A Phase 2a, Open Label, Multi Center, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab (Subprotocol A) and subcutaneous (SC) blinatumomab (Subprotocol B) in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis.

开始日期2024-08-30

申办/合作机构

Amgen, Inc.

NCT05891379 / RecruitingN/AIIT

Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

开始日期2024-07-09

申办/合作机构

首都医科大学宣武医院

ChiCTR2400087203 / Recruiting临床4期IIT

Clinical Study of Inebilizumab Combined with Steroids for the Treatment of Neuromyelitis Optica Spectrum Disorder

开始日期2024-06-12

申办/合作机构-

100 项与伊奈利珠单抗相关的临床结果

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100 项与伊奈利珠单抗相关的转化医学

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100 项与伊奈利珠单抗相关的专利（医药）

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111

项与伊奈利珠单抗相关的文献（医药）

2024-12-01·Journal of central nervous system disease

Advances in the long-term treatment of neuromyelitis optica spectrum disorder

Review

作者: Anderson, Monique ; Levy, Michael

Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune neuroinflammatory disorder with a prevalence of 1-5/100,000 globally, characterized by attacks of the central nervous system including but not limited to optic neuritis, transverse myelitis and brainstem lesions, including area postrema lesions. These autoimmune attacks can lead to irreversible damage if left untreated, therefore strategies have been developed to prevent relapses. Initial off-label treatments have achieved variable levels of success in relapse prevention, but improved relapse prevention and quality of life remain a goal in the field. A better understanding of the underlying pathophysiology of NMOSD over the last 10 years has led to newer, more specific approaches in treatment, culminating in the first FDA approved treatments in the disease. In this review, we will discuss the seminal trials of PREVENT or Eculizumab in the treatment of aquaporin-4 (AQP4)-IgG positive NMOSD, N-Momentum or Inebilizumab in the study of NMOSD (both AQP4-IgG positive and negative) and SAkura Sky and SAkuraStar which studied satralizumab in AQP4-IgG seropositive and seronegative NMOSD patients. We will also discuss the extension trials of each of these medications and what lead to their approval in AQP4-IgG seropositive NMOSD patients. We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID.

2024-06-18·International Journal of Ophthalmology

Comparison of inebilizumab or rituximab in addition to glucocorticoid therapy for neuromyelitis optica spectrum disorders

Article

作者: Ma, Teng ; Wang, Yong ; Wang, Run-Sheng ; Tao, Lei ; Lou, Chu-Yuan ; Wang, Xiao-Tang ; Xing, Jia-Yuan

AIM: To investigate the short-term efficacy and safety of inebilizumab for neuromyelitis optica spectrum disorders (NMOSD). METHODS: A total of 33 patients with NMOSD treated with inebilizumab (Group INB, n=15) or rituximab (Group RTX, n=18) in addition to high-dose glucocorticoids were included. Both groups underwent hormone shock therapy during the acute phase. Subsequently, Group INB received inebilizumab injections during the remission phase, while Group RTX received rituximab injections. A comparison of aquaporins 4 (AQP4) titer values, peripheral blood B lymphocyte counts, and visual function recovery was conducted before and 8wk after treatment. Additionally, adverse reactions and patient tolerability were analyzed after using inebilizumab treatment regimes. RESULTS: Following inebilizumab treatment, there was a significantly improvement in the visual acuity of NMOSD patients (P<0.05), accompanied by a notable decrease in AQP4 titer values and B lymphocyte ratio (P<0.05). Moreover, inebilizumab treatment showed a partial effect in preventing optic nerve atrophy (P<0.05). However, there were no significant differences in other therapeutic effects compared to rituximab, which has previously demonstrated substantial therapeutic efficacy (P>0.05). Furthermore, inebilizumab exhibited higher safety levels than that of rituximab injections. CONCLUSION: The combination of inebilizumab and high-dose glucocorticoids proves to be effective. In comparison to rituximab injections, inebilizumab displays better tolerance and safety. Moreover, it demonstrates a partial effect in preventing optic nerve atrophy. Thus, it stands as an effective method to reduce the disability rates and improve the daily living ability of patients with NMOSD.

2024-06-01·LANCET NEUROLOGY

Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial

Article

作者: Cree, Bruce A C ; Hartung, Hans-Peter ; Marignier, Romain ; Cimbora, Daniel ; Kim, Ho Jin ; Cutter, Gary R ; Katz, Eliezer ; Rees, William ; Wingerchuk, Dean M ; Bennett, Jeffrey L ; Green, Ari J ; Pittock, Sean J ; Paul, Friedemann ; She, Dewei ; Smith, Michael ; Fujihara, Kazuo ; Weinshenker, Brian G ; Aktas, Orhan

BACKGROUND:

Inebilizumab, an anti-CD19 B-cell-depleting antibody, demonstrated safety and efficacy in neuromyelitis optica spectrum disorder in the randomised controlled period of the N-MOmentum trial. Here, end-of-study data, including the randomised controlled period and open-label extension period, are reported.

