A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata

This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed.
The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).

开始日期2024-06-06

申办/合作机构

Sanofi

CTR20241301 / Recruiting临床3期

一项 III 期、随机、双盲、安慰剂对照、平行组、3 组、多国家、多中心研究，旨在评价 18 岁及以上中重度特应性皮炎受试者皮下接受 amlitelimab 单药治疗的疗效和安全性

主要：证明与安慰剂相比，18 岁及以上中重度特应性皮炎（AD）受试者接受 amlitelimab 单药皮下（SC）注射给药的疗效。次要：评估与安慰剂相比，18 岁及以上中重度 AD 受试者接受 amlitelimab 单药皮下注射给药的疗效。评估 18 岁及以上中重度 AD 受试者接受 amlitelimab 单药皮下注射给药的安全性特征。表征 18 岁及以上中重度 AD 受试者接受 amlitelimab 单药皮下注射给药的药代动力学（PK）。表征 18 岁及以上中重度 AD 受试者接受 amlitelimab 单药皮下注射给药的免疫原性

开始日期2024-05-10

申办/合作机构

Sanofi-Aventis Recherche et Développement SA

[+2]

NCT06407934 / Recruiting临床3期

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 48-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered as Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).
The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal.
Study details include:
The study duration will be up to 64 weeks (for participants not entering the LTS17367 [RIVER-AD] study) including a 48-week randomized double-blind period, and a 16-week safety follow-up.
The study duration will be up to 48 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 48 visit of EFC17600 (ESTUARY).
The total treatment duration will be up to 48 weeks. The total number of visits will be up to 14 visits (or 13 visits for those entering LTS17367 [RIVER-AD] study).

开始日期2024-05-08

申办/合作机构

Sanofi

100 项与 Amlitelimab 相关的临床结果

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100 项与 Amlitelimab 相关的转化医学

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100 项与 Amlitelimab 相关的专利（医药）

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项与 Amlitelimab 相关的文献（医药）

2023-10-25·The British journal of dermatology

Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial.

Article

作者: Brennan, Nuala ; Weidinger, Stephan ; Gilbert, Sally ; Reich, Adam ; Porter-Brown, Ben ; Quaratino, Sonia ; Cork, Michael J ; Wilson, Rosamund ; Stebegg, Marisa ; Bieber, Thomas ; O'Malley, John T

BACKGROUND:

Atopic dermatitis (AD) is an inflammatory skin disease with significant unmet need. Blockade of the OX40-OX40 ligand (OX40L) costimulation pathway by targeting OX40L on antigen-presenting cells (APCs) with a fully human noncytotoxic, nondepleting anti-OX40L monoclonal antibody (amlitelimab; SAR445229; KY1005) is a novel way to modulate persistent inflammation.

OBJECTIVES:

To assess the safety and efficacy of amlitelimab over 16 weeks in adults with AD in a phase IIa double-blind placebo-controlled study.

METHODS:

The study was conducted at 19 hospitals in Germany, Poland, Spain and the UK. Eligible patients with moderate-to-severe AD were randomized (1 : 1 : 1) to low-dose intravenous (IV) amlitelimab (200 mg), high-dose IV amlitelimab (500 mg) or placebo, followed by three maintenance doses (50% of loading dose) at 4, 8 and 12 weeks, with safety follow-up to week 36. The co-primary endpoints were the incidence of treatment-emergent adverse events (all patients who received ≥ 1 dose of the study drug) and mean percentage change in Eczema Area and Severity Index (EASI) to week 16 (full analysis set).

