Ogeda SA

PARIS--( BUSINESS WIRE )--EGLE Therapeutics, a clinical-stage biotechnology company uniquely positioned to advance the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, announced today the appointment of Michel Detheux Ph.D, as Chairman of the Board and Independent Board Member, and Mojgan Hossein-Nia as Director representative of Takeda Ventures. “We are thrilled to welcome Michel Detheux and Mojgan Hossein-Nia to our Board of Directors. Michel and Mojgan’s expertise and outstanding track record will be invaluable to Egle as we advance our clinical pipeline of novel therapies addressing the unmet medical need of patients with advanced cancer and autoimmune diseases. Their expertise in the field of oncology and their experience are instrumental for us to successfully execute on our strategic priorities, ” said Vincent Brichard, M.D., EGLE’s Interim CEO and Board member. “With the role of regulatory T cells becoming clearer in oncology and auto-immunity, I am excited to join the Board of Egle in order to help the team to move their differentiated pipeline toward a clinical proof of concept and help patients with innovative drugs targeting IL-2,” said Michel Detheux, independent chairman at Egle and CEO of iTeos Therapeutics. “ I am excited to join the Board of Egle in order to help the team strategize and continue to advance their pipeline to help patients in areas of unmet needs , ” said Mojgan Hossein-Nia, Board Member at Egle Therapeutics. Michel Detheux , Ph.D, Michel has held the role of Chief Executive Officer at iTeos Therapeutics since the company’s inception in 2012. During his tenure, Michel has led the company from its origins to NASDAQ listing, raising $335MM in 2020 through a crossover round and IPO. More recently, he spearheaded the strategic collaboration with GlaxoSmithKline in 2021 to co-develop and co-commercialize iTeos’ differentiated anti-TIGIT antibody for a total value of $2B. He previously served as a director at Ludwig Cancer Research and worked in various scientific and business development roles at Ogeda (f/k/a Euroscreen). Dr. Detheux holds a degree of Bio-engineer and a Ph.D. in Biochemistry from Université Catholique de Louvain, and a business certificate from Solvay Business School. Mojgan Hossein-Nia , Ph.D., Mojgan is the Head of R&D Global Portfolio Strategy and Strategic Finance, Research and Development at Takeda. She joined the company in September 2017 and currently directs portfolio strategy and management across all therapeutic areas facilitating investment decisions and overseeing R&D governance process. Additionally, she manages enabling capabilities that support portfolio management including the center of operational performance and integrated portfolio/finance digital solutions. In previous roles, she led the R&D investor relations group and built up the R&D Partnership Office, which was created to manage the overall health of R&D’s pipeline partnerships and their integration into R&D processes. Before joining Takeda, Mojgan worked at Novartis Pharmaceuticals, building and leading multiple global functions across R&D. Mojgan’s career spans over 30 years, comprising dedicated roles in development outsourcing, global program leadership and project management, business development & licensing, and across multiple therapeutic areas including cardiovascular, metabolism, and cell & gene therapies. Dr. Hossein-Nia holds a B.Sc, and Ph.D. in biochemistry from University of London, UK, and a diploma in pharmaceutical medicine from University of Surrey, UK. About Egle Therapeutics SAS (Egle) Egle Therapeutics is a biotechnology company focused on developing immunotherapies targeting suppressive regulatory T cells. Egle is leveraging a proprietary discovery platform to unveil novel Treg specific targets and to develop innovative Treg-focused drug candidates for oncology and autoimmune diseases. Egle aspires to advance toward the clinic its most advanced drug candidates, EGL-001 (a potential best-in-class Treg-selective anti-CTLA4-IL-2m) and EGL-003 (non-targeted IL-2 Treg engager), which are currently in IND-enabling studies. Find out more at www.egle-tx.com .

