A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.
Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.
This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor has decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).
People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for up to 3 years or up to 5 years, depending on when they start the study.

开始日期2025-01-22

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT05536297

/ Active, not recruiting临床3期

An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

开始日期2022-09-26

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT04435366

/ Completed临床3期

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

开始日期2020-06-22

申办/合作机构

IVERIC bio, Inc.

100 项与 Avacincaptad pegol 相关的临床结果

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100 项与 Avacincaptad pegol 相关的转化医学

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100 项与 Avacincaptad pegol 相关的专利（医药）

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项与 Avacincaptad pegol 相关的文献（医药）

2025-02-01·EYE

Gene therapy for geographic atrophy in age-related macular degeneration: current insights

Review

作者: Waheed, Nadia K ; Waheed, Nadia K. ; Jamil, Muhammad Usman

Geographic atrophy (GA) is the advanced stage of non-neovascular (dry) age-related macular degeneration, defined by the presence of sharply demarcated atrophic lesions of the outer retina. The complement system is integral to the body's natural immune response, and hence its overactivation can lead to tissue damage and inflammation. It has been shown to play a significant role in GA lesion development and progression, and therefore, complement inhibition is emerging as a promising avenue for therapeutic intervention. With the recent approval by the Food and Drug Administration of drugs like SYFOVRE™ (pegcetacoplan injection) and IZERVAY™ (avacincaptad pegol intravitreal solution), there is hope for the development of interventions capable of slowing down or arresting the progression of GA. In particular, gene therapy intervention is gaining traction for halting GA atrophy at the source of our genes. The concept is to insert a gene into the eye that will act as an ocular "bio-factory," producing a desired protein. This can either lead to overproduction of an already available protein or produce a substance not typically generated in the eye. This review aims to provide an overview of the present understanding of GA, encompassing risk factors, prevalence, pathophysiology, and genetic associations. It will also highlight the current landscape of GA treatment, with particular emphasis on gene therapy intervention.

2025-02-01·Pharmacology Research & Perspectives

Intravitreal Administration of Avacincaptad Pegol in a Nonhuman Primate Model of Dry Age‐Related Macular Degeneration

Article

作者: Natsume, Takahiro ; Itani, Yoshitaka ; Fujii, Rintaro ; Takamatsu, Hiroyuki ; Matsushita, Mayumi ; Hama, Aldric

ABSTRACT:

The lack of effective treatments for dry age‐related macular degeneration (AMD) is in part due to a lack of a preclinical animal model that recapitulates features of the clinical state including macular retinal pigment epithelium (RPE) degeneration, also known as geographic atrophy (GA). A nonhuman primate model of GA was developed and its responsiveness to an approved treatment, avacincaptad pegol (ACP), a complement C5 inhibitor, was evaluated. Intravitreal (ivt) administration of sodium iodate (SI) into one eye of male Macaca fascicularis leads to retinal areas (mm2) of hyper‐ or hypo‐autofluorescence. Qualitative changes to the retinal structure over time were observed with spectral domain optical coherence tomography (OCT). Six days after SI administration, prior to treatment, mean (± SEM) GA of all eyes was 8.2 ± 1.8 mm2. Following randomization to treatment groups, either vehicle or ACP was ivt injected and treatment was continued every 4 weeks, for a total of four treatments. Sixteen weeks after SI administration, the GA area in vehicle‐treated eyes was 18.9 ± 6.6 mm2, whereas GA in ACP‐treated eyes was 11.4 ± 4.0 mm2, a reduction by about 36%. Increased, followed by decreased, overall macular thickness was observed with OCT over time following SI administration. Treatment with ACP did not change alter macular thickness thinning. Geographic atrophy‐like lesions that expand over time are observed following SI administration. The current macaque model could be utilized to further explore the mechanism of dry AMD and to develop more novel therapeutics.

2025-01-01·International ophthalmology clinics

The Safety of Recently Approved Therapeutics in Age-Related Macular Degeneration

Review

作者: Khanani, Ibrahim ; Gahn, Greggory M. ; Rahimzadeh, Tyler S. ; Khan, Hannah ; Vannavong, Jordyn ; Sulahria, Humza ; Khan, Huma ; Khanani, Arshad M. ; Mojumder, Ohidul ; Aziz, Aamir A. ; Khanani, Zoha A. ; Ali, Haaziq

Recent developments in treatments for both forms of advanced age-related macular degeneration (AMD) have led to the approval of multiple agents and modalities within the last few years. Five new medications for both neovascular AMD (nAMD) and geographic atrophy (GA) secondary to nonexudative AMD (neAMD) have been FDA-approved within the last 5 years, along with a new device designed for sustained drug delivery for nAMD. In nAMD, the newest agents approved by the FDA are brolucizumab (Novartis Pharmaceuticals, Basel, Switzerland), faricimab (F. Hoffman-La Roche, Basel, Switzerland), aflibercept 8 mg (Regeneron Pharmaceuticals, Tarrytown, NY, USA), and a new device in the port delivery system with ranibizumab (Genentech, San Francisco, CA, USA). The first agents FDA-approved for GA secondary to neAMD are pegcetacoplan (Apellis Pharmaceuticals, Waltham, MA, USA) and avacincaptad pegol (Iveric Bio, Parsippany, NJ, USA). Evaluation of safety in both clinical trials and the real-world has been of paramount importance after the approval of these newest agents to understand their effects in real patients. Real-world data, as demonstrated in both registrational studies along with retrospective chart review studies, has shown to be an important factor in the implementation of newer drugs, along with the treatment decisions that physicians choose to make regarding their dosing and follow-up. This review article discusses the safety of the most recently approved FDA as seen in both clinical trials and real-world studies.