RESULTS:

Between 13 December 2018 and 12 May 2020, 89 patients were randomly assigned to low- (n = 29) or high-dose amlitelimab (n = 30) or placebo (n = 29), of whom 88 proceeded to treatment [37 women (42%), 51 (58%) men; mean (SD) age 33.6 (11.9) years]. Amlitelimab was generally well tolerated with an unremarkable safety profile; no hypersensitivity events were reported. For the primary endpoint, the least square mean percentage change in EASI from baseline to week 16 was -80.12% [95% confidence interval (CI) -95.55 to -64.68; P = 0.009 vs. placebo] and -69.97% (95% CI -85.04 to -54.60; P = 0.07 vs. placebo) for the low- (n = 27) and high-dose (n = 27) amlitelimab groups, respectively, vs. -49.37% (95% CI -66.02 to -32.72) for placebo (n = 24). Numerically greater reductions in EASI were observed for amlitelimab vs. placebo from weeks 2 to 16.

CONCLUSIONS:

Novel targeting of OX40L-expressing APCs with amlitelimab was well tolerated and resulted in clinically meaningful improvements in AD.

2023-10-25·The British journal of dermatology

Safety and effectiveness of amlitelimab, a potential new treatment for atopic dermatitis: results of a clinical trial.

Article

2022-05-01·Clinical pharmacology and therapeutics2区 · 医学

OX40L Inhibition Suppresses KLH‐driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof‐of‐Pharmacology for KY1005

2区 · 医学

Article

作者: Moerland, Matthijs ; Quaratino, Sonia ; Rissmann, Robert ; Yateman, Martin ; Grievink, Hendrika W. ; Gal, Pim ; Saghari, Mahdi ; Brennan, Nuala ; van Doorn, Martijn B. A. ; Porter‐Brown, Ben ; Klaassen, Erica S. ; Bergmann, Kirsten R. ; Powell, John ; Gilbert, Sally ; Wilson, Rosamund ; Burggraaf, Jacobus

The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti‐OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated. Pharmacodynamic (PD) effects were explored using keyhole limpet hemocyanin (KLH) and tetanus toxoid (TT) immunizations. Sixty‐four healthy male subjects (26.5 ± 6.0 years) were randomized to single doses of 0.006, 0.018, or 0.05 mg/kg, or multiple doses of 0.15, 0.45, 1.35, 4, or 12 mg/kg KY1005, or placebo (6:2). Serum KY1005 concentrations were measured. Antibody responses upon KLH and TT immunizations and skin response upon intradermal KLH administration were performed. PD data were analyzed using repeated measures analysis of covariances (ANCOVAs) and post hoc exposure‐response modeling. No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. A nonlinear increase in mean serum KY1005 concentrations was observed (median time to maximum concentration (Tmax) ~ 4 hours, geometric mean terminal half‐life (t½) ~ 24 days). Cutaneous blood perfusion (estimated difference (ED) −13.4 arbitrary unit (AU), 95% confidence interval (CI) −23.0 AU to −3.8 AU) and erythema quantified as average redness (ED −0.23 AU, 95% CI −0.35 AU to −0.11 AU) decreased after KY1005 treatment at doses of 0.45 mg/kg and above. Exposure‐response analysis displayed a statistically significant treatment effect on anti‐KLH antibody titers (IgG maximum effect (Emax) −0.58 AU, 95% CI −1.10 AU to −0.06 AU) and skin response (erythema Emax −0.20 AU, 95% CI −0.29 AU to −0.11 AU). Administration of KY1005 demonstrated an acceptable safety and tolerability profile and PK analyses displayed a nonlinear profile of KY1005. Despite the observed variability, skin challenge response after KY1005 treatment indicated pharmacological activity of KY1005. Therefore, KY1005 shows potential as a novel pharmacological treatment in immune‐mediated disorders.

