A Window of Opportunity Trial Evaluating the Oral TGF-beta Receptor I Inhibitor Vactosertib in Patients Undergoing Standard of Care Chemoradiotherapy for Locally Advanced Esophageal Adenocarcinoma

This interventional clinical trial aims to find ways of improving treatments for individuals with esophageal cancer. Laboratory-based studies show that using medicines that affect a protein called TGF-beta (TGFβ) can kill esophageal cancer cells in individuals who have localized esophageal adenocarcinoma and are being considered for standard-of-care chemoradiation prior to surgery. Participants of this study will take a pill called vactosertib for two weeks before starting standard of care chemoradiation. At the end of the two weeks of taking vactosertib, participants will have a Positron Emission Tomography Computer Assisted Tomography (PET CT) scan and undergo an endoscopy with a biopsy to determine if the vactosertib is working. After chemoradiation, participants will take vactosertib again for four weeks and then be considered for surgery.

开始日期2024-09-30

申办/合作机构

The Case Comprehensive Cancer Center

NCT05588648

/ Recruiting临床1/2期

A Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib as a Single Agent in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma

MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 14 years of age and older who meet the criteria for study enrollment.

开始日期2023-03-31

申办/合作机构

MedPacto, Inc.

KCT0007745

/ Not yet recruiting临床2期IIT

A phase II multicenter study to assess the antitumor activity of vactosertib in combination with pembrolizumab in acral and mucosal melanoma patients progressed from prior immune check point inhibitor)

开始日期2022-10-03

申办/合作机构

Yonsei University Severance Hospital

100 项与 Vactosertib 相关的临床结果

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100 项与 Vactosertib 相关的转化医学

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100 项与 Vactosertib 相关的专利（医药）

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项与 Vactosertib 相关的文献（医药）

2025-01-01·Neurology Research International

Inhibition of the Transforming Growth Factor‐β Signaling Pathway Confers Neuroprotective Effects on Beta‐Amyloid‐Induced Direct Neurotoxicity and Microglia‐Mediated Neuroinflammation

Article

作者: Thang, Zi Qing ; Tiong, Shao Qin ; Mohgan, Raxshanaa N ; Liew, Jennifer Yue Suan ; Quek, Jia Yee ; Chan, Zhi Ling ; Wong, Grace Yee Seen ; Gan, Sook Yee ; Chan, Elaine Wan Ling

Background: Abnormal elevation of transforming growth factor‐beta (TGF‐β) has been observed among Alzheimer’s disease (AD) patients. This may be due to microglia‐mediated release of proinflammatory cytokines, which promote neuroinflammation and neuronal apoptosis. Silencing of TGFBR1, a gene encoding TGF‐β receptor type I (TGF‐βR1), has resulted in neuronal survival from amyloid‐beta (Aβ)‐induced neurotoxicity. Therefore, the present study investigated the neuroprotective effect of TGF‐βR1 inhibitors (RepSox, Galunisertib, and Vactosertib) against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation.Methods: The neuroprotective effect of TGF‐βR1 inhibitors against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation were investigated using the RealTime‐Glo™ MT Cell Viability Assay. The inhibitory effect of TGF‐βR1 inhibitors on Aβ‐induced microglia‐mediated production of proinflammatory cytokines (TNF‐α and IL‐1β) was determined using enzyme‐linked immunosorbent assay (ELISA).Results: TGF‐βR1 inhibitors (RepSox, Galunisertib, and Vactosertib) at the tested concentrations (6.25–150 nM) showed no significant cytotoxicity effects on SH‐SY5Y and BV‐2 cells. Moreover, treatments with these inhibitors exhibited neuroprotection on SH‐SY5Y cells against Aβ‐induced direct neurotoxicity. The trend of cell viability after 24 h treatment also supports the microscopic images of the cells’ morphology. Furthermore, pretreatment with these inhibitors conferred indirect neuroprotective effect against Aβ‐induced microglia‐mediated neuroinflammation by attenuating the production of proinflammatory cytokines (TNF‐α and IL‐1β).Conclusion: The inhibition of the TGF‐β signaling pathway in neuronal and microglia cells by TGF‐βR1 inhibitors resulted in neuroprotection against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation. Hence, targeting the TGF‐β signaling pathway in both neuronal and microglia cells could provide a promising therapeutic strategy in AD.

2025-01-01·Small

Harnessing the Engineered Probiotic‐Nanosystem to Remodulate Tumor Extracellular Matrix and Regulate Tumor‐Colonizing Bacteria for Improving Pancreatic Cancer Chemo‐Immunotherapy

Article

作者: Wang, Jia‐Wei ; Meng, Ran ; Chen, Wei‐Hai ; Song, Wen‐Fang ; Lin, Yan‐Tong ; Deng, Xin‐Chen ; Zhang, Xian‐Zheng ; Yao, Wei‐Qin

Abstract:

Poor chemotherapy efficacy in pancreatic cancer is attributed to limited drug permeation caused by the dense extracellular matrix (ECM) and drug degradation induced by tumor‐colonizing bacteria. Here, a tumor‐targeting probiotic‐nanosystem is elaborately designed to remodulate ECM and selectively regulate tumor‐colonizing bacteria for improving chemo‐immunotherapy against pancreatic cancer. Specifically, drug‐loaded liposomes are conjugated with Clostridium Butyricum (CB) via matrix metalloproteinase‐2 (MMP‐2)‐responsive peptide to construct a probiotic‐nanosystem. Particularly, vactosertib (VAC, a transforming growth factor‐β1 receptor inhibitor) is delivered by probiotic‐nanosystem to silence the active pancreatic stellate cells (PSCs) for inhibiting the development of ECM, resulting in a loosened ECM and providing a golden opportunity for the deep penetration of chemotherapy drugs and immune cells. Subsequently, gemcitabine (GEM) is efficiently delivered into the core of tumors via probiotic‐nanosystem, achieving an enhanced chemotherapy efficacy. Noteworthily, CB can alleviate γ‐proteobacteria‐mediated GEM degradation through competitively reducing the contents of γ‐proteobacteria and promoting the amounts of tumor‐inhibiting bacteria, thereby significantly potentiating the therapeutic effect of GEM. The engineered probiotic‐nanosystem can not only enhance the GEM‐induced immunogenic cell death (ICD) of a pancreatic tumor to activate antitumor immune responses but also markedly increase the tumor‐infiltration of effector immune cells to heighten tumoricidal immunity, offering a promising strategy for chemo‐immunotherapy of pancreatic cancer.