207

项与 Avacincaptad pegol 相关的新闻（医药）

2025-03-25

·抗体圈

2025年国外药企融资追踪

我们将继续深入剖析创新型公司和较大规模的融资轮次，并将更多报道聚焦于临床试验结果、并购活动以及特别报告。三月 3月24日——奥古斯丁治疗公司（Augustine Therapeutics）系列：A轮金额：8480万美元投资者：Jeito资本、诺沃控股（Novo Holdings）、Asabys Partners、礼来公司（Eli Lilly）、AdBio Partners、V-Bio Ventures、PMV、VIB、GemmaFrisius基金、Charcot-Marie-Tooth研究基金会以及牛顿生物资本（Newton Biocapital）。这家法国生物技术公司计划利用这笔资金推动其主打候选药物AGT-100216（一种HDAC6抑制剂）进入Charcot-Marie-Tooth病的2期概念验证试验，同时“支持在心血管代谢疾病和神经退行性疾病领域的重要管线扩展”。 3月24日——坦普罗生物（Tempero Bio）系列：B轮金额：7000万美元投资者：8VC、Aditum Bio、Khosla Ventures以及其他未具名投资者。这家专注于药物滥用障碍的公司已将新资金预留用于推动其主打候选药物TMP-301（一种mGluR5负变构调节剂）进入针对酒精使用障碍和可卡因使用障碍的两项2期试验。这家加州生物技术公司还将开展3期使能活动，并计划启动针对其他适应症和制剂的临床前研究。 3月19日——安培生物医学（Ampersand Biomedicines）系列：B轮金额：6500万美元投资者：Flagship开拓创新、礼来公司以及其他未具名新投资者。 Flagship的生物技术公司已获得6500万美元用于继续构建其计算驱动的平台，旨在开发新的生物药物。安培生物医学的目标是开发能够改善靶点参与度，同时限制靶点相关、非靶组织副作用的治疗药物，涵盖多种疾病。这笔新资金将用于推进一个免疫炎症资产和一个免疫肿瘤学项目，这两个项目都预计将于今年进入IND使能研究。该公司还与辉瑞公司（Pfizer）合作开发针对代谢途径的下一代可编程药物。 3月18日——阿博尔生物技术（Arbor Biotechnologies）系列：C轮金额：7390万美元投资者：由Arch Venture Partners和TCGX领投，新投资者QIA、Partners Investment、Revelation Partners和Kerna Ventures加入，以及其他现有投资者。当其他基因编辑项目倒闭或被出售时，阿博尔生物技术公司已获得近7400万美元用于将其领先的肝脏靶向基因疗法推进到人体试验。此次融资将支持ABO-101，这是一种基于CRISPR的基因编辑疗法，旨在治疗原发性高草酸尿症1型，以及阿博尔管线的其他分支，包括针对一种未公开的罕见肝脏疾病和肌萎缩侧索硬化症的编辑项目。 3月17日——麦克斯恩治疗公司（Maxion Therapeutics）系列：A轮金额：7200万美元投资者：由General Catalyst领投，英国患者资本（British Patient Capital）、Solasta Ventures、礼来公司、LifeArc Ventures、MonographCapital和BGF参与。这家英国生物技术公司将利用超额认购的资金进一步开发其基于抗体的KnotBody平台，用于治疗离子通道和G蛋白偶联受体驱动的疾病。该公司的主打资产MAX001目前处于针对特应性皮炎和炎症性肠病等炎症性疾病的临床前开发阶段，而其他早期项目则旨在针对疼痛和心血管疾病。 3月17日——拉提戈生物治疗公司（Latigo Biotherapeutics）系列：B轮金额：1.5亿美元投资者：Blue Owl Capital、Deep Track Capital、Access Biotechnology、卡塔尔投资局（Qatar Investment Authority）和赛诺菲风险投资（Sanofi Ventures）。拉提戈将利用1.5亿美元的B轮融资推进其非阿片类止痛药物管线。更具体地说，这笔资金将帮助该公司将其口服小分子Nav1.8抑制剂LTG-001和LTG-305推进临床试验，其中主打资产LTG-001目前正处于1期试验中。 3月17日——库里沃疫苗（Curevo Vaccine）系列：B轮金额：1.1亿美元投资者：Medicxi、OrbiMed、赛诺菲风险投资、HBM医疗投资（HBM Healthcare Investments）、RA资本管理（RA Capital Management）、Janus Henderson Investors、Adjuvant Capital和GC生物制药（GC Biopharma）。这家总部位于西雅图的生物技术公司计划将新资金注入amezosvatein的2期扩展项目，这是一种非mRNA佐剂亚单位疫苗，旨在预防带状疱疹。为了与带状疱疹疫苗Shingrix竞争，库里沃还招募了两位前GSK高管加入其董事会。 3月10日——莉拉科学（Lila Sciences）系列：种子轮金额：2亿美元投资者：Flagship开拓创新、General Catalyst、March Capital、ARK风险基金（ARK Venture Fund）、Altitude生命科学风险投资（Altitude Life Science Ventures）、Blue Horizon Advisors、密歇根州退休系统（Stateof Michigan Retirement System）、Modi Ventures以及阿布扎比投资局（Abu Dhabi Investment Authority）的全资子公司。