Betrixaban

近日，Nuvig Therapeutics（以下简称Nuvig）宣布完成1.61亿美元的B轮融资。此次融资由Sanofi Ventures（赛诺菲风险投资基金）、Blue Owl Healthcare Opportunities（前身为Cowen Healthcare Investments）和Norwest Venture Partners共同牵头，新投资者B Capital、Leaps by Bayer、Global BioAccess Fund、LOTTE Holdings、Alexandria Venture Investments和abrdn Inc及现有股东Novo Holdings（诺和控股）、Platanus、Bristol Myers Squibb（百时美施贵宝）、Digitalis Ventures和Mission BioCapital参投。 2022年5月，成立仅1年的Nuvig获得4700万美元A轮融资。短短三年，Nuvig融资总额已经超过2亿美元，它究竟有什么过人之处，能在短时间内吸引各大投资机构关注呢？ 01 三院院士领衔，深耕抗体Fc结构域的炎症调节机制 Nuvig是一家临床阶段的生物技术公司，总部位于美国加利福尼亚，专注于将新的科学见解转化为炎症和自身免疫性疾病患者的治疗方法。与依赖传统免疫抑制机制治疗不同，Nuvig专注于通过治疗诱导免疫稳态的自然机制来调节免疫功能。目前，Nuvig的主要候选药物NVG-2089即将进入2期临床开发，用于治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）和其他未公开的适应症。 Nuvig的联合创始人之一、首席科学官和首席执行官Pamela Conley博士在生物技术行业拥有超过30年的从业经验。Pamela博士拥有得克萨斯大学奥斯汀分校生物化学学士学位，加州大学伯克利分校生物化学博士学位，并曾在斯坦福大学霍华德休斯研究所和卡内基研究所担任博士后研究员。 Pamela Conley 图源：Nuvig官网  在创立Nuvig之前，她曾是美国商用阶段制药公司Portola Pharmaceuticals的研究高级副总裁和执行团队成员。在那里，她领导了已获批上市的凝血因子Xa抑制剂逆转剂—Andexxa和Bevyxxa的开发。Andexxa是FDA首个批准的凝血因子Xa抑制剂逆转剂。基于其领先性，Alexion在2020年以14亿美元收购Portola，以拓展药物管线。在Portola期间，Pamela和她的团队还为血栓形成、止血、炎症和血液系统癌症领域的研究分子提交了多个新药临床试验申请。 Nuvig的另一位联合创始人Jeffrey V. Ravetch，是洛克菲勒大学的教授，也是分子遗传学和免疫学实验室的负责人。 Jeffrey V. Ravetch 图源：The Rockefeller University 他的实验室专注于抗体的Fc结构域及其参与的受体，确定该结构域使抗体能够在体内介导其各种生物活性的机制。Ravetch教授的工作为Fc结构域的功能多样性提供了新的结构基础，并确立了FcR通路在宿主防御、炎症反应和免疫耐受中的关键作用。 此外，Ravetch教授的研究还描述了新的抑制信号通路。新通路有助于解释抗体在促进和抑制炎症反应中的复杂作用。这些研究已广泛应用于治疗肿瘤、炎症性疾病和传染病的临床实践中。 在过去的二十年里，Ravetch教授一直活跃在生物技术领域，目前担任Asylia、Biohaven、Harpoon、Jasper、Palleon、Vir和Xencor等创业公司的科学顾问委员会成员。他是美国国家科学院院士（National Academy of Sciences ，2006）、美国国际医学研究所院士（Institute of Medicine，2007）、美国艺术与科学院院士（American Academy of Arts and Sciences，2008）和美国科学促进会院士（American Association for the Advancement of Science，2009）。 02 “0”免疫抑制副作用，同类首创Fc片段免疫调节剂有望应对多种炎症 慢性炎症性脱髓鞘性多发性神经病（CIDP）是一种神经系统自身免疫性疾病，其特征为四肢对称型肌无力及感觉障碍。尽管CIDP的发病机制尚不明确，但普遍认为与免疫系统异常有关。目前，临床上针对CIDP患者的治疗分为一线和二线治疗。一线治疗主要包括静脉注射免疫球蛋白（IVIg或SCIg）、血浆置换等，而二线治疗则涵盖免疫抑制剂/调节剂、单克隆抗体以及造血干细胞治疗等，多数患者在应用免疫治疗后可获得临床缓解。 但中华神经科杂志《慢性炎性脱髓鞘性多发性神经根神经病的研究进展》指出，相当一部分的患者在初期的免疫治疗后需要长期的激素或免疫抑制剂维持治疗，少数患者在经过积极的治疗后仍可能落下残疾，或因长期应用免疫抑制剂而出现并发症。 作为主要的一线治疗方法，IVIg已被证实具有重建免疫稳态的功效。在完成首次疗程后，多数CIDP患者往往需要定期进行IVIg维持治疗。然而，IVIg不仅成本高昂，而且资源稀缺，长期治疗可能导致患者出现其他免疫并发症。根据德邦证券2023年的报告，在美国，IVIg每次治疗的费用接近10000美元，且每年消耗量巨大。因此，若CIDP患者能够使用其他疗法替代IVIg，将有望为其他疾病患者节省宝贵的医疗资源。 而二线治疗方案普遍存在样本量小，对CIDP的疗效和风险尚需进一步验证等问题。 Nuvig自2022年成立以来，便一直专注于开发一种既能减少自身免疫失调反应，又能避免免疫抑制副作用的新药物。