2024-12-01·JOURNAL OF CONTROLLED RELEASE

Surface-engineered mesenchymal stem cell for refractory asthma therapy: Reversing airway remodeling

Article

作者: Zhao, Yu-Chen ; Han, Meng-Meng ; Wang, Guang-Ji ; Jeong, Jee-Heon ; Wang, Jing ; Tang, Ling ; He, Xing-Yue ; Jiang, Hu-Lin ; Xing, Lei ; Wang, Yi ; Wei, Ning ; Zhou, Fang

In the development of asthma, subepithelial fibrosis and vascular proliferation cause airway remodeling and narrowing, leading to disease deterioration and respiratory failure. In the clinic, the treatment of asthma was aimed at reducing the frequency of acute asthma attacks through inhaled corticosteroids (ICSs). However, ICSs cannot prevent the progression into refractory asthma due to the formation of airway remodeling mainly by subepithelial fibrosis and angiogenesis surrounding the tracheal lumen. Herein, we constructed surface-engineered mesenchymal stem cells (MSCs/PVLA) via the bioconjugation of MSCs and reactive oxygen species-responsive polymeric micelles loaded with vactosertib (VST) and linifanib (LFN) for treating refractory asthma through reversing airway remodeling. MSCs/PVLA migrated to the tracheal lumen due to the inflammation tropism of MSCs, and subsequently released VST and LFN could inhibit the formation of airway remodeling by preventing subepithelial fibrosis and angiogenesis. Meanwhile, MSCs reduced inflammatory cell infiltration and cytokine secretion to regulate the pathological microenvironment. Our results suggested that MSCs/PVLA could serve as a promising candidate to prevent disease exacerbations and treat refractory asthma.

项与 Vactosertib 相关的新闻（医药）

2024-11-09

·药渡

肿瘤微环境中的免疫抑制性细胞因子

来源：小药说药前言癌细胞表观遗传学和生长动力学的改变导致细胞外分泌多种细胞因子，这些细胞因子控制免疫细胞的活性，使其有利于肿瘤生长。其中，免疫调节细胞因子的分泌是招募免疫抑制细胞的主要因素。肿瘤微环境中的免疫调节细胞因子招募其他免疫抑制细胞，并负责效应免疫细胞的表型和功能转换，使其支持肿瘤的发展。表型转换的免疫细胞进一步提高免疫抑制细胞因子的水平，并使肿瘤环境抵抗抗肿瘤免疫细胞的活性。其中MDSCs、TAMs、Treg和Breg细胞是调节性细胞因子的主要来源。在广泛的免疫抑制细胞因子中，IL-10、TGF-β、IL-4和IL-35在多种癌症的肿瘤环境中占主导地位，主要负责免疫抑制。这些细胞因子改变先天性和适应性免疫细胞的命运，并调节癌细胞的生长和增殖能力。同时，免疫抑制细胞因子也改变了幼稚免疫细胞的表观基因组和转录网络，有利于免疫抑制细胞谱系的形成。此外，这些细胞因子可以直接作用于细胞毒性CD8+T细胞或自然杀伤（NK）细胞，并抑制其效应器功能和增殖。 IL-10 IL-10是一种多功能的免疫抑制细胞因子，具有免疫调节和血管生成功能。IL-10由癌细胞和几种免疫细胞分泌，包括髓系和淋巴细胞。已有证据表明IL-10具有促进肿瘤和抑制肿瘤的双重功能。一方面，IL-10通过下调癌细胞和APC上的MHC表达来抑制细胞毒性T细胞活化，从而阻止抗原特异性T细胞识别癌细胞。另一方面，高剂量的IL-10可增强CD8+T细胞的增殖及其细胞毒性活性。某些炎性细胞因子和条件可能会促进组织损伤和肿瘤发生，IL-10可以抑制这些炎症状态，从而防止随后的肿瘤发生。最近的研究表明，基于西妥昔单抗的IL-10融合蛋白（CmAb-IL10）通过阻止树突状细胞介导的肿瘤浸润性CD8+T细胞凋亡，显示出强大的抗肿瘤作用。CmAb-IL10与免疫检查点阻断剂的联合应用显示，晚期肿瘤小鼠的抗肿瘤免疫力得到明显改善。因此，有必要根据具体癌症类型和患者亚群的具体情况，通过抑制或促进IL-10通路来评估潜在的治疗干预。 TGF-β TGF-β作为一种免疫抑制细胞因子，通过不同的机制对免疫应答产生广泛的抑制作用。TGF-β降低Th1、Th2细胞和细胞毒性T淋巴细胞（CTL）的分化和功能，所有这些都提供重要的抗肿瘤反应。此外，TGF-β还通过调节Treg细胞的数量和功能，增强免疫耐受和肿瘤逃避。