项与 Amlitelimab 相关的新闻（医药）

2024-06-23

·药渡

欧洲杯来了！哪些国家最有望夺得“最佳药物管道”奖杯？

来源：药渡撰文：Maskey 编辑：哦呼欧洲杯激战正酣，各国球队为了荣誉和胜利而奋力拼搏。但如果换个角度，设想一下，若是让这些参加欧洲杯的国家在“最佳药物管道”这一特殊领域展开角逐，谁又将脱颖而出，问鼎桂冠呢？目前，世界各地的制药公司都在竞相开发最具创新性和最有效的常见人类疾病治疗方法。他们进行临床前研究和临床试验，希望他们的治疗方法能得到监管机构的批准。监管机构会为可能治疗严重疾病的新型试验药物授予突破性疗法认定和快速通道认定。近年来，越来越多的新型治疗方法（如细胞和基因疗法、单克隆抗体和抗体-药物偶联物）已获得监管机构的批准[1]。因此，制药公司正在加大对这些创新疗法的开发投入。一些最大的制药公司位于欧洲，所有这些公司都在建立庞大的创新疗法药物管线。图1.近年来美国食品药品监督管理局(FDA)批准的新分子实体（NME）和生物制剂的数量【1】图2.获得批准的单克隆抗体百分比【2】德国拜耳是德国领先的制药公司之一。老年性黄斑变性药物阿柏西普、前列腺癌药物达罗他胺、抗凝药物利伐沙班和慢性肾病药物Finerenone是其产品组合中最有价值的药物。该公司正在开发33种新疗法，其中19种疗法正在进行1期临床试验，3种疗法正在进行2期临床试验[3]。该公司正在测试几种创新的重组腺相关病毒 (rAAV) 基因疗法，用于治疗亨廷顿氏病、帕金森氏病和庞贝氏病。另一家德国制药公司勃林格殷格翰正在临床试验中测试40多种药物[4]。该公司已经开发出用于治疗多种疾病的小分子药物、T细胞接合剂和癌症疫苗。该公司的产品组合中包括有效的治疗药物，包括肺纤维化药物尼达尼布和抗糖尿病药物恩格列净。默克集团是另一家德国制药公司，正在开发10多种用于治疗癌症、自身免疫性疾病和疟疾的药物[5]。其药物管线中一些有前景的在研药物包括小分子药物Enpatoran、抗体药物偶联物M9140和免疫检查点抑制剂avelumab。 BioNtech也是一家德国大型生物制药公司，与辉瑞公司成功开发了COVID-19疫苗BNT162b2(Comirnaty)。该公司还在对患有不同类型癌症（如结直肠癌和胰腺导管腺癌）的患者测试癌症疫苗Autogene Cevumeran[6]。BioNTech SE正在临床试验中测试30多种治疗方法，包括mRNA治疗、细胞疗法、基于蛋白质的疗法和小分子免疫调节剂。这些治疗方法旨在治疗癌症和传染病。其管道中最有前途的候选药物之一是单克隆抗体Gotistobart，正在非小细胞肺癌患者中进行测试。该公司开发的其他重要药物包括双特异性抗体Acasunlimab、BNT312/GEN1042和BNT327/PM8002。德国规模较小的生物制药公司也在努力扩大其药物研发线。Ethris开发了一种新型吸入式mRNA治疗药物ETH47，用于治疗呼吸道病毒感染。海德堡制药公司研发线中的一种主要候选药物是用于治疗多发性骨髓瘤的抗体-药物偶联物HDP-101。Affimed开发了用于治疗非小细胞肺癌的双特异性先天细胞接合剂AFM24。Atai Life Sciences研发线中有几种用于治疗抑郁症和焦虑症的药物。法国法国最大的制药公司赛诺菲拥有庞大的药物管线，包括60多种临床阶段治疗药物[7]。该公司正在开发双特异性抗体、疫苗、单克隆抗体、NK细胞接合剂、酶替代疗法和基因疗法。其最畅销的药物是与Regeneron合作开发的单克隆抗体度匹鲁单抗。该药物已被批准用于多种适应症，例如特应性皮炎、嗜酸性食管炎和哮喘。其投资组合中的另一项重要资产是与阿斯利康合作开发的呼吸道合胞病毒 (RSV) 疫苗nirsevimab。其管线中的几种药物，如小分子药物SAR441566、单克隆抗体Amlitelimab和单克隆抗体Frexalimab，都有可能获得监管部门的批准并成为变革性的治疗方法。法国还有几家不太知名的制药公司，包括Genfit、Abivax和Enterome，它们正在研发新的创新疗法。Genfit正在开发治疗胆管癌和高氨血症的新疗法。今年6月，FDA加速批准其药物Elafibranor，用于治疗原发性胆汁性胆管炎。Amolyt Pharma的药物管线包括治疗肢端肥大症和甲状旁腺功能减退症的药物。Enterome正在开发新的基于肽的免疫疗法，用于治疗惰性非霍奇金淋巴瘤和胶质母细胞瘤。Abivax已开发小分子药物obefazimod，用于治疗溃疡性结肠炎和克罗恩病。Antabio正在开发治疗铜绿假单胞菌感染和医院内感染的药物。Ipen的临床阶段管线中有10多种药物，包括治疗偏头痛、阿拉吉耶综合征、多发性骨髓瘤和胆道闭锁的药物[8]。英国英国-瑞典制药公司阿斯利康拥有最大的药物管线之一，拥有超过90种不同的临床阶段治疗药物[9]。该公司正在开发用于治疗癌症、呼吸系统疾病、代谢疾病、肾脏疾病和心血管疾病的新药。