生物技术孵化器Flagship开拓创新已推出其最新公司。莉拉科学计划利用其2亿美元的种子资金开发新的先进人工智能技术，以驱动完全自主的研究实验室。Flagship声称该公司的技术已经取得了突破性成果，包括开发出优于商业疗法的新基因药物，以及发现和验证了数百种新抗体。 3月4日——迦楼罗治疗公司（Garuda Therapeutics）系列：A-1轮金额：5000万美元投资者：OrbiMed、Northpond Ventures、Cormorant资产管理（Cormorant Asset Managemen t）和协和麒麟（Kyowa Kirin）。专注于现成细胞疗法治疗血液疾病，迦楼罗将利用这笔资金将其首个造血干细胞移植候选药物推进到临床试验，用于治疗骨髓衰竭综合征和地中海贫血。资金还将用于扩大迦楼罗的团队、扩大生产以及其他一般运营活动。 3月3日——卡利欧治疗公司（Callio Therapeutics）系列：A轮金额：1.87亿美元投资者：Frazier生命科学（Frazier Life Sciences）、Jeito资本、诺沃控股、Omega基金（Omega Funds）、ClavystBio、Platanus、Norwest、Pureos Bioventures、SEEDS资本（SEEDS Capital）和EDBI。卡利欧由Frazier发起，专注于一种从蜂鸟生物科学（Hummingbird Biosciences）获得许可的HER2靶向双载荷抗体药物偶联物。这两家生物技术公司共享一位首席执行官以及多个财务支持者。二月 2月26日——伊科恩治疗公司（Eikon Therapeutics）系列：D轮金额：3.507亿美元投资者：Lux资本（Lux Capital）、亚历山大风险投资（Alexandria Venture Investments）、AME云风险投资（AME Cloud Ventures）、The Column Group、E15风险投资（E15 VC）、Foresite资本（Foresite Capital）、General Catalyst、索罗斯资本（Soros Capital）、StepStone集团（StepStone Group）、由T. Rowe Price Associates建议的基金和账户，以及加州大学首席投资官办公室（UC Investments）等。这家专注于癌症的生物技术公司并不陌生于令人惊叹的融资轮次，将利用D轮融资为其多项临床试验提供资金，包括一项针对晚期黑色素瘤的3期研究，研究一种Toll样受体7和8激动剂免疫调节剂。 2月14日——竹子治疗公司（Bambusa Therapeutics）系列：A轮金额：约9000万美元投资者：RA资本管理（RA Capital Management）、Janus Henderson Investors、Redmile Group、Invus、ADAR1资本管理（ADAR1 Capital Management）以及其他未具名现有投资者。竹子公司已获得约9000万美元用于开发针对免疫和炎症（I&I）疾病的下一代双特异性抗体管线。这家波士顿生物技术公司的A轮融资紧随2024年9月完成的1500万美元种子融资。新资金将用于支持主要项目通过1期临床试验，包括目前正在进行临床测试的双特异性抗体BBT001。 2月13日—Newleos Therapeutics融资轮次：A轮金额：9350万美元投资方：高盛另类投资部门、Longwood基金、Novo Holdings、DCVC Bio和Arkin Bio Capital。Newleos Therapeutics公司首次亮相，获得9350万美元A轮融资，旨在开发下一代神经科学治疗方案，首批临床项目来自瑞士罗氏公司。该公司以未公开的预付款从罗氏获得了几个临床阶段的口服小分子药物，并以全球权利换取成功里程碑和版税。Newleos将利用A轮融资资金开展各项项目的概念验证试验。 2月12日—Abcuro融资轮次：C轮金额：2亿美元投资方：New Enterprise Associates、Foresite Capital、RA Capital Management、Bain Capital Life Sciences、Redmile Group、Samsara BioCapital、Sanofi Ventures、Pontifax、Mass General Brigham Ventures、New Leaf Ventures、abrdn管理的基金、BlackRock管理的基金和账户、Eurofarma Ventures和Soleus Capital。由Sanofi支持的Abcuro公司获得2亿美元C轮融资，用于推动其抗KLRG1抗体（即ulviprubart，又名ABC008）通过2/3期肌肉疾病试验，并计划向监管机构提交申请。其理念是该抗体能清除引发自身免疫疾病的细胞，而不影响调节性T细胞和中央记忆T细胞。 2月3日—AdvanCell融资轮次：C轮金额：1.12亿美元投资方：SV Health Investors、Sanofi Ventures、Abingworth、SymBiosis、Morningside、Tenmile、Brandon Capital等。澳大利亚放射药公司AdvanCell获得1.12亿美元C轮融资，用于推进其主打候选药物通过前列腺癌研究。该Pb-212基放射性核素治疗药物（代号ADVC001）目前正在开展针对转移性前列腺癌的1/2期剂量递增试验。