Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.

开始日期2018-05-31

申办/合作机构

Ichnos Sciences, Inc.初创企业

[+1]

NL-OMON44196 / CompletedN/A

A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects - GBR 830 SAD and MAD study

开始日期2017-07-05

申办/合作机构

Ichnos Sciences SA

NL-OMON42954 / CompletedN/A

An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route - GBR 830 pharmacokinetics, absolute bioavailability and safety study

开始日期2017-01-09

申办/合作机构

Ichnos Sciences SA

100 项与 Telazorlimab 相关的临床结果

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100 项与 Telazorlimab 相关的转化医学

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100 项与 Telazorlimab 相关的专利（医药）

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项与 Telazorlimab 相关的文献（医药）

2024-02-01·The journal of allergy and clinical immunology. Global

Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis

Article

作者: Mozaffarian, Neelufar ; Anstett, Victor ; Sher, Lawrence D ; Pulka, Grazyna ; Rewerska, Barbara ; Martinet, Camille ; Jabert, Wafaa ; Blein, Stanislas ; Turrini, Riccardo ; Alpizar, Sady ; Macoin, Julie ; Ca, Vinu ; Doucey, Marie-Agnès ; Pauser, Sylvia ; Machkova, Martina ; Gn, Sunitha ; Konto, Cyril ; Salhi, Yacine ; Gudi, Girish

Background:

Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases.

Objective:

This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis.

Methods:

In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks' blinded treatment, followed by 38 weeks' open-label treatment and 12 weeks' drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events.

Results:

The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (-54.4% vs -34.2% for part 1 and -59.0% vs -41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2.

Conclusion:

Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis.

2022-02-17·The Journal of dermatological treatment4区 · 医学

Review and analysis of biologic therapies currently in phase II and phase III clinical trials for atopic dermatitis

4区 · 医学

Review

作者: Uppal, Shelley K. ; Wu, Jashin J. ; Han, George ; Chat, Vipawee S. ; Kearns, Donovan G.

Biologic medications are recent advances that have clinical significance in the treatment of moderate-to-severe AD. A systemic literature review was performed to examine the efficacy and safety of biologic therapies currently in phase II and phase III of clinical trials for moderate-to-severe AD. Our team searched the databases, PubMed, Google Scholar, and ClinicalTrials.gov, on September 2019 for studies pertaining to the use of biologic drugs in AD. Key words included each drug (lebrikizumab, tralokinumab, fezakinumab, etokimab, nemolizumab, tezepelumab, and GBR 830) or 'biologic drugs' or 'immunotherapies' combined with 'atopic dermatitis.' References within retrieved articles were also reviewed to identify potentially missed studies. A total of 19 articles were included in this review. Lebrikizumab, tralokinumab, fezakinumab, nemolizumab, and GBR 830 lead to statistically significant improvements in disease severity and multiple endpoint outcome scores. Tezepelumab and etokimab, however, did not demonstrate statistically significant changes in primary outcome endpoints. Further assessment of tezepelumab and etokimab are needed to assess their safety and efficacy in patients with moderate-to-severe AD. Tralokinumab, lebrikizumab, fezakinumab, nemolizumab, and GBR 830 are effective treatment options for adults with moderate-to-severe AD, but further large-scale studies are needed to confirm their efficacy as monotherapy in children with moderate-to-severe AD.

2022-02-01·Allergy1区 · 医学

A mathematical model to identify optimal combinations of drug targets for dupilumab poor responders in atopic dermatitis

1区 · 医学

Article

作者: Irvine, Alan D. ; Tanaka, Reiko J. ; Miyano, Takuya

Abstract:

Background:

Several biologics for atopic dermatitis (AD) have demonstrated good efficacy in clinical trials, but with a substantial proportion of patients being identified as poor responders. This study aims to understand the pathophysiological backgrounds of patient variability in drug response, especially for dupilumab, and to identify promising drug targets in dupilumab poor responders.