关注并星标CPHI制药在线 近日，拜耳（Bayer）已向美国FDA提交了一份新药申请（NDA），寻求批准在研疗法elinzanetant用于治疗与更年期相关的中度至重度血管运动症状（VMS，也称为潮热）。如果获得批准，这将是第二种治疗热潮红的非激素药物。 此次申请基于OASIS 1、2和3研究的积极结果，评估了elinzanetant与安慰剂的疗效和安全性。研究结果显示，elinzanetant(每日一次口服120毫克)显著降低了中重度VMS的频率和严重程度，并显示出良好的安全性，在elinzanetant组中，头痛和疲劳是最常见的治疗紧急不良事件(TEAE)。 Elinzanetant是第一个双重神经激肽-1，3（NK-1，3）受体拮抗剂，每天一次口服给药，它可通过调节下丘脑中的雌激素敏感神经元（KNDy神经元）来解决VMS问题。 拜耳在2020年斥资约8.75亿美元（包括4.25亿美元前期付款和4.5亿美元里程碑付款）收购了KaNDy Therapeutics公司，囊获这款潜在“first-in-class”疗法。 NK3受体拮抗剂在更年期潮热市场潜力渐起 血管舒缩症（VMS），即更年期绝经后妇女潮热和盗汗症状。更年期是女性生命中正常、自然的变化，通常发生在45岁到55岁之间，大约80%的更年期妇女会出现潮热，包括持续几分钟的出汗、潮红和发冷，其中约三分之一的女性长达十年都患有中度至重度血管舒缩症。 血管舒缩症状给围绝经期女性的生活工作都带来严重困扰，但传统治疗方法仍有局限。目前缓解绝经相关VMS最常用的治疗方法为绝经激素治疗。然而，绝经激素治疗的使用禁忌症较多，具有治疗窗口期，研究证明还可能会增加乳腺癌、心血管疾病和血栓栓塞发生风险。 神经激肽3受体（NK3R）参与大脑调节体温的机制。研究显示，针对NK3R的拮抗剂可以阻断神经激肽B（NKB）的信号通路，调控下视丘温度调节中心的神经活动，进而降低中重度停经血管舒缩症状的频率与严重程度。目前多家药企正在开发用于绝经期女性潮热的NK3受体拮抗剂，为不能或不愿接受激素疗法的患者提供新的治疗选择。 据美国Female Founders Fund的研究数据显示，预计2025年全球将有11亿更年期女性，而更年期市场将达到6000亿美元的规模。在更年期管理中，有效的药物治疗是关键，更年期综合征对女性健康的影响日益显现，但同时该领域缺乏有效的药物，这就意味着该领域的市场潜力巨大。 拜耳将是安斯泰来强劲对手，国内豪森金赛药业领衔 现阶段仅有一款治疗VMS的NK3受体拮抗剂获批上市，即安斯泰来的小分子口服药物非唑奈坦片（fezolinetant，商品名Veozah）。其他在研的NK3受体拮抗剂除了拜耳的Elinzanetant（NDA）和赛诺菲的Osanetant（2期）外，Sojournix的SJX-653（2期）、第一三共的CS-003（2期）和Millendo的Pavinetant（2期）的临床试验目前都处于终止的状态。国内方面，豪森的HS-10384领跑国产赛道，已进入3期临床，金赛药业的GS1-144紧随其后，处于1期临床阶段。 Fezolinetant最早由比利时药企Ogeda开发，2017年安斯泰来以5亿欧元（约合5.34亿美元）的价格收购Ogeda获得这款药物。2023年5月，美国食品药品监督管理局(FDA)已经批准Veozah (fezolinetant)用于治疗因绝经引起的中度至重度血管舒缩症状(VMS)，Veozah是首款获FDA批准用以治疗此类患者的神经激肽3（NK3）受体拮抗剂，也是FDA批准用于治疗因绝经引起的中度至重度血管舒缩症状(VMS)的首个非激素疗法。全球VMS市场潜力庞大且持续增长。据预测，2027年fezolinetant销量有望高达15亿美元，到 2029 年将达到 25 亿美元。 目前Fezolinetant已经取得了先发优势，至于Fezolinetant能否快速抢占市场，这还要看后续真实世界的疗效以及营销手段。同时Fezolinetant还面临着Elinzanetant的追赶，若Elinzanetant成功上市，NK1/NK3双靶点受体拮抗剂是否优于单靶点NK3受体拮抗剂，到时免不了一番激烈竞争，疗效胜者为王。 另外，目前开发NK3受体拮抗剂用于VMS的赛道尚不拥挤，但未来在仿制药和创新药的共同角逐下，竞争将逐渐激烈。国内在此布局的药企应抓住窗口期，早日将产品推向市场。 参考来源：        1.Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47.        2.Kimball A Johnson and others, Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT, The Journal of Clinical Endocrinology & Metabolism, 2023;, dgad058.        3.S. Lederman, F.D. Ottery, A. Cano, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study, Lancet, 401 (2023) 1091-1102.     4.Simon, JA; Anderson, RA; Ballantyne, E, et al. (2023). Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause; 30 (3): 239–246. 26      5.Trower, M; Anderson, RA; Ballantyne, E, et al. (2020). Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause; 27 (5): 498–505. END 【智药研习社直播预告】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

Pictured: Astellas U.S. headquarters in Illinois/iStock, JHVEPhoto Astellas on Thursday announced positive Phase IIIb trial results for Veozah (fezolinetant), an oral, nonhormonal treatment for moderate to severe vasomotor symptoms such as hot flashes and night sweats due to menopause. In May 2023, the menopause drug received FDA approval for treating moderate to severe symptoms. Astellas said in Thursday’s announcement that the late-stage results “will support health technology assessment and reimbursement dossiers throughout Europe.” The data were presented on Thursday at the 15th Congress of the European Society of Gynecology in Amsterdam. According to Astellas, the study reached the main objective of showing a statistically significant reduction from the baseline in the frequency of moderate to severe vasomotor symptoms (VMS) to week 24 against a placebo. Adverse events occurred in less than 5% of the over 450 patients, the most common being headaches and COVID-19. The patients investigating the drug were considered unsuitable for hormone therapy. “DAYLIGHT is the first 24-week placebo-controlled efficacy study for fezolinetant. Astellas is committed to advancing innovative science, and these data provide further affirmation to healthcare providers of the positive impact fezolinetant can have on reducing the frequency and severity of VMS, as well as sleep disturbances over a longer period of time” Marci English, vice president and head of biopharma development at Astellas, said in a statement. Astellas initially announced the positive topline results of the trial in June 2023 but gave no detailed numbers at the time. Thursday’s data readout showed that for the primary endpoint of the mean change from baseline in the frequency of moderate to severe VMS, the 45-mg dosage of the drug had a reduction of -1.93, giving a value of p<0.001. The secondary endpoints of mean change from baseline in the moderate to severe VMS severity and patient-reported sleep disturbance had reductions of -0.39 and -2.5, respectively. Both secondary endpoints had a value of p<0.001. “The statistically significant reductions observed over the 24 weeks demonstrate the potential fezolinetant has to help women who are experiencing VMS due to menopause yet cannot or choose not to take hormone therapy,” Rossella Nappi, professor of obstetrics and gynecology at the University of Pavia, said in a statement. Astellas acquired fezolinetant when it bought Belgium-based Ogeda in a 2017 deal valued at up to $853 million. Bayer’s elinzanetant, a late-stage investigational dual neurokinin-1,3 receptor antagonist acquired as part of a $875 million buyout of KaNDy Therapeutics in 2020, is currently in clinical development for the treatment of VMS associated with menopause. However, Astellas beat Bayer in becoming the first-in-class non-hormonal option. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.