Omilancor

MNC公司有很多新药项目需求，欢迎联系药时代BD团队（BD@drugtimes.cn）！2024年3月25日，一日出现三笔并购。如此密集的并购频率，让不少业内人士认为今年是并购元年。据预测，2024年制药界的并购交易额预计在2250亿美元到2750亿美元之间，与2023年的水平相近。在频率增加的条件下，交易金额相应会随着降低，即今年将可能出现更多的小额并购。就像3月25日一天三笔并购，金额也未超过20亿美元……诺和诺德拿下逆转心衰的潜力FIC药物2024年3月25日，诺和诺德宣布将以10.25亿欧元的价格收购Cardior Pharmaceuticals，加强其心血管领域布局。Cardior成立于2016年，一直致力于RNA疗法的发现与开发，旨在预防、修复和逆转心脏疾病，其核心候选产品正是一种靶向miR-132（一种非编码RNA）的ASO药物CDR132L。当患者处于心肌细胞应激条件时，心脏miR-132表达上调，而心脏组织中miR-132高表达将会导致进行性不良心脏重构，最终导致心衰（HF）发生。而CDR132L则可以选择性阻断miR-132分子异常水平，从而停止并部分逆转细胞病理学，可能带来心功能的长期改善。目前，CDR132L正在开展治疗心衰的II期临床（HF-REVERT），2022年7月完成了该试验的首次患者给药。而在其Ib研究中，CDR132L安全性和耐受性良好，其血浆药代动力学曲线呈线性，没有积累的迹象，并且可改善心脏功能。除了CDR132L，Cardior管线内还有多个治疗肥厚性和扩张型心肌病等心脏疾病的疗法正在开发。 实际上，自从司美格鲁肽三期试验SELECT的心血管结局阳性，诺和诺德在心血管领域的实力得到不断加强，包括IL-6抑制剂ziltivekimab正在开展的三期试验，与Heartseed合作，在早期阶段研究中测试一种细胞疗法等。值得一提的是，2024年3月9日，FDA批准了Wegovy的新适应症，用于降低患有心血管疾病和肥胖或超重的成人心血管死亡、心脏病发作和中风的风险。AI制药的“是是非非”同日（3月25日），艾伯维宣布将以2.125亿美元总价收购Landos Biopharma。前者将支付1.375亿美元现金，以及7500万美元或有价值权（CRV）。Landos成立于2017年，专注于利用其LANCE人工智能平台为自身免疫疾病患者研发新型口服治疗药物。其中，Landos目前的核心候选产品正是基于LANCE人工智能平台开发的口服NLRX1激动剂NX-13。NX-13能够作用于线粒体相关受体NLRX1靶点，具有调节免疫反应的能力。目前该候选药物正处于2期临床试验的入组阶段，用于评估中重度溃疡性结肠炎（UC）患者疗效，该数据预计今年Q4可读出。为什么称NX-13为目前的核心产品？因为在此之前，Landos的核心资产为omilancor（一款在研的新型口服肠道限制性LANCL2通路激动剂），同样用于UC、克罗恩病（CD）的治疗。2023年3月，Landos的前CEO兼董事长Josep Bassaganya-Riera以个人名义收购了Landos的Omilancor、NIM-1324（LABP-104）以及整个LANCL免疫调节治疗资产后成立了NImmune Biopharma。值得一提的是，2021年5月，Landos与联拓生物达成合作，双方将一同在大中华区和亚洲特定市场，对新药Omilancor和NX-13进行开发和商业化。而联拓却在“胜利前夕”，即今年2月宣布启动资产出售，逐步缩减业务。或许对于如今的本土药企，license-in模式不再适用。至于艾伯维，于2023年相继大金额并购了ADC公司Immuno Gen（101亿美元）和CNS公司Cerevel Therapeutics（87亿美元），强化肿瘤与CNS领域的实力。此次，艾伯维2亿美元收购Landos相较于去年手笔只能算是“小动作”，可以理解为为自身自免领域强项“试错”。第三家本土biotech被外企完整收购同日（3月25日），Nuvation Bio宣布将以全股票交易的方式收购AnHeart Therapeutics（葆元医药）。相较于前者MNC作为收购方的交易，Nuvation Bio之名或许并不被人熟知。该公司成立于2018年，公司创始人David Hung曾创立了Medivation，后于2016年以143亿美元的价格出售给了辉瑞。值得一提的是，David Hung是一名华裔。作为被收购方的葆元医药，其创始团队王钧源博士（CEO）、颜冰博士（CMO）以及郑利华博士（CBO）经验丰富，均有MNC领导经历。葆元医药成立于2018年，早期运营模式也是license-in，在研临床阶段药物均为从外部引进。包括三款从第一三共引进的ROS1/NTRK双靶点抑制剂taletrectinib（他雷替尼）；IDH-1突变体抑制剂safusidenib；AXL抑制剂AB-329。目前，他雷替尼正在开展两项II期临床研究，用于评估其对ROS1 阳性 NSCLC 患者疗效。2021年，信达以1.89亿美元总价（首付款、里程碑付款及销售分成）获得他雷替尼大中华区权益。韩国的NewG Lab Pharma和日本的Nippon Kayaku也成为了taletrectinib在相应区域的商业化合作伙伴。自成立之初，葆元医药获得了多轮投资，A+融资2400万美元，B轮融资6000万美元。而收购方Nuvation Bio截至2023年底账上现金6.11亿美元，双方资金均算充裕。此次并购被视为免税重组，Nuvation Bio将作为葆元医药的母公司，接手所有资产包括职工，葆元医药投资者德诚资本创始及管理合伙人崔相民博士及王钧源博士将加入Nuvation Bio董事会。结语据药时代不完全统计，2024年至今，全球共发生并购交易19笔。相较于2023年多笔大额交易（辉瑞430亿美元收购Seagen、BMS140亿美元收购Karuna、默沙东108亿美元收购Prometheus Biosciences等），今年以来还未发生超过50亿美元的大型并购交易。但在并购频次和并购主体上，与去年存在较大区别。包括本土药企的加入，如亘喜生物、信瑞诺等。相信未来，被并购也将成为众多本土Biotech，更为普通的退出路径。据药时代不完全统计，目前ADC并购还只有强生/Ambrx，好丽友/LegoChem两笔，主要考虑去年多个MNC已完成了大额相关交易。另外，目前看来，癌症与自免还是并购主力军。未来可能出现的变数，或许会是GLP-1带动的一系列代谢疾病领域产品。总的来说，并购活动的主要驱动力大型制药公司对中型生物技术公司的收购，以填补即将到期的专利缺口，以及对创新技术的竞争，如GLP-1药物、精准医疗等。此外，私募基金也有大量的资金用于收购或合作制药资产。封面图来源：pixabay版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn复宏汉霖首次全年盈利5.46亿，强大产品力加速国际化步伐毕井泉：营造最具竞争力生态环境 共迎创新药蓬勃发展春天陆舜教授、张剑教授、黑永疆博士、谢雨礼博士、邱杨博士、顾薇女士、花海清博士、胡朝红博士、朱梅英博士精彩分享！| 药时代视频荟萃急聘！知名Biotech公司诚聘药物化学负责人，领导ADC项目点击这里，观看精彩直播！

NIMML founders Dr. Bassaganya-Riera, Dr. Hontecillas, and scientific director Dr. Leber discovered, characterized, and led the development of NX-13 from discovery to successful clinical testing in Ulcerative Colitis (UC) patients. NIMML’s TITAN-X, an A.I. powered precision medicine platform, has also guided the target discovery and biomarker-driven development of first and best in class LANCL2 agonists, including omilancor, in Phase 3 development as a once daily, gut-restricted oral therapeutic in Ulcerative Colitis by NImmune Biopharma. Novel scientific discoveries made by the NIMML Institute team continue to yield novel druggable targets for autoimmune diseases and strengthen a global pipeline for safer and more effective oral I&I therapeutics. BLACKSBURG, Va.