它拥有非常强大的肿瘤学产品组合，包括抗体药物偶联物trastuzumab deruxtecan和酪氨酸激酶抑制剂奥希替尼。该公司还通过购买和公司收购在其管线中增加了嵌合抗原受体T细胞(CAR-T)疗法、呼吸道合胞病毒疫苗和2型糖尿病药物。其与第一三共联合开发的抗体药物偶联物Datopotamab deruxtecan可能很快会在美国获得监管部门的批准。葛兰素史克 (GSK) 已开发出60多种用于治疗艾滋病毒、癌症、传染病以及呼吸道和免疫疾病的药物。该公司最近开发的最成功的治疗方法之一是呼吸道合胞病毒疫苗Arexvy，该疫苗已获得FDA批准用于50岁以上的人群[10]。该公司在开发高效疫苗方面有着良好的记录，例如Gardasil、Arexvy和 Shingrix。今年，GSK收购了一家新兴生物制药公司Aiolos Bio，该公司开发了一种新型哮喘药物。 Verona Pharma开发了一种用于治疗慢性阻塞性肺病的药物Ensifentrine，今年可能会获得FDA的批准。Ellipses Pharma正在对2期临床试验中的四种药物进行评估[11]。该公司正在研发不同类别的药物，例如用于治疗癌症的双重抑制剂、纳米颗粒-药物偶联物和选择性雄激素受体调节剂 (SARM)。Evox Therapeutics正在临床前研究中开发外泌体递送的腺相关病毒(AAV) 基因疗法，用于治疗苯丙酮尿症和心血管疾病[12]。瑞士罗氏的研发管线中有70多种药物[13]。该公司开发的转化疗法之一是双特异性单克隆抗体Faricimab，用于治疗糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性。其他成功获得监管部门批准的重要治疗方法是抗体-药物偶联物polatuzumab vedotin-piiq双特异性单克隆抗体Emicizumab和双特异性抗体glofitamab-gxbm。其阿尔茨海默氏症药物gantenerumab在3期临床试验中未能显示出疗效。该公司已将小分子抑制剂camonsertib和双特异性抗体RG6286等抗癌药物从其管线中移除。罗氏正在优先考虑那些更有可能获得监管机构批准的治疗方法。诺华是全球销售额最大的制药公司之一。其药物研发管线中有超过60种治疗方法[14]。其研发管线包括单克隆抗体、CAR-T疗法、基因疗法、小分子抑制剂、合成小干扰RNA (siRNA) 和其他治疗不同疾病的药物。其产品组合中的重要资产是心力衰竭组合药物Sacubitril/valsartan、多发性硬化症药物 Ofatumumab、乳腺癌药物ribociclib和高脂血症药物inclisiran。其布鲁顿氏酪氨酸激酶(BTK)抑制剂remibrutinib很有可能被批准用于治疗慢性自发性荨麻疹。 ADC Therapeutics正在临床试验中测试大约3种治疗方法[14]。该公司开发了抗体药物偶联物loncastuximab tesirine-lpyl，该药物已获得FDA加速批准，用于治疗大B细胞淋巴瘤。Alentis Therapeutics的研发管线中有大约4种治疗方法，包括抗体药物偶联物和单克隆抗体[15]。图3.销售额最高的制药公司和治疗方法【16】丹麦丹麦制药公司诺和诺德是欧洲最大的制药公司之一。诺和诺德的药物管线包括35多种药物，其中大多数药物正在对患有非酒精性脂肪性肝炎和糖尿病等慢性疾病的患者进行测试[17]。其最成功的药物是用于治疗肥胖症和糖尿病的索马鲁肽。诺和诺德开发了一种每周一次的糖尿病药物胰岛素Icodec，该药物已获准在欧洲使用。Genmab有10多种治疗方法正在临床试验中测试。它与辉瑞联合开发了抗体-药物偶联物tisotumab vedotin，该药物已获准用于治疗宫颈癌。其T细胞结合双特异性抗体epcoritamab也已获准用于治疗弥漫性大B细胞淋巴瘤。比利时比利时生物制药公司Union Chimique Belge (UCB)正在开发用于治疗系统性红斑狼疮和严重纤维肌痛综合征等神经和自身免疫性疾病的药物。其研发管线中有大约10种小分子药物和单克隆抗体[18]。其药物bimekizumab已在美国获批用于治疗斑块状银屑病。荷兰荷兰制药公司Argenx开发了抗体片段efgartigimod，该片段已获批用于治疗全身性重症肌无力。该公司正在对患有干燥综合征和特发性炎症性肌病的患者进行efgartigimod测试。该公司正在研发的另一种药物是单克隆抗体Empasiprubart，该药物已被开发用于治疗多灶性运动神经病。总之，欧洲几家大型制药公司正在开发用于多种疾病的一流和一流药物。这些公司通过研究、收购和与其他公司的联合合作建立了强大的药物管线。在这些欧洲国家中，德国、英国、瑞士和法国都有成熟和新兴的生物制药公司，专注于开发创新疗法。大多数公司都开发出了有效的治疗方法，并已在许多国家获准使用。编者按：在这场假想的“最佳药物管道”欧洲杯中，每个国家都有机会展现自己的实力和风采，我们都期待看到其在“赛场”上展现出最佳的状态。