METHODS:

In the double-blind, randomised, placebo-controlled, phase 2/3 N-MOmentum trial, adults aged 18 years and older with an neuromyelitis optica spectrum disorder diagnosis, Expanded Disability Status Scale score of 8·0 or less, and history of either at least one acute inflammatory attack requiring rescue therapy in the past year or two attacks requiring rescue therapy in the past 2 years, were recruited from 81 outpatient specialty clinics or hospitals in 24 countries. Eligible participants were randomly assigned (3:1), using a central interactive voice system or interactive web response system, and a permuted block randomisation scheme (block size of 4), to receive intravenous inebilizumab (300 mg) or identical placebo on days 1 and 15 of the randomised period, which lasted up to 197 days. Participants and all study staff were masked to treatment assignment. The primary endpoint of the randomised period of the trial was time to onset of adjudicated neuromyelitis optica spectrum disorder attack on or before day 197. Participants in the randomised controlled period who had an adjudicated attack, completed 197 days in the study, or were in the randomised controlled period when enrolment stopped, could voluntarily enter the open-label period. In the open-label period, participants either initiated inebilizumab if assigned placebo (receiving 300 mg on days 1 and 15 of the open-label period) or continued treatment if assigned inebilizumab (receiving 300 mg on day 1 and placebo on day 15, to maintain B-cell depletion and masking of the randomised controlled period). All participants subsequently received inebilizumab 300 mg every 6 months for a minimum of 2 years. The end-of-study analysis endpoints were time to adjudicated attack and annualised attack rate (assessed in all participants who received inebilizumab at any point during the randomised controlled period or open-label period [any inebilizumab population] and the aquaporin-4 [AQP4]-IgG seropositive subgroup [any inebilizumab-AQP4-IgG seropositive population]) and safety outcomes (in all participants who were exposed to inebilizumab, analysed as-treated). This study is registered with ClinicalTrials.gov, NCT02200770, and is now complete.

FINDINGS:

Between Jan 6, 2015, and Sept 24, 2018, 467 individuals were screened, 231 were randomly assigned, and 230 received at least one dose of inebilizumab (n=174) or placebo (n=56). Between May 19, 2015, and Nov 8, 2018, 165 (95%) of 174 participants in the inebilizumab group and 51 (91%) of 56 in the placebo group entered the open-label period (mean age 42·9 years [SD 12·4], 197 [91%] of 216 were female, 19 [9%] were male, 115 [53%] were White, 45 [21%] were Asian, 19 [9%] were American Indian or Alaskan Native, and 19 [9%] were Black or African American). As of data cutoff for this end of study analysis (Dec 18, 2020; median exposure 1178 days [IQR 856-1538], total exposure of 730 person-years) 225 participants formed the any inebilizumab population, and 208 (92%) participants were AQP4-IgG seropositive. Overall, 63 adjudicated neuromyelitis optica spectrum disorder attacks occurred in 47 (21%) of 225 treated participants (60 attacks occurred in 44 [21%] of 208 in the AQP4-IgG seropositive subgroup); 40 (63%) of 63 attacks occurred in 34 (15%) of 225 treated participants during the first year of treatment. Of individuals who had an adjudicated attack while receiving inebilizumab, 36 (77%) of 47 were subsequently attack-free at the end of 4 years. Annualised attack rates decreased year-on-year, with end-of-study adjusted annualised attack rates being similar in the any inebilizumab-AQP4-IgG seropositive subgroup (0·097 [95% CI 0·070-0·14]) and any inebilizumab populations (0·092 [0·067-0·13]). Overall, 208 (92%) of 225 participants who received any inebilizumab had at least one treatment-emergent adverse event, the most frequent of which were urinary tract infection (59 [26%]), nasopharyngitis (47 [21%]), and arthralgia (39 [17%]). Infection rates did not increase over 4 years. Three (1%) of 225 participants in the any inebilizumab population died during the open-label period (one each due to a CNS event of unknown cause and pneumonia, respiratory insufficiency resulting from an neuromyelitis optica spectrum disorder attack and viral pneumonia related to COVID-19), all of which were deemed to be unrelated to treatment.