--(BUSINESS WIRE)-- The NIMML Institute (“NIMML”), a 501 (c)(3) nonprofit institute dedicated to the discovery of novel precision medicines for autoimmune diseases, today recognized its co-founders, Dr. Josep Bassaganya-Riera and Dr. Raquel Hontecillas, and scientific director Dr. Andrew Leber for their leadership in the discovery and development of NX-13 that enabled today’s acquisition of Landos Biopharma, Inc. (“Landos”) by AbbVie, Inc. (NYSE: ABBV) (“AbbVie”). Dr. Bassaganya-Riera founded Landos in 2017 and led the Company’s subsequent growth from inception through multiple rounds of private funding, a successful IPO, growth as a NASDAQ-listed biopharma company with market capitalization in excess of $625 million, 7 INDs and 17 therapeutic development programs, including the successful clinical development of NX-13 and omilancor for the treatment of ulcerative colitis (UC) and potentially other autoimmune diseases. “NIMML’s TITAN-X Precision Medicine platform and its advanced A.I. and computational modeling capabilities were instrumental for the characterization of NLRX1 as a therapeutic target for autoimmune diseases and the development of NX-13. The acquisition of Landos and NX-13 by AbbVie, the maker of several blockbuster IBD drugs, validates the value of the TITAN-X platform to discover a portfolio of first and best in class biomarker-driven immunoregulatory therapeutics for inflammatory and autoimmune diseases with high unmet patient needs,” said Dr. Bassaganya-Riera, President and CEO of NIMML. “Importantly, AbbVie is one of the world’s largest biopharma companies with an incredibly successful I&I franchise that it has built over the last two decades. This transaction is a tremendous validation of the work and dedication of the entire NIMML team and the robustness of the TITAN-X drug discovery platform in strengthening a global pipeline of I&I therapeutics.” Drs. Bassaganya-Riera, Hontecillas and Leber were the sole inventors of NX-13 and first designed the small molecule to target NLRX1 in 2017. After discovery, the three accelerated the de-risking of NX-13 preclinically, including translational target engagement and multiple mouse models (published in the Journal of Immunology), and a novel proprietary pig model of IBD previously developed by Drs. Bassaganya-Riera and Hontecillas, following the same path that was used to develop omilancor. With this robust data package, the team opened INDs for NX-13 in UC and Crohn’s disease (CD) and successfully completed a Phase I study in normal healthy volunteers. Prior to their departure from Landos, Drs. Bassaganya-Riera, Hontecillas and Leber designed, initiated, and conducted a Phase Ib study in UC patients for NX-13, which has yielded the only clinical efficacy results released to the public to date. In addition to Landos Biopharma, Dr. Bassaganya-Riera founded NImmune Biopharma (“NImmune”) with the purpose to advance the clinical development of the LANCL2 portfolio of immunoregulatory precision medicines. NImmune is led by Dr. Bassaganya-Riera as the Chief Executive Officer, Dr. Hontecillas as the Chief Scientific Officer, and Dr. Leber as the Chief Development Officer. In May 2023, the NIMML Institute executed a precision medicine research collaboration with NImmune to develop the LANCL2 portfolio of immunoregulatory therapeutics, including omilancor and NIM-1324, oral, once-daily agonistic therapeutics that bind and activate the LANCL2 pathway. Omilancor is currently in a global registration-directed Phase 3 program to treat UC. Final and complete Phase 2 data published on October 2023 at ACG showed that once daily omilancor induced a best-in-class remission rate of 30.4% in UC patients versus 3.7% in the placebo arm (P=0.01) with an unrivaled safety profile. NIM-1324 is anticipated to begin a Phase 2 program in Systemic Lupus Erythematosus (SLE) patients during 2H’24. NIM-1324 is also in clinical development for Rheumatoid Arthritis (RA) and other systemic autoimmune diseases. Both omilancor and NIM-1324 are guided by precision biomarkers discovered and developed by NIMML’s TITAN-X A.I.