其主要候选药物NVG-2089是一种同类首创的重组Fc片段免疫调节剂，经过改造设计为能够结合Ⅱ型Fcγ受体，并参与改善自身免疫失调的内源性调节机制。 NVG-2089是一种工程化的Fc片段，设计用于精确靶向Ⅱ型Fcγ受体，激活内源性调节机制，从而改善自身免疫失调。临床研究表明，NVG-2089在无需免疫抑制的情况下，仍能展现出显著的抗炎效果。此外，基于NVG-2089的研究还创造了一种可重复且可扩展的重组方法：能够模拟IVIg的作用，同时避免了IVIg的副作用和供应限制等问题。 具体来看，传统高剂量的IVIg能够重建免疫稳态，其中含有少量唾液酸化（抗体糖基化）的血源性产品（占总IgG的5%～15%）。临床前和临床研究表明，IVIg减轻自身免疫症状的效果严格依赖于与Ⅱ型Fcγ受体结合的免疫球蛋白G（IgG）唾液酸化部分。而自身免疫性患者在炎症症状恶化期间，唾液酸化水平较低，导致促炎反应增强。 人体对炎症刺激（如致病性感染）的反应是保护性的炎症级联反应。这种反应受到涉及循环抗体的分子机制的严格调节，这些抗体能够在感染清除后重新建立体内平衡。因此，这些抗体可以是促炎的也可以是抗炎的，且取决于IgG抗体的特定部分（Fc结构域）上的调节。当唾液酸化时，它们能够与Ⅱ型Fcγ受体结合，从而使免疫环境恢复到抗炎状态。 作用机理 图源：Nuvig官网 当NVG-2089与其靶标结合时，它会上调Ⅱ型Fcγ受体的表达，并导致T调节细胞的扩增和许多炎症途径的下调，从而改善免疫失调。这种方法提供了一种新的治疗策略，旨在通过调节免疫系统的自然机制来治疗自身免疫性疾病，而无需传统的免疫抑制治疗。 目前，NVG-2089 已进入Nuvig的2期临床开发规划，用于治疗CIDP和其他未公开的适应症。这些适应症对非免疫抑制、有效的新疗法存在高度未满足的需求。值得一提的是，美国食品药品监督管理局（FDA）已授予 NVG-2089 在治疗大疱性类天疱疮方面的快速通道资格（FTD）。据悉，本次B轮融资将用于支持NVG-2089的临床概念验证研究，并推进Nuvig的临床前管线。 Nuvig管线 图源：Nuvig官网 03 多家MNC投身CIDP蓝海，国内首张生物制剂处方已落地 先前，由于缺乏明确的生物标志物和与其他神经病变疾病的相似性，CIDP经常被误诊。但随着人们认识的提高和诊断能力的增强，CIDP患病率在全球范围内呈上升趋势。 据Nuvig官网，仅在美国，CIDP的患病率就约有30000例。 在海外，早在2021年12月，FDA就已批准Argenx的FcRn拮抗剂Efgartigimod（艾加莫德）上市，用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身性重症肌无力。据该公司财报显示，2023年，艾加莫德销售额达11.9亿美元。2024年6月，FDA批准了该产品治疗CIDP成年患者。2024年8月强生宣布已向FDA申请其在研的新生儿FcRn靶向抗体疗法nipocalimab上市。该药物在2021年获得FDA用于治疗CIDP的认定。 据Data Bridge Market Research，全球CIDP市场在2023年为17.4亿美元，预计到2031年将达到31.1亿美元，预计在2024年至2031年的预测期内复合年增长率为7.50%。 2023-2031CIDP市场规模 图源：Data Bridge Market Research 在国内，自去年9月CIDP被纳入国家六部委联合发布的《第二批罕见病目录》，国内对CIDP的重视度进一步提高。 今年11月，再鼎医药和Argenx共同宣布。用于治疗CIDP的艾加莫德皮下注射获得国家药监局（NMPA）批准，成为中国首个获批CIDP适应症的靶向生物制剂。该药为皮下注射剂型，临床使用中，患者只需在腹部选择1个注射部位，1分钟左右即可完成给药，大大提高了患者治疗的依从性和治疗体验。 值得一提的是，早在今年1月1日，艾加莫德就被纳入新版国家医保药品目录，在全国范围内统一正式执行。获批CIDP这一新适应症后，12月，复旦大学附属华山医院开出了全国首张用于治疗CIDP的靶向生物制剂艾加莫德皮下注射的处方，正式进入临床应用。国内CIDP患者拥有了全新的治疗选择。 据中国慢性炎性脱髓鞘性多发性神经根神经病（CIDP）行业市场前景预测及投资价值评估分析报告，2023年中国CIDP治疗市场的总规模约为21亿元，预计到2025年，CIDP治疗市场的总规模将达到23亿元，年复合增长率约为6%。 全球范围内已有赛诺菲、礼来、阿斯利康等多家MNC也纷纷押注CIDP市场。 中国药物临床试验登记与信息公示平台官网显示，赛诺菲正在开展BIVV020（一款靶向补体C1s的单克隆抗体，SAR445088）治疗CIDP成人患者的2期概念验证研究，其最新用于治疗CIDP的Riliprubart（一款靶向补体C1s的单抗，通过阻止补体系统的过度激活，从而减轻CIDP患者的炎症反应）已进入3期临床试验研究。 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。 动脉网，未来医疗服务平台