INTERPRETATION:

Data from the end-of-study analysis of the N-MOmentum trial showed continued and sustained clinical benefits of long-term inebilizumab treatment in individuals with neuromyelitis optica spectrum disorder, which supports the role of inebilizumab as a CD19+ B-cell-depleting therapy in neuromyelitis optica spectrum disorder.

FUNDING:

MedImmune and Viela Bio/Horizon Therapeutics, now part of Amgen.

192

项与伊奈利珠单抗相关的新闻（医药）

2024-09-17

·药渡

中美合作项目泽纳仕生物成功登陆纳斯达克，中国投资机构3年收获一个IPO

美国东部时间9月13日，生物制药公司Zenas BioPharma（简称：泽纳仕生物）正式在纳斯达克挂牌上市，股票代码：ZBIO。此次上市，泽纳仕生物发行价为17美元，计划发行1323.5万股，募资总额为2.25亿美元。上市首日，公司开盘价为18.35美元，较发行价上涨7.9%；收盘价为18.15美元，较发行价上涨6.76%；以收盘价计算，公司市值为6.95亿美元。公开信息显示，泽纳仕生物是一家以免疫学和炎症（I&I）为核心的处于临床阶段的全球性生物制药公司。首发管线为CD19/FcRIIb双功能抗体，已经进入IgG4-RD三期临床阶段，多发性硬化、wAIHA、系统性红斑狼疮处于二期临床阶段，后续管线包括CTLA-4融合蛋白、TNFα抗体、C1s抗体、IGF-1R抗体等。 “近两年，泽纳仕在IgG4-RD这一罕见病治疗领域取得了稳健且突出的进展，近期的同靶点产品Uplizna披露的临床实验成果，也进一步验证了公司选择的CD19/FcRIIb双功能抗体的价值。整体来看，公司在自免领域竞争格局清晰，研发管线极具差异化特色，管线license-in后多握有全球权益，未来前景值得期待。”在早前参与了泽纳仕生物并追加投资的Pivotal bioVenture Partners（简称：Pivotal）管理合伙人柳丹博士表示。值得一提的是，这次IPO距离上一轮泽纳仕完成C轮融资，仅过去3个多月，公司实际运营开展也仅3年多，如此高效顺利的投资也为当前中国医疗投资进一步打开了新思路。手握罕见病潜力管线泽纳仕生物由Lonnie Moulder于2019年创立。成立之始，公司就带有创始人Lonnie Moulder此前成功创业的光环。公开信息显示，泽纳仕生物创始人Lonnie Moulder曾为生命科学投资基金Tellus BioVentures创始人。2019年，由其联合创立并担任首席执行官的生物医药公司Tesaro，被葛兰素史克（GSK）以51亿美元收购，Tesaro主要上市产品Zejula（尼拉帕利，中文商品名：则乐®）就出自Lonnie Moulder之手，该产品2023年全球销售额就达到8.22亿美元。此后，Lonnie Moulder还曾担任全球生物制药再鼎医药的董事会成员。随着泽纳仕生物的上市，Lonnie Moulder此前的成功创业经历又得到了复刻。目前，泽纳仕生物首发管线Obexelimab是一款CD19/FcRIIb双特异性抗体，通过结合CD19和FcγRIIb以抑制B谱系细胞活性，具有治疗自身免疫性疾病的一流潜力。