AdvanCell希望ADVC001能证明自身为靶向α治疗领域的佼佼者。一月 1月28日—Atalanta Therapeutics融资轮次：B轮金额：9700万美元投资方：EQT Life Sciences、Sanofi Ventures、F-Prime Capital、Novartis Venture Fund、RiverVest Venture Partners、abrdn管理的基金、Pictet Alternative Advisors、Mirae Asset Financial Group和GHR Foundation。Atalanta Therapeutics继2021年完成1.1亿美元A轮融资后，又完成了一次超募的9700万美元B轮融资。该公司计划利用这笔资金启动针对癫痫和亨廷顿病的小干扰RNA（siRNA）候选药物的临床试验。这些试验性疗法旨在沉默中枢神经系统的特定基因。 1月28日—Helicore Biopharma融资轮次：A轮金额：6500万美元投资方：创始投资方Versant Ventures、OrbiMed、Longitude Capital和Wellington Management。位于加州的Helicore Biopharma公司从幕后走出，凭借针对肥胖症的管线产品获得6500万美元A轮融资。其中，HCR-188是一种直接靶向葡萄糖依赖性胰岛素促泌多肽（GIP）的单克隆抗体，Helicore称其为“临床就绪”。此外，该公司还有一款名为HCR-488的肠促胰岛素共轭体，计划于今年下半年开始作为每月一次的减重选择开展临床前研究。 1月22日—深圳靶向药融资轮次：C轮金额：5000万美元投资方：未披露这家中美合资企业承诺将C轮融资资金用于“推进多个创新药物的海外临床开发”。新闻稿 1月15日—Be Bio融资轮次：C轮金额：9200万美元投资方：Nextech、ARCH Venture Partners、Atlas Venture、RA Capital Management、Alta Partners、Longwood Fund、Bristol Myers Squibb、Takeda Ventures等。Be Bio公司计划将这笔资金用于继续推进其主打B细胞药物BE-101的1/2期试验，该药物针对血友病B患者。资金还将用于推动另一候选药物BE-102进入临床试验，用于治疗一种名为低磷血症的罕见骨骼发育障碍。新闻稿 1月14日—Umoja Biopharma融资轮次：C轮金额：1亿美元投资方：由Double Point Ventures和DCVC Bio共同领投，ARK Invest、Cormorant Asset Management、MPM Capital、Qiming Venture Partners USA、RTW Investments、Alexandria Venture Investments、SoftBank Vision Fund 2、CaaS Capital、由Yosemite管理的Emerson Collective Investments、K2 HealthVentures、Myeloma Investment Fund、University of Minnesota Endowment等参与。Umoja Biopharma计划利用这笔资金将更多的细胞疗法引入临床，包括UB-VV400，这是一种现成的、多结构域融合蛋白表面工程化慢病毒载体，旨在在患者体内生成靶向CD22的CAR-T细胞。C轮融资资金将用于启动UB-VV400在多个肿瘤学和自身免疫学临床研究中的临床试验。 1月13日—Normunity融资轮次：B轮金额：7500万美元投资方：由Samsara BioCapital和Enavate Sciences共同领投，Regeneron Ventures、Pfizer Ventures、YK Bioventures、Canaan Partners、Sanofi Ventures、Taiho Ventures、Osage Venture Partners、HongShan Capital Group、Connecticut Innovations等参与。在2022年完成6500万美元A轮融资后，Normunity再次获得7500万美元融资，用于推进其主打项目NRM-823，这是一种T细胞接合剂。Normunity计划在2025年下半年启动NRM-823的1期试验，并计划推进其他针对肿瘤特异性免疫抑制新靶点的管线项目。 1月13日—Tune Therapeutics融资轮次：B轮金额：1.75亿美元投资方：由New Enterprise Associates、Yosemite、Regeneron Ventures和Hevolution Foundation领投。Tune Therapeutics的B轮融资资金将用于推进其细胞和基因治疗管线，其中主打产品为Tune-401。该公司最近几个月一直在争取获得许可，以便在新西兰和香港开展Tune-401的临床试验。这种针对慢性乙型肝炎的表观遗传沉默药物基于Tune的TEMPO表观遗传编辑平台，该平台通过脂质纳米颗粒递送至细胞。 1月10日—Kardigan融资轮次：A轮金额：3亿美元投资方：Perceptive Advisors、ARCH Venture Partners和Sequoia Heritage。由MyoKardia前领导团队共同创立的Kardigan公司将利用这笔资金构建专注于心脏学未满足需求的管线，包括导致心力衰竭的原发性和继发性心肌病。