Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers

The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.

开始日期2021-06-21

申办/合作机构

Inovio Pharmaceuticals, Inc.

[+1]

LBCTR2020113522 / Completed临床2期

Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers - MERS-201

开始日期2021-06-21

申办/合作机构

Inovio Pharmaceuticals, Inc.

PACTR202012691703415 / Suspended临床2期

A Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate the safety, tolerability and immunological profile of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRATM 2000 device in healthy adult volunteers

开始日期2021-05-01

申办/合作机构

Inovio Pharmaceuticals, Inc.

100 项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的临床结果

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100 项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的转化医学

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100 项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的专利（医药）

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177

项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的文献（医药）

2024-07-09·Blood Advances

Defining primary refractory large B-cell lymphoma

Article

作者: Wang, Yucai ; Ayyappan, Sabarish ; Maurer, Matthew J. ; Reicks, Tanner ; Ayers, Amy ; Lossos, Izidore S. ; Cohen, Jonathon B. ; Nowakowski, Grzegorz S. ; Nastoupil, Loretta J. ; Cerhan, James R. ; Kahl, Brad S. ; Farooq, Umar ; Khurana, Arushi ; Bock, Allison M. ; Habermann, Thomas M. ; Flowers, Christopher R. ; Mwangi, Raphael ; Martin, Peter ; Casulo, Carla ; Witzig, Thomas E.

AbstractPatients with large B-cell lymphoma (LBCL) that fail to achieve a complete response (CR) or who relapse early after anthracycline-containing immunochemotherapy (IC) have a poor prognosis and are commonly considered to have “primary refractory disease.” However, different definitions of primary refractory disease are used in the literature and clinical practice. In this study, we examined variation in the time to relapse used to define refractory status and association with survival outcomes in patients with primary refractory LBCL in a single-center prospective cohort with validation in an independent multicenter cohort. Patients with newly diagnosed LBCL were enrolled in the Molecular Epidemiological Resource cohort (MER; N = 949) or the Lymphoma Epidemiology of Outcomes cohort (LEO; N = 2755) from September 2002 to May 2021. Primary refractory LBCL was defined as no response (stable disease [SD]) or progressive disease (PD) during, or by the end of, frontline (1L) IC (primary PD; PPD); partial response at end of treatment (EOT PR); or relapse within 3 to 12 months after achieving CR at EOT to 1L IC (early relapse). In the MER cohort, patients with PPD had inferior overall survival (OS; 2-year OS rate: 15% MER, 31% LEO) when compared with other subgroups considered in defining primary refractory disease, EOT PR (2-year OS rate: 38% MER, 50% LEO) and early relapse (2-year OS rate: 44% MER, 58% LEO). Among patients receiving 1L IC with curative intent, we identified that patients with PPD are the key subgroup with poor outcomes. We propose a definition of primary refractory LBCL as SD or PD during, or by the end of, 1L treatment.

2024-06-01·Breastfeeding Medicine

No Measurable Transfer of Oxytocin-Receptor Agonist Merotocin Detected in Human Breast Milk

Article

作者: Holmqvist, Carina ; Bagger, Yu ; Urban, Lorien E ; Hale, Thomas W ; Lorch, Ulrike ; Jonker, Daniël M ; Baker, Teresa

Objective: The study aimed to assess the transfer of merotocin from systemic circulation to breast milk in early postpartum women and women with established lactation. Methods: This was a two-part, multicenter, open-label, parallel-group study. Merotocin was administered as a single 90-minute intravenous (iv) infusion mimicking the intranasal pharmacokinetic profile. In Part A, 12 early postpartum women received doses of either 4 μg (n = 6) or 16 μg (n = 6) of merotocin within 4 days of delivery. In Part B, six women with established lactation received 20 μg of merotocin. The total concentration of merotocin in plasma and breast milk and its metabolites excreted in breast milk were measured at various time points. Adverse events (AEs) were also assessed for both parts of the study. Results: In both early postpartum and established lactation groups (mean age, 26.3 years; 83.3% Caucasian), merotocin and its metabolites in breast milk were below the limit of quantification (25.0 pg/mL) at all time points. Sixteen treatment-emergent AEs occurred in early postpartum women only, including seven events of uterine spasm and three of breast engorgement. There was one moderate event, whereas all the other events were considered mild. Conclusion: Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation.

