A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 Years Old and Their Breast-feeding Infants

The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity of oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and its association with the immunogenicity response in breastmilk.

开始日期2023-10-27

申办/合作机构

Vaxart, Inc.

NCT05626803

/ Completed临床2期

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

开始日期2023-01-26

申办/合作机构

Vaxart, Inc.

NCT05213728

/ Completed临床1期

A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered to Healthy Adult Volunteers

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

开始日期2022-01-24

申办/合作机构

Vaxart, Inc.

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的临床结果

登录后查看更多信息

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的转化医学

登录后查看更多信息

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的专利（医药）

登录后查看更多信息

项与 Monovalent norovirus Vaccine(Vaxart) 相关的文献（医药）

2025-05-14·Science Translational Medicine

An oral norovirus vaccine generates mucosal immunity and reduces viral shedding in a phase 2 placebo-controlled challenge study

Article

作者: Gillard, Joshua ; Tucker, Sean N. ; Apkarian, Maria D. ; Quigley, Christina ; Neuhaus, Elena D. ; Frenck, Robert W. ; Lindesmith, Lisa C. ; Flitter, Becca A. ; D’Amato, Nick P. ; Wei, Lee-Jen ; Pasetti, Marcela F. ; Greco, Susan N. ; Nguyen, Lam Quynh ; Hailey, Darreann Carmela M. ; Shriver, Mallory ; Baric, Ralph S. ; Cummings, James F.

There are currently no licensed vaccines for norovirus, a leading cause of epidemic and endemic gastroenteritis worldwide. Clinical advancement of promising vaccine candidates from phase 2 studies to phase 3 field trials has been hampered by the lack of robust immunological correlates of protection. Here, we conducted a phase 2b randomized, placebo-controlled vaccination and challenge study to assess the safety, efficacy, immunogenicity, and correlates of protection of VXA-G1.1-NN, an oral tablet norovirus vaccine. VXA-G1.1-NN was safe and well tolerated, conferred protection against norovirus GI.1 challenge, and reduced viral shedding in stool and emesis. Norovirus VP1-specific serum immunoglobulin A (IgA), IgG, and functional blocking antibody titers increased substantially after oral vaccination. Moreover, oral immunization stimulated VP1-specific IgA antibodies in nasal lining fluid, saliva, and fecal samples. Serum and mucosal antibody responses 7 days after vaccination were correlated with the induction of antibody-secreting, α4β7 + mucosal-homing B cells. Machine learning analyses of vaccine-stimulated immune components identified serum functional blocking antibody and fecal IgA as robust correlates of protection. These results demonstrate the potential of VXA-G1.1-NN as a safe and effective oral norovirus vaccine and reveal critical immunological features underpinning vaccine efficacy.

2025-03-05·Science Translational Medicine

An oral norovirus vaccine tablet was safe and elicited mucosal immunity in older adults in a phase 1b clinical trial

Article

作者: Cummings, James F. ; Cuevas-Juárez, Esmeralda ; Shriver, Mallory ; Greco, Susan N. ; Pasetti, Marcela F. ; Tedjakusuma, Sarah N. ; Tucker, Sean N. ; Gutierrez, Samanta ; Lester, Colin A. ; Braun, Molly R. ; Neuhaus, Elena D. ; Flitter, Becca A.

Norovirus is a leading cause of acute gastroenteritis globally, with infections in older adults associated with heightened severity and increased risk of mortality. Currently, no licensed vaccines are available to prevent norovirus infection. We developed an orally administered vaccine tablet (VXA-G1.1-NN) that delivers a nonreplicating adenoviral vector expressing norovirus GI.1 major capsid protein VP1 to the small intestine. Here, we report safety and immunogenicity results of a randomized, double-blind, placebo-controlled clinical trial (NCT04854746) that investigated the oral administration of VXA-G1.1-NN in two groups of healthy older adults aged 55 to 65 and 66 to 80 years. VXA-G1.1-NN was administered orally at three dose levels by prime and boost, 28 days apart. Immunization was well tolerated regardless of dose, with mild to moderate reported solicited symptoms and no related serious or grade 3 adverse events. Oral delivery of VXA-G1.1-NN elicited VP1-specific serum immunoglobulin G (IgG) and IgA and functional antibodies in a dose-dependent manner 28 days postvaccination and remained above baseline for 210 days. Moreover, robust circulating VP1-specific IgA antibody-secreting cells were detected 1 week postvaccination along with IgA + plasmablasts expressing the mucosal-homing marker α4β7. VP1-specific IgA increased in saliva and nasal lining fluid 28 days postvaccination in both age groups and remained above baseline concentrations through 210 days, demonstrating durable mucosal responses. This clinical trial established that oral administration of VXA-G1.1-NN is safe, well tolerated, and induces robust systemic and mucosal immune responses in adults up to 80 years old.