该公司计划利用其发现平台——结合许可和收购——来构建其产品组合，目前该产品组合包括多个晚期候选药物。 1月10日—Windward Bio融资轮次：A轮金额：2亿美元投资方：由OrbiMed、Novo Holdings和Blue Owl Healthcare Opportunities领投，SR One、Omega Funds、RTW Investments、Qiming Venture Partners、Quan Capital和Pivotal bioVenture Partners参与。新兴的瑞士生物技术公司Windward Bio将利用这笔资金推进其改善晚期免疫性疾病治疗方案的使命，并推进其双特异性药物发现管线。具体来说，这笔资金旨在将两个未披露的项目推进至新药研究（IND）启用研究。Windward还在开发临床阶段的WIN378，这是一种单克隆抗体，该公司从Kelun-Biotech和Harbour BioMed的交易中获得。 1月10日—Ouro Medicines融资轮次：A轮金额：1.2亿美元投资方：由TPG Life Sciences Innovations、NEA和Norwest Venture Partners共同领投，Monograph Capital、GSK、UPMC Enterprises、Boyu/Zoo Capital、LongRiver Investments以及其他未命名投资者参与。Ouro Medicines公司进入竞争日益激烈的T细胞接合剂（TCE）领域，目标是利用T细胞重置慢性免疫性疾病患者的免疫系统。与A轮融资同时进行的是从中国生物技术公司Keymed Biosciences许可的双特异性TCE，现称为OM336。Ouro计划今年将OM336推进至针对B细胞介导免疫疾病的临床试验。 1月10日—Numab Therapeutics融资轮次：C轮扩展金额：5000万瑞士法郎（约合5460万美元）投资方：Cormorant Asset Management、Forbion Growth Opportunities Fund、HBM Healthcare Investment、Novo Holdings、BVF Partners、Octagon Capital Advisors、RTW Investments以及由BlackRock管理的基金和账户。瑞士生物技术公司Numab Therapeutics完成了C轮融资扩展，总计筹集了1.8亿瑞士法郎（约合1.96亿美元），用于支持其在炎症和肿瘤学领域的多特异性抗体管线。 1月9日—Timberlyne Therapeutics融资轮次：A轮金额：1.8亿美元投资方：由Abingworth、Bain Capital Life Sciences和Venrock Healthcare Capital Partners领投，Boyu Capital、Lilly Asia Ventures、Braidwell LP和3H Health Investment参与。由美国生物技术孵化器Mountainfield Venture Partners和中国Keymed Biosciences联合推出的Timberlyne Therapeutics公司获得了1.8亿美元A轮融资，用于推进其临床阶段的CD38靶向抗体。该公司的努力将集中在IgG1单克隆抗体CM313上，Keymed已将CM313的中国大陆以外权利以未公开的预付款、潜在里程碑、版税和Timberlyne的股权出售给了该公司。 1月9日—Light Horse Therapeutics融资轮次：A轮金额：6200万美元投资方：Versant Ventures、Mubadala Capital、Bristol Myers Squibb、Taiho Ventures和AbbVie。由Versant Ventures创立的Light Horse Therapeutics公司计划将精准基因编辑应用于小分子药物发现，初期重点是癌症靶点。Light Horse的平台旨在发现疾病生物学中发挥关键作用的靶点内的新功能位点。 1月9日—Leyden Labs融资轮次：未披露金额：7000万欧元（约合7000万美元）投资方：由ClavystBio和Polaris Partners共同领投，Qiming Venture Partners和现有投资者参与。荷兰生物技术公司Leyden Labs计划将此轮融资资金用于其粘膜保护平台，这是一种鼻喷雾方法，旨在抵御流感病毒和冠状病毒等呼吸道病毒。资金将特别用于开展PanFlu的人体功效研究，以及平台研究和其他管线活动。新闻稿 1月9日—Verdiva Bio融资轮次：A轮金额：4.1亿美元投资方：由Forbion和General Atlantic共同领投，RA Capital Management、OrbiMed、Logos Capital、Lilly Asia Ventures和LYFE Capital参与。Verdiva Bio公司刚刚成立，其CEO Khurem Farooq告诉Fierce Biotech，这可能是英国生物技术公司有史以来最大的A轮融资。该公司从中国Sciwind Biosciences公司许可了三项资产，包括一种每周口服一次的GLP-1激动剂，Verdiva相信该药物将从每日剂量的药物中脱颖而出。 1月9日—A2 Biotherapeutics融资轮次：C轮金额：8000万美元投资方：包括The Column Group和Samsara BioCapital在内的投资方联盟。