2024-06-01·Neuromodulation: Technology at the Neural Interface

Anesthetic Effect on the Subthalamic Nucleus in Microelectrode Recording and Local Field Potential of Parkinson’s Disease

Review

作者: Lin, Sheng-Huang ; Huang, Pin-Han ; Chen, Shin-Yuan ; Pan, Yu-Shen

OBJECTIVESAnesthetic agents used during deep brain stimulation (DBS) surgery might interfere with microelectrode recording (MER) and local field potential (LFP) and thus affect the accuracy of surgical target localization. This review aimed to identify the effects of different anesthetic agents on neuronal activity of the subthalamic nucleus (STN) during the MER procedure.MATERIALS AND METHODSWe used Medical Subject Heading terms to search the PubMed, EMBASE, EBSCO, and ScienceDirect data bases. MER characteristics were sorted into quantitative and qualitative data types. Quantitative data included the burst index, pause index, firing rate (FR), and interspike interval. Qualitative data included background activity, burst discharge (BD), and anesthetic agent effect. We also categorized the reviewed manuscripts into those describing local anesthesia with sedation (LAWS) and those describing general anesthesia (GA) and compiled the effects of anesthetic agents on MER and LFP characteristics.RESULTSIn total, 26 studies on MER were identified, of which 12 used LAWS and 14 used GA. Three studies on LFP also were identified. We found that the FR was preserved under LAWS but tended to be lower under GA, and BD was reduced in both groups. Individually, propofol enhanced BD but was better used for sedation, or the dosage should be minimized in GA. Similarly, low-dose dexmedetomidine sedation did not disturb MER. Opioids could be used as adjunctive anesthetic agents. Volatile anesthesia had the least adverse effect on MER under GA, with minimal alveolar concentration at 0.5. Dexmedetomidine anesthesia did not affect LFP, whereas propofol interfered with the power of LFP.CONCLUSIONSThe effects of the tested anesthetics on the STN in MER and LFP of Parkinson's disease varied; however, identifying the STN and achieving a good clinical outcome are possible under controlled anesthetic conditions. For patient comfort, anesthesia should be considered in STN-DBS.