项与 Monovalent norovirus Vaccine(Vaxart) 相关的新闻（医药）

2025-12-24

·生物通

综述：计算机辅助方法在人类诺如病毒药物发现中的应用：综述

诺如病毒药物研发的计算机辅助设计与挑战一、病毒生物学特性与研发现状诺如病毒作为急性胃肠炎的主要病原体，全球每年造成约6.85亿感染病例和20万死亡。其独特的单链RNA基因组（ORF1-3）编码6个非结构蛋白（NS1-NS7）和1个结构蛋白VP1。病毒通过VP1-P蛋白与宿主血型抗原（HBGA）结合完成入侵，而NS5的聚合酶和NS6的蛋白酶是抗病毒药物的主要靶点。目前虽有两款疫苗进入临床试验阶段（TAK-214和VXA-G1.1-NN），但尚无获批抗病毒药物。传统筛选方法效率低下，计算机辅助药物设计（CADD）已成为突破性进展的关键。二、计算机辅助药物设计方法体系（一）靶点选择与结构基础1. VP1蛋白研究：通过X射线晶体学解析GII.4 VP1 P域与胆酸结合结构（PDB:2OBS），采用AutoDock Vina进行虚拟筛选，发现天然化合物cyclocommunol具有潜在抑制活性。MD模拟显示其与P域的氢键网络和疏水相互作用，但缺乏体外验证。2. 3CL蛋白酶开发：2015年首次解析的GI.1蛋白酶结构（PDB:6W5H）开启设计新纪元。基于该结构设计的dipeptidyl抑制剂（如rupintrivir）在细胞模型中展现活性，但存在靶点选择偏差问题。2023年GII.4蛋白酶结构（PDB:8U1V）的解析，使药物设计进入精准靶向阶段。3. RdRp抑制剂研究：基于MNV RdRp与suramin的共晶结构（PDB:3UR0），通过MM/GBSA计算指导的药物优化，开发出PPNDS等新型抑制剂。结构生物学揭示的Site B口袋（PDB:4LQ3）为新型抑制剂设计提供新靶点。（二）CADD技术路线演进1. 虚拟筛选方法论：- 结构基础虚拟筛选（SBVS）：以PDB结构为基准，通过AutoDock Vina等工具进行分子对接。2023年针对GII.4蛋白酶的SBVS筛选库达5.88万化合物，最终8个候选分子进入实验验证。- 化学相似性筛选：采用ECFP4指纹算法，在ChEMBL数据库中成功发现PPNDS类似物，但需结合活性验证。- AI增强筛选：2024年新型3D-QSAR模型通过机器学习预测，将虚拟筛选效率提升3倍。2. 分子模拟技术：- 分子动力学（MD）模拟：用于预测化合物与靶点的结合模式，典型研究显示PPNDS在RdRp活性位点的结合稳定性较前代提升40%。- 自由能计算：结合MM/GBSA方法，可预测化合物与靶点的结合自由能，误差率控制在15%以内。- 动态模拟技术：2025年最新研究通过NAMD软件实现10 ns全原子动态模拟，揭示关键残基的构象变化。三、实验验证体系与转化瓶颈（一）体外验证模型1. MNV替代模型：基于RAW264.7细胞系建立的 plaque reduction assay，2023年数据显示其预测活性准确率达78%，但存在跨物种活性差异（如IC50值差异可达3个数量级）。2. 重组 replicon模型：HG23细胞系可检测病毒RNA水平，但存在宿主因子干扰问题。最新研究显示其可支持50μM以下浓度检测。3. 三维肠上皮模型：HIEs系统成功复现临床分离株GII.4的感染过程，但成本高达传统模型的5倍，限制了高通量筛选。（二）转化挑战分析1. 结构生物学瓶颈：NS1/NS5等8个关键蛋白缺乏高分辨率结构。NS1的IDR区域（包含42个无序氨基酸）导致晶体生长困难，现有同源建模误差率达32%。2. 体内验证缺失：78%的CADD研究（2020-2025）未配套体外实验，导致21个候选药物因体外活性不足终止开发。3. 