细胞疗法专家A2 Biotherapeutics将利用这笔资金推进其三个临床开发项目和基于其Tmod平台技术的CAR-T细胞疗法管线。该公司目前正在开展两项针对不同癌症适应症的1/2期试验。 1月8日—Tenvie Therapeutics融资轮次：未披露金额：2亿美元投资方：Arch Venture Partners、F-Prime Capital和Mubadala Capital，其他未命名投资者参与。Tenvie Therapeutics公司以2亿美元的融资亮相，目标是改变神经学治疗格局。这家位于南旧金山的生物技术公司拥有多个小分子资产，其中一些是从专注于神经退行性和溶酶体贮积病的Denali公司收购的。Tenvie表示，这笔融资将用于推进多个资产进入临床阶段。目前，该公司最先进的一些候选药物——一种NLRP3抑制剂和一种变构SARM1抑制剂——处于新药研究启用阶段。 1月8日—Aspect Biosystems融资轮次：B轮金额：1.15亿美元投资方：由Dimension领投，现有和新投资者Novo Nordisk、Radical Ventures、一家未公开的全球领先投资公司、InBC、Pallasite Ventures、Pangaea Ventures、Rhino Ventures和T1D Fund：突破性1型糖尿病基金参与。Aspect Biosystems计划利用这笔资金开发一类新型细胞药物——生物打印组织治疗药物，重点是内分泌和代谢疾病。部分资金还将用于公司的全栈组织治疗平台，该平台结合了AI驱动的生物打印技术、计算设计工具、治疗性细胞和先进生物材料。 1月8日—Alesta Therapeutics融资轮次：A轮金额：6500万欧元（约合6700万美元）投资方：由Frazier Life Sciences和Droia Ventures共同领投，Novartis Venture Fund、RTW Investments、RV Invest、Thuja Capital和SSI Strategy参与。荷兰生物技术公司Alesta Therapeutics将利用这笔资金推进其两个主打口服小分子药物进入临床阶段。ALE1正在开发用于治疗低磷血症，这是一种导致骨骼脆弱的罕见遗传性疾病；而ALE2旨在治疗Charcot-Marie-Tooth疾病，这是一种导致进行性肌肉无力、感觉丧失和肢体畸形的遗传性疾病。 1月7日—Aviceda Therapeutics融资轮次：C轮金额：2.075亿美元投资方：由Omega Funds和TCGX共同领投，Enavate Sciences、Jeito Capital、Blue Owl Healthcare Opportunities、Longitude Capital、OrbiMed、Logos Capital、Marshall Wace、Catalio Capital Management、abrdn Inc.管理的基金以及Digitalis Ventures参与。Aviceda Therapeutics将利用这笔资金推进其主打产品AVD-104，这是一种正在开展2b/3期试验的玻璃体注射糖萼纳米颗粒，与Astellas公司获批的眼科药物Izervay进行比较，用于治疗地贫，这是一种退行性眼部疾病。该研究12个月的数据预计将于2025年下半年公布，而针对糖尿病性黄斑水肿的2期试验已于9月启动。 1月7日—Alebund Pharmaceutical融资轮次：C轮金额：5.5亿元人民币（约合7500万美元）投资方：未公开的医疗保健基金、扬州国金投资集团和Kingray Capital。中国生物技术公司Alebund的这笔新资金将支持其肾病管线的开发和潜在商业化活动。这笔融资将支持该公司在中国的新药申请以及其铁基磷酸结合剂AP301的全球关键研究，以及AP306的2期研究和罗氏Mircera在中国的进一步商业化拓展。 1月7日—XyloCor Therapeutics融资轮次：B轮金额：6750万美元投资方：新投资者Jeito Capital和现有机构投资者EQT、Fountain Healthcare Partners和Lumira Ventures。XyloCor Therapeutics完成了B轮融资，资金将用于推进其心血管疾病基因治疗使命。具体来说，新资金将用于支持XC001（encoberminogene rezmadenovec）的2b期临床试验，用于治疗难治性心绞痛，以及该候选药物作为冠状动脉旁路移植手术辅助治疗的第二项中期研究。 1月6日—Orbis Medicines融资轮次：A轮金额：9000万欧元（约合9340万美元）投资方：New Enterprise Associates（NEA）、Eli Lilly、Cormorant、丹麦出口和投资基金，以及创始投资者Novo Holdings和Forbion。丹麦生物技术公司Orbis完成了其首次融资，资金将用于口服大环药物发现。该公司还任命Morten Graugaard为首席执行官，此前他曾担任Orbis董事会主席三年。Graugaard是Novo Holdings的合伙人，拥有超过20年的生命科学行业经验。在他的领导下，该公司将致力于开发口服大环药物——这一类药物历史上一直难以开发口服版本——作为重磅药物的替代品。参考资料：https://www.fiercebiotech.com/biotech/fierce-biotech-fundraising-tracker-25 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基因疗法临床2期临床3期并购