项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的新闻（医药）

2022-11-21

·生物探索

【探报24H】剑桥科学家合成可摧毁新冠病毒的生物酶！发现胚胎发育中关键基因，若变异将导致各种器官系统畸形！

导语：剑桥科学家合成可摧毁新冠病毒的生物酶；发现胚胎发育中关键基因，若变异将导致各种器官系统畸形；赛诺菲治疗溶血性贫血药物Enjaymo获欧盟委员会上市许可……生物探索与您一同关注“药”闻，探索生物科技的价值！01剑桥科学家合成可摧毁新冠病毒的生物酶11月16日，一项发表于Nature Communications的研究显示，英国剑桥大学科学家利用合成生物学创造了人工酶，这些人工酶被编程为靶向新冠病毒的遗传密码并能摧毁该病毒，该方法可用于开发新一代抗病毒药物。2014年，Alex Taylor博士及其同事发现，被称为XNA的人工遗传物质，即RNA和DNA的合成化学替代品，可用于制造世界上第一种全人工酶，Taylor将其命名为XNAzymes。今年早些时候，他的实验室报告了新一代XNAzymes，经过精心设计，在细胞内条件下更加稳定和高效。这些人工酶可以切割长而复杂的RNA分子，而且非常精确，能够对仅存在一个核苷酸差异的目标序列有所区分。这意味着它们可以被编程为攻击与癌症或其他疾病有关的突变RNA，而让正常的RNA分子不受干扰。在发表于Nature Communications的研究中，Taylor和他在剑桥大学剑桥治疗免疫学和传染病研究所的团队报告了他们如何使用这项技术成功地“杀死”活的SARS-CoV-2病毒。02发现胚胎发育中关键基因变异将导致各种器官系统畸形11月15日，由波恩大学医学院领导的一项国际研究确定了一种在人类胚胎发育中起重要作用的基因，如果它发生突变，就会导致各种器官系统的畸形，研究结果发表在Journal of Medical Genetics。研究人员在研究两名患有先天性畸形的个体时追踪到了该基因。与健康个体相比，受影响个体的一种名为SHROOM4的基因发生了改变。SHROOM4在大脑功能中也起着关键作用。突变可导致智力障碍、癫痫发作和行为异常。 SHROOM4在进化的早期就已经出现，例如，在斑马鱼中。研究人员发现，当关闭斑马鱼幼体中的SHROOM4基因将导致与人类患者相似的畸形。如果将完整人类遗传物质随后注射到关闭SHROOM4基因的斑马鱼幼体中去，这些斑马鱼则可以健康发育。03赛诺菲治疗溶血性贫血药物Enjaymo获EC上市许可11月17日，赛诺菲（Sanofi）已获得欧盟委员会（EC）的Enjaymo（sutimlimab）上市许可，用于治疗患有冷凝集素病的成人溶血性贫血，这是一种罕见、严重和慢性的自身免疫性溶血性贫血，身体的免疫系统错误地攻击健康的红细胞并导致其破裂。赛诺菲表示，Enjaymo是第一个也是唯一一个被批准用于患有冷凝集素病的成年患者溶血性贫血的治疗选择。Enjaymo是一流的人源化单克隆抗体，旨在选择性靶向和抑制经典补体途径特异性丝氨酸蛋白酶C1s，将以50mg/mL的输注溶液形式提供。赛诺菲首席医疗官兼开发全球负责人Dietmar Berger表示：“这一批准凸显了我们开发一流和一流药物以改变人们生活的雄心。04Inovio放弃MERS和拉沙热疫苗11月17日，Inovio宣布，将停止拉沙热（INO-4500）和中东呼吸综合征（Middle East respiratory syndrome，MERS）（INO-4700）疫苗的研发工作。Inovio表示，这些疫苗在试验中表现出良好的安全性，并产生了免疫反应，但“不符合CEPI 进一步开发的选择标准。”Inovio此前一直在与流行病防范创新联盟（Coalition for Epidemic Preparedness Innovations，CEPI）合作进行试验。CEPI是一家帮助资助和推进疫苗开发以及其他公共卫生工作的非营利组织。根据2018年签署的合作伙伴关系，CEPI已同意提供高达5600万美元的资金，用于使疫苗进入第二阶段。 INO-4500拉沙热试验是一项Ib期研究，涉及加纳的220名参与者。通过这次试验，INO-4500成为第一个进入西非针对拉沙热的人体临床试验的候选产品。INO-4700试验是一项旨在预防MERS的II期研究。该试验的第一组涉及来自约旦、肯尼亚和黎巴嫩的192名参与者。Inovio打算发布数据以帮助后续研究。05复星以8.4亿美元价格获得汉斯状在美国权利11月18日，上海复星医药宣布，以8.4亿美元的协议从其长期合作伙伴复宏汉霖获得PD-1候选药物汉斯状的美国权利。复星虽然是复宏汉霖的控股股东，但就在三个月前，复宏汉霖宣布寻找美国合作伙伴。尽管存在关系，复宏汉霖还是通过谈判与复星达成了一份令人羡慕的合同，其中包括1.4亿美元的预付款、一次性5000万美元的监管里程碑付款以及高达6.5亿美元的销售里程碑付款以及特许权使用费。汉斯状（药品名：斯鲁利单抗）是公司控股子公司复宏汉霖自研的PD-1单抗，于 2022年3月在中国上市，现已获批MSI-H实体瘤、联合化疗用于sqNSCLC两项适应症。整理|风立宵排版|风立宵End 往期精选围观36岁战胜12种癌症！1/80亿基因突变改造了免疫系统，进化出杀死癌细胞的能力热文“减肥神器”Ozempic爆火海外抖音，这款降糖药真能“无痛掉秤”吗？热文基因编辑+CAR-T强强联手！癌细胞定向清除，史上最复杂的基因疗法：实现癌症个性化治疗热文智商越高，自控力越强！对诱惑说“不”，你我或许做不到，但松鸦可以！热文点击“阅读原文”，了解更多~

