A Phase I Open Label Followed by a Phase II Randomized, Controlled Study to Assess the Efficacy and Safety of ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic

A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

开始日期2021-05-06

申办/合作机构

Ability Pharmaceuticals SL

NCT03417921

/ Suspended临床1/2期

A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy

开始日期2021-04-26

申办/合作机构

Ability Pharmaceuticals SL

[+1]

NCT03366480

/ Completed临床1/2期

A Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC

A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC.

开始日期2016-12-01

申办/合作机构

Ability Pharmaceuticals SL

[+5]

100 项与 Ibrilatazar 相关的临床结果

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100 项与 Ibrilatazar 相关的转化医学

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100 项与 Ibrilatazar 相关的专利（医药）

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项与 Ibrilatazar 相关的文献（医药）

2025-04-01·Plant Physiology and Biochemistry

The protective roles of boron against copper excess in citrus roots: Insights from physiology, transcriptome, and metabolome

Article

作者: Shen, Qian ; Huang, Wei-Lin ; Chen, Li-Song ; Huang, Wei-Tao ; Huang, Zeng-Rong ; Lu, Fei ; Chen, Xu-Feng ; Yang, Lin-Tong ; Lai, Ning-Wei

Boron (B) deficiency and copper (Cu) excess are common problems in citrus orchard soils. Citrus sinensis seedlings were exposed to 25 (B25) or 2.5 (B2.5) μM H₃BO₃ and 0.5 (Cu0.5) or 350 (Cu350) μM CuCl₃ for 24 weeks. Cu350 upregulated 2210 (1012) genes and 482 (341) metabolites and downregulated 3201 (695) genes and 175 (43) metabolites in roots at B2.5 (B25). Further analysis showed that the B-mediated mitigation of Cu toxicity in roots involved the coordination of the following aspects: (a) enhancing the ability to maintain cell wall and plasma membrane stability and function; (b) lowering the impairment of Cu350 to primary and secondary metabolisms and enhancing their adaptability to Cu350; and (c) alleviating Cu350-induced oxidative stress via the coordination of reactive oxygen species (ROS) and methylglyoxal detoxification systems. Cu350 upregulated the abundances of some saccharides, amino acids and derivatives, phospholipids, secondary metabolites, and vitamins, and the expression of several ROS detoxification-related genes in roots of B2.5-treated seedlings (RB2.5), but these adaptive responses did not prevent RB2.5 from Cu-toxicity (oxidative damage). The study identified some genes, metabolites, and metabolic processes/pathways possibly involved in root Cu tolerance. Additionally, the responses of gene expression and metabolite profiling to Cu-B treatments differed between leaves and roots. Therefore, this study provided novel information for B to reduce Cu toxicity in roots and might contribute to the development of soil amendments targeting Cu excess in citrus and other crops.

2025-03-01·Lung Cancer

ENDOLUNG trial, part II. A phase II study of the Akt/mTOR inhibitor and autophagy inducer ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with squamous non-small cell lung cancer

Article

作者: Estévez-García, Purificación ; Rodon, Jordi ; Muñoz-Guardiola, Pau ; Yeste-Velasco, Marc ; Sais, Elia ; Pérez-Campos, Antonio ; Morán, Teresa ; Lizcano, Jose M ; Gascón, Pere ; Oaknin, Ana ; Domènech, Carles ; Fierro-Durán, Gemma ; Pérez-Montoyo, Héctor ; Pedrós-Gámez, Oriol ; Bosch-Barrera, Joaquim ; Nadal, Ernest ; Alfón, José ; Cortal, Marc ; Sabatier, Renaud ; Martín-Martorell, Paloma

BACKGROUNDAdvanced squamous non-small cell lung cancer (sq-NSCLC) has long relied on chemotherapy and, more recently, on its combination with PD-1 immunotherapy. Ibrilatazar (ABTL0812) is an innovative oral agent that induces cytotoxic autophagy selectively in cancer cells. In the ENDOLUNG trial we have evaluated the efficacy and safety of ibrilatazar combined with chemotherapy in sq-NSCLC patients.METHODSPatients with stage III/IV sq-NSCLC received ibrilatazar (1300 mg tid) alongside paclitaxel (175 mg/m2) and carboplatin (AUC 5) every 3 weeks for up to 8 cycles, followed by ibrilatazar maintenance until progression or toxicity. Primary endpoint was overall response rate (ORR) per RECIST v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.RESULTS40 patients were enrolled constituting the intention-to-treat (ITT) population (90 % male, median age 66, ECOG 0-1). The efficacy analysis (FA) subset included 25 patients, excluding 15 patients without a measurement of the primary variable. For ITT and FA populations, the ORR was 32.5 % (95 % Confidence Interval (CI) 21.3-50.1) vs 52.0 % (95 % CI 34.2-65.9), the disease control rate (DCR) was 52.5 % (95 % CI: 36.1-68.5) vs 84.0 % (95 % CI: 63.9-95.5), the PFS was identical (6.2 months; 95 % CI: 4.4-8.8) and the OS was 18.4 months (95 % CI: 9.5-NC) and 22.5 months (95 % CI: 10.4-NC), respectively. Most common adverse events included asthenia (62.5 %), diarrhea (45.0 %), nausea (37.5 %), anemia (32.5 %) and neutropenia (27.5 %). Pharmacokinetic and pharmacodynamic data confirmed ibrilatazar activity.CONCLUSIONSIbrilatazar combined with paclitaxel and carboplatin shows promising efficacy and safety in sq-NSCLC, warranting further clinical development.