Methods:

We conducted model‐based meta‐analysis of recent clinical trials of AD biologics and developed a mathematical model that reproduces reported clinical efficacies for nine biological drugs (dupilumab, lebrikizumab, tralokinumab, secukinumab, fezakinumab, nemolizumab, tezepelumab, GBR 830, and recombinant interferon‐gamma) by describing system‐level AD pathogenesis. Using this model, we simulated the clinical efficacy of hypothetical therapies on virtual patients.

Results:

Our model reproduced reported time courses of %improved EASI and EASI‐75 of the nine drugs. The global sensitivity analysis and model simulation indicated the baseline level of IL‐13 could stratify dupilumab good responders. Model simulation on the efficacies of hypothetical therapies revealed that simultaneous inhibition of IL‐13 and IL‐22 was effective, whereas application of the nine biologic drugs was ineffective, for dupilumab poor responders (EASI‐75 at 24 weeks: 21.6% vs. max. 1.9%).

Conclusion:

Our model identified IL‐13 as a potential predictive biomarker to stratify dupilumab good responders, and simultaneous inhibition of IL‐13 and IL‐22 as a promising drug therapy for dupilumab poor responders. This model will serve as a computational platform for model‐informed drug development for precision medicine, as it allows evaluation of the effects of new potential drug targets and the mechanisms behind patient variability in drug response.