未来我们应给予各国更多在医药研究上付出与收获的关注，以及他们为全人类的健康福祉所作出的杰出贡献。参考文献（可上下滑动）： [1] Senior, M. (2023). Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology, 41(2), 174. [2] Walsh, G., & Walsh, E. (2022). Biopharmaceutical benchmarks 2022. Nature Biotechnology, 40(12), 1722-1760. [3] Bayer (2024, 30 April ). Pharmaceuticals Pipeline Overview and Progress. https://www.bayer.com/sites/default/files/ph-rd-pipeline-2024-05-final-1.pdf [4] Boehringer Ingelheim (n.d.). Boehringer Ingelheim Human Pharma Clinical Pipeline. https://www.boehringer-ingelheim.com/bipdf/pipeline-february-2024 [5] Merck Group (n.d.). HEALTHCARE PIPELINE. https://www.merckgroup.com/en/research/healthcare-pipeline.html [6] BioNTech SE (2024, 7 April). Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized [7] Sanofi (n.d.). Our Pipeline. https://www.sanofi.com/en/our-science/our-pipeline [8] Ipsen (n.d.). Pipeline. https://www.ipsen.com/pipeline/ [9] AstraZeneca (n.d.). Our pipeline. https://www.astrazeneca.com/our-therapy-areas/pipeline.html#cvrm [10] GSK. (2024, 7 June). US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,who%20are%20at%20increased%20risk. [11] Ellipses Pharma (n.d.). PORTFOLIO. https://ellipses.life/portfolio/ [12] Evox Therapeutics (n.d.). Pipeline. https://www.evoxtherapeutics.com/pipeline/ [13] Johnston, I (2024, 24 April). Roche cuts drug pipeline in effort to revitalise business. Financial Times https://www.ft.com/content/d2dfc0c4-85e0-4cf5-b926-c10d630b2772 [14] ADC Therapeutics (n.d.). Our Pipeline. https://www.adctherapeutics.com/our-pipeline/ [15] Alentis Therapeutics (n.d.). Novel therapies for cancer and fibrosis. https://alentis.ch/pipeline/ [16] Verdin, P. (2024). Top companies and drugs by sales in 2023. Nature reviews. Drug Discovery. [17] Novo Nordisk (n.d.). R&D pipeline. https://www.novonordisk.com/science-and-technology/r-d-pipeline.html [18] UCB (n.d.). PIPELINE. https://www.ucb.com/our-science/pipeline *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容美国Arthrosi公司创新药AR882溶解痛风石，2期临床试验成果亮相2024欧洲风湿病学大会全球First-in-class！迪哲医药戈利昔替尼重磅获批 2024年上半年FDA批准药物或新适应症（下）点击蓝字关注我们

