Latozinemab

T1药讯 | 前沿新闻，一触即达 NEWS 新闻早知道 小报速递 21亿美元！Alkermes收购Avadel 10亿欧元！Ipsen收购ImCheck 1.83亿美元！Electra获C轮融资 7000万美元！Elevara获A轮融资 5000万美元！Expedition获融资 NMPA批准那米司特上市 翰森制药RET抑制剂HS-10365申报上市 赛诺菲收购药物在罕见病试验中成功 Terns放弃肥胖药项目因二期数据不佳 Alector痴呆药三期失败后裁员近半 默克集团计划关闭爱尔兰API工厂 诺和诺德股价两日连跌，市值蒸发约100亿美元 21 亿美元！Alkermes 收购 Avadel 10 月 22 日，Alkermes plc 宣布将以每股 20 美元、总计约 21 亿美元的现金收购 Avadel Pharmaceuticals plc。此次收购预计于 2026 年第一季度完成，完成后，Avadel 的 FDA 批准产品 LUMRYZ™（羟丁酸钠口服混悬液）将纳入 Alkermes 产品组合，用于治疗 7 岁以上发作性睡病患者的猝倒或白天过度嗜睡。LUMRYZ™自 2023 年推出以来，已有约 3100 名患者使用，预计 2025 年净收入为 2.65 亿至 2.75 亿美元。 10 亿欧元！Ipsen 收购 ImCheck 10 月 22 日，Ipsen 宣布将以 10 亿欧元（15.9亿美元）收购 ImCheck Therapeutics，重点是其一线急性髓系白血病（AML）患者的 I/II 期先导项目 ICT01。ICT01 是一种 first in class 靶向 BTN3A 单克隆抗体，于 2025 年 7 月获得美国 FDA 和欧洲药品管理局的孤儿药物资格。此次收购预计 2026 年第一季度末完成。 1.83 亿美元 ！Electra 获 C 轮融资 10 月 22 日，Electra Therapeutics 完成 1.83 亿美元 C 轮融资，由 Nextech 和 EQT Life Sciences 领投，赛诺菲等跟投。融资将用于推进 ELA026 在继发性噬血细胞淋巴组织细胞增生症（sHLH）中的全球关键 2/3 期研究，以及推进第二个 SIRP 靶点项目 ELA822 进入临床。ELA026 在 sHLH 的 1b 期研究中，对恶性肿瘤相关 HLH 患者的一线治疗在 8 周时实现了 100%的总生存率，远高于历史基准中可用疗法的约 50%。  7000 万美元！Elevara 获 A 轮融资  10 月 22 日，Elevara Medicines 完成 7000 万美元 A 轮融资，由 Forbion 和 Sofinnova Partners 领投，Monograph Capital 跟投。融资将资助其主要候选药物 ELV001 进行 2 期临床试验，该试验预计 2025 年底前开始招募约 180 名对甲氨蝶呤和 TNF 抑制剂反应不足的患者。ELV001 是一款 first in class 的口服 CDK4/6 抑制剂，选择性靶向成纤维样滑膜细胞，用于治疗类风湿性关节炎等慢性炎症性疾病。  5000 万美元！Expedition 获融资 10 月 22 日，Flagship Pioneering 孵化的 Expedition Medicines 获得 5000 万美元初始资金，用于支持其小分子药物生成平台扩展到任何靶点，并进一步开发其在肿瘤学、免疫学和其他疾病领域的发现项目。此外，Expedition 还启动了与辉瑞公司的战略合作，确定前列腺癌症的新型候选治疗药物。 NMPA 批准那米司特上市 10 月 22 日，勃林格殷格翰宣布其口服磷酸二酯酶 4B（PDE4B）抑制剂那米司特通过优先审评审批程序获批上市，用于治疗成人特发性肺纤维化（IPF）。这是十年来首个在 III 期临床试验中达到主要终点并成功获批的 IPF 治疗药物。那米司特的获批基于其关键性 III 期临床试验 FIBRONEER™-IPF 的积极结果，该试验显示那米司特在治疗第 52 周时，患者用力肺活量较基线有显著改善。 翰森制药RET抑制剂HS-10365申报上市 10月23日，翰森制药自主研发的RET抑制剂HS-10365胶囊上市申请获国家药监局药品审评中心（CDE）受理，用于治疗RET融合阳性非小细胞肺癌（NSCLC），成为国内第3款申报上市的国产RET抑制剂。目前国内已有两款RET抑制剂上市，分别为普拉替尼和塞普替尼。 赛诺菲收购药物在罕见病试验中成功 10月22日，赛诺菲（Sanofi）宣布其通过2024年收购Inhibrx获得的药物efdoralprin alfa在针对alpha-1抗胰蛋白酶缺乏症（AATD）的二期试验中达到所有终点，治疗组AAT蛋白水平提升优于每周输注疗法，安全性相似。赛诺菲计划向全球监管机构提交数据，该药有望为约23.5万患者提供新选择。 Terns 放弃肥胖药项目因二期数据不佳 10月21日，Terns Pharmaceuticals 表示其口服GLP-1肥胖药TERN-601在二期试验中疗效不具竞争力（500mg剂量组体重仅减少4.6%），且出现肝酶升高安全信号，因此决定放弃该资产。公司此前已计划退出代谢疾病领域，现将全力推进慢性髓系白血病药物TERN-701的开发，预计本季度公布临床数据。 Alector 痴呆药三期失败后裁员近半 10月21日，Alector 宣布因其针对前额叶痴呆的抗体药物 latozinemab 在三期INFRONT-3试验中未能减缓疾病进展（虽能显著提升生物标志物progranulin水平），将终止该药物开发，并裁员约116人（占员工49%）。该药物是与葛兰素史克（GSK）合作开发，失败导致公司股价暴跌51%，研发主管Sara Kenkare-Mitra将于12月离职；公司现金储备2.911亿美元可维持至2027年，将转向阿尔茨海默病项目PROGRESS-AD。 默克集团计划关闭爱尔兰API工厂 10月22日，默克集团（Merck KGaA）宣布将在2028年底前关闭其位于爱尔兰Arklow的原料药（API）生产工厂（2015年收购），裁员约100人。此举是战略审查结果，公司计划停止该站点API产品组合；同期其旗下MilliporeSigma在Cork的新过滤设备工厂已投产，以强化生物制药产能。 诺和诺德股价两日连跌，市值蒸发约100亿美元 诺和诺德因与基金会战略分歧，宣布董事长Helge Lund及六名董事将于11月离职。此举引发市场强烈反应，公司股价于10月21日（周二）下跌1.3%，次日（10月22日周三）再跌3%，年内累计跌幅达45%，市值蒸发约100亿美元。  信息来源：网络 — END — 关于仕揽 Talent One 仕揽（Talent One）是一家专注于生命科学领域中高端人才招聘及一站式人力资源整体解决方案服务商，致力于成为创业者、科学家和高管们值得信赖的伙伴。我们的团队成员充满激情和经验丰富，曾成功为国内多家知名药企寻聘C-level高管和搭建创始管理团队，擅长为制药公司输入药物早期发现、临床前研究、临床开发、药政事务、CMC开发、生产质量、BD/投资、市场销售等方向的高品质、高价值人才。未来，仕揽（T1）将坚定以客户为中心，持续为客户创造价值，为医疗大健康行业贡献一份力量。

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced results from the Phase 3 INFRONT-3 clinical trial evaluating latozinemab (AL001) in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In the 96-week, double-blind INFRONT-3 trial, latozinemab, developed in collaboration with GSK, did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer’s Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB). Although treatment resulted in a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin (PGRN) concentrations, the secondary and exploratory endpoints, such