TGF-β通过抑制或刺激细胞增殖来调节免疫细胞的命运，从而影响胸腺和外周T细胞的发育。 TGF-β在TME中起着双重作用，这是由于肿瘤发展的不同阶段和基因改变背景决定的。在早期肿瘤中，TGF-β途径可诱导细胞凋亡并抑制包括癌细胞在内的细胞增殖。矛盾的是，在晚期，它通过调节基因组不稳定性、EMT、新生血管生成、免疫逃避和转移，具有促肿瘤作用。当促肿瘤功能压倒细胞中TGF-β信号的抗肿瘤作用时，它将以一致的方式作为肿瘤促进剂发挥作用。尽管有许多因素增加了TGF-β信号转导的复杂性，但在肿瘤治疗中TGF-β信号靶向药物显示出了强大的活性。这些特异性或非特异性药物包括靶向TGF-β受体的小分子、反义寡核苷酸、疫苗、中和抗体以及受体IgG-Fc融合蛋白。 Galunsertib（LY2157299）是第一个进入临床试验的小分子阻断剂，它抑制TGF-βRI激酶。在一项1/2期临床试验中，与安慰剂吉西他滨相比，Galunisertib联合吉西他滨治疗PAC患者的OS明显改善。TEW-7197是另一种TGF-βRI激酶抑制剂。 GC-1008（fresolimumab）是一种能中和TGF-β所有亚型的人源单克隆抗体。M7824（Bintrafusp-alfa）是一种由抗PD-L1的抗体和TGF-βRII分子的胞外段组成的双功能分子，可以“捕获”在TME中的TGF-β。ABBV-151影响TGF-β主动释放的复杂过程是另一种治疗干预手段。抗GARP抗体ABBV-151阻断其与LAP的结合显著减缓乳腺癌细胞系的肺转移。 Belagenpumatucel-L（Lucanix）是一种治疗性、基因修饰的异基因肿瘤细胞疫苗，用于NSCLC，抑制TGF-β2 mRNA的产生。虽然针对NSCLC的3期试验没有达到预定的临床终点，但额外的分析表明在患者亚群中取得了令人鼓舞的结果，在一线化疗结束后12周内随机使用Lucanix治疗的患者中，观察到OS的显著增加。Trabedersen（ap12009）是TGF-β2基因mRNA区域的反义互补物，通过下调TGF-β2 mRNA发挥抑制作用。在一项2期研究中，与标准化疗治疗相比，使用10 mM trabedersen治疗的复发/难治性晚期胶质瘤患者的2年生存率更高。 IL-4 IL-4主要作用于Th2细胞的谱系特异性分化和体液免疫反应的调节。除嗜碱性粒细胞和肥大细胞外，IL-4主要由Th2细胞通过自分泌信号分泌。IL-4在肿瘤微环境中发挥着多种作用，并具有免疫抑制和抗肿瘤活性。研究表明，在结肠癌和乳腺癌小鼠模型中，阻断IL-4可减少特定肿瘤微环境中免疫抑制M2表型和MDSCs的生成，并改善肿瘤特异性CD8+T细胞反应。此外，阻断IL-4可提高抗OX40免疫治疗的反应性。在非小细胞肺癌小鼠模型中进行的类似研究表明，阻断IL-4可通过肿瘤抗原特异性树突状细胞增加IL-12的生成，从而增强效应T细胞的浸润和增殖，并减轻肿瘤负担。此外，在间变性甲状腺癌（ATC）小鼠模型中，IL-4的缺失可增强抗肿瘤免疫和总体存活率，且无任何明显毒性。研究表明，IL-4是一个新的治疗靶点，阻断可以减少肿瘤诱导的免疫抑制，提高传统癌症治疗的疗效。因此，与其他免疫抑制性细胞因子类似，IL-4是肿瘤发生和转移的关键调节因子，可能单独或与当前有效治疗癌症患者的治疗方案相结合，是一个有吸引力的免疫治疗靶点。 IL-35 与IL-10、TGF-β和IL-4相比，IL-35是一种异二聚体且相对较新发现的细胞因子，属于IL-12家族细胞因子，由p35和EBi3亚单位组成。IL-35已被证明在良性和恶性肿瘤的发展中发挥重要作用，包括肝细胞癌、晚期乳腺癌、胰腺导管腺癌、非小细胞肺癌和前列腺癌。此前，已有研究证明IL-35主要由Tregs产生，近年来，肿瘤细胞中IL-35的表达逐渐得到证实。在体内，IL-35通过增强其他细胞因子的分泌，如IL-6和G-CSF（粒细胞集落刺激因子），促进肿瘤生长、进展和转移。IL-35还抑制多种细胞因子，包括IFN-γ，以实现促肿瘤效应。积累的数据表明，IL-35可以参与TME中恶性肿瘤细胞与周围免疫细胞之间的相互作用，诱导免疫抑制环境并限制有效抗肿瘤免疫反应的参与。随着多种IL-35+免疫细胞类型如M1 TAM和DC的发现和分离，目前的证据表明，肿瘤源性IL-35广泛参与不同细胞环境的促肿瘤特性，可能是通过抑制肿瘤浸润淋巴细胞（TIL）浸润和效应细胞增殖。总的来说，恶性肿瘤细胞以及周围基质细胞产生的IL-35有助于肿瘤微环境内的免疫抑制，从而支持肿瘤的持续生长和转移小结细胞因子在决定肿瘤发生命运的肿瘤免疫微环境中起着至关重要的作用。这些免疫抑制细胞因子限制抗肿瘤免疫细胞的增殖和效应功能，改变其可塑性，并将其转化为抑制表型。由于受限制的渗透或缺乏效应免疫细胞，导致免疫检查点抑制剂无法发挥最佳效果。因此，靶向或消耗这些细胞因子具有显著的临床益处。几种细胞因子在肿瘤发生中发挥免疫抑制作用，具体取决于肿瘤类型和肿瘤免疫环境。最近的多项研究显示，IL-10、TGF-β、IL-4和IL-35，这些细胞因子在限制抗肿瘤免疫和肿瘤生长进展中发挥重要作用。阻断IL-10、TGF-β、IL-4和IL-35等免疫抑制性细胞因子可能在使肿瘤对常规和免疫疗法敏感方面发挥显著的效果，从而激活抗肿瘤免疫，并控制肿瘤发生。参考文献： 1.Tumorpromoting roles of IL-10, TGF-β, IL-4, and IL-35: Its implications in cancerimmunotherapy. SAGE Open Med. 2022; 10: 20503121211069012. 2. Roles ofTGF-β signaling pathway in tumor microenvirionment andcancer therapy. Int Immunopharmacol. 2020 Oct 21;89(Pt B):107101. 3. IL-35 Regulatesthe Function of Immune Cells in Tumor Microenvironment. Front Immunol. 2021;12: 683332. 药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