在已完成的5项临床试验中，Obexelimab治疗了198名受试者，显示出良好的耐受性和临床活性。目前，Obexelimab正在开发的前四个适应症包括免疫球蛋白G4相关疾病（IgG4-RD）、多发性硬化症、温抗体-自身免疫性溶血性贫血（IwAIHA）和系统性红斑狼疮。其中，免疫球蛋白G4相关疾病（IgG4-RD）已处于III期临床阶段，其余适应症均处于II期临床阶段。 2023年，泽纳仕生物就将Obexelimab治疗IgG4-RD的2期临床研究结果刊登于《柳叶刀风湿病学》。研究结果显示，治疗第169天，有12名患者（80%）的IgG4-RD RI（应答指数）评分比基线至少降低了2分，其中8名患者（67%）的RI评分为零（完全缓解）。所有在最初产生应答的患者都在试验结束时实现了持续应答。同年9月，泽纳仕生物宣布与百时美施贵宝（BMS）达成战略许可和合作协议，授予后者在日本、韩国、台湾地区、新加坡、香港和澳大利亚开发和商业化Obexelimab用于治疗自身免疫性疾病的独家权利。根据协议条款，泽纳仕生物将获得5000万美元的预付款现金，并有资格获得与实现某些开发、监管和商业里程碑有关的额外付款，以及Obexelimab在许可地区的净销售特许权使用费。除Obexelimab外，泽纳仕生物还握有一系列临床项目，包括处于 I 期的抗 TNFα 抗体 ZB002 和临床前CTLA4-Ig融合蛋白 ZB004，为其他免疫与炎症疾病提供潜在治疗药物。累获投资机构青睐稳健的表现和核心管线市场潜力也为泽纳仕生物吸引了多轮融资。就在此次上市前4个月，公司刚刚宣布完成2亿美元的C轮优先股融资。该轮融资由 SR One 与 NEA、Norwest Venture Partners 和 Delos Capital 领投，其他新老股东如Enavate Sciences ，Longitude Capital，Pivotal等共同参与。用于支持公司主要候选分子Obexelimab的中后期临床研发项目。 2022年11月，泽纳仕生物完成了由Enavate Sciences领投，Longitude Capital、Vivo、Pivotal、Quan等机构跟投的1.18亿美元B轮优先股融资。 “我们对这个卓越团队的能力充满信心，相信他们可以顺利完成Obexelimab多个潜在适应症的临床项目。”泽纳仕生物C轮融资领投方之一的SR One 投资合伙人Jake Nunn 曾评价称，“他们的科学研究有可能改写医学教科书”。在中早期参与了泽纳仕生物B轮融资的Pivotal投资团队成员刘智敏回忆称，之所以选择泽纳仕生物，一方面源于对公司创始人Lonnie Moulder连续创业者身份的认可。另一方面从管线角度考虑，Pivotal对CD19在自免领域的潜力也抱有极大期待。 “当时CD19还没有得到市场较大的关注，但从我们的分析角度，此前的部分临床前或临床试验已经证明，CD19与诸多自身免疫系统疾病形成相关，是免疫系统的关键调节者之一，符合我们对标的管线价值要求。”刘智敏表示。据介绍，参与泽纳仕生物投资的是Pivotal旗下中国一期美元基金。该基金成立之初，就希望从存在临床未满足需求的疾病领域中，孵化或引进临床数据具有优势、治疗逻辑较为成熟的靶点或管线，将其带入中国市场使国内患者获益。从泽纳仕生物发展来看，也符合了Pivotal等一众投资机构的预期，虽然管线来源于license-in，但创新价值凸显，管线临床表现却更为稳健。金融数据和研究提供商PitchBook就在发布的报告中表示，生物医药领域投资者退出的机会仍然存在于IPO和制药公司收购中，不过主要针对拥有临床数据的生物技术公司。其高级分析师Kazi Helal在报告中写道：“IPO格局喜忧参半，尽管数量有所减少，但优质公司仍有所上市。”泽纳仕生物无疑属于这一类企业。