2025-02-01·Food Research International

Comprehensive metabolite profiling reveals the dynamic changes of volatile and non-volatile metabolites in albino tea cultivar ‘Ming guan’ (MG) during white tea withering process

Article

作者: Zhang, Hui ; Zhong, Qiusheng ; Chen, Quanbin ; Wang, Xiuping ; Zhang, Yinggen ; Huang, Ting ; Chen, Changsong

'Ming guan'(MG), an elite albino cultivar deriving from the progeny of the traditional albino cultivar 'Bai jiguan', is a promising candidate for white tea production due to its favorable amino acid to phenol ratio. In this study, a comprehensive metabolomics analysis using ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) and headspace solid-phase microextraction-gas chromatography mass spectrometry (HS-SPME-GC-MS) were conducted to reveal the dynamic changes of non-volatile and volatile organic compounds (VOCs) throughout the withering processing of MG white tea. Meanwhile, multivariate statistical analyses were applied to screen for the characteristic components in the flavor and aroma of MG white tea. A total of 625 non-volatile metabolites and 118 VOCs were determined, of which 90 non-volatile metabolites (VIP ≥ 1, FC ≥ 2 or ≤ 0.5) were identified as key flavor components significantly changed throughout the withering process. The relative odor activity value (ROAV) analysis highlighted 22 VOCs (ROAV ≥ 1) with substantial effect on aroma formation, of which geraniol, (E)-2-hexenal, 4-methoxy-benzaldehyde and guaiacol emerging as the most key aroma constituents of MG white tea, endowing MG white tea with fruity and floral odor notes. This study offered a comprehensive investigation into metabolite changes in MG white tea, contributing valuable insights for the innovation of new white tea products utilizing albino tea plant mutants.