as fluid biomarkers and volumetric magnetic resonance imaging (vMRI), demonstrated no treatment-related effects on FTD-GRN. Preliminary safety data have not highlighted any major safety concerns at present. More in-depth analysis of the data is ongoing. “While latozinemab did not demonstrate a clinical benefit in INFRONT-3, the insights gained are invaluable for understanding progranulin-related neurodegeneration," said Giacomo Salvadore, M.D., Chief Medical Officer of Alector. "We extend our deepest gratitude to the patients, caregivers, and investigators who made this trial possible, and we plan to share the results with the scientific community to support continued progress in understanding progranulin biology and FTD pathophysiology.” Based on these results, the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued. The INFRONT-3 trial results will be presented at an upcoming medical congress. Alector Pipeline Outlook Alector remains focused on advancing a pipeline of programs designed to treat neurodegenerative diseases through mechanisms that remove toxic proteins, replace deficient proteins, and restore immune and neuronal function. In the ongoing collaboration with GSK, nivisnebart (AL101/GSK4527226) is being evaluated in PROGRESS-AD, a global, 76-week Phase 2 clinical trial in individuals with early Alzheimer’s disease (AD). Enrollment was completed in April 2025, and trial completion is expected in 2026. An independent interim analysis is planned for the first half of 2026. A key pillar of Alector’s focus is its proprietary blood-brain barrier (BBB) technology platform, Alector Brain Carrier (ABC). Built on the core design principles of versatility, tunability, and differentiated binding to a distinct region of the transferrin receptor (TfR), ABC is intended to support the targeted delivery of therapeutics to the brain and to optimize safety and efficacy at lower doses. The platform’s tunable TfR binding affinities allow adjustment of binding strength to align with the needs of diverse therapeutic cargos, including antibodies, enzymes, proteins, and siRNA, aiming to achieve efficient transport across the BBB with the goal of balancing brain uptake, potency, and safety. Alector is progressing multiple preclinical programs enabled by ABC and has selected lead candidate AL137 for its ABC-enabled anti-amyloid beta (Aβ) antibody program in AD, and AL050 for its ABC-enabled glucocerebrosidase (GCase) enzyme replacement therapy program in Parkinson’s disease (PD). The company is targeting submission of investigational new drug (IND) applications for AL137 in 2026 and for AL050 in 2027. Alector is also continuing to advance its ABC-enabled siRNA platform. The platform is being designed for peripheral dosing, offering the potential for more convenient administration compared with traditional intrathecal or intracerebroventricular delivery. The most advanced siRNA program is ADP064-ABC, targeting tau for the potential treatment of AD and FTD. Collectively, these programs reflect Alector’s continued commitment to advancing innovative approaches to treat neurodegenerative diseases. Alector Executive Leadership and Business Update To align resources with these strategic priorities, Alector is reducing its workforce by approximately 49%. This is intended to focus the company’s resources on its highest-priority programs and to ensure continued progress across its portfolio. Alector thanks all employees affected by these measures for their dedication and contributions to the company’s mission. In parallel, Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development (R&D), has resigned