项与 Telazorlimab 相关的新闻（医药）

2024-03-20

·药融圈

印度TOP10制药：Glenmark集中力量创新，仿制药企转型综合性药企

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。20世纪70年代开始，印度制药产业开始崛起，当前印度已经是名副其实的仿制药大国，在之前介绍过不少印度药企，今天想和大家聊聊该国的TOP10药企——Glenmark Pharmaceuticals（以下简称Glenmark），Glenmark成立于1977年，致力于在皮肤科、呼吸系统和肿瘤学领域建立品牌药、仿制药和OTC的全球业务，同时还在糖尿病、心血管和口服避孕药等其他治疗领域拥有一系列产品。公司旗下包括Glenmark life science（GLS）和Ichnos Glenmark Innovation（IGI）两个子公司。其中Glenmark life science成立于2019年，在全球主要市场制造和销售API（活性药物成分），目前有接近140个产品，全球前20仿制药企业均是其客户。作为高质量原料药的领先生产商，还为许多跨国和专业制药公司提供CDMO服务，为客户提供定制的解决方案，包括支持监管申请、研究、技术援助和专业API的制造。2023年9月，Glenmark宣布与Nirma Limited达成最终协议，剥离GLS 75%的股份，经过此交易后，Glenmark持有GLS 7.84%的股份。Ichnos Glenmark Innovation（IGI）专注于肿瘤治疗药物的研发，目前拥有三种处于临床阶段的针对多发性骨髓瘤、急性髓系白血病和实体瘤的创新肿瘤分子。该公司的主要优势在于其专有的BEAT蛋白工程平台，该平台能够创造出高度灵活和可制造的全长多特异性抗体，通过利用这个平台，公司的目标是发现能够同时针对多个因素的化合物，从而扩大它们的管线并产生长期价值。2024年1月底，Glenmark宣布与其子公司Ichnos Sciences成立联盟-Ichnos Glenmark Innovation（IGI），该联盟将Glenmark在小分子方面的研发能力与Ichnos Sciences在新型生物制剂方面的研发能力结合，以继续开发治疗血液系统恶性肿瘤和实体瘤的治疗方案。位于仿制药企林立的印度，Glenmark打算涉足艰难的创新药赛道，在公司长期发展战略中，公司决定集中其创新力量将公司从一家仿制药企业发展为一家具有多样化先进药物组合的综合型全球制药公司。当前研发管线专注于肿瘤和自身免疫性疾病01 主打产品药融云数据（www.pharnexcloud.com）显示：Glenmark针对呼吸系统疾病的主要产品包括Indame DPI（用于治疗哮喘）、VirX Nasal Spray（用于预防呼吸道感染的鼻喷雾剂）、Airz FB（用于慢性阻塞性肺病）、Pirfenidone（治疗特发性肺纤维化）、Ipratropium（可用于扩大肺部气道）、Ascroil Expectorant（用于治疗咳嗽）、Aerogold（用于治疗支气管痉挛）、Glemont tablet（用于治疗哮喘和过敏）和Ryaltris（糠酸莫米松+盐酸奥洛他定）。皮肤病类产品主要包括Candid Prickly Heat Powder（用于控制细菌生长和感染）、Minym Gel（用于治疗痤疮）、La Shield Probiotic Moisturizer（保湿霜）、Isavuconazole（用于治疗真菌感染）、Lasderma Cream（针对色素沉淀并有提亮功效）、Tacroz（用于治疗特应性湿疹）、Momate Ointment（治疗皮肤湿疹和牛皮藓）、Powercort Cream（治疗特应性皮炎和牛皮藓）和Fenismart gel（用于缓解皮肤瘙痒和皮疹等）。肿瘤学领域产品包括Abiraterone（阿比特龙）、Sunitinib（舒尼替尼）、Pazopanib（培唑帕尼）等，另外还有针对糖尿病和心脏领域的产品。药融云数据（www.pharnexcloud.com）显示：其中，Ryaltris作为公司第一个全球产品，目前已在70多个国家/地区提交上市申请，这是一种创新的鼻腔喷雾剂，由糠酸莫米松和盐酸奥洛他定固定剂量组合而成，2022年1月获FDA批准，用于治疗12岁及以上的成人和儿童患者的季节性过敏性鼻炎。2019年2月，远大医药与Glenmark签订独家授权协议，获得商业化Ryaltris的独家授权和为期20年的中国独家专利权，2024年2月20日，远大医药宣布用于治疗成人和儿童过敏性鼻炎(AR)的全球创新药Ryaltris复方鼻喷剂(GSP 301 NS)向国家药监局递交的新药上市申请已获受理。目前Glenmark还专注于加强与Bausch、Hikma和Menarini等主要合作者的合作伙伴关系，以在新的地区将该产品商业化。药融云数据库：药品基本信息除了以上提到的产品外，API也是公司的营收大头，以下是公司部分API清单：02 研发管线Glenmark当前正在进展的研发管线包括肿瘤学和自身免疫性疾病的产品，各管线具体进展情况如下：1、肿瘤学（1）ISB 1442ISB 1442是一种靶向CD38和CD47的first-in-class双特异性抗体，由Ichnos实验室的科学家研发，通过抑制CD47-SIRPα轴来杀死表达CD38的肿瘤细胞，以增加抗体依赖性细胞吞噬作用（ADCP）并增强抗体依赖性细胞毒性（ADCC）以及补体依赖性细胞毒性（CDC）。2023年3月ISB 1442被FDA授予多发性骨髓瘤孤儿药资格，目前研究进行到临床试验1期。从2023年介绍的临床试验1期的信息来看，ISB1442治疗耐受性良好，观察到的CRS事件为低级别（1或2次），大多在一天内消退，迄今为止，尚未观察到神经毒性事件且没有感染或贫血的信号。同时，公司还计划开发ISB1442用于急性髓系白血病（AML），研究表明，通过多种抗体依赖性作用机制杀伤测定来衡量，ISB1442在CD38高/低肿瘤模型中相对于达雷妥尤单抗的体外效力更高。（达雷妥尤单抗是全球获批的首个针对肿瘤浆细胞表面的CD38分子、人源化免疫球蛋白IgG1单克隆抗体。最初由丹麦药企Genmab研发的，2012年强生通过签署11亿美元的协议从Genmab获得其全球独家权利）（2）ISB 2001ISB 2001是first-in-class的靶向多发性骨髓瘤细胞上BCMA和CD38的T细胞结合抗体，它是一种基于Ichnos专有BEAT平台的三特异性抗体，可实现全长多特异性抗体的最大灵活性和出色的可制造性。目前正在进行ISB2001针对复发/难治性多发性骨髓瘤患者的临床试验1期、首次人体剂量递增和剂量扩展研究。首位患者于2023年11月给药，目前正在积极招募队列4的患者。