项与 Ibrilatazar 相关的新闻（医药）

2024-09-15

·药明康德

94%患者肿瘤缩小的靶向疗法；将化疗效果提高40%的抗癌疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 口服人类表皮生长因子受体2（HER2）酪氨酸激酶抑制剂（TKI）zongertinib治疗非小细胞肺癌（NSCLC）患者在一项早期临床试验中获积极结果，94%患者的肿瘤有缩小。 2. HER2靶向疗法BAY 2927088在一项1/2期临床试验中治疗携带HER2 YVMA插入突变的晚期NSCLC患者，客观缓解率（ORR）达90%。 3. 口服靶向抗癌化合物ibrilatazar联用化疗（紫杉醇/卡铂）在一项1/2期临床试验中使子宫内膜癌患者的无进展生存期（PFS）相比历史对照组延长了40%。药明康德内容团队整理 Zongertinib：公布1b期临床试验的初步数据勃林格殷格翰（Boehringer Ingelheim）公布了旗下口服HER2靶向疗法zongertinib（BI 1810631）在NSCLC患者中的最新积极临床结果。Zongertinib不与野生型表皮生长因子受体（EGFR）结合，进而相关毒性较低。Zongertinib于2023年获得美国FDA授予快速通道资格，并随后于2024年获得美国FDA和中国国家药监局药品审评中心（CDE）授予的突破性疗法认定，用于治疗曾接受过全身性疗法、携带HER2激活突变的晚期NSCLC成人患者。此次公布的结果显示，截至2024年5月，共132例患者每天接受一次120 mg/240 mg zongertinib治疗（n=75/n=57）。经盲法独立中央审评（BICR）评估，试验达到主要终点，患者的确认ORR为66.7%（97.5% CI：53.8–77.5，p<0.0001）。在所有剂量的患者中，94%的患者观察到任何程度的肿瘤缩小。此外，数据还显示，zongertinib具有初步的脑活性。根据BICR评估的RANO-BM（神经肿瘤脑转移瘤的疗效评估），33%（120 mg，n=27）和40%（240 mg，n=25）的无症状脑转移患者达成确认的客观缓解，疾病控制率（DCR）分别为74%和92%。Zongertinib在120 mg和240 mg剂量下的耐受性通常良好，没有因治疗导致的死亡，且导致剂量减少（11%）和停药（3%）的不良事件发生率低。 BAY 2927088：公布1/2期临床试验数据拜耳（Bayer）公布了1/2期SOHO-01研究扩展部分的积极结果。该研究评估了其口服、可逆的HER2靶向疗法BAY 2927088在携带HER2变异的晚期NSCLC患者中的安全性和初步疗效。入组患者在接受≥1种晚期疾病全身治疗后病情出现进展，但未曾接受过HER2靶向治疗。BAY 2927088能够强效抑制突变的HER2，包括HER2外显子20插入突变和HER2点突变，同时也能抑制EGFR，对突变型EGFR具有高选择性，且不和野生型EGFR相结合。美国FDA和中国药品审评中心于2024年授予BAY 2927088突破性疗法认定，用于治疗携带HER2激活突变且曾接受过全身治疗的不可切除或转移性NSCLC成年患者。此次公布的结果显示，43名可评估疗效患者的确认ORR为72.1%，1名（2.3%）患者实现完全缓解（CR）。中位缓解持续时间（DOR）和PFS分别为8.7个月和7.5个月。在携带HER2 YVMA插入突变（最常见的变异）的患者中，ORR为90.0%，DOR为9.7个月，PFS为9.9个月。此外，BAY 2927088的安全性是可控的，并且与之前的报告一致。 Ibrilatazar（ABTL0812）：公布1/2期临床试验数据 AbilityPharma公司公布了ibrilatazar联用化疗（紫杉醇/卡铂）治疗晚期或复发性子宫内膜癌患者的1/2期临床试验ENDOLUNG的最终数据。Ibrilatazar是一种潜在“first-in-class”、差异化的口服靶向抗癌化合物，通过诱导内质网应激和抑制PI3K/Akt/mTOR通路来引发自噬。在临床试验中，ibrilatazar对子宫内膜癌和肺癌患者显示出临床益处。此外，它在包括肺癌、子宫内膜癌、胰腺癌、神经母细胞瘤和胶质母细胞瘤等癌症类型的动物模型中展示了强有力的临床前概念验证。此次公布的结果显示，ibrilatazar联用化疗的总缓解率为65.8%，其中13.2%的患者达到CR，52.6%的患者达到部分缓解（PR），中位DOR为7.4个月。中位PFS为9.8个月，相比历史对照组延长了40%。中位总生存期（OS）为23.6个月。这些结果表明，接受ibrilatazar联用化疗治疗的患者的ORR、PFS和OS相较于历史对照组（分别为51%、7.1个月和20.4个月）均有所提高。安全性方面，ibrilatazar联用化疗治疗显示出良好的安全性，未引入与化疗相关的重大不良事件，其安全性与历史对照组一致。药代动力学参数与临床前试验中观察到的靶点作用相符，血液药效学生物标志物表明治疗开始后至少28天内靶点调节持续存在。 RLY-2608：公布首个人体试验数据 Relay Therapeutics公司公布了其在研疗法RLY-2608的首个人体试验的积极中期数据。RLY-2608是Relay Therapeutics开发针对PI3Kα突变体的选择性抑制剂。该激酶是所有癌症中最常出现突变的激酶之一，约在14%的实体瘤患者检测出PI3Kα的致癌突变。传统上，PI3Kα抑制剂的开发聚焦于蛋白的活性位点。然而，这些抑制剂缺乏对突变型PI3Kα的选择性，导致治疗效果欠佳。为了增强PI3Kα抑制剂的选择性，Relay Therapeutics解析了PI3Kα的全长蛋白冷冻电镜结构，以阐明野生型和突变型PI3Kα的构象差异，并利用这些见解支持RLY-2608的设计。此次公布的数据显示，此前接受过大量治疗，携带PI3Kα突变的HR阳性、HER2阴性局部晚期或转移性乳腺癌患者在接受RLY-2608（600 mg）联合fulvestrant治疗后，表现出具有临床意义的PFS。中位随访时间为7.5个月时，所有携带PI3Kα突变患者的中位PFS为9.2个月。在30名具有可测量疾病的患者中，1/3的患者达到PR，ORR为33%。新闻稿指出，RLY-2608是首个针对PI3Kα，具有突变体和异构体（isoform）选择性的别构抑制剂。 ▲RLY-2608让73%患者的肿瘤缩小（图片来源：Relay Therapeutics公司官网） Mosliciguat：公布1b期临床试验数据 Roivant公司公布了其肺动脉高压（PH）疗法mosliciguat的1b期概念验证试验的结果。Mosliciguat是一种每日给药一次、潜在"first-in-class"和“best-in-class”的吸入性可溶性鸟苷酸环化酶（sGC）激动剂，可靶向递送至肺部。sGC是一种一氧化氮（NO）/环磷酸鸟苷（cGMP）信号通路中的关键酶，可催化cGMP生成，从而增加血管扩张、减少炎症和细胞凋亡、逆转血管重塑和抗纤维化作用。与需要减少血红素和NO才能对sGC产生作用的sGC激动剂不同，mosliciguat是一种独立于血红素和NO的sGC激活剂。这使mosliciguat可能在典型PH患者体内高氧化环境中保持有效性。该疗法目前正在开发用于治疗与间质性肺病（PH-ILD）相关的肺动脉高压。此次公布的结果显示，1.0、2.0和4.0毫克mosliciguat分别使患者的肺血管阻力（PVR）相对于基线的平均最大峰值降低达25.9%、38.1%和36.3%，超过预定主要结果≥20%降幅的阈值。此外，该疗法的耐受性良好，治疗引起的不良事件发生率低。根据新闻稿，这是迄今为止PH相关试验中观察到PVR的最大降低幅度之一。Mosliciguat的全球2期PHocus研究即将启动。 CT-996：公布1期临床试验数据罗氏（Roche）公布了其每日一次的口服胰高血糖素样肽-1（GLP-1）受体小分子激动剂CT-996的1期临床试验结果。罗氏在去年12月与Carmot Therapeutics达成合并协议，斥资约31亿美元收购了Carmot公司，囊获包括CT-996在内的多款处于临床开发阶段的皮下和口服肠促胰岛素疗法。