-powered Precision Medicine platform. “Today’s transaction reinforces the novel immunoregulatory target discovery programs of the NIMML Institute, including LANCL2 and NLRX1, as well as the strong efficacy and safety pro the innovative therapeutics we continue to develop at NImmune,” said Dr. Hontecillas, Co-Director and Chief Scientific Officer at NIMML. “The acquisition of NX-13 by one of the world’s leading biopharma companies signals continued momentum behind the important work we are doing to advance the development of effective treatments that can safely address the significant unmet clinical needs of millions of patients living with autoimmune diseases.” Crucial to the development of NX-13, the NIMML team first characterized the key role of NLRX1 – a mitochondria-associated receptor involved in down-regulating inflammation – in the protection from IBD. NLRX1 modulates epithelial cell metabolism and the gut microbiota, which was demonstrated through seminal publications of immunology studies conducted by Dr. Bassaganya-Riera’s team, finding deficiency of NLRX1 worsens inflammatory responses in both CD4+ T cells and epithelial cells and shifts the metabolic preferences of cells. The NIMML team identified transdisciplinary mechanisms of NLRX1 anti-inflammatory effects whereby the regulation of lactate metabolism by NLRX1 aids in the prevention of effector T cell responses and the regulation of glutamine metabolism aids in the maintenance of epithelial barrier integrity. These immunometabolic findings laid the groundwork for Dr. Bassaganya-Riera’s team’s clinical development of NX-13 as a novel NLRX1 agonist oral therapy for the treatment of UC. About Omilancor By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, Omilancor is currently in Phase 3 clinical testing for UC and Phase 2 clinical testing for CD. About NIM-1324 NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis, and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. About the TITAN-X Platform The TITAN-X Precision Medicine Platform combines A.I. methodologies, bioinformatics, and advanced computational modeling to accelerate the development of precision medicines to address the unmet clinical needs of patients with autoimmune diseases. Building upon NIMML’s expertise in engineering large-scale computational models that study immunity as a massive and dynamically interacting system, the TITAN-X Platform integrates each step from new target discovery to enabling biomarker-driven precision clinical drug development. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, the TITAN-X Platform can identify transcriptional predictive signatures by using advanced A.I. algorithms. By analyzing gene expression patterns and integrating clinical data, the TITAN-X Platform can identify responder patterns, facilitating precision medicine approaches for drug development. This ensures that patients receive therapies that are most likely to benefit them according to their unique genetic signatures and clinical pro and that are tailored to maximize efficacy, safety, tolerability and minimize adverse side effects. About NIMML The NIMML Institute is a 501 (c) (3) non-profit foundation focused on applying transdisciplinary, team-science approaches to precision medicine. The NIMML Institute applies its TITAN-X advanced A.I.-powered platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. NIMML combines the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists to translate novel scientific discoveries into medicines for human diseases. The Institute is headquartered in Blacksburg, VA. For more information, please visit or contact pio@nimml.org.