体外研究表明，与目前被批准用于治疗多发性骨髓瘤或正在进行临床研究中测试的所有测试抗体相比，ISB 2001对肿瘤细胞的杀伤力更高。多发性骨髓瘤模型的体内研究也表明，与批准的多发性骨髓瘤抗体治疗相比，ISB 2001的效力更高。2023年4月，Ichnos获得了FDA和澳大利亚HREC的批准，启动了ISB 2001用于治疗复发/难治性多发性骨髓瘤的临床试验1期首次人体研究，公司正在考虑同时将临床研究扩展到其他国家。（3）GRC 54276GRC 54276是一种HPK1抑制剂，目前正在开发作为实体瘤患者的口服IO（免疫肿瘤学）辅助治疗药物。造血祖细胞激酶1（HPK1）是T细胞和B细胞受体信号转导的负调节因子，是一种有吸引力的癌症免疫肿瘤治疗策略。GRC 5427作为一种新型的口服活性HPK1抑制剂，具有独立的疗效，可增强目前的免疫治疗效果，目前正在首次人体临床试验1期研究中对其进行评估。自2022年7月以来，该研究的临床试验1a期单药治疗阶段在印度进行。该研究的50 mg单药疗法回填队列正在招募其他受试者，以进一步评估GRC 54276单药疗法的安全性和耐受性。GRC 54276与帕博利珠单抗和阿替利珠单抗的临床试验1b期联合研究分别于24财年第一季度和24财年第二季度在印度和美国启动。截至24财年第三季度，GRC 54276与帕博利珠单抗和阿替利珠单抗的两个剂量队列已经完成，第三个队列的患者招募和给药正在进行中。2、炎症和自身免疫性疾病公司目前有两项针对自身免疫性疾病的单克隆抗体候选药物处于研发阶段，具体进展情况如下：抗体ISB 830（telazorlimab），ISB 830是一种OX40拮抗剂，在2021年完成了一项针对中度至重度特应性皮炎的临床试验2b期研究。2023年10月Ichnos与Astria Therapeutics签订了ISB 830治疗自身免疫性疾病的独家全球许可协议。ISB 880是一种阻断IL-1RAP信号转导的全人源、高亲和力单克隆抗体，已完成针对自身免疫性疾病患者的IND研究，目前正在进行临床试验1期研究。2021年12月与Almirall签订了ISB 880治疗自身免疫性疾病的独家全球许可协议。根据协议条款，Almirall承担该化合物的全球开发和商业化的全部成本和责任。财务状况Glenmark 2023-2024财年前三季度（2023.04-2023.12）综合运营收入为981.91亿卢比（11.97亿美元），上年同期为961.64亿卢比（12.08美元），同比增长2.9%。2023-2024财年第三季度综合运营收入290.96亿卢比（3.491亿美元），而去年同期为346.39亿卢比（4.226亿美元），同比下降16%，这一季度销售额下降的主要原因是公司的印度业务受到了较大影响，因为公司通过整合库存点和合理化渠道库存，对其整体分销模式进行了调整，这将有助于该公司在未来提高营业利润率和整体营运资本。（注：2023-2024财年数据根据汇率1.00美元=82.69印度卢比换算，2022-2023财年数据根据汇率1.00美元=79.58印度卢比换算）2023-2024财年第三季度财政营收分区域来看，印度配方业务销售额为26.22亿卢比（2080万美元），上年同期为107.45亿卢比（1.307亿美元），下降了75.6%；北美业务的成品制剂销售收入为76.29亿卢比（9160万美元），上年同期83.73亿卢比（1.023亿美元），同比下降8.9%；欧洲业务收入63.57亿卢比（7640万美元），与上年同期相比增长了28.9%；其他地区收入72.50亿卢比（8720万美元），与上年同期相比增长10.8%；GLS的API产品销售额为41.29亿卢比（4960万美元），与上年同期相比增长9.9%。以下是该季度公司全球产品Ryaltris在主要地区的市场份额情况：2022-2023财年，Glenmark的综合运营收入为1299.01亿卢比（16.19亿美元），与上年同期相比增长5.6%。根据IQVIA MAT 2023年3月的数据，Glenmark在印度制药市场的呼吸系统细分市场中排名第二，与整个呼吸系统市场相比，价值增长高出1.5倍。整体来看，Glenmark现在在印度的皮肤科和呼吸科领域均排名第二。国内合作最新动态药融云数据（www.pharnexcloud.com）显示：2024年1月25日，康宁杰瑞与思路迪医药共同宣布，双方就皮下注射PD-L1抗体药物恩维达（恩沃利单抗注射液）与Glenmark全资附属公司Glenmark Specialty S.A.达成协议，授予Glenmark在印度、亚太地区（除新加坡、泰国、马来西亚）、中东和非洲、俄罗斯、独联体和拉丁美洲的肿瘤适应症开发和商业化独家许可权益。有关KN035开发及商业化费用由Glenmark自行承担。恩维达由康宁杰瑞自主研发，2020年康宁杰瑞、思路迪医药、先声药业三方达成战略合作，康宁杰瑞作为原研方负责生产和质量，思路迪医药负责肿瘤领域的临床开发，先声药业负责产品在中国大陆的独家商业推广。2021年11月，恩维达在中国率先获批上市，适用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者的治疗，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者以及既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。目前在中国和国外多个地区针对多个肿瘤适应症开展研究。参考：NMPA/CDE药融云数据，www.pharnexcloud.comFDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）；https://glenmarkpharma.com/；https://www.cphi.cn/news/show-wiki-195214.html；https://www.grandpharm.com/news/%e8%bf%9c%e5%a4%a7%e5%8c%bb%e8%8d%af%e5%85%a8%e7%90%83%e5%88%9b%e6%96%b0%e4%ba%a7%e5%93%81ryaltris%e5%a4%8d%e6%96%b9%e9%bc%bb%e5%96%b7%e5%89%82%e5%9b%bd%e5%86%85nda%e8%8e%b7%e5%9b%bd%e5%ae%b6/；https://xueqiu.com/4376152234/276426105；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月底 • 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。