此次公布的结果显示，CT-996在未患有2型糖尿病的肥胖人群中，在4周内将受试者体重减轻7.3%（约7公斤），安慰剂同期将体重降低1.2%。与安慰剂相比，CT-996提供了具有临床意义的体重减轻。安全性方面，所有的治疗伴发不良事件（TEAE）均为轻度或中度，没有发现3级以上TEAE。没有出现与在研药物相关的停止用药。最常见的TEAE为胃肠道相关不良事件，与其它肠促胰岛素疗法类似。接受更高剂量治疗的参与者TEAE更多，不过更缓慢的剂量滴定可能改善耐受性。基于这些积极结果，该公司计划在2025年启动2期临床试验。 ▲CT-996的减重效果（图片来源：参考资料[5]） Radiprodil：公布1b期临床试验数据 GRIN Therapeutics公司公布了其正在进行的全球1b期开放标签临床试验的初步结果。该试验的两个部分正在评估radiprodil的安全性、耐受性、药代动力学以及疗效。Radiprodil是一种在研选择性强效N-甲基-D-天冬氨酸受体亚基2B（GluN2B）的负变构调节剂，用于治疗GRIN相关神经发育障碍。GRIN相关神经发育障碍是一组由GRIN基因突变引起的罕见儿科神经发育障碍，目前尚无批准的疗法。此次公布的结果显示，radiprodil在具有GRIN基因功能增加突变的患者中，无论基线时是否存在可数的运动性癫痫发作（CMS），均表现出良好的耐受性。具有CMS患者的中位癫痫发作频率与基线相比降低了86%，超过了背景抗癫痫药物，其中71%的患者癫痫发作频率降低了50%以上。这些结果预计将支持GRIN Therapeutics与监管机构的讨论，以推动radiprodil进入3期关键性试验。 Elraglusib：公布1/2期临床试验的新数据 Actuate Therapeutics公司更新了elraglusib用于治疗复发/难治性尤文氏肉瘤（r/r EWS）的1/2期临床试验进展。该研究旨在评估elraglusib在复发/难治性恶性肿瘤儿科患者中的安全性和疗效，涵盖EWS及EWS相关的小圆细胞肉瘤。所有患者均接受了elraglusib与环磷酰胺/拓扑替康的联合治疗。此次公布的结果显示，在首批8名复发/难治性EWS及相关肉瘤患者中，两名患者正在经历持续的CR，两名患者实现疾病稳定（SD），1名患者取得了PR，肿瘤缩小了52%。Elraglusib展现了抗肿瘤活性，DCR为62.5%。该研究招募正在进行，预计2025年上半年有望公布顶线数据。 ▲Elraglusib联用环磷酰胺/拓扑替康的1/2期临床试验结果（图片来源：参考资料[6]） ▲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] Relay Therapeutics Announces Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful Progression Free Survival. Retrieved September 9, 2024, from https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-positive-interim-data-rly-2608 [2] Boehringer’s zongertinib shows encouraging efficacy and tolerability profile in previously treated HER2 mutated lung cancer patients. Retrieved September 10, 2024 from https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/zongertinib-positive-results-non-small-cell-lung-cancer [3] New results from the Investigational agent BAY 2927088 in HER2-mutant non-small cell lung cancer (NSCLC) presented at WCLC. Retrieved September 10, 2024 from https://www.businesswire.com/news/home/20240909979023/en/New-results-from-the-Investigational-agent-BAY-2927088-in-HER2-mutant-non-small-cell-lung-cancer-NSCLC-presented-at-WCLC [4] Roivant Unveils New Pipeline Program Mosliciguat, A Potential First-In-Class and Best-In-Category Inhaled Once-Daily Soluble Guanylate Cyclase (sGC) Activator. Retrieved September 10, 2024 from https://www.globenewswire.com/news-release/2024/09/10/2943472/0/en/Roivant-Unveils-New-Pipeline-Program-Mosliciguat-A-Potential-First-In-Class-and-Best-In-Category-Inhaled-Once-Daily-Soluble-Guanylate-Cyclase-sGC-Activator.html [5] Safety, Pharmacokinetics, and Pharmacodynamics of CT-996, an Oral Small-Molecule, Signal-Biased GLP-1 Receptor Agonist Over 4 Weeks in Adults With Obesity. Retrieved September 11, 2024, from https://medically.roche.com/global/en/metabolism/easd-2024/medical-material/EASD-2024-presentation-chakravarthy-ct-996-an-oral-small-molecule-signal-biased-pdf.html [6] Actuate Therapeutics Obtains Complete Responses and Provides Update on Clinical Trial of Elraglusib for the Treatment of Relapsed/Refractory Ewing Sarcoma. Retrieved September 14, 2024, from https://actuatetherapeutics.com/press_releases/actuate-therapeutics-obtains-complete-responses-and-provides-update-on-clinical-trial-of-elraglusib-for-the-treatment-of-relapsed-refractory-ewing-sarcoma/ [7] IBRILATAZAR (ABTL0812) from AbilityPharma increases chemotherapy effectiveness by 40% in patients with endometrial cancer. Retrieved September 14, 2024, from https://abilitypharma.com/en/main-menu/media-center-2/press-release/ibrilatazar-(abtl0812)-from-abilitypharma-increases-chemotherapy-effectiveness-by-40-in-patients-with-endometrial-cancer [8] GRIN Therapeutics Announces Positive Topline Data from Honeycomb Trial of Radiprodil in GRIN-Related Neurodevelopmental Disorder. Retrieved September 14, 2024, from https://www.prnewswire.com/news-releases/grin-therapeutics-announces-positive-topline-data-from-honeycomb-trial-of-radiprodil-in-grin-related-neurodevelopmental-disorder-302240847.html [9] Seres Therapeutics Reports SER-155 Phase 1b Placebo-Controlled Cohort 2 Study Safety and Clinical Results in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT). Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945049/0/en/Seres-Therapeutics-Reports-SER-155-Phase-1b-Placebo-Controlled-Cohort-2-Study-Safety-and-Clinical-Results-in-Patients-Undergoing-Allogeneic-Hematopoietic-Stem-Cell-Transplant-allo-.html [10] Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever Clinical Trial of an AAV-delivered Cancer Immunotherapy. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945063/0/en/Vironexis-Biotherapeutics-Launches-with-FDA-Clearance-of-IND-Application-for-First-Ever-Clinical-Trial-of-an-AAV-delivered-Cancer-Immunotherapy.html [11] Cytonics Announces Completion Of Enrollment For Phase 1 Clinical Study Evaluating CYT-108, A Novel Recombinant Protease Inhibitor, In Patients Suffering From Osteoarthritis Of The Knee. Retrieved September 13, 2024, from https://www.prnewswire.com/news-releases/cytonics-announces-completion-of-enrollment-for-phase-1-clinical-study-evaluating-cyt-108-a-novel-recombinant-protease-inhibitor-in-patients-suffering-from-osteoarthritis-of-the-knee-302239925.html [12] Phanes Therapeutics Announces First Patient Dosed in Clinical Study of PT886 in Combination with Chemotherapy. Retrieved September 13, 2024, from https://www.prnewswire.com/news-releases/phanes-therapeutics-announces-first-patient-dosed-in-clinical-study-of-pt886-in-combination-with-chemotherapy-302242421.html [13] Upstream Bio Announces Oral Presentation of New Data from a Phase 1b Multiple Ascending Dose Trial of Verekitug (UPB-101) in Adults with Asthma at the European Respiratory Society Congress. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/09/2942765/0/en/Upstream-Bio-Announces-Oral-Presentation-of-New-Data-from-a-Phase-1b-Multiple-Ascending-Dose-Trial-of-Verekitug-UPB-101-in-Adults-with-Asthma-at-the-European-Respiratory-Society-Co.html [14] CytomX Therapeutics Announces First Patient Dosed with CX-801, a Dually-Masked Interferon-Alpha 2b PROBODY®, in a Phase 1 Study in Patients with Solid Tumors. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/09/2942754/37704/en/CytomX-Therapeutics-Announces-First-Patient-Dosed-with-CX-801-a-Dually-Masked-Interferon-Alpha-2b-PROBODY-in-a-Phase-1-Study-in-Patients-with-Solid-Tumors.html#:~:text=SOUTH%20SAN%20FRANCISCO%2C%20Calif.%2C%20Sept.%2009%2C%202024%20%28GLOBE,1%20study%20%28NCT06462794%29%20in%20patients%20with%20solid%20tumors. [15] ORYZON announces first patient dosed in an Investigator-initiated Phase Ib study of iadademstat in first-line acute myeloid leukemia. Retrieved September 13, 2024, from https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-investigator-initiated-phase-ib-study [16] PolTREG Treg cell therapy for patients with type-1 diabetes shows long-term clinical remission and insulin independence. Retrieved September 13, 2024, from https://poltreg.com/poltreg-treg-cell-therapy-for-patients-with-type-1-diabetes-shows-long-term-clinical-remission-and-insulin-independence/ [17] Centessa Announces Positive Interim Phase 1 Clinical Data with its Novel Orexin Receptor 2 (OX2R) Agonist, ORX750, in Acutely Sleep-Deprived Healthy Volunteers. Retrieved September 13, 2024, from https://investors.centessa.com/news-releases/news-release-details/centessa-announces-positive-interim-phase-1-clinical-data-its [18] Cytokinetics Announces Data From Phase 1 Study of CK-4021586. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/09/2942724/35409/en/Cytokinetics-Announces-Data-From-Phase-1-Study-of-CK-4021586.html [19] Antennova to Present Latest Data of ATN-037 in a Mini Oral Presentation at ESMO Congress. Retrieved September 13, 2024, from https://www.prnewswire.com/news-releases/antennova-to-present-latest-data-of-atn-037-in-a-mini-oral-presentation-at-esmo-congress-2024-302240448.html [20] TILT Biotherapeutics Presents Clinical Data on TILT-123 After Fully Intravenous Delivery Regimen at ESMO 2024. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/09/2942525/0/en/TILT-Biotherapeutics-Presents-Clinical-Data-on-TILT-123-After-Fully-Intravenous-Delivery-Regimen-at-ESMO-2024.html [21] Terns Pharmaceuticals Announces Positive Phase 1 Clinical Trial Results with TERN-601 Once-Daily Oral GLP-1R Agonist for the Treatment of Obesity. Retrieved September 9, 2024 from https://ir.ternspharma.com/news-releases/news-release-details/terns-pharmaceuticals-announces-positive-phase-1-clinical-trial [22] Zealand Pharma announces positive topline results from 13-week Phase 1b multiple ascending dose clinical trial with GLP-1/GLP-2 receptor dual agonist dapiglutide. Retrieved September 9, 2024 from https://www.globenewswire.com/news-release/2024/09/09/2943004/0/en/Zealand-Pharma-announces-positive-topline-results-from-13-week-Phase-1b-multiple-ascending-dose-clinical-trial-with-GLP-1-GLP-2-receptor-dual-agonist-dapiglutide.html [23] BridgeBio Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for BBP-812 Canavan Disease Gene Therapy Program. Retrieved September 11, 2024 from https://www.globenewswire.com/news-release/2024/09/10/2944157/0/en/BridgeBio-Receives-FDA-s-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-BBP-812-Canavan-Disease-Gene-Therapy-Program.html [24] NKGen Biotech’s Positive Phase 1 Clinical Data in Moderate Alzheimer’s Disease Advances Troculeucel into Phase 2 with First Patient Dosed in Phase 1/2a Trial. Retrieved September 12, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945163/0/en/NKGen-Biotech-s-Positive-Phase-1-Clinical-Data-in-Moderate-Alzheimer-s-Disease-Advances-Troculeucel-into-Phase-2-with-First-Patient-Dosed-in-Phase-1-2a-Trial.html [25] HotSpot Therapeutics Presents First-in-Human Phase 1 Clinical Data on its Novel CBL-B Inhibitor, HST-1011, at ESMO Congress 2024. Retrieved September 13, 2024, from https://www.prnewswire.com/news-releases/hotspot-therapeutics-presents-first-in-human-phase-1-clinical-data-on-its-novel-cbl-b-inhibitor-hst-1011-at-esmo-congress-2024-302246957.html [26] Sernova Announces New Positive Data from Phase I/II Trial Regarding Islet Survival and Function. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945121/0/en/Sernova-Announces-New-Positive-Data-from-Phase-I-II-Trial-Regarding-Islet-Survival-and-Function.html [27] VYNE Therapeutics Announces Positive Phase 1a SAD Data for VYN202, a Novel BD2-Selective BET Inhibitor. Retrieved September 13, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945109/0/en/VYNE-Therapeutics-Announces-Positive-Phase-1a-SAD-Data-for-VYN202-a-Novel-BD2-Selective-BET-Inhibitor.html 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