基因疗法疫苗突破性疗法信使RNA临床1期

2024-05-10

·echemi

Top Scientist Resigns as Sanofi Reinvents Itself: A Shift Towards Immunology

In a significant move to establish its dominance in the field of immunology, pharmaceutical giant Sanofi has witnessed the departure of its Chief Scientific Officer and Research Director, Dr. Frank Nestle. The resignation of Dr. Nestle, announced on May 8, marks the highest-level exit since Sanofi initiated its global implementation of a streamlined research and development structure. This article delves into the company's strategic transformation, shedding light on its focus on immunology and the implications of Dr. Nestle's departure. Sanofi, a renowned player in the pharmaceutical industry, has been committed to creating its "immunology kingdom." CEO Paul Hudson had already hinted at a shift in the company's focus towards oncology in November 2023, outlining ambitious plans to increase the number of Phase 3 projects by 50% within two years, with a particular emphasis on immunology, neurology, and vaccines. As part of this initiative, Sanofi aimed to streamline its pipeline and allocate more funds to advance high-potential projects. Since the beginning of 2024, in alignment with the "Play to Win" program, Sanofi has relinquished several oncology projects acquired from Denali, Kymab, and Amunix, thereby reducing collaborations. Simultaneously, the company has initiated up to five rounds of layoffs, aiming to save up to €2 billion by the end of 2025. These measures reflect Sanofi's commitment to simplifying its research and development structure while optimizing resources for future endeavors. One notable development was the recent closure of a nearly $400 million acquisition of an NK cell therapy company, as announced during the update of the SAR445419 clinical trial information. SAR445419, an allogeneic NK cell therapy developed by Sanofi, was intended for the treatment of relapsed or refractory acute myeloid leukemia. However, due to Kiadis' withdrawal of funding, the SAR445419 Phase 1 study was prematurely terminated, resulting in the dissolution of the collaboration between Kiadis and Sanofi. Dr. Nestle joined Sanofi in September 2016, initially serving as the Global Head of Immunology and North America Chief Scientific Officer. Four years later, he was promoted to Global Head of Research and Chief Scientific Officer of the entire company. From April 2021 to October 2022, Dr. Nestle also chaired the board of Kiadis (now dissolved). With Kiadis' dissolution, Dr. Nestle's departure followed suit. Sanofi expressed its appreciation for Dr. Nestle's contributions in a statement to Fierce on May 8, stating that he played a key role in establishing a world-class research organization at Sanofi and remained an unwavering supporter of the company's "Play to Win" cultural transformation. The company acknowledged his exceptional leadership and dedication to advancing drug development for patients. Sanofi's relentless efforts to establish itself as an "immunology giant" involve capitalizing on the potential of its flagship immunoinflammatory agent, dupilumab. While fully exploring the potential of dupilumab, Sanofi also devotes resources to the development of successor products. The company's pipeline currently includes 34 projects related to immunology and inflammation, many of which hold tremendous potential to become groundbreaking therapies. Within the immunology pipeline, there are three potential Pipeline-In-a-Product (PIP) assets: amlitelimab, frexalimab, and the oral TNF blocker SAR441566. Each of these drugs possesses peak sales potential exceeding €5 billion. Sanofi's ongoing restructuring and streamlining efforts aim to generate the necessary funding for the development of a new generation of immunology products. Immunology occupies a crucial position in the company's strategic plans as it strives to establish itself as a leader in this therapeutic area. Recently, Sanofi further reduced its collaboration with IGMBiosciences, opting to prioritize antibodies targeting three immune and inflammatory (I&I) targets while abandoning three antibodies intended for oncology. Sanofi's transformation into an immunology-focused pharmaceutical powerhouse has witnessed the departure of Dr. Frank Nestle, its Chief Scientific Officer and Research Director. This strategic shift reflects the company's commitment to advancing innovative therapies in the field of immunology, with a particular emphasis on high-potential projects. As Sanofi strives to establish its "immunology kingdom," the departure of Dr. Nestle marks a significant milestone in the company's journey towards redefining its research and development landscape.