申请上市

2024-03-11

·Pharmaceutical Technology

Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis

Sanofi’s investigational drug amlitelimab is forecast to generate $581m in sales by 2030, as per GlobalData analysis. Credit: Golden Shrimp via Shutterstock. Sanofi has announced encouraging findings from the second part of a study with the OX40 antibody amlitelimab, which showed sustained improvement in treating moderate to severe atopic dermatitis symptoms in previously treated patients. In the second part of the STREAM-AD study, patients initially responding to amlitelimab were re-randomised to either continue treatment or withdraw over 28 weeks. Those continuing treatment maintained high responder rates for Eczema Area and Severity Index (EASI-75) and/or Investigator Global Assessment (IGA 0/1), as did those withdrawn from treatment – 69.2% of patients continued IGA 0/1 and/or EASI-75 response compared to 58.8% in those who had withdrawn. A pooled analysis showed that those who continued treatment maintained an IGA 0/1 response in 71.9% compared to 57% in the treatment-withdrawn group, with EASI-75 response maintained in 69% compared to 61.6% of patients, respectively. Atopic dermatitis-related biomarkers remained reduced at week 52 in both groups, highlighting durable control of the condition post-amlitelimab withdrawal. Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy, which means less frequent dosing every 12 weeks could be evaluated, explained chair of the department of dermatology and allergy at the University Hospital Schleswig-Holstein Stephan Weidinger, in the 11 March press release. The 12-week dosing schedule of amlitelimab 250mg with a 500mg loading dose is now being investigated in a larger Phase III clinical program (OCEANA). See Also: AD/PD 2024: BioVie’s novel NE3107 shows promise but confirmatory trial needed Amlitelimab, a human anti-OX40 ligand monoclonal antibody, is under development for the treatment of atopic dermatitis, hidradenitis suppurativa, asthma, alopecia areata, celiac disease and systemic sclerosis. The antibody is forecast to generate $581m in sales by 2030, as per GlobalData analysis. GlobalData is the parent company of Clinical Trials Arena. Another OX40 inhibitor in the atopic dermatitis space is Amgen and Kyowa Kirin’s KHK4083 (rocatinlimab), with Amgen handling the development, production, and marketing for all worldwide markets, excluding Japan. KHK4083 is forecast to generate $960m in 2029, according to GlobalData. In October 2023, Astria Therapeutics signed an exclusive global agreemen t to license Ichnos Sciences’ OX40 portfolio to treat atopic dermatitis in a $305m deal, paying $15m upfront. The portfolio includes monoclonal antibody OX40 antagonists STAR-0310 and telazorlimab. Atopic dermatitis is a long-term chronic form of eczema commonly seen in people with sensitive skin and a malfunctioning immune system. In the announcement accompanying the data, the head of global development, immunology and inflammation at Sanofi, Naimish Patel said: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal programme.”