from her role, effective December 22, 2025, to pursue new leadership opportunities. She will remain with Alector until then to ensure a smooth transition and continuity across the R&D organization. The company is deeply appreciative of Dr. Kenkare-Mitra for her leadership and impactful contributions to Alector. “Sara has been an extraordinary builder and operator who transformed Alector into a mature, fully integrated R&D organization,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “Her sage leadership has been critical for the successful execution of our preclinical and clinical pipeline programs. Sara’s integrity and vision have left a lasting mark on the science, culture, and people at Alector, and we wish her continued success in her next chapter.” Alector estimates that it had approximately $291.1 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which the company expects will provide runway through 2027. Alector plans to issue guidance for 2026 when it reports fourth quarter and full year 2025 financial results. About INFRONT-3 INFRONT-3 (ClinicalTrials.gov identifier NCT04374136) was a pivotal, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the safety and efficacy of latozinemab (AL001) in slowing disease progression in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). The trial enrolled symptomatic and at-risk FTD-GRN participants at multiple sites across North America, Europe, Argentina, and the Asia-Pacific region. The primary analysis was conducted in symptomatic participants only, in alignment with regulatory guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Based on the FDA’s recommendation, Alector and GSK amended the statistical analysis plan in the U.S. to include plasma progranulin (PGRN) concentration as a co-primary endpoint along with the Clinical Dementia Rating® plus National Alzheimer’s Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB). This designation of plasma PGRN as a co-primary endpoint does not apply outside the United States. Participants were randomized to receive 60 mg/kg of latozinemab or placebo intravenously every four weeks over the 96-week treatment period (Part 1, the double-blind period). Following completion of Part 1, participants could either enter a 10-week safety follow-up or roll over into a 96-week open-label extension (OLE) study. Those who completed the OLE had the option to roll over into a continuation study (ClinicalTrials.gov identifier NCT06111014). About Alector Alector is a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegenerative diseases. Leveraging the principles of genetics, immunology, and neuroscience, the company is advancing a portfolio of programs that aim to remove toxic proteins, replace missing proteins, and restore immune and nerve cell function. Supported by biomarkers, Alector’s product candidates seek to treat a range of indications, such as Alzheimer’s disease, Parkinson's disease, and frontotemporal dementia. The company is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its preclinical and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, workforce reduction, product candidates, research and preclinical pipeline, blood-brain barrier technology platform, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for PROGRESS-AD, expected milestones, expectations of our collaborations and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law. Alector Contacts: Alector Katie Hogan 202-549-0557 katie.hogan@alector.com Argot Partners (media) David Rosen 646-461-6387 alector@argotpartners.com Argot Partners (investors) Laura Perry 212-600-1902 alector@argotpartners.com Source: Alector, Inc.