免疫疗法高管变更临床1期细胞疗法并购

2024-05-09

·药研网

重组后，赛诺菲首席科学官也离职

5月8日，据外媒Fierce Biotech报道，赛诺菲首席科学官兼研究主管Dr. Frank Nestle将离开公司。Nestle的离职是自上个月赛诺菲开始在全球实行“简化的研发结构”以来披露的最高级退出。重磅！赛诺菲分拆，裁员4次！早在 2023 年 11 月，首席执行官Paul Hudson就提前预告了从肿瘤学转向的重心，阐明未来两年内将3期项目数量增加50%的雄心，重点是免疫学、神经学和疫苗。基于此，将精简管线，把更多资金用于推进高潜力项目。2024年开年以来，为响应“Play to Win”计划，赛诺菲相继放弃了从Denali 、Kymab、Amunix 获得的多个肿瘤学项目，削减合作。简化研发结构的同时，赛诺菲还启动了高达5次的裁员，计划从2024年到2025年底节省高达20亿欧元。就在上个月，赛诺菲更新SAR445419临床试验信息时，公布将关闭近4亿美元收购的NK细胞疗法公司。SAR445419是赛诺菲研发的一种异基因NK细胞疗法，用于治疗复发/难治性急性髓系白血病。据美国临床试验数据库信息，SAR445419第一阶段研究因Kiadis的撤资而终止，Kiadis本身也因赛诺菲的优先级调整而被迫“消失”。Nestle于2016年9月加入赛诺菲，担任免疫治疗研究领域的全球负责人和北美首席科学官。四年后，他晋升为全球研究负责人兼整个公司的首席科学官。从2021年4月到2022年10 月，Nestle一直担任现Kiadis（现已解散）董事会主席。随着Kiadis的“消失”，Nestle也离职。“在过去的八年中，弗兰克表现出了杰出的领导力，并坚定地致力于为患者推进新药研发，”赛诺菲在5月8日向《Fierce》发表的声明中说：“他在赛诺菲打造一流研究机构的过程中发挥了关键作用，并一直是我们 “Play to Win ”文化转变的不懈支持者。我们非常感谢弗兰克为研发组织做出的贡献。”打造“免疫学王国”赛诺菲正在全力以赴打造自己的“免疫学王国”。免疫炎症“王牌”度普利尤单抗是赛诺菲扩张免疫版图的底气来源。在充分挖掘度普利尤单抗潜力的同时也在将精力倾注于后继产品的开发。放眼赛诺菲目前的管线中，包含34个涉及免疫和炎症的项目，很多具有成为重磅炸弹的潜力，在免疫学产品管线中就有3款PIP（Pipeline-In-a-Product，特指那些自带管线的产品，也就是潜在针对广阔适应症的药物）资产。潜在的PIP免疫产品包括amlitelimab、frexalimab和口服活性TNF阻滞剂SAR441566，每种药物的峰值销售潜力都超过50亿欧元。赛诺菲免疫和炎症管线潜在重磅炸弹资产| 来源：药智网目前，赛诺菲在部署精简和重组，其核心目标就是筹集新一代免疫学产品开发需要的现金，把免疫学开发放在了极其重要的位置，以将自己打造成“免疫学巨头”。近期，赛诺菲又在削减与IGM Biosciences达成的合作协议，优先选择专注三种靶向免疫学和炎症（I&I）靶点的抗体，并放弃三种用于肿瘤学的抗体。细胞系产品查询投稿丨商务合作转载丨加交流群往期推荐视角 | 纸面之外的药明康德2023年报Claudin18.2ADC赛道群雄逐鹿：3家率先进入III期临床下一个10亿美元重磅炸弹选手"裁员潮”仍在加剧：2月多家药企裁员点击下方“药研网”，关注更多精彩内容