临床3期临床结果引进/卖出

2024-01-30

·PRNewswire

Ichnos and Glenmark take a collaborative leap to accelerate innovation in Cancer Treatment with their alliance - 'Ichnos Glenmark Innovation'

This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors. IGI harnesses the collective expertise of over 150 scientists, operating through its three centers of innovation across the USA, Switzerland and India. There are currently three oncology molecules in clinical trials, with two having received orphan drug designation from the U.S. FDA. The synergies derived from this alliance will substantially reduce Glenmark's investment in innovative research. NEW YORK, Jan. 30, 2024 /PRNewswire/ -- Ichnos Sciences Inc. (Ichnos), a global, fully integrated, clinical-stage biotech company and Glenmark Pharmaceuticals Ltd. (Glenmark), a leading, research-driven, global pharmaceutical company, today announced the launch of their alliance – Ichnos Glenmark Innovation – to accelerate new drug discovery in cancer treatment. This alliance combines Ichnos' research and development proficiencies in novel biologics with those of Glenmark in new small molecules, to continue developing cutting-edge therapy solutions that treat hematological malignancies and solid tumors. The newly formed IGI features a robust pipeline of three innovative oncology molecules targeting multiple myeloma, acute myeloid leukemia, and solid tumors currently undergoing clinical trials. Two of these molecules have received orphan drug designation from the U.S. FDA. Additionally, IGI has two autoimmune disease assets that have been out licensed to leading companies. The alliance will also further explore the in-licensing of late-stage clinical assets to augment its novel oncology drug pipeline. Harnessing the combined proficiency of over 150 scientists, IGI will leverage the capabilities of its three global centers of innovation. These comprise the Ichnos' headquarters in New York City, NY, USA which is focused on clinical development; the biologics research center in Lausanne, Switzerland; and Glenmark's small molecule research center at Mahape in Mumbai, India. "We are proud to announce the Ichnos Glenmark Innovation alliance, which brings together the legacy of Glenmark and passion of Ichnos to accelerate the search for curing cancer. Innovation is an integral part of our organization's fabric and through IGI, we are confident of getting closer to our quest to develop a novel cancer drug for the world. Additionally, this will also enhance shareholder value by optimizing the cost of development." remarked Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Ltd. Cyril Konto, President and CEO, Ichnos Glenmark Innovation, said, "Ichnos Glenmark Innovation is a collaborative venture backed by a strong, collective pipeline of novel multispecifics and small molecules. Supported by an experienced leadership and comprising a team that ardently believes in challenging the frontiers of science, IGI seeks to accelerate drug development by combining technologies, expertise, and forces while leveraging Glenmark's footprint in India. We look forward to joining hands with other like-minded entities, including biotech companies and academia." IGI - Brand Identity: IGI's brand identity succinctly expresses its belief. The letters IGI combine the graphic of a compass to suggest how collaboration guides IGI towards innovation. The brand line 'Collaboration propels innovation' completes the message. This new alliance promises myriad new possibilities for Glenmark, Ichnos and the world at large. IGI – Asset Pipeline: Oncology Pipeline Has an exciting platform of novel biologics and small molecules targeting the spectrum of hematological cancers and solid tumors. Autoimmune Disease Pipeline The autoimmune disease assets were out licensed to enable greater focus on oncology. Available for Licensing Logo: SOURCE Ichnos Sciences Inc.