2022-11-18

·Endpts

Inovio drops MERS and Lassa fever vaccines after early trials disappoint

Inovio will stop work on its vaccines for Lassa fever and for MERS after the shots didn’t produce results that were strong enough to take forward in future tests, the company said Thursday afternoon. It’s disappointing news for a company that announced job cuts in July, a tactic meant to preserve resources for its lead DNA vaccine candidates for HPV and Covid-19. Earlier this month, the company reported that it had $22 million in cash and equivalents on the books, down from $71 million a year prior, meaning that it’s quickly burning through resources. Inovio had been working on the trials with CEPI, the Coalition for Epidemic Preparedness Innovations, a nonprofit that helps fund and advance vaccine development, among other public health work. Inovio said that the vaccines showed a good safety profile in the trials and generated an immune response, but “did not meet CEPI’s selection criteria for further development.” Under a 2018 partnership, CEPI had agreed to provide as much as $56 million to take the vaccines through Phase II. “We continue to believe in the potential of our DNA medicine candidates based on their characteristics,” Inovio CEO Jacqueline Shea said in a statement. As the pandemic high wanes, Inovio chops headcount again while chasing Covid win Inovio’s shares $INO hit a 20-year high in 2020 amid the early days of the Covid-19 pandemic, when investors poured into the stock as they did many other vaccine companies. But since that peak of around $30 a share, they’ve plunged to $2.34 a share, as of Thursday’s close. The Lassa fever vaccine was called INO-4500 and was being studied in a Phase Ib trial of 220 patients in Ghana. INO-4700, for MERS, had 192 patients in the first part of a Phase II test. The company said it plans to release the data from the trials at a later date.

疫苗临床2期临床结果临床1期

2022-11-18

·FierceBiotech

Inovio drops Lassa, MERS vaccines as clinical data fall short, gutting infectious disease pipeline

Shares in Inovio fell 3% to $2.26 in premarket trading. Inovio’s Lassa fever and Middle East respiratory syndrome (MERS) vaccine candidates have fallen short of the bar set by the biotech’s partner, prompting the collaborators to pull the plug on the programs after getting a look at clinical data. The Coalition for Epidemic Preparedness Innovations (CEPI) partnered with Inovio in 2018, committing up to $56 million to support development of DNA vaccine candidates against Lassa and MERS through to phase 2. Inovio began a phase 2 clinical trial of the MERS candidate, INO-4700, and a phase 1b study of the Lassa prospect, INO-4500, last year. CEPI footed the bill for the studies. Inovio provided an update on the programs after the market closed Thursday, revealing the data didn’t meet CEPI’s selection criteria for further development. In response, the partners stopped work on the two vaccine candidates. In a statement, Inovio CEO Jacqueline Shea said the two vaccines “were well-tolerated” and “generated immune responses.” A clearer picture of the factors that led the partners to decide against continuing the development of the candidates should emerge when Inovio shares data from the trials. The discontinuation of INO-4700 and INO-4500 development blows a hole in Inovio’s infectious disease pipeline but leaves other key opportunities intact. The candidates accounted for half of the biotech’s clinical infectious disease prospects, with the other assets being its phase 3 COVID-19 vaccine and early-phase Ebola shot. All of the infectious disease candidates are externally funded. Inovio is pumping its own cash into VGX-3100 and INO-3107, candidates aimed at conditions related to human papillomavirus. Data from the second phase 3 trial of VGX-3100 are due around the turn of the year. The FDA is recommending that the trial, REVEAL2, is used as an exploratory study to evaluate a biomarker population, leaving Inovio one or two new trials from having the data to support approval. Shares in Inovio fell 3% to $2.26 in premarket trading.

临床2期疫苗临床3期临床1期

100 项与 Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
冠状病毒感染	药物发现	韩国	Inovio Pharmaceuticals, Inc.	2018-08-28
下呼吸道感染	药物发现	韩国	Inovio Pharmaceuticals, Inc.	2018-08-28
严重急性呼吸综合征	药物发现	美国	Inovio Pharmaceuticals, Inc.	2016-02-01

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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


NCT03721718 (MERS-002, ASGCT2020)	临床1/2期	冠状病毒感染	-	GLS-5300 Vaccine	繭願願鹽製壓簾鏇憲窪(築淵憲鹽艱憲鏇製淵築) = 廠糧糧艱遞鹽齋選鏇齋遞醖夢壓膚衊艱鹽窪獵 (襯膚糧淵獵壓範願餘壓 )	积极	2020-04-28
				GLS-5300 Vaccine	願製糧夢範獵範鑰築夢(範夢膚糧膚簾窪願構獵) = 膚醖製構觸蓋構鏇製積遞糧繭範鑰鹽選艱壓廠 (壓醖鏇淵膚襯鑰淵膚選 ) 更多