免疫疗法

2024-07-14

·药明康德

令过半患者肿瘤完全消失的突破性细胞疗法；12周减重超13%的口服减肥疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 治疗对CD19靶向CAR-T细胞疗法耐药的大B细胞淋巴瘤（LBCL）患者的CD22靶向CAR-T细胞疗法firi-cel公布积极1期临床试验数据，过半患者肿瘤完全消失。 2. 口服GLP-1和胰淀素的长效共激动剂amycretin在一项1期临床试验中使肥胖患者在用药12周后减重超过13.1%。 3. 治疗帕金森病的细胞疗法TED-A9在一项早期临床试验中使3名患者的运动能力获得显著改善。药明康德内容团队整理 Firicabtagene autoleucel（firi-cel）：公布1期临床试验数据 CARGO Therapeutics公司宣布，《柳叶刀》杂志发表了斯坦福大学医学院进行的一项单中心1期临床研究的积极数据，该研究评估了CARGO公司的CD22靶向CAR-T细胞疗法firicabtagene autoleucel（firi-cel）治疗对CD19靶向CAR-T细胞疗法耐药的大B细胞淋巴瘤患者。这款CAR-T疗法是由患者自体T细胞经慢病毒载体（m971-BBZ）转导而制造出来的，目前CARGO Therapeutics拥有它的研发权利。发布于《柳叶刀》的临床数据截至2023年5月22日，在中位随访时间23.3个月期间，所有接受治疗患者的总缓解率（ORR）和完全缓解（CR）率分别为68%和53%。CARGO在今年5月的欧洲血液学协会（EHA）大会上公布了该试验的更新数据。截至2024年2月1日，在中位随访31.4个月期间，所有接受治疗患者的ORR和CR率仍分别为68%和53%。其中，29例接受剂量水平1（DL1）治疗的患者在中位随访29.8个月时的中位总生存期（mOS）为25.7个月（95% CI：9.2-NE），预估的2年生存率为52%。对于达到CR的患者，其中位无进展生存期（PFS）、缓解持续时间和总生存期尚未达到。自2023年11月的最后一次数据截止以来，20名达到CR的患者中没有观察到新的复发。此外，在DL1中持续没有观察到3级或更高级别的细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性综合征（ICANS）的发生。新闻稿指出，美国FDA在检视试验初步数据后罕见地主动联系斯坦福医学中心，敦促其为该疗法申请突破性疗法认定（BTD）。 Amycretin：公布1期临床试验的新数据诺和诺德（Novo Nordisk）公布了其口服GLP-1和胰淀素的长效共激动剂amycretin的详细1期临床试验结果。分析显示，试验12周时，接受最高剂量amycretin的受试者的体重降幅高达13.1%，且受试者的体重下降尚未达到平台期。根据此积极结果，诺和诺德将对amycretin进行进一步开发。 ▲Amycretin在1期试验中的减重效果（图片来源：参考资料[6]）行业媒体Fierce Biotech在过去的报道中指出，已过STEP-1临床试验结果显示司美格鲁肽组患者在68周试验期间的体重降幅为14.9%。虽然不同临床试验之间的结果难以一同比较，但amycretin在1期试验早期结果中所展现的快速减重效果，体现了该药物的巨大潜力。目前诺和诺德正在计划进行更大规模和更长时间的研究以全面评估amycretin的疗效和安全性，其中，旨在评估该疗法皮下注射剂型的2期试验正在进行患者招募。 TED-A9：公布1/2a期临床试验数据 S.BIOMEDICS公司宣布了其细胞疗法TED-A9在治疗帕金森病的1/2期临床试验中的首批3名受试者的1年随访数据。TED-A9是一款通过对人类胚胎干细胞（hESC）进行小分子化合物处理而生成的高度纯化中脑多巴胺能祖细胞。此次公布的3名接受低剂量TED-A9治疗的患者的数据表明了TED-A9的安全性和有效性。患者在细胞植入一年后进行的核磁共振成像（MRI）和CT扫描显示，细胞移植或手术均未出现相关的不良反应；多巴胺转运蛋白（DAT）脑成像（FP-CIT-PET）显示多巴胺转运蛋白水平增加，意味着多巴胺神经元可能已定植并与患者的帕金森病症状改善相关；客观测量运动功能的MDS-帕金森病统一评定量表（MDS-UPDRS）第III部分评估显示，平均得分从基线的61.7分下降到一年后治疗后的49.0分，改善了12.7分，显示患者的运动能力得到了显著的改善。 INT2104：获得澳大利亚人类研究伦理委员会批准启动1期临床试验 Interius BioTherapeutics公司宣布，已获得澳大利亚治疗用品管理局（TGA）的人类研究伦理委员会（HREC）批准和临床试验通知（CTN）许可，以进行其在研体内CAR-T疗法INT2104的临床1期试验，用以治疗B细胞恶性肿瘤。INT2104是一种在研慢病毒载体基因疗法，设计靶向CD7阳性的T细胞和NK细胞，并传递CAR转基因，以在体内生成效应CAR-T和CAR-NK细胞。这些CAR细胞靶向CD20阳性B细胞，用于治疗B细胞恶性肿瘤。与体外CAR-T疗法不同，INT2104是一种现货型的单剂量疗法，可通过静脉输注系统性给药，患者无需进行淋巴清除，治疗时不需要任何特殊设备或人员培训。该疗法在临床前实验中展现出积极的抗肿瘤作用。在系统性淋巴瘤小鼠模型中，单次静脉输注广泛剂量范围的INT2104可实现肿瘤完全消除。在未进行化疗预处理的非人灵长类动物中，单次载体输注后观察到显著的B细胞耗竭且没有观察到药物毒性，其中一只动物的B细胞耗竭效果已持续超过6个月。Interius计划在2024年第四季度开始试验，并有望在2025年第一季度实现关键里程碑。根据行业媒体STAT报道，INT2104是首个进入人体临床试验的体内CAR-T疗法。 Rebonuputemcel：公布1/2期临床试验数据 DiscGenics公司宣布在International Journal of Spine Surgery杂志上发表了同种异体椎间盘祖细胞疗法（IDCT）rebonuputemcel治疗疼痛性腰椎退行性椎间盘疾病（DDD）的1/2期联合临床研究的结果。IDCT是一种独立的单次注射生物疗法，旨在阻止有症状的腰椎间盘退行性病变的进展，并使椎间盘由内而外再生。IDCT中的活性成分是从捐赠的成人椎间盘组织中提取的活的祖细胞群。这些细胞经过多步骤的富集和扩增，导致细胞显著增殖和表型变化。随后，这些椎间盘源细胞会与粘性透明质酸钠溶液和辅料混合，成为最终的现货型细胞疗法IDCT。IDCT需要冷冻保存，可在门诊环境下经皮注射到椎间盘中使用。IDCT已获得美国FDA的再生医学先进疗法（RMAT）认定和快速通道资格。此次公布的结果显示，该研究达到了主要的安全性和有效性终点，单次椎间盘内注射高剂量IDCT可安全地增加椎间盘体积，并在腰椎间盘退行性病变患者注射后的2年内对患者的背痛、残疾和生活质量产生具有统计学意义和临床意义的改善。安全性方面，少数患者（18.3%）报告了严重不良事件，其中最高比例的报告来自安慰剂组。 AMT-130：公布1/2期临床试验的新数据 uniQure公司宣布其通过大脑直接注射的在研基因疗法AMT-130在治疗亨廷顿病（HD）的1/2期临床试验中获得积极中期结果。uniQure同时宣布AMT-130获得针对HD的首个RMAT认定。AMT-130是uniQure首个聚焦中枢神经系统的基因疗法，由AAV5载体携带专门沉默亨廷顿（HTT）基因表达的微RNA（microRNA），利用该公司专有的miQURE沉默技术，抑制突变亨廷顿蛋白的产生。在这项试验中，研究人员利用MRI成像引导，将基因疗法直接注射到大脑的壳核和尾状核中。此次公布的结果显示，在24个月时，接受高剂量AMT-130治疗的HD患者的疾病进展减缓达80%，且其脑脊液（CSF）中的神经丝蛋白轻链（NfL）水平显著低于基线水平。此外，与基线相比，在24个月的随访中，接受高剂量AMT-130治疗患者的运动和认知功能测量结果几乎保持稳定。根据迄今为止的数据，AMT-130在两种剂量下均显示出良好的耐受性和安全性。没有报告新的与AMT-130相关的严重不良事件。 SKY-0515：公布1期临床试验数据 Skyhawk Therapeutics公司公布了SKY-0515在1期临床试验A部分和B部分中的积极结果。SKY-0515正被开发为亨廷顿氏病的潜在治疗药物。SKY-0515是Skyhawk公司通过其新型RNA剪接平台开发的在研小分子RNA剪接修饰剂，旨在减少HTT蛋白和PMS1蛋白。PMS1蛋白是体细胞CAG重复扩增和HD病理学的一个关键驱动因素。 ▲多剂量递增研究的结果（图片来源：参考资料[9]）此次公布的结果显示，SKY-0515在健康受试者中显示出剂量依赖性的HTT mRNA降低，在多剂量递增研究中，最高剂量组的降低幅度为72%。