2025-03-07

·PRNewswire

February Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including business strategies shaping the future of healthcare and three major health news trends. NEW YORK, March 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, February 2025. Photos provided by CINDE, Sebela Pharmaceuticals Inc and WeWard. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value "Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care," said Tom Polen, chairman, CEO and president of BD. FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients Self-pay patients with obesity now have additional Zepbound vial options, including 2.5 mg, 5 mg, 7.5 mg and 10 mg doses. In addition to expanding the doses available, Lilly has reduced prices of the 2.5 mg and 5 mg vials to $349 per month and $499 per month, respectively. Costa Rica Continues to Strengthen Its Position as a Leading Hub for Life Sciences Companies Since 2017, Costa Rica's medical device exports have grown at an average annual rate of 18%, surpassing $8 billion in 2024. This rapid expansion has positioned the country as Latin America's second-largest exporter of medical devices and the fifth-largest supplier of these products to the United States. The Cigna Group Launches Actions to Drive Positive Change for Customers and Patients "The health care system in America needs to be better, and we have challenged ourselves to help lead and drive systemic change," said David M. Cordani, chairman and CEO of The Cigna Group. "We do a lot of good for many people, but we need to do better for everyone. We are committed to implementing tangible actions across our company to help drive better health outcomes and health care experiences." Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare, genetic, life-threatening neurodegenerative disease. AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop Novel Tumor-Activated Immunotherapies The collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers. Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B "We are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions," said Bryan Hanson, Solventum CEO. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Chan Zuckerberg Initiative Launches Billion Cells Project with 10x Genomics and Ultima Genomics to Advance AI in Biology "Biology not only needs more data – the field needs more data faster and in interoperable formats to support AI models that address specific problems, and this project represents a unique approach to scaling and standardizing scientific outputs for AI and more," said Jonah Cool, Cell Science Senior Science Program Officer at CZI. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in February, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. American Heart Month: February featured extensive focus on cardiovascular health with diverse awareness initiatives across multiple sectors. Prevention took center stage as Venus Williams invested in the WeWard walking app, Planet Fitness promoted strength training accessibility, and Texas advocates rallied for cardiac emergency response plans in schools during Heart Month. Former Miss Ohio Lindsay Davis joined cardiologists to raise awareness for hypertrophic cardiomyopathy, while NFL Hall of Famer Jerome Bettis partnered with the CDC Foundation's Live to the Beat campaign to address hypertension's impact on Black adults. HIMSS25: The healthcare technology sector generated significant wire activity surrounding the 2025 HIMSS Global Health Conference in Las Vegas (March 3-6). AI innovation dominated announcements, with companies unveiling solutions ranging from Kontaktio's agentic AI for care orchestration to Amtelco's AI-powered virtual agent Ellie. Industry collaboration also emerged as a key theme, with major EHR providers MedAllies, Epic, Netsmart, and eClinicalWorks announcing a joint demo, while Microsoft partnered with Canary Speech to advance digital health transformation. Rare Disease Day: As Rare Disease Day approached on Feb. 28, PR Newswire distributed numerous announcements highlighting advocacy efforts and research breakthroughs. The National Organization for Rare Disorders (NORD) released a critical report on newborn screening programs and later partnered with Paramount Pictures to amplify awareness. The Rare Disease Diversity Coalition prepared to host its 2nd Annual RISE Awards, while NFL legends joined advocates from 49 states for the 14th annual Rare Disease Week on Capitol Hill. Additional mainstream support for the rare disease community came from the New York Stock Exchange with a special pre-market update commemorating Rare Disease Day. Looking ahead: This March, women's health themes will likely dominate coverage surrounding International Women's Day (March 8) and throughout Women's History Month. PR Newswire also anticipates significant activity around National Nutrition Month, with releases spotlighting dietary innovations and wellness campaigns. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. 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上市批准免疫疗法

2025-03-06

·Endpoints

Luxa's stem cell therapy for dry AMD shows early promise

Luxa Biotechnology said Thursday that its stem cell therapy helped improve vision in a handful of people with a common form of an age-related eye condition. In its lowest dose cohort, the Phase 1/2a study enrolled six participants with dry age-related macular degeneration, or dry AMD, which leads to blurred vision or worse central vision. The six people each received a suspension of 50,000 adult retinal pigment epithelial stem cells, which are cells found in the eye. The cells were implanted under the macula, the part of the eye that’s responsible for central vision, or seeing what’s directly in front of you. The six participants also received immune suppression for the first six months after receiving the stem cells. These patients were divided into two groups: a worse-seeing group and a better-seeing group. In the data shared this week, the three participants in the worse-seeing group were followed for 12 months, showing an average gain of +21.67 letters on an ETDRS chart, a vision test that measures how well a person can see. The three participants in the better-seeing group saw a +3.3-letter improvement at three months. Some of the participants were close to legal blindness, according to Luxa CEO Keith Dionne. “It was heartening to know that the worse-seeing subjects are the subjects most in need of vision improvement, and it was good to find that they had the largest improvement,” Luxa CMO Jeffrey Stern said in an interview. “With magnification, they can read, possibly drive with daytime driving, restricted driving. But importantly, it reverses the disease progression, which is inexorable, gradual loss.” Stern said that there were no significant safety events to date. The data were presented Thursday at the annual Wills Eye Conference in Philadelphia. Luxa is a joint venture operated by the Korean tech company Y2 Solution and the Neural Stem Cell Institute, an organization based in Albany, NY that was founded by stem cell pioneer Sally Temple and Stern. (The two are married.) Temple also serves as the biotech’s chief scientist. In recent years, two new treatments — Astellas’ Izervay and Apellis’ Syfovre — have been approved for geographic atrophy, the advanced form of dry AMD. Dry AMD accounts for around 80% of cases of age-related macular degeneration, which is one of the leading causes of blindness in the elderly. Luxa is also studying higher dose groups, which includes six participants at 150,000 cells and six at 250,000 cells. The biotech hopes to have initial results from the mid-dose cohort of 150,000 cells later this year, Stern said.

细胞疗法临床结果上市批准

100 项与 Avacincaptad pegol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11748	-	-	DB15165

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
地图样萎缩	美国	Astellas Pharma US, Inc.	2023-08-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
年龄相关性黄斑变性	临床3期	美国	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	阿根廷	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	澳大利亚	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	奥地利	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	比利时	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	巴西	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	加拿大	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	哥伦比亚	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	克罗地亚	IVERIC bio, Inc.	2020-06-22
年龄相关性黄斑变性	临床3期	捷克	IVERIC bio, Inc.	2020-06-22

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临床结果

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分期

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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