突破性疗法临床结果快速通道临床2期

2024-05-09

·药融圈

2次私有化的Biotech

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：赛生药业控股有限公司（6600.HK）（简称：赛生药业）是一家拥有产品开发和商业化集成平台的生物制药公司，战略上专注于在中国规模较大、增长迅速且存在巨大未被满足医疗需求的治疗领域，包括肿瘤科及重症感染。凭借赛生药业的产品开发及商业化实力，公司在重点治疗领域均衡和优质的上市产品及具有较佳潜力的在研产品的开发及商业化组合方面已建立良好的往绩记录。第一次私有化赛生药业前身是 SciClone US，最早成立于1990年，早期创始人为创始人Thomas E. Moore和Nelson M. Schneider；于1992 年在美国纳斯达克上市，是一家老牌上市公司。2013年新的中国管理团队加入公司，后公司在2017年被私有化。(2017年6月7日，由德福资本/GL发起、中银投资、鼎晖投资、上达资本、Boying Investment组成的买方财团Silver Biotech与SciClone US签订合并协议，以每股11.18美元的现金对价，收购SciClone US所有发行在外的普通股。)港股上市2021上市招股书，所示图片进展2021 年“全新”的赛生药业于中国香港上市，当时募集资金总额约为21.80亿港元。目前赛生药业三大业务：自有特色产品日达仙（胸腺法新的原研产品）(港股上市前2017~2019年间，日达仙分别实现销售额人民币11.26亿元、人民币11.68亿元和人民币13.49亿元)；授权引入候选新药产品（肿瘤与抗感染领域）；销售合作推广分销服务（辉瑞及百特成熟产品）。具体到新药引进/License-in合作开发方面：根据赛生药业2022年8月与美纳里尼亚太公司达成的许可及合作协议，赛生药业可根据美纳里尼与 Melinta Therapeutics, Inc. 此前签订的相关协议，在中国境内独家开发和商业化Vaborem®（注射用美罗培南韦博巴坦）。2023年3月，赛生药业递交的Vaborem®临床试验申请获得了中国国家药品监督管理局（NMPA）批准。Vaborem®在中国开展的III期临床试验于2023年7月完成首例受试者入组给药，并于2024年1月完成全部受试者入组。药融云数据www.pharnexcloud.com；截图来源该研究是在中国开展的一项随机、双盲双模拟、阳性药物对照(辉瑞的注射用哌拉西林钠他唑巴坦钠 )、多中心的III期临床试验，旨在评价Vaborem®在复杂性尿路感染（包括急性肾盂肾炎）患者中的有效性和安全性，由复旦大学附属华山医院王明贵教授和上海交通大学医学院附属仁济医院郑军华教授担任主要研究者，在全国27家研究中心共入组了108例受试者。该研究结果，及同时开展的一项在中国健康志愿者中评估Vaborem®药代动力学特征的研究结果，将用于桥接国外临床试验数据，并支持Vaborem®在中国的上市申请。其他新药布局：ORSERDU®（艾拉司群）ORSERDU®（艾拉司群）是一款口服选择性雌激素受体降解剂，用于治疗既往至少接受过一线内分泌治疗后疾病进展的雌激素受体1基因（ESR1）突变的雌激素受体（ER）阳性、人类表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌的绝经后女性和成年男性。Vibativ®(telavancin)Vibativ®是新型脂糖肽类抗生素，用于治疗金黄色葡萄球菌所致的医院获得性细菌性肺炎（HABP）与呼吸机相关细菌性肺炎（VABP），以及复杂性皮肤及皮肤软组织感染（cSSSIs）。RRx-001RRx-001是一款具有First-in-Class（FIC）潜质的小分子药物，具有多种作用机制，包括CD47-SIRPα靶向、RONs生成以及表观遗传调节。RRx-001可以对多种肿瘤微环境异常起到调节作用，包括：下调CD47-SIRPα, 使肿瘤相关巨噬细胞（TAM）复极化，由抗炎症M2表型转为促炎症 M1表型；通过表观遗传抑制活性激活抑癌基因，逆转化疗耐药；使肿瘤血管正常化以增加化疗药物渗透，产生代谢产物RONs导致肿瘤细胞坏死。OmburtamabOmburtamab是一种放射性核素碘131标记的靶向B7-H3（CD276）的单克隆抗体，靶向实体肿瘤中表达B7-H3的细胞，并结合到B7-H3分子上的生物功能的关键区域--FG环依赖型构象。药融云数据www.pharnexcloud.com；截图来源PEN-866PEN-866是一款小分子偶联药物，药物的一端为可靶向结合被激活的HSP90蛋白，另一端为拓扑异构酶抑制剂（SN-38）。PEN-866的独特桥接设计及细胞毒素释放机理使得SN-38可以特异性地在肿瘤部位聚集，同时随着连接分子的持续分解，持久地在肿瘤部位释放，并最终造成DNA的破坏及肿瘤的消退。PT-112这是一种创新型铂类小分子药物，通过细胞凋亡、免疫特性及高耐受性来抗肿瘤效果。PT-112的设计初衷是为了减少传统铂类药化疗中的毒性及耐药性。ABTL-0812这是一种具有独特作用机制的潜在候选药物。ABTL-0812通过与核受体PPARα和γ偶联来抑制PI3K/Akt/mTOR (PAM) 通路，从而诱导与Akt结合并阻碍其激活的假激酶TRIB3，并导致mTOR发生抑制，从而导致自噬依赖性癌细胞死亡。HSP90-PI3K偶联物HSP90-PI3K偶联物是一款小分子偶联药物，由磷脂酰肌醇3-激酶（PI3K）抑制剂、连接体与热休克蛋白90（HSP90）结合构成。再次被提出要约私有化2023财年，赛生药业营收为31.56亿元，同比增长约为14.8%；净利润同比增长增31.2%至11.2亿元。此前在2024年3月28日，德福资本及赛生药业联合公告：3月19日，要约人(Silver Pegasus Investment Limited)根据公司法第86条以协议安排方式将赛生药业私有化，要求董事会向计划股份持有人提呈建议，其中涉及注销计划股份，作为代价，就每股计划股份以现金向计划股东支付注销价（以换取每股计划股份现金18.8港元），并撤销股份于联交所的上市地位。注销价18.8港元较不受干扰日期收市价每股14.04港元溢价约33.90%，较最后交易日(2024年3月18日)收市价每股16.04港元溢价约17.21%。药融圈密切关注后续进展。参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；www.sciclone.com；http://www.sciclone.com/Modules/research.aspx；https://pharma.bcpmdata.com/database/1/detail/39/Wsbrmo4B6rPXm79Mnp50?aliasId=d361ca6640；https://quote.eastmoney.com/hk/06600.html；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

引进/卖出临床3期医药出海并购

2024-03-11

·PRNewswire

AbilityPharma Announces € 7 Million Financing Round to Advance Development of its Clinical Phase 2b Autophagy Inducer ABTL0812 in Metastatic Pancreatic Cancer