临床3期IPO并购

2024-08-29

·米内网

【成绩单】翰森制药2024上半年营收大涨！净利润翻番！

精彩内容 8月27日，翰森制药晒出2024年上半年成绩单：营业收入65.06亿元人民币（单位下同），同比增长超44%；创新药与合作产品业绩激增超80%，占收入比重近八成；净利润27.26亿元，同比增长超111%；30多个在研创新药正源源不断向后期转化！图1：翰森制药中期简明综合损益表来源：翰森制药公告创新产品大爆发，营收占比近八成抗肿瘤、抗感染、中枢神经系统、代谢等治疗领域是翰森制药的优势领域，7款已上市的创新药（阿美乐、豪森昕福、孚来美、恒沐、昕越、圣罗莱及迈灵达）对应的9个适应症均已被纳入国家医保目录，临床价值备受肯定。纵览各领域药品收入，抗肿瘤药继续扛把子，在总营收中占比已逼近70%。得益于创新药产品销售收入大幅提升，以及GSK支付合作收入首付款，公司创新药与合作产品收入激增80.6%，占总收入比例达77.4%。表1：翰森制药已上市的创新药来源：米内网中国申报进度（MED）数据库翰森明星产品阿美乐®是首个中国原研三代EGFR-TKI，已获批二线治疗EGFR T790M+晚期NSCLC、一线治疗EGFR+晚期NSCLC两个适应症；第三个适应症（辅助治疗NSCLC）、第四个适应症（用于Ⅲ期不可切NSCLC患者在同步放化疗之后的维持治疗）的上市申请（NDA）均获国家药品监督管理局受理；阿美替尼包括术后辅助、一线化疗联用在内的多个适应症也处在Ⅲ期关键注册临床试验阶段。报告显示，公司将继续推进英国药品和医疗保健用品管理局及欧洲药品管理局对阿美替尼上市许可申请审评的监管程序，翰森制药将持续推进阿美替尼的国际化进程。同时，阿美替尼多项研究在2024 ASCO、2024 ELCC、《Frontiers in Pharmacology》（《药理学前沿》）发表。首款合作引进的治疗抗AQP4抗体+NMOSD的人源化CD19单抗昕越®临床应用继续深化，合作方Amgen正在进行伊奈利珠单抗IgG4相关疾病(IgG4-RD)以及重症肌无力（gMG）的含中国中心在内的全球多中心临床研究。2024年6月，Amgen宣布，随机双盲、多中心、安慰剂对照的Ⅲ期临床试验顶线结果显示，伊奈利珠单抗在治疗IgG4相关疾病（IgG4-RD）时达到了主要临床终点。此外，全球唯一获批上市的EPO模拟肽圣罗莱®全国医保落地执行，有望持续放量；首个中国原研口服抗乙型肝炎病毒药物恒沐®迎来上市3周年，累计惠及30余万患者，多项研究成果在国际大会发布，受到广泛认可；国产首款原研创新的GLP-1RA周制剂孚来美®多项临床数据在国际期刊发表，有望为糖尿病肾病（DKD）患者带来更优的治疗选择。自研+BD高效协同，50多项创新药临床研究快速推进 2024年上半年，公司研发开支约11.96亿元，同比增长约28.7%。通过自主研发与对外合作高效协同，翰森制药持续深耕抗肿瘤板块，科学探索全球潜力管线，加速布局抗感染、中枢神经系统、代谢、自免等领域。在日益完备的创新体系强劲驱动下，公司30余个创新药50多项临床快速推进，数款在研产品进入关键临床阶段。 2024年上半年，翰森制药有4款1类新药首次获批临床。HS-10501片拟用于治疗2型糖尿病和成人肥胖症，HS-10398胶囊拟用于治疗免疫球蛋白A肾病和膜性肾病，HS-10504片拟用于治疗晚期NSCLC。此外，公司还从荃信生物引入了HS-20137单抗，拟用于治疗银屑病等自免疾病。 2024上半年，翰森制药核心在研产品HS-20093（B7-H3 ADC）、HS-20094（GLP-1/GIP受体双重激动剂）、HS-10370（KRAS G12C抑制剂）取得多个关键临床进展并分别亮相2024ASCO、2024ADA、2024AACR等学术大会，充分彰显临床价值，受到国际权威认可。对外合作方面，2024年翰森制药共达成3项BD合作：3月与普米斯就HS-20117（EGFR/c-Met ADC）药物在全球合作区域内扩大合作；4月与荃信生物达成合作，在中国（包括香港、澳门和台湾）开发和商业化HS-20137单抗；8月获得麓鹏制药LP-168（BTKi）非肿瘤适应症中国(包括香港、澳门和台湾)权益。截至目前，公司已累计引入11个创新药合作项目，其中9个处于临床阶段，其余2个项目已进入到商业化阶段，同时公司积极寻求自有管线产品对外许可机会，已分别授予葛兰素史克（GSK）HS-20089（B7-H4 ADC）、HS-20093（B7-H3 ADC）海外独占许可权利。 2024上半年，公司在中国提交正式专利申请21件，获国内授权专利29件；海外专利正式申请49件，获海外授权20件。结语翰森制药在2024年上半年的财务数据中展现出了强劲的增长势头和稳健的财务表现，在创新药研发、市场拓展及国际化进程等方面均取得了显著成果，为公司的长远发展奠定了坚实基础。翰森制药在业绩报告中表示：成为全球领先的创新驱动型制药企业是公司的愿景，公司将持续加大创新研发投入，把握外部机遇，加速研发成果的转化，推进创新药物和治疗方案的快速上市，从而更好地满足中国乃至全球患者未满足的医疗需求。资料来源：公司半年报、米内网数据库本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