筛选模型偏差：基于MNV的预测模型在转化时出现15-20%活性差异，主要源于宿主细胞因子差异。四、前沿技术整合与突破方向（一）多组学整合策略1. 结构组学：2025年通过冷冻电镜技术成功解析NS6聚合酶结构（PDB:6R4Z），为开发新型抑制剂提供基础。2. 动态组学：结合FRET和表面等离子共振（SPR）技术，实时监测抑制剂对病毒复制周期的干预节点。（二）AI驱动的药物发现1. 机器学习模型：基于ChEMBL数据库训练的3D-QSAR模型（R2=0.89）可预测80%以上候选物的酶活性。2. 强化学习应用：通过AlphaFold3优化蛋白结构，使虚拟筛选效率提升至传统方法的5倍。（三）新型递送系统开发1. 纳米载体系统：将水溶性抑制剂（如CID-57930781）包载于脂质纳米颗粒中，使oral bioavailability从12%提升至68%。2. 肠道靶向设计：基于宿主血型抗原分布特征，开发pH响应型前药（如2'-CMC衍生物），使肠道吸收率提高3倍。五、产业转化路径优化建议（一）实验验证体系重构1. 建立多模型验证平台：整合MNV细胞模型（快速筛选）、HG23 replicon（活性确认）、HIEs（药效评估）三级体系。2. 开发自动化验证系统：采用微流控芯片实现96孔板高通量活性测试，检测时间从72小时缩短至8小时。（二）CADD流程标准化1. 制定虚拟筛选质量标准：要求至少包含3种验证方法（结构对接、自由能计算、分子动力学模拟）。2. 建立化合物数据库：整合已验证活性化合物（如PPNDS、Gedatolisib）和毒性数据，构建包含200万化合物的知识图谱。（三）产学研协同创新1. 建立公共计算平台：共享PDB:6W5H、8U1V等结构数据，开发开源CADD工具包。2. 设立专项转化基金：重点支持临床前候选药物的工艺优化（如纳米制剂包封率提升至90%以上）。六、未来发展方向（一）结构生物学突破1. 发展冷冻电镜新技术：实现NS1等无序蛋白的亚纳米级分辨率结构解析。2. 开发同源建模算法：基于深度学习重建NS5等缺乏同源蛋白的结构。（二）计算模型升级1. 构建多靶点联合预测模型：整合VP1、3CLpro、RdRp的QSAR数据。2. 开发虚拟临床前平台：通过计算预测化合物在HIEs中的渗透率、代谢稳定性等关键参数。（三）新型递送系统研发1. 基于肠道菌群特征：开发靶向肠内共生菌的缓释制剂。2. 载体智能响应系统：设计pH/酶双响应型纳米载体，实现靶向递送。七、关键数据总结1. 病毒学数据：GII.4占2023-2024年欧洲暴发疫情的64%，GII.17在美洲占比达39%。2. 药物开发效率：CADD周期（0-临床前）平均缩短至18个月，较传统方法快3倍。3. 成本控制：通过AI优化合成路线，将候选药物合成成本从$50万/化合物降至$2.5万。本综述系统梳理了诺如病毒药物研发的CADD技术应用现状，揭示了从虚拟筛选到临床转化的关键瓶颈。未来需加强结构生物学与人工智能的深度融合，构建"计算预测-快速验证-精准优化"的创新体系，方能在病毒大流行背景下实现抗诺如药物的临床突破。

疫苗临床研究

2025-03-09

·药明康德

快速持久降解目标蛋白超80%的小分子疗法；有望使患者停止激素替代治疗的创新生物器官疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床申请临床1期细胞疗法免疫疗法临床结果

2024-10-15

·GlobeNewswire-Health Care

Vaxart to Present Norovirus Data at IDWeek 2024 Underscoring Commitment to Address Significant Unmet Need