NCT02686658 \| NCT04435366 (GATHER2, EURETINA2024) 人工标引	临床2/3期	地图样萎缩	-	Avacincaptad Pegol 2 mg	艱鹽壓淵繭鹽獵顧夢蓋(獵壓醖鏇鹹網憲選願蓋) = 簾範願簾築積淵構獵憲繭鏇繭構願鏇獵簾觸餘 (艱膚網觸繭淵構壓觸選 )	积极	2024-09-19
NCT04435366 (GATHER2, PRNewswire) 人工标引	临床3期	年龄相关性黄斑变性	-	IZERVAY	積蓋願鬱獵簾鹽簾構遞(積網憲廠顧鹽艱鏇簾獵) = IZERVAY was well tolerated over 2 years, with one case each of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or retinal vasculitis. 遞衊築膚窪糧憲鹽範糧 (艱廠繭顧簾壓鏇築夢選 ) 更多	积极	2023-11-04
				IZERVAY
EURETINA2023	N/A	-	-	Avacincaptad pegol 2 mg	積鬱鏇範餘獵廠鏇積襯(顧選範範艱築夢窪觸夢) = 餘觸餘鹽艱淵糧顧鏇選鏇繭鑰鬱鏇遞鏇鹹餘積 (鏇壓簾範夢淵網壓糧壓 ) 更多	-	2023-10-05
EURETINA2023	N/A	地图样萎缩	-	Avacincaptad pegol 2 mg	鏇醖壓築網壓簾網鬱鏇(蓋鑰簾鏇製範觸鹹網積) = 鬱鹽願鹹積網遞餘襯構鹽範艱範淵糧淵構繭鬱 (網範艱鹽顧鬱製遞範網, 0.56 ~ 0.15-2.06)	-	2023-10-05
NCT02686658 \| NCT04435366 (GATHER2, FDA) 人工标引	临床2/3期	地图样萎缩	624	IZERVAY (GATHER1)	糧廠鑰製簾醖鹽簾壓顧(衊鬱製鬱憲蓋齋築鏇壓) = 艱糧蓋鏇願選淵襯繭壓壓淵窪鏇膚蓋繭積範繭 (鏇淵齋願衊繭獵鏇糧製 )	积极	2023-08-04
				Sham (GATHER1)	糧廠鑰製簾醖鹽簾壓顧(衊鬱製鬱憲蓋齋築鏇壓) = 廠鬱願簾鏇艱選壓範選壓淵窪鏇膚蓋繭積範繭 (鏇淵齋願衊繭獵鏇糧製 )
NCT04435366 (GATHER2, Corporate Publications) 人工标引	临床3期	地图样萎缩	447	Avacincaptad pegol	窪遞願憲積齋鹹積範蓋(積醖齋鬱製顧願鬱襯遞) = 網鬱鑰遞遞鹹遞窪鬱製構簾觸願蓋廠憲淵繭鹽 (網網繭糧築膚蓋鏇顧簾 ) 更多	积极	2022-09-06
				Sham	窪遞願憲積齋鹹積範蓋(積醖齋鬱製顧願鬱襯遞) = 襯衊齋簾壓願獵鬱獵簾構簾觸願蓋廠憲淵繭鹽 (網網繭糧築膚蓋鏇顧簾 ) 更多
NCT02686658 (GATHER1, ARVO2022)	临床2/3期	地图样萎缩	-	Avacincaptad pegol 2 mg	壓積齋醖夢鹽選選廠廠(簾鏇遞構襯餘築衊鹽憲) = 製壓選鑰製蓋繭選積顧襯壓積製顧鬱觸遞築膚 (範選製範鬱鬱鹹襯鬱憲 )	-	2022-05-01
				avacincaptad pegol (Sham)	壓積齋醖夢鹽選選廠廠(簾鏇遞構襯餘築衊鹽憲) = 窪糧淵艱網範鏇鑰壓選襯壓積製顧鬱觸遞築膚 (範選製範鬱鬱鹹襯鬱憲 )
NCT03362190 (CTgov)	临床2期	湿性年龄相关性黄斑变性	64	Avacincaptad Pegol+Lucentis (Cohort 1)	廠鏇願網構餘鬱鬱醖襯 = 糧糧廠膚鏇憲鹹願艱夢淵鏇淵願膚衊鏇鏇蓋餘 (蓋製繭窪衊簾積願鹽鹹, 餘蓋築構遞鏇願壓築襯 ~ 鹹衊鏇鬱廠廠糧鏇衊觸) 更多	-	2022-02-02
				Avacincaptad Pegol+Lucentis (Cohort 2)	廠鏇願網構餘鬱鬱醖襯 = 糧餘顧製構蓋簾範遞壓淵鏇淵願膚衊鏇鏇蓋餘 (蓋製繭窪衊簾積願鹽鹹, 選淵遞製鏇壓願鏇淵鏇 ~ 齋憲獵遞繭淵壓糧構廠) 更多
NCT02686658 (GATHER1, AAO2021)	临床2/3期	干性年龄相关性黄斑病变 \| 地图样萎缩	286	Avacincaptad Pegol 2mg	壓艱繭壓壓獵範選鑰淵(製蓋繭鏇窪鏇鬱簾蓋鑰) = 艱鬱製選壓製醖願齋衊餘遞壓願鏇繭顧膚築鑰 (窪蓋遞觸構齋積糧夢艱 )	-	2021-11-13
				Avacincaptad Pegol 4mg	壓艱繭壓壓獵範選鑰淵(製蓋繭鏇窪鏇鬱簾蓋鑰) = 築觸獵蓋網範積淵窪壓餘遞壓願鏇繭顧膚築鑰 (窪蓋遞觸構齋積糧夢艱 )