The Canadian venture capital fund CTI Life Sciences Fund III, Inveready and the EIC Fund from the European Commission close a round with the additional participation of CDTI Innvierte, FiTalent, family offices as well as founders. BARCELONA, Spain, MONTREAL and LUXEMBOURG, March 11, 2024 /PRNewswire/ -- The Catalan biopharmaceutical company Ability Pharmaceuticals, SA (AbilityPharma), focused on the development of innovative oral autophagy-inducing anticancer compounds, announces a €7M investment from a European-Canadian syndicate of life sciences investors, including CTI Life Sciences Fund, Inveready, the EIC Fund, Fitalent and CDTI Innvierte. The funding will allow the Company to fully finance its phase 2b clinical study of antitumor compound ABTL0812 in patients with pancreatic cancer. AbilityPharma is completing a Phase 2b clinical trial with ABTL0812 in metastatic pancreatic cancer (all 140 patients recruited) with the aim of demonstrating greater efficacy than standard treatment FOLFIRINOX. The double-blind, placebo-controlled, first-line study in combination with FOLFIRINOX is ongoing in 23 hospitals in Spain, USA, France, and Israel. Efficacy results are expected by year-end. Significant superior efficacy results will allow AbilityPharma to obtain financing for final development of ABTL0812 or to license it to a multinational pharmaceutical or biotechnology company, with the goal of making ABTL0812 available to pancreatic cancer patients in 2028. "We are very pleased to complete this financing round and welcome CTI Life Sciences Fund's Shermaine Tilley to our board of directors, which will enable us to accelerate the development of ABTL0812 in the short term", stated Carles Domènech, PhD, Executive Chairman and CEO at AbilityPharma. "We are thankful to CTI Life Sciences, Inveready and the EIC Fund for completing this financing round, and to all our new and existing investors for their confidence in our team and for their support to our goals. This investment will allow us to continue working tirelessly on taking ABTL0812 to patients with pancreatic cancer". Shermaine Tilley, PhD, MBA, Managing Partner at CTI Life Sciences Fund, said "We are delighted to provide financing for late-stage development of Ability Pharma's innovative and highly promising treatment for pancreatic cancer. I am pleased to assume a position on their board of directors and will work with management and the board to optimize the value of ABTL0812 for patients and for investors". Sara Secall, MSc, MBA, General Partner Inveready, said "We are excited to bring in savvy investors that can help move forward AbilityPharma's treatment for cancer patients". Svetoslava Georgieva, Chair of the EIC Fund Board, said: "The EIC Fund has become a strong player in EU deep-tech investments. The unique financing approach through the EIC, combining grants and equity, is attracting significant interest from Europe's most promising start-ups and provides them with the means to develop and scale their businesses in Europe. Our investment will help Ability Pharma with the development of their product for patients with metastatic pancreatic cancer." SOURCE AbilityPharma

临床2期

100 项与 Ibrilatazar 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16027

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
神经母细胞瘤	临床2期	西班牙	Ability Pharmaceuticals SL	2023-07-18
胰腺癌	临床2期	欧盟	SciClone Pharmaceuticals LLC	2022-01-30
胰腺癌	临床2期	欧盟	赛生药业控股有限公司	2022-01-30
转移性胰腺癌	临床2期	西班牙	Ability Pharmaceuticals SL	2021-04-26
鳞状细胞癌	临床2期	中国	SciClone Pharmaceuticals LLC	2018-10-29
鳞状非小细胞肺癌	临床2期	西班牙	Ability Pharmaceuticals SL	2016-12-01
晚期癌症	临床2期	西班牙	Ability Pharmaceuticals SL	2014-02-01
晚期恶性实体瘤	临床2期	西班牙	Ability Pharmaceuticals SL	2014-02-01
子宫内膜癌	临床2期	西班牙	Ability Pharmaceuticals SL	-
肺癌	临床2期	西班牙	Ability Pharmaceuticals SL	-

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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


NCT03366480 (ENDOLUNG, Pubmed) 人工标引	临床1/2期	子宫内膜癌	51	Ibrilatazar (ABTL0812) + Carboplatin/Paclitaxel (The phase 1 part)	-	积极	2024-07-22
NCT03366480 (ENDOLUNG, Pubmed) 人工标引	临床1/2期	子宫内膜癌	51	Ibrilatazar (ABTL0812) + Carboplatin/Paclitaxel	(鹹獵鹹淵遞夢襯繭衊積) = 壓壓網願築製範憲繭鹽繭鹽獵網築構鬱膚鏇窪 (淵壓糧製顧選壓構鏇鏇 ) 更多	积极	2024-07-22
NCT03366480 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	晚期肺非小细胞鳞癌一线	40	ABTL0812+Paclitaxel+Carboplatin	(鏇鬱選鹹鏇夢網構醖鬱) = 遞願憲醖夢淵選願鏇簾淵鬱蓋簾鹽積鬱築壓築 (廠衊壓鹹鑰糧淵鏇餘築, 34.2 ~ 65.9) 更多	积极	2023-05-26
WCLC2021	N/A	非小细胞肺癌一线	22	ABTL0812+Paclitaxel+Carboplatin	(憲衊醖淵鹽餘鏇壓獵糧) = 鹹顧遞簾鬱餘艱艱壓膚顧鹹觸鑰廠願淵醖築艱 (鏇構觸鏇獵網鬱鑰蓋淵, 32.2 ~ 75.6) 更多	-	2021-01-29
EUCTR2016-001352-21-ES (ESMO2020)	临床2期	复发性子宫内膜癌一线	42	ABTL0812+Paclitaxel+Carboplatin	(廠構襯願鹹膚鬱餘網鬱) = 鏇憲糧網選製窪範繭鏇鏇鹹蓋壓衊顧憲鬱齋窪 (糧網蓋鏇淵齋齋鏇製選, 46 ~ 80) 更多	积极	2020-09-17
NCT03366480 (ASCO 12019 \| ASCO 22019) 人工标引	临床1期	鳞状细胞肺癌 \| 晚期子宫内膜癌一线	21	Paclitaxel+Carboplatin+ABTL 0812	(壓製鹹淵鹹獵衊遞窪遞) = neutrophil count decreased (43%), nausea (24%), fatigue (19%), anemia, vomiting, dyspepsia, platelet count decreased, arthralgia and neurotoxicity (10% each) 餘憲範顧鑰選鬱齋憲製 (蓋積齋糧簾製艱膚襯蓋 ) 更多	积极	2019-06-01