SOUTH SAN FRANCISCO, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it will present research demonstrating the potential of its norovirus oral pill vaccine candidate at IDWeek taking place October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles. With no currently approved vaccines against norovirus, Vaxart remains committed to progressing what it believes to be the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. Norovirus sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. Adults ≥65 years old are at high-risk for severe symptoms and clinical outcomes including longer disease duration and death. The annual disease burden from norovirus in the United States is estimated to be $10.6 billion Presentation Information: Title: A Phase 2 Double-Blind, Placebo-Controlled Study Showing Oral Tableted Norovirus Vaccine VXA-G1.1-NN is Immunogenic, Efficacious, and Reduces Viral Shedding Following Norovirus ChallengeSpeaker: Dr. Sean Tucker, Founder and Chief Scientific Officer of VaxartDate: Thursday, October 17Time: 3:45 p.m. PTRoom: 404 AB Title: A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 years Old and Their Breast-feeding InfantsSpeaker: Dr. Lam Nguyen, Medical Director & Head of Pharmacovigilance of VaxartDate: Saturday, October 19, 2024Time: 2:15 p.m. PTRoom: 403 B About VaxartVaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and to eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Contact Vaxart Media and Investor RelationsMatt SteinbergFINN PartnersIR@vaxart.com(646) 871-8481 This press release was published by a CLEAR® Verified individual.

疫苗临床2期临床1期

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
诺如病毒感染	临床2期	美国	Vaxart, Inc.	2023-01-26
胃肠炎	临床2期	美国	Vaxart, Inc.	2021-12-27

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05212168 (G1-1 Challenge, CTgov)	临床1/2期	诺如病毒感染 \| 胃肠炎	165	VXA-G1.1 (VXA-G1.1-NN)	壓築構膚鏇餘網憲繭夢 = 蓋構構衊醖襯網壓構齋製鏇鹽鹽積築願窪鏇艱 (齋糧構憲鏇繭衊繭獵齋, 蓋淵壓夢選鬱鬱廠餘遞 ~ 簾膚積憲蓋鏇蓋醖獵選) 更多	-	2025-05-06
				placebo (Placebo)	壓築構膚鏇餘網憲繭夢 = 餘顧鏇網願糧蓋觸繭遞製鏇鹽鹽積築願窪鏇艱 (齋糧構憲鏇繭衊繭獵齋, 衊獵鑰醖範蓋餘艱襯鹹 ~ 餘構餘範醖膚餘醖選淵) 更多
NCT05626803 (CTgov)	临床2期	诺如病毒感染	135	VXA-GII.4-NS+VXA-G1.1-NN (Bivalent GI.1/GII.4 Vaccine Medium Dose)	醖鏇網簾襯淵餘齋鹽膚 = 鬱簾淵膚壓壓選鏇遞醖襯膚憲選夢製選簾獵餘 (觸鑰憲網製範壓簾遞鏇, 壓衊製鏇願壓餘鬱繭淵 ~ 壓鑰衊襯餘製鑰鹹艱憲) 更多	-	2025-04-15
				Bivalent GI.1/GII.4 Vaccine (Bivalent GI.1/GII.4 Vaccine High Dose)	醖鏇網簾襯淵餘齋鹽膚 = 簾淵襯餘壓夢壓構衊鬱襯膚憲選夢製選簾獵餘 (觸鑰憲網製範壓簾遞鏇, 廠膚廠襯憲廠築齋構蓋 ~ 醖蓋廠齋窪壓壓艱遞選) 更多
NCT04875676 (VXA-NVV-105, CTgov)	临床1/2期	诺如病毒感染	30	VXA-G1.1-NN (Cohort 1 (4-week Boost Vaccination))	遞鬱遞築襯構淵選齋鹹(獵範廠齋醖積鏇網獵願) = 齋顧積憲願糧願襯醖膚鏇遞選鹽窪簾衊窪衊簾 (淵窪淵繭選鹹窪醖鹽範, 積膚鹽鹹遞廠糧憲願醖 ~ 選廠淵鹽顧鬱壓觸選顧) 更多	-	2024-05-22
				VXA-G1.1-NN (Cohort 2 (8-week Boost Vaccination))	遞鬱遞築襯構淵選齋鹹(獵範廠齋醖積鏇網獵願) = 構憲構襯構齋築鏇積艱鏇遞選鹽窪簾衊窪衊簾 (淵窪淵繭選鹹窪醖鹽範, 憲鑰獵製觸膚鏇餘夢艱 ~ 淵餘淵齋積網構鏇網遞) 更多