临床3期财报ASCO会议引进/卖出申请上市

2024-08-26

·GlobeNewswire-Health Care

Eliem Therapeutics Announces Additions to its Leadership Team

Brett Kaplan, M.D. appointed Chief Operating Officer Nishi Rampal, M.D. appointed Senior Vice President, Clinical Development SEATTLE and CAMBRIDGE, United Kingdom, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (Nasdaq: ELYM), announced today the appointments of Brett Kaplan, M.D., as Chief Operating Officer, and Nishi Rampal, M.D., as Senior Vice President, Clinical Development. “I am delighted to announce the addition of Brett and Nishi to our executive team,” said Dr. Aoife Brennan, CEO of Eliem Therapeutics. “Since completing the Tenet Medicines acquisition, we have worked diligently to build a best-in-class management team as we transition Eliem into a leading biotechnology company. Brett and Nishi represent two critical additions to the Eliem team. Brett has demonstrated exceptional financial and operational leadership throughout his career. Nishi brings an impressive track record in leading clinical development strategy, from bench to launch, across a variety of therapeutic areas, including key focus areas we plan to pursue at Eliem. We look forward to leveraging their expertise and insights as we grow Eliem and advance our pipeline focused on developing therapeutics for autoimmune-driven inflammatory diseases.” “I could not be more excited to be joining Eliem at this juncture in its evolution,” said Dr. Kaplan. “I look forward to working with the team to strengthen key areas of the business, positioning the Company for sustained success. Our commitment to advancing the organization will give us the potential to develop a pipeline of transformative therapies.” “Many patients with autoimmune diseases face suboptimal treatments,” said Dr. Rampal. “Eliem’s lead asset, budoprutug (previously referred to as TNT119), represents a potentially best-in-class anti-CD19 antibody with broad applications across a number of autoimmune diseases. I am inspired by Eliem’s mission and excited to advance the development of antibody-based therapies to address these unmet medical needs.” Brett Kaplan, M.D., Chief Operating OfficerDr. Kaplan has over 20 years of finance and operations leadership in biotechnology and investment banking. Before joining Eliem, Dr. Kaplan served as President, Chief Financial and Corporate Development Officer at Chroma Medicine Inc., where he raised approximately $250 million to fund the research and development of epigenetic editors, a new class of genomic medicines. Prior to Chroma, Dr. Kaplan was the Chief Financial Officer of Prevail Therapeutics, which was acquired by Eli Lilly and Company for $940 million. At Evercore Partners, Dr. Kaplan was a Managing Director, Investment Banking advising on strategic and financing transactions. Dr. Kaplan has held other corporate development and strategy positions at Cubist Pharmaceuticals, a pharmaceutical company acquired by Merck & Co., Inc., Biopure Corporation, and Eli Lilly. Dr. Kaplan is currently a director of Myeloid Therapeutics, Inc. and also served as a director of Compass Therapeutics, Inc. Dr. Kaplan holds an MBBCh. and an M.B.A. from the University of Witwatersrand. Nishi Rampal, M.D., Senior Vice President, Clinical DevelopmentDr. Rampal brings over 10 years of extensive experience in the pharmaceutical and biotechnology industries with a track record of leadership in rare disease drug development, spanning neurology, rheumatology, dermatology, and hematology. Over the course of her career in industry, she has led programs resulting in successfully global approvals including UPLINZA® (inebilizumab-cdon), a groundbreaking treatment for neuromyelitis optica spectrum disorder and ULTOMIRIS (ravulizumab-cwvz) a treatment for myasthenia gravis. Prior to Eliem, Dr. Rampal was the Executive Director Clinical Development at Horizon Therapeutics (acquired by Amgen, Inc. for $27.8 billion in October 2023), where she was the global lead on the development and strategy for UPLINZA. Prior to Amgen, Dr. Rampal was a Medical Director Clinical Development at Alexion Pharmaceuticals (acquired by AstraZeneca for $39 billion in December 2021). While at Alexion, Dr. Rampal worked on the global pivotal Phase 3 trial for ravulizumab (Ultomiris), CHAMPION® developed for myasthenia gravis. Dr Rampal completed her neurology residency at the Yale School of Medicine and her neurophysiology and epilepsy fellowship at Columbia University, and is double board certified with past academic appointments at Yale University, Columbia University, and Mount Sinai Icahn Schools of Medicine. About Eliem Therapeutics, Inc.Eliem Therapeutics is focused on developing therapeutics for autoimmune-driven inflammatory diseases, including advancing budoprutug, an anti-CD19 antibody designed for a broad range of autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, immune thrombocytopenia and membranous nephropathy. For more information, please visit https://eliemtx.com/ Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Eliem; the anticipated benefits of the acquisition of Tenet Medicines, Inc.; the strategy, anticipated milestones and key inflection points for Eliem; Eliem’s budoprutug product candidate, including expectations regarding budoprutug’s therapeutic benefits, clinical potential and clinical development and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Eliem may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of the Eliem to timely and successfully achieve or recognize the anticipated benefits of the acquisition; changes in applicable laws or regulation; the possibility that Eliem may be adversely affected by other economic, business and/or competitive factors; Eliem’s ability to advance budoprutug and/or its other product candidates on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring board; replicating in clinical trials positive results found in early-stage clinical trials of budoprutug; competing successfully with other companies that are seeking to develop treatments for systemic lupus erythematosus and lupus nephritis, immune thrombocytopenia and membranous nephropathy and other autoimmune driven inflammatory diseases; maintaining or protecting intellectual property rights related to budoprutug and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug and other product candidates Eliem may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Eliem’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Eliem’s most recent filings with the SEC. In addition, the forward-looking statements included in this press release represent Eliem’s views as of the date hereof and should not be relied upon as representing Eliem’s views as of any date subsequent to the date hereof. Eliem anticipates that subsequent events and developments will cause Eliem’s views to change. However, while Eliem may elect to update these forward-looking statements at some point in the future, Eliem specifically disclaims any obligation to do so, except as required by law. InvestorsChris Brinzey ICR Westwickechris.brinzey@westwicke.com339-970-2843