Dr. Gibson joining Lexaria's new scientific advisor board KELOWNA, BC / ACCESSWIRE / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented DehydraTECH drug delivery platform continues to expand its applications in GLP-1 and hypertension.C. Michael Gibson M.S., M.D., is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Gibson founded PERFUSE in 1987 which served as the TIMI Data coordinating center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.The combined institutes have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal of Medicine) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. His work has been cited over 170,000 times."Lexaria's drug delivery technology offers exciting new pathways towards improving pharmacokinetic drug performance that could unlock a new era of reduced drug waste and adverse side effects combined with enhanced efficacy," said Dr. Gibson. "I'm excited to pursue new and improved applications for this exciting technology.""Dr. Gibson has a wealth of knowledge and experience that will benefit Lexaria, particularly in the area of hypertension which remains an area of intense interest for Lexaria," said John Docherty, President. "On behalf of everyone at Lexaria, I welcome Dr. Gibson's contributions as our new Chief Medial Advisor and member of our scientific advisory board."As Chief Medical Advisor, Dr. Gibson will participate with other scientific and medical experts within Lexaria's newly-formed scientific advisory board in pursuing Lexaria's prioritized objectives in the fields of drug delivery optimization.Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 34,000 patients which eventuate in international approval of drugs like prasugrel, rivaroxaban, betrixaban and andexanet as well as devices such as one that alarms to alert a patient to heart attack. He founded WikiDoc.org and WikiPatient.org and is Editor-In-Chief of over 2,200 active contributors who have edited the content of over 100,000 chapters millions of times over the past 15 years. Gibson also founded www.clinicaltrialresults.org. Gibson serves as Chief Medical Correspondent for the American College of Cardiology. Gibson has over 435,000 followers on social media where he is a leading influencer, second only to Sanjay Gupta in some pollsAbout Lexaria Bioscience Corp. & DehydraTECHDehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.CAUTION REGARDING FORWARD-LOOKING STATEMENTSThis press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.INVESTOR CONTACT:George Jurcic - Head of Investor Relations[email protected]Phone: 250-765-6424, ext 202SOURCE: Lexaria Bioscience Corp.