并购疫苗免疫疗法高管变更细胞疗法

100 项与 Amlitelimab 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
特应性皮炎	临床3期	美国	Sanofi	2023-11-08
特应性皮炎	临床3期	中国	Sanofi	2023-11-08
特应性皮炎	临床3期	澳大利亚	Sanofi	2023-11-08
特应性皮炎	临床3期	巴西	Sanofi	2023-11-08
特应性皮炎	临床3期	加拿大	Sanofi	2023-11-08
特应性皮炎	临床3期	智利	Sanofi	2023-11-08
特应性皮炎	临床3期	法国	Sanofi	2023-11-08
特应性皮炎	临床3期	德国	Sanofi	2023-11-08
特应性皮炎	临床3期	印度	Sanofi-Aventis Recherche et Développement SA	2023-11-08
特应性皮炎	临床3期	印度	Genzyme Ireland Ltd.	2023-11-08

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临床结果

适应症

分期

评价

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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


NCT05131477 (STREAM-AD, GlobeNewswire) 人工标引	临床2期	特应性皮炎	390	amlitelimab (patients with continued treatment)	積壓廠鬱夢鑰糧鏇製窪(窪醖顧蓋築淵淵觸齋願) = 衊範襯構築窪觸積夢構膚夢膚鹹齋製壓鹹製範 (鹹鹽鬱夢鬱繭遞餘淵膚 ) 更多	积极	2024-03-11
				amlitelimab (patients withdrawn from treatment)	積壓廠鬱夢鑰糧鏇製窪(窪醖顧蓋築淵淵觸齋願) = 窪醖蓋觸淵願網積積觸膚夢膚鹹齋製壓鹹製範 (鹹鹽鬱夢鬱繭遞餘淵膚 ) 更多
STREAM-AD (NEWS) 人工标引	临床2期	特应性皮炎	390	amlitelimab	艱構築簾鹽鏇鏇鹽襯築(遞範艱廠餘膚壓鬱艱網) = 遞製積醖鏇夢顧衊夢範獵糧顧糧鹽鬱願觸醖淵 (顧窪夢艱齋繭鹹衊糧範 ) 更多	积极	2023-10-15
				placebo	艱構築簾鹽鏇鏇鹽襯築(遞範艱廠餘膚壓鬱艱網) = 鬱鹹鑰簾獵繭艱積積鑰獵糧顧糧鹽鬱願觸醖淵 (顧窪夢艱齋繭鹹衊糧範 ) 更多
NCT03754309 (AAD2023)	临床2期	特应性皮炎	89	Amlitelimab low-dose	構選淵鑰鏇鬱齋願鬱淵(鹹積壓繭餘鬱壓製選簾) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study 蓋鹽夢鏇範蓋壓鬱憲遞 (壓積築選糧範獵顧製艱 ) 更多	-	2023-03-17
				Amlitelimab high-dose
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	临床1期	-	64	KY1005	網鏇網夢鹹窪壓壓鬱齋(憲壓觸築範艱觸願構積) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. 蓋築觸壓選齋窪鬱齋蓋 (襯鹹築憲製艱獵憲鹽獵 ) 更多	-	2022-01-29
				Placebo