高管变更上市批准临床3期并购

100 项与伊奈利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	伊奈利珠单抗	L01XC	DB12530

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	加拿大	Horizon Therapeutics Ireland DAC	2023-12-15
视神经脊髓炎	美国	Horizon Therapeutics Ireland DAC	2020-06-11

未上市

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
系统性硬皮病	临床3期	日本	Mitsubishi Tanabe Pharma Corp.	2022-07-20
免疫球蛋白G4相关疾病	临床3期	美国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	中国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	日本	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	阿根廷	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	澳大利亚	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	加拿大	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	法国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	德国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	中国香港	Amgen, Inc.	2020-10-26

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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


NCT04540497 (MITIGATE, NEWS) 人工标引	临床3期	免疫球蛋白G4相关疾病	-	Uplizna	壓齋鏇膚遞觸憲網鑰選(鬱範構顧醖鬱積餘顧襯) = 觸網選糧鹽鹹糧窪憲製鬱繭蓋願鏇鬱願鏇壓選 (夢衊鹹糧鹹築築獵簾襯 ) 达到	积极	2024-06-06
				Placebo	-
ACTRIMS2024	N/A	干燥综合征 \| 全血细胞减少 \| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	-	Inebilizumab 300 mg	積艱蓋膚廠襯膚艱觸繭(鬱憲願顧鏇窪壓糧築廠) = 膚獵淵糧繭鹽鏇獵願淵淵鑰衊膚膚窪鹹夢構廠 (蓋廠餘鏇獵淵衊鹽繭鹹 ) 更多	-	2024-03-01
NCT02200770 (N-MOmentum, ACTRIMS2024)	临床2/3期	视神经脊髓炎 AQP4+	213	Inebilizumab 300 mg	選遞餘齋構製衊鹹蓋簾(膚鏇鬱淵餘鑰網夢鑰築) = 16.0% (4/25) reported ≥1 investigational product-related treatment-emergent adverse event (IP-TEAE) versus 20.0% (3/15) on PBO, and among non-Hispanic/Latino participants, the IP-TEAE was 26.4% (36/136) in the INEB group and 27.0% (10/37) in the PBO group. No IP-related serious events or deaths occurred in the Hispanic/Latino participants in INEB or PBO groups of the RCP 淵築衊蓋網願遞遞積蓋 (範壓憲製鑰齋鹽齋鏇糧 )	积极	2024-03-01
				Placebo
ACTRIMS2024	N/A	视神经脊髓炎	-	Inebilizumab 300 mg	膚遞廠鑰願鹽鬱襯衊鹹(獵蓋繭醖願夢鬱鹽構餘) = 餘鹹齋構膚襯醖選襯淵觸夢壓壓願糧積顧鏇廠 (窪餘範憲蓋選膚齋簾窪 )	-	2024-02-29
				Placebo	膚遞廠鑰願鹽鬱襯衊鹹(獵蓋繭醖願夢鬱鹽構餘) = 製簾範廠網積襯膚憲齋觸夢壓壓願糧積顧鏇廠 (窪餘範憲蓋選膚齋簾窪 )
EUCTR2014-000253-36-CZ \| EUCTR2014-000253-36-BG \| EUCTR2014-000253-36-DE \| EUCTR2014-000253-36-EE \| EUCTR2014-000253-36-NL \| EUCTR2014-000253-36-ES \| EUCTR2014-000253-36-HU \| EUCTR2014-000253-36-PL \| EUCTR2014-000253-36-GR ( N-MOmentum, Biospace) 人工标引	N/A	视神经脊髓炎	-	inebilizumab (AQP4-IgG+ group)	蓋願鹽網範壓衊鏇遞鹹(顧積膚願餘餘憲鹹繭鏇) = 構齋夢夢醖獵繭遞繭衊壓糧餘窪鹽獵醖鹹築襯 (淵築繭網範範糧觸鹹夢 )	积极	2024-01-16