孤儿药引进/卖出

100 项与 Telazorlimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16374

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
中度特应性皮炎	临床2期	美国	Ichnos Sciences SA	2016-03-01
中度特应性皮炎	临床2期	美国	Ichnos Sciences, Inc.初创企业	2016-03-01
中度特应性皮炎	临床2期	加拿大	Ichnos Sciences, Inc.初创企业	2016-03-01
中度特应性皮炎	临床2期	加拿大	Ichnos Sciences SA	2016-03-01
重度特应性皮炎	临床2期	美国	Ichnos Sciences SA	2016-03-01
重度特应性皮炎	临床2期	美国	Ichnos Sciences, Inc.初创企业	2016-03-01
重度特应性皮炎	临床2期	加拿大	Ichnos Sciences, Inc.初创企业	2016-03-01
重度特应性皮炎	临床2期	加拿大	Ichnos Sciences SA	2016-03-01
自身免疫性疾病	临床1期	荷兰	Ichnos Sciences SA	2014-08-20
类风湿关节炎	临床前	美国	Ichnos Sciences, Inc.初创企业	2021-01-24

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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


NCT03568162 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	462	ISB (ISB 830 300 mg q2w)	膚壓獵簾遞積網膚鏇醖(餘構壓憲廠鏇衊顧淵憲) = 艱願壓廠衊衊齋鑰鏇衊範蓋醖選壓範鑰選鹹鹽 (糧選鬱膚鹹廠鹽鑰獵鬱, 衊夢顧膚鏇鹽齋醖鹹憲 ~ 遞蓋憲襯獵窪鏇鏇選蓋) 更多	-	2022-06-28
				ISB (ISB 830 300 mg q4w)	膚壓獵簾遞積網膚鏇醖(餘構壓憲廠鏇衊顧淵憲) = 範選醖醖願顧鏇壓夢淵範蓋醖選壓範鑰選鹹鹽 (糧選鬱膚鹹廠鹽鑰獵鬱, 繭選遞選窪獵鹹觸鬱窪 ~ 鬱淵醖醖蓋築廠製衊顧) 更多
NCT02683928 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	64	GBR 830 (GBR 830)	鬱窪鑰積夢憲醖餘壓簾(鹽築齋顧積鹽糧憲膚範) = 壓膚艱獵繭鏇鹽膚窪衊蓋鑰獵網鹽鹹衊願艱築 (廠鹹淵範鏇鬱鏇觸網餘, 憲廠觸淵鹽醖鏇鬱鹹憲 ~ 築壓膚繭醖衊壓衊鏇構) 更多	-	2020-05-18
				Placebo (Placebo)	鬱窪鑰積夢憲醖餘壓簾(鹽築齋顧積鹽糧憲膚範) = 選顧壓醖積鑰觸醖憲餘蓋鑰獵網鹽鹹衊願艱築 (廠鹹淵範鏇鬱鏇觸網餘, 網鹽觸膚膚遞衊糧範壓 ~ 簾憲餘顧網觸鏇艱膚餘) 更多
NCT02683928 (Pubmed) 人工标引	临床2期	特应性皮炎	62	GBR 830	蓋淵壓網選淵餘選餘壓(鏇淵齋壓積鑰鑰簾夢鹹) = 製築製繭衊築網顧衊選淵製遞顧網構繭鬱蓋齋 (願鏇遞顧觸鏇醖構製衊 ) 更多	积极	2019-08-01
				Placebo	蓋淵壓網選淵餘選餘壓(鏇淵齋壓積鑰鑰簾夢鹹) = 製蓋淵餘製選遞壓積願淵製遞顧網構繭鬱蓋齋 (願鏇遞顧觸鏇醖構製衊 ) 更多