SKY-0515在所有测试剂量下的耐受性均良好，鉴于这些积极的初步结果，该公司计划在2024年第三季度在患者组中进行剂量测试，并计划在明年年初启动2期研究。 STP122G：公布1期临床试验的中期数据圣诺制药（Sirnaomics）宣布在研RNAi疗法STP122G用于抗凝治疗的1期临床试验的第二患者队列圆满完成，并公布了中期数据。STP122G为第三代靶向凝血因子XI的抗凝血药物，适用于先前治疗不能完全防止出血情况的凝血障碍患者。因子XI是一种主要由肝脏内的肝细胞所产生的酶，其在人体凝血过程中发挥着重要作用。作为一种基于圣诺制药的GalAhead mxRNA递送平台的候选RNAi疗法，STP122G以肝细胞为靶点，抑制因子XI的产生，具有长期疗效及较小的出血风险。该临床试验的第二患者队列组由8名健康受试者组成。受试者通过皮下注射完成了50毫克剂量的注射，并接受了140天的随访。安全数据显示，没有发现剂量限制性毒性或严重不良事件，同时观察到了与剂量相关的靶点沉默活性。故此本次临床研究将推进至下一队列剂量组。 Danuglipron：公布1期临床试验数据辉瑞（Pfizer）宣布，基于进行中1期试验的药代动力学研究结果，公司已选择推进每日一次改良释放剂型danuglipron的临床开发用于治疗肥胖患者。Danuglipron（PF-06882961）是一款小分子口服胰高血糖素样肽-1（GLP-1）受体激动剂，与大分子GLP-1类似物不同的是，它们可通过更为简便的口服方式使用，并且不受食物或者服用时间的限制。此次公布的研究结果显示支持每日一次给药的药代动力学特征，其安全性与之前的danuglipron研究一致，在超过1400名研究受试者中未观察到肝酶升高。辉瑞计划在2024年下半年进行剂量优化研究，评估多种改良释放剂型的剂量，以为注册性试验提供信息。 RGT-61159：IND申请获得FDA许可 Rgenta Therapeutics公司宣布，其口服小分子RNA调节剂RGT-61159的IND申请获得FDA批准，可开展1a/1b期临床试验。RGT-61159旨在特异性调节转录因子MYB的RNA剪接，从而抑制致癌MYB蛋白的产生。RGT-61159有潜力抑制MYB蛋白过度表达的癌细胞的增殖或诱导细胞死亡。MYB是细胞增殖分化过程的主调节因子，它的异常表达已在多种人类癌症中得到证实，包括腺样囊性癌（ACC）、急性髓性白血病（AML）、T细胞急性淋巴细胞白血病（T-ALL）、结直肠癌（CRC）、小细胞肺癌（SCLC）和乳腺癌。RGT-61159正在开发用于治疗ACC、CRC和其他实体瘤，以及AML。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease. Retrieved July 9, 2024, from https://www.globenewswire.com/news-release/2024/07/09/2910220/0/en/uniQure-Announces-Positive-Interim-Data-Update-Demonstrating-Slowing-of-Disease-Progression-in-Phase-I-II-Trials-of-AMT-130-for-Huntington-s-Disease.html [2] Interius BioTherapeutics Receives HREC Approval and CTN Clearance from the TGA to Commence a Phase 1 Clinical Trial for Its First-in-Class In Vivo CAR Therapeutic for B Cell Malignancies. Retrieved July 9, 2024, from https://interiusbio.com/2024/07/interius-biotherapeutics-receives-hrec-approval-and-ctn-clearance-from-the-tga-to-commence-a-phase-1-clinical-trial-for-its-first-in-class-in-vivo-car-therapeutic-for-b-cell-malignancies-will-initiate/ [3] Sirnaomics宣布基于GalNAc RNAi疗法药物STP122G用于抗凝治疗的I期临床试验第二序列圆满完成并公布了中期数据. Retrieved July 8, 2024, from https://www.prnasia.com/story/453316-1.shtml [4] S.BIOMEDICS Dopamine Cell Therapy for Parkinson’s Disease with TED-A9 Shows Promising Results at 12 months in Phase I/IIa Clinical Trial. Retrieved July 9, 2024, from https://www.businesswire.com/news/home/20240709317387/en [5] CARGO Therapeutics Announces Phase 1 Clinical Study of Firi-cel CAR T-Cell Therapy Published in The Lancet. Retrieved July 11, 2024, from https://investors.cargo-tx.com/news-releases/news-release-details/cargo-therapeutics-announces-phase-1-clinical-study-firi-cel-car [6] Safety, tolerability and weight reduction findings of oral amycretin: a novel amylin and glucagon-like peptide-1 receptor co-agonist, in a first-in-human study. Retrieved July 8, 2024 from https://cattendee.abstractsonline.com/meeting/20620/presentation/846 [7] Pfizer Advances Development of Once-Daily Formulation of Oral GLP-1 Receptor Agonist Danuglipron. Retrieved July 11, 2024, from https://www.businesswire.com/news/home/20240710971928/en/Pfizer-Advances-Development-of-Once-Daily-Formulation-of-Oral-GLP-1-Receptor-Agonist-Danuglipron [8] DiscGenics Announces the International Journal of Spine Surgery Has Published Results from an FDA-Approved Study of an Allogeneic Disc Progenitor Cell Therapy for the Treatment of Adults with Lumbar Disc Degeneration. Retrieved July 11, 2024, from https://www.prnewswire.com/news-releases/discgenics-announces-the-international-journal-of-spine-surgery-has-published-results-from-an-fda-approved-study-of-an-allogeneic-disc-progenitor-cell-therapy-for-the-treatment-of-adults-with-lumbar-disc-degeneration-302192071.html [9] Skyhawk Therapeutics Announces Positive Topline Results from Parts A and B of its Phase 1 Clinical Trial of SKY-0515 as a Treatment for Huntington’s Disease, Reaching 72% Huntingtin mRNA Reduction. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/10/2911098/0/en/Skyhawk-Therapeutics-Announces-Positive-Topline-Results-from-Parts-A-and-B-of-its-Phase-1-Clinical-Trial-of-SKY-0515-as-a-Treatment-for-Huntington-s-Disease-Reaching-72-Huntingtin-.html# [10] Spur Therapeutics Completes Enrollment in Phase 1/2 GALILEO-1 Trial of FLT201 in Gaucher Disease and Selects Dose for Planned Phase 3 Trial. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/08/2909533/0/en/Spur-Therapeutics-Completes-Enrollment-in-Phase-1-2-GALILEO-1-Trial-of-FLT201-in-Gaucher-Disease-and-Selects-Dose-for-Planned-Phase-3-Trial.html [11] MedPacto's vactosertib shows positive results in US osteosarcoma pre-clinical trial. Retrieved July 12, 2024, from https://www.koreabiomed.com/news/articleView.html?idxno=24495 [12] Immorna Biotherapeutics Receives U.S. FDA IND Clearance to Conduct Phase 1/2 Study of JCXH-211 IV as Monotherapy and in Combination with Checkpoint Inhibitor in Patients with Advanced Solid Tumors. Retrieved July 12, 2024, from https://www.prnewswire.com/news-releases/immorna-biotherapeutics-receives-us-fda-ind-clearance-to-conduct-phase-12-study-of-jcxh-211-iv-as-monotherapy-and-in-combination-with-checkpoint-inhibitor-in-patients-with-advanced-solid-tumors-302190627.html [13] Immix Biopharma Doses 1st Patient in U.S. AL Amyloidosis Trial with CAR-T NXC-201. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/08/2909719/0/en/Immix-Biopharma-Doses-1st-Patient-in-U-S-AL-Amyloidosis-Trial-with-CAR-T-NXC-201.html [14] Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer. Retrieved July 12, 2024, from https://www.businesswire.com/news/home/20240707808760/en/ [15] Abata Therapeutics Announces FDA Clearance of Investigational New Drug Application for Clinical Evaluation of ABA-101 in Progressive Multiple Sclerosis. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/09/2910147/0/en/Abata-Therapeutics-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-Clinical-Evaluation-of-ABA-101-in-Progressive-Multiple-Sclerosis.html [16] Gain Therapeutics Announces the Completion of Dosing in the Multiple Ascending Dose (MAD) of the Phase 1 Study of GT-02287, a Novel Small Molecule Therapy for Parkinson’s Disease. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/09/2910198/0/en/Gain-Therapeutics-Announces-the-Completion-of-Dosing-in-the-Multiple-Ascending-Dose-MAD-of-the-Phase-1-Study-of-GT-02287-a-Novel-Small-Molecule-Therapy-for-Parkinson-s-Disease.html [17] Monopar Announces First Patient Enrolled in First-in-Human Phase 1 Trial for Its Novel Radiopharmaceutical MNPR-101-Zr. Retrieved July 12, 2024, from https://www.globenewswire.com/news-release/2024/07/09/2910208/0/en/Monopar-Announces-First-Patient-Enrolled-in-First-in-Human-Phase-1-Trial-for-Its-Novel-Radiopharmaceutical-MNPR-101-Zr.html [18] Rgenta Therapeutics Announces FDA Clearance of IND Application for RGT-61159, an Oral Small Molecule RNA Modulator Designed to Halt Disease-Driver MYB Production in Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC). Retrieved July 12, 2024, from https://www.prnewswire.com/news-releases/rgenta-therapeutics-announces-fda-clearance-of-ind-application-for-rgt-61159-an-oral-small-molecule-rna-modulator-designed-to-halt-disease-driver-myb-production-in-adenoid-cystic-carcinoma-acc-and-colorectal-cancer-crc-302192676.html [19] Tr1X Announces First Patient Dosed in Proof of Concept GvHD Trial Evaluating TRX103, a First-in-Class Type 1 Treg (Tr1) Cell Therapy. Retrieved July 12, 2024, from https://pipelinereview.com/tr1x-announces-first-patient-dosed-in-proof-of-concept-gvhd-trial-evaluating-trx103-a-first-in-class-type-1-treg-tr1-cell-therapy/ 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

