produce disease-modifying, life-saving therapies. Visit for more information and follow Blade on LinkedIn. Special Note Regarding Forward-Looking Statements Certain statements included in this press release that are not historical facts but rather are forward-looking statements. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other performance metrics and projections of market opportunity. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of BAC's and Blade's respective management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of BAC and Blade. Some important factors that could cause actual results to differ materially from those in any forward-looking statements could include changes in domestic and foreign business, market, financial, political and legal conditions. These forward-looking statements are subject to a number of risks and uncertainties, including, BAC's or Blade's ability to execute its respective business plans and strategy; the ability to protect and enhance Blade's respective corporate reputation and brand; the impact from future regulatory, judicial, and legislative changes in Blade's industry; the timing, costs, conduct, and outcome of clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for product candidates; whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; the potential market size and the size of the patient populations for product candidates, if approved for commercial use, and the market opportunities for product candidates; the ability to locate and acquire complementary products or product candidates and integrate those into Blade's business; and, the uncertain effects of the COVID-19 pandemic; and those factors set forth in documents of BAC or to be with SEC. The foregoing list of risks is not exhaustive. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither BAC nor Blade presently know or that BAC and Blade currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect BAC's and Blade's current expectations, plans and forecasts of future events and views as of the date of this press release. BAC and Blade anticipate that subsequent events and developments will cause BAC's and Blade's assessments to change. However, while BAC and Blade may elect to update these forward-looking statements at some point in the future, BAC and Blade specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing BAC's or Blade's assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Company Codes: NASDAQ-NMS:BIOT

IPO并购

100 项与 Cudetaxestat 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床2期	-	Blade Therapeutics, Inc.	2022-05-31
慢性肝病	临床1期	澳大利亚	Blade Therapeutics, Inc.	2020-01-10
非酒精性脂肪性肝炎	临床1期	澳大利亚	Blade Therapeutics, Inc.	2020-01-10

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2022	N/A	-	-	Cudetaxestat oral solution	鹹齋憲蓋憲鑰淵築鹹選(積淵夢蓋選獵簾鏇窪構) = only transient, mild, gastrointestinal (GI) treatment emergent adverse events (TEAE) occurred with cudetaxestat oral solution, and no GI TEAE with cudetaxestat oral tablet 鬱醖簾鏇鹹顧積網積積 (壓鬱鹽觸鬱窪繭範衊壓 ) 更多	-	2022-05-15
				Cudetaxestat oral tablet
NCT04814498 (Corporate Publications) 人工标引	临床1期	特发性肺纤维化	-	Cudetaxestat	蓋範簾夢糧積夢顧餘憲(鏇觸鏇鑰製鹽鏇鬱蓋構) = subjects demonstrated no alteration of plasma levels of substrates for cytochromes 3A4, 2B6, 1A2, and 2C9. 觸範膚夢遞鏇艱膚選廠 (觸獵範積醖積餘範範窪 )	积极	2021-11-30
				CYP450 enzymes cocktail+Cudetaxestat