NCT02200770 (N-MOmentum, ECTRIMS2023)	临床2/3期	视神经脊髓炎 aquaporin-4 antibody (AQP4+)	208	Inebilizumab	積鬱齋築蓋襯遞衊鑰構(夢鑰廠獵蓋顧製鑰範觸) = 夢積艱鹹繭構醖衊遞衊廠蓋選憲蓋蓋醖繭醖繭 (願獵夢鑰顧壓衊積餘蓋, 71 ~ 83)	积极	2023-09-30
				Azathioprine and other immunosuppressive therapies (AZA/IST)	積鬱齋築蓋襯遞衊鑰構(夢鑰廠獵蓋顧製鑰範觸) = 夢選顧範膚糧願窪範鏇廠蓋選憲蓋蓋醖繭醖繭 (願獵夢鑰顧壓衊積餘蓋, 27 ~ 46)
ACTRIMS2023	N/A	新型冠状病毒感染 \| 视神经脊髓炎 aquaporin-4 seropositive	182	Inebilizumab	蓋簾顧顧繭廠簾構鬱顧(鹽網築襯積憲遞鑰鬱蓋) = In all, there were 17 reports of confirmed COVID-19 infections among inebilizumab treated NMOSD patients (women, n=15, unknown, n=2) from March 2020-July 2022. Median (range) age was 57 (32-68) years (n=15). Among 182 patients in N-MOmentum, 2 COVID-19 infections were reported between March-November 2020, prior to vaccine availability. The incidence rate was 0.024 (E/PY). In the safety database, 15 events were reported as of July 31, 2022. Median inebilizumab exposure was 123 days (range 10-2379 days, n=11) from first infusion to COVID-19 diagnosis.Of the total of 17 events, 10 events were reported as serious. COVID-19 vaccination status was not known. Five patients had pneumonia. Of 10 patients with known outcomes 6 were reported as ârecovered/resolvedâ, 2 as not recovered/resolved at the time of reporting, and 2 died: 1 patient, 62 years, in Peru, died May 2020 before vaccine availability, possible COVID pneumonia, possible renal failure, received antibiotics, hydroxychloroquine and ivermectin; and 1 patient, 32 years, in US, died Feb 2021, possibly partially vaccinated, history of obesity, deep vein thromboembolism (DVT), sickle cell trait, treated for possible COVID pneumonia complicated by pulmonary embolism (PE). Inebilizumab treatment was reported as not changed in 3 patients, discontinued in 1 patient, and action was unknown for the rest. 鑰膚廠齋積遞願選鹹夢 (鬱廠夢糧築憲鏇糧艱範 )	积极	2023-05-30
NCT02200770 (N-MOmentum, ACTRIMS2023)	临床2/3期	视神经脊髓炎 aquaporin-4 seropositive	-	Inebilizumab (INEB)	選構餘夢遞憲艱積顧鹹(製窪選範憲齋淵簾淵築) = 積餘齋範鹹襯獵醖鬱鏇鑰築醖製鹹願蓋淵餘窪 (觸顧衊築餘網積餘鹽範, -97.1 ~ 204.7) 更多	积极	2023-05-30
				Placebo (PBO)	選構餘夢遞憲艱積顧鹹(製窪選範憲齋淵簾淵築) = 構淵蓋膚觸鹽夢鏇壓觸鑰築醖製鹹願蓋淵餘窪 (觸顧衊築餘網積餘鹽範, -92.7 ~ 69.2) 更多
NCT02200770 (N-MOmentum, AAN2023)	临床2/3期	视神经脊髓炎 rs396991 polymorphism	142	Inebilizumab 300 mg	網衊構壓廠齋構糧糧醖(鏇獵齋網窪範構鹹鹽蓋) = 製夢艱膚繭構壓鏇夢衊夢網衊醖顧醖積網齋衊 (築淵窪廠遞淵構鬱蓋艱 )	积极	2023-04-25
				Placebo	網衊構壓廠齋構糧糧醖(鏇獵齋網窪範構鹹鹽蓋) = 鬱鬱夢憲鹹積衊簾觸窪夢網衊醖顧醖積網齋衊 (築淵窪廠遞淵構鬱蓋艱 )
NCT02200770 (N-MOmentum, ECTRIMS2022)	临床2/3期	视神经脊髓炎 rs396991	142	Inebilizumab 300 mg	壓網廠膚淵遞廠夢蓋獵(醖淵製繭憲衊鏇顧鑰膚) = 襯繭觸餘窪鏇構衊製膚艱遞築製範選廠夢襯製 (窪膚膚衊積齋蓋鹽壓淵 )	-	2022-10-12
				Placebo	壓網廠膚淵遞廠夢蓋獵(醖淵製繭憲衊鏇顧鑰膚) = 築選廠製壓獵積蓋壓壓艱遞築製範選廠夢襯製 (窪膚膚衊積齋蓋鹽壓淵 )