临床1期细胞疗法免疫疗法突破性疗法临床结果

2023-11-28

·PRNewswire

Navigating the Evolving Market Dynamics of Bone Sarcoma: A Comprehensive Analysis of Osteosarcoma, Ewing Sarcoma, and Chondrosarcoma | DelveInsight

Each individual's risk of being diagnosed with primary bone sarcoma and their chances of recovery following diagnosis are influenced by a range of unique factors. In 2023, it is anticipated that 4K individuals of all ages in the United States will be diagnosed with primary bone sarcoma, including 2K males and 1.8K females. In 2020, approximately 400 cases were reported among those aged 15 to 19. LAS VEGAS, Nov. 28, 2023 /PRNewswire/ -- Bone sarcoma is a rare and aggressive form of cancer that originates in the bone tissue. It poses significant challenges during its treatment due to several factors. Firstly, its rarity often leads to delayed diagnosis, as symptoms can mimic other common conditions. Additionally, bone sarcoma typically affects children and young adults, making the emotional toll of the disease particularly challenging. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, which can be physically demanding and cause severe side effects. Moreover, because bone sarcoma tends to occur in the extremities, treatment may require complex and lengthy surgical procedures, potentially affecting mobility and quality of life. Furthermore, the risk of recurrence remains a constant concern, necessitating long-term monitoring and follow-up care. Despite these challenges, ongoing research and advancements in medical technology offer hope for improved outcomes and a better quality of life for those battling bone sarcoma. DelveInsight has recently released a series of epidemiology-based market reports focusing on benign bone sarcoma including Osteosarcoma Market Report, Ewing Sarcoma Market Report, and Chondrosarcoma Market Report. These reports include a comprehensive understanding of current treatment practices, historical and forecasted patient pool, emerging drugs, market share of individual therapies, and historical and forecasted market size from 2019 to 2032 segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Additionally, the reports feature exhaustive analysis of prominent companies working with their emerging candidates in different stages of clinical development. Let's deep dive into the assessment of these bone sarcoma markets individually. Osteosarcoma Market Osteosarcoma is a rare bone tumor affecting having an annual incidence of 3.4 cases per million. It is the most prevalent form of bone cancer, primarily developed in the osteoblast cells of bones, with a predilection for long bones near the knee joint. However, it can also manifest in other locations, including the upper leg, lower leg, upper arm, and virtually any bone in the body, including those in the pelvis, shoulder, and skull. It has the potential to invade adjacent tissues, such as tendons and muscles, and can metastasize to distant organs or other bones via the bloodstream. As per DelveInsight analysts, the total incident population of osteosarcoma in the 7MM was ~2K in 2022. The estimates show the highest incident cases of osteosarcoma in the United States with ~1K cases in 2022, and it is expected to increase by 2032. Osteosarcoma is commonly treated through a combination of chemotherapy, surgery, and radiation therapy. Despite some recent developments, limited progress has been achieved since the late 1980s when chemotherapy was added to surgical treatment, leading to improved survival rates. Radiation therapy impacts both normal and cancerous cells, causing various effects. Chemotherapeutic drugs like cisplatin, doxorubicin, ifosfamide, and high-dose methotrexate with leucovorin calcium rescue (HDMTX) are widely used. Additionally, a few FDA-approved products, such as FUSILEV and KHAPZORY, are available for osteosarcoma treatment. As per DelveInsight analysis, the osteosarcoma market size is expected to increase at a significant CAGR by 2032. This growth would be fuelled by the increase in the patient pool and the expected entry of emerging therapies. Osteosarcoma Pipeline Therapies and Companies Lenvatinib: Eisai Naxitamab: Y-mAbs Therapeutics BAY80-6946: Bayer Vactosertib: MedPacto For a comprehensive view of the osteosarcoma market, check out the Osteosarcoma Market Assessment Ewing Sarcoma Market Ewing Sarcoma, a malignant tumor, typically initiates its growth within the bones, with a higher incidence among children and young adults, often manifesting during adolescence. Although it can originate in any bone, it predominantly affects the long bones, such as the thigh bone, shin bone, and upper arm bone. The pelvis bones are also frequently involved. In some cases, the tumor may originate in muscle and soft tissues. Common symptoms include bone stiffness, pain, swelling, or tenderness, along with tissue surrounding the affected bone. As per the assessment done by DelveInsight, the total incident cases of Ewing sarcoma in the 7MM comprised approximately 1.2K cases in 2022 and are projected to increase during the forecasted period. The management of Ewing sarcoma typically adopts a comprehensive approach, which may encompass surgery, chemotherapy, and radiation therapy. The National Comprehensive Cancer Network (NCCN) offers specific chemotherapy regimens for localized and metastatic Ewing sarcoma. For first-line treatment, NCCN suggests VDC/IE (vincristine, doxorubicin, and cyclophosphamide alternating with ifosfamide and etoposide), VAIA (vincristine, doxorubicin, ifosfamide, and dactinomycin), and VIDE (vincristine, ifosfamide, doxorubicin, and etoposide) for both initial presentations and as primary therapy for metastatic disease. In the second-line setting, NCCN recommends options like Cyclophosphamide and topotecan, Irinotecan + temozolomide ± Vincristine, Ifosfamide, carboplatin, etoposide, and Lurbinectedin. As per the latest Ewing Sarcoma Market Report, the total Ewing sarcoma market size in the 7MM is approximately USD 26 million in 2022 and is projected to increase during the forecast period (2023–2032). The expected introduction of upcoming therapies and the deepened integration of early patient screening, medication management in secondary care, and diverse clinical setups, ongoing research into optimal implementation approaches, and a surge in public awareness will ultimately pave the way for the advancement of efficient treatment choices. Ewing Sarcoma Pipeline Therapies and Companies SECLIDEMSTAT (SP-2577): Salarius Pharmaceuticals ZEPZELCA (LURBINECTEDIN): Jazz Pharmaceuticals and PharmaMar VERZENIO (ABEMACICLIB): Eli Lilly IBRANCE (PALBOCICLIB): Pfizer MECBOTAMAB VEDOTIN (BA3011): Bioatla IOPOFOSINE I 131 (CLR 131): Cellectar Biosciences TP-1287: Sumitomo Pharma Oncology NBRX-109: Inhibrx Explore in-depth for a comprehensive understanding of the Ewing Sarcoma Clinical Trials Chondrosarcoma Market Chondrosarcoma comprises a group of bone tumors originating from cells that overproduce cartilage. Among these tumors, conventional chondrosarcoma is the most frequent type and is generally associated with slow growth. Conversely, rarer subtypes like dedifferentiated chondrosarcoma, myxoid chondrosarcoma, clear cell chondrosarcoma, and mesenchymal chondrosarcoma tend to exhibit a more aggressive growth pattern and have the potential to spread to distant body parts. DelveInsight estimated that the total incident cases of chondrosarcoma in the 7MM comprised approximately 2K cases in 2022 and are projected to increase during the forecasted period. The management approach for chondrosarcoma is contingent upon factors like tumor type, grade, and location, with the grading system serving as the most reliable indicator of clinical prognosis. It is firmly established that surgical intervention remains the gold standard and sole effective treatment for chondrosarcoma, as alternative modalities such as radiotherapy and chemotherapy exhibit limited responsiveness and resistance. Surgical options encompass curettage, radical resection, and amputation, each necessitating comprehensive clinical judgment and contingent upon variables such as lesion size, location, and malignant characteristics. Anticipated advancements in upcoming therapies and increased integration of early patient screening and medication within secondary care and other clinical settings, along with ongoing research to determine the best implementation methods, are expected to contribute to the development of more effective treatment options. However, chondrosarcoma, being an orphan disease, presents challenges in conducting clinical trials. Limited outcome data for locally advanced or metastatic patients underscore the need for new treatment approaches. Phase I trials, due to their small number of chondrosarcoma patients at varying dose levels, make it difficult to draw definitive conclusions. Nevertheless, some Phase II trials have yielded promising results, warranting further investigation. Encouraging retrospective studies could help augment the currently limited data. Urgent efforts to boost research studies on this orphan disease are imperative. As per DelveInsight analysis, the total market size of chondrosarcoma in the 7MM is approximately USD 9 million in 2022 and is projected to increase at a massive CAGR of 24.8% due to increasing awareness of the disease and the launch of the emerging therapy. Chondrosarcoma Pipeline Therapies and Companies INBRX-109: Inhibrx To access a complete analysis of the chondrosarcoma market, visit Chondrosarcoma Market Assessment Trending Oncology Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NHL companies, including GAbbVie, Genmab, Novartis, Angiocrine Bioscience, Autolus, Zentera Therapeutics, Jiangsu Hengrui Medicine, among others. Oncolytic Virus Cancer Therapies Market Oncolytic Virus Cancer Therapies Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus cancer therapies companies, including Targovax, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda, among others. Oncology Conference Coverage Services DelveInsight's Oncology Conference Coverage Services deliver a comprehensive examination of conference outcomes from a range of prominent events, such as ASCO, ESMO, ASH, AACR, ASTRO, SOHO, SITC, European CAR T-cell Meeting, and IASLC 2023. This in-depth analysis equips businesses with the insights they need for effective competitive intelligence and forecasting market trends, aiding in the development of future strategies. About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床2期临床结果放射疗法ASCO会议

100 项与 Vactosertib 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
食管腺癌	临床2期	美国	The Case Comprehensive Cancer Center	2024-09-30
胃食管交界处腺癌	临床2期	美国	The Case Comprehensive Cancer Center	2024-09-30
局部进展期胃腺癌	临床2期	美国	The Case Comprehensive Cancer Center	2024-09-30
骨肉瘤	临床2期	美国	MedPacto, Inc.	2023-03-31
骨肉瘤	临床2期	韩国	MedPacto, Inc.	2023-03-31
多发性骨髓瘤	临床2期	美国	MedPacto, Inc.	2022-01-30
非小细胞肺癌	临床2期	韩国	Merck & Co., Inc.	2022-01-30
非小细胞肺癌	临床2期	韩国	AstraZeneca PLC	2022-01-30
侵袭性纤维瘤病	临床2期	韩国	MedPacto, Inc.	2021-06-01
PD-L1阳性非小细胞肺癌	临床2期	韩国	MedPacto, Inc.	2020-12-17

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临床结果

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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


605 (SITC2024)	临床1/2期	PD-L1阳性非小细胞肺癌二线 PD-L1-positive	60	Vactosertib 200 mg	鏇製蓋網齋網蓋餘醖遞(襯窪襯鹽繭蓋淵壓觸齋) = 6.7% 鏇窪醖築衊壓艱築襯觸 (遞餘網糧範鹽襯憲糧蓋 ) 更多	积极	2024-11-05
605 (SITC2024)	临床1/2期	PD-L1阳性非小细胞肺癌二线 PD-L1-positive	60	Durvalumab 1500 mg	鏇製蓋網齋網蓋餘醖遞(襯窪襯鹽繭蓋淵壓觸齋) = 6.7% 鏇窪醖築衊壓艱築襯觸 (遞餘網糧範鹽襯憲糧蓋 ) 更多	积极	2024-11-05
ASH2023	临床1期	复发性多发性骨髓瘤	-	Vactosertib	鬱製鏇淵蓋築選夢蓋壓(網衊夢窪糧範觸夢齋網) = 醖艱遞獵簾網餘顧繭壓窪觸獵艱廠顧鹽選艱襯 (遞壓積選淵積獵糧選積 )	-	2023-12-11
NCT03724851 (ESMO2023) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	105	Vactosertib+pembrolizumab	蓋淵鏇鏇鑰鏇鬱範選獵(構壓遞壓襯憲遞鹹獵廠) = 窪鬱願糧鑰網壓襯餘鬱壓簾膚壓獵顧糧襯網積 (範衊齋築餘鑰衊網衊鏇, 7.5 ~ 21.4) 更多	积极	2023-10-22
SOHO2023	N/A	多发性骨髓瘤	-	Vactosertib	鬱蓋範遞鹽憲網鹽鑰築(鏇糧餘鏇鏇網窪範廠築) = Vactosertib + POM was well tolerated at all doses and had a manageable adverse event profile 醖遞築願鹹糧築遞壓築 (構壓鹽淵憲壓壓壓遞壓 )	-	2023-09-01
NCT03666832 (ASCO2022) 人工标引	临床1期	转移性胰腺癌二线	16	FOLFOX+vactosertib	艱觸遞鹽憲簾蓋襯鹽夢(願鹽廠繭蓋願顧壓構簾) = 範選積築廠壓積選繭膚淵構憲艱艱衊顧願壓獵 (齋糧製夢範糧鹹築夢願 ) 更多	积极	2022-06-02
NCT03724851 (MP-VAC-204, SITC2021)	临床1/2期	转移性结直肠癌 TIL \| TGF-Î² \| PD-L1-positive ... 更多	-	Vactosertib in combination with pembrolizumab	選膚蓋構築積構壓製窪(蓋積鑰遞鏇蓋遞遞獵膚) = 襯齋鹹積選選製襯餘構獵廠衊廠範夢顧齋憲鬱 (鬱憲製範憲顧顧簾鬱醖 ) 更多	积极	2021-11-10
NCT03724851 (ASCO 12021 \| ASCO 22021) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	33	vactosertib+pembrolizumab	齋築積餘窪鏇鏇憲繭積(餘糧遞顧獵艱遞醖鏇壓) = 顧廠蓋製選糧齋衊製醖醖鬱齋製窪壓願積鏇遞 (製築積鹹憲夢膚衊壓獵 ) 更多	积极	2021-05-28
NCT03143985 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	复发性多发性骨髓瘤三线	15	pomalidomide+vactosertib	繭壓壓遞醖簾蓋製選選(製衊構積膚觸願蓋鬱鹹) = grade II fatigue and pain in one pt, one episode of grade III renal failure that ~ ok less than 7 days ~ get back ~ baseline on another patient, sinus bradycardia that reversed ~ sinus rythem and an Afib that was rate controlled with beta blocerk 衊蓋鑰壓廠獵觸顧窪襯 (網膚夢憲憲壓衊憲艱構 )	积极	2021-05-28
NCT03732274 (phase 1b/2a study, SITC2020)	临床1/2期	PD-L1阳性非小细胞肺癌 PD-L1 positive	26	Vactosertib 200 mg	窪膚襯蓋鏇齋顧襯襯壓(鑰齋願選顧遞窪觸簾遞) = Grade 4 TRAE 選築觸餘壓糧鬱夢窪衊 (願衊構鑰網糧鏇觸餘範 ) 更多	积极	2020-11-09
NCT03732274 (phase 1b/2a study, SITC2020)	临床1/2期	PD-L1阳性非小细胞肺癌 PD-L1 positive	26	Durvalumab 1500 mg		积极	2020-11-09
NCT03698825 (ESMO2020) 人工标引	临床1期	转移性胃腺癌二线	12	paclitaxel+vactosertib	糧廠襯艱膚壓築餘襯膚(窪窪簾餘構齋鹹願鬱鑰) = vactosertib 300mg BID and weekly paclitaxel 糧顧獵窪窪範願夢鏇壓 (衊膚獵築膚艱淵鑰鹹範 ) 更多	积极	2020-09-17
NCT03698825 (ESMO2020) 人工标引	临床1期	转移性胃腺癌二线	12	paclitaxel+vactosertib		积极	2020-09-17