Core B - MappBiopharmaceutical, Inc.
核心 B - MappBiopharmaceutical, Inc.
基本信息
- 批准号:10581494
- 负责人:
- 金额:$ 64.29万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-03-20 至 2025-02-28
- 项目状态:未结题
- 来源:
- 关键词:AntibodiesAntiviral AgentsBiological AssayCell LineCell physiologyClinicalCommunicable DiseasesDataDevelopmentDoseDrug KineticsEbolaEffectivenessEtiologyEuropeanFamilyFatality rateFormulationGenerationsGoalsHamstersHandHendra VirusHenipavirusHumanIndividualInfectionInvestigational DrugsLeadLicensingMarburgvirusMedicineModelingMonoclonal AntibodiesNew AgentsNipah VirusParamyxovirusPoint MutationPreventionPublic HealthRNARNA VirusesReagentResearch Project GrantsResearch SupportRespiratory DiseaseSafetySpecificityTestingTherapeuticTherapeutic Monoclonal AntibodiesToxicologyUnited States Food and Drug AdministrationVaccinesVariantVirulentVirusWorkZoonosesclinical developmentdrug developmentefficacy studyglycosylationimprovedin vivoin vivo evaluationinfectious disease treatmentlead candidatemanufacturenervous system disordernonhuman primatepathogenic viruspre-Investigational New Drug meetingresearch clinical testingresponse
项目摘要
Abstract
Over the past 40 years, the majority of the major etiological agents of newly emerged or identified infectious
diseases in humans have been viruses, and most have been zoonoses caused by RNA viruses. The
emergence or reemergence of pathogenic viruses are continuous threats to public health. Two recently
emergent, zoonotic RNA viral pathogens come from the henipavirus genus within the paramyxovirus family:
Hendra virus (HeV) and Nipah virus (NiV). HeV and NiV can cause a systemic and often fatal respiratory
and/or neurological disease in at least 11 mammalian species including humans, with fatality rates ranging
from 40-100%. There are no vaccines or therapeutics licensed for these viruses, highlighting an important
unmet public health need.
Due to their high potency and specificity, as well as their excellent clinical safety and efficacy record,
monoclonal antibodies (mAbs) are an appealing platform for anti-viral therapeutics. With over 50 mAbs
approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), many of the
manufacturing, formulation, and regulatory challenges of mAb drug development are well understood. The
utility of antibodies, both naturally occurring and passively applied, has been evident for prevention and post-
exposure treatment of infectious diseases for over a century.
Three highly potent lead candidate therapeutic mAbs with anti-henipaviral activity are currently in hand,
allowing development activities to begin immediately at the initiation of the CETR effort. Core B will focus on
optimizing these candidates, down-selecting to the lead product format (a single mAb vs. a cocktail), and
advancing the product towards clinical evaluation and development. To achieve these goals, we propose the
following Specific Aims: 1. Optimize the individual in vivo potency of the 3 lead mAbs; 2. Evaluate the
optimized mAbs in combinations to identify a lead product candidate; 3. Perform Investigational New Drug
(IND)-enabling work. The 5 year effort will culminate with a final milestone of conducting a pre-IND meeting
with the FDA.
摘要
在过去的40年里,大多数新出现或确定的传染性疾病的主要病原体
人类的疾病都是病毒引起的,大多数是由RNA病毒引起的人畜共患病。的
致病性病毒的出现或重新出现是对公共卫生的持续威胁。两名最近
新出现的人畜共患RNA病毒病原体来自副粘病毒科的亨尼帕病毒属:
亨德拉病毒(HeV)和尼帕病毒(NiV)。HeV和NiV可引起全身性且通常致命的呼吸道感染。
包括人类在内的至少11种哺乳动物的死亡率
40- 100%。目前还没有针对这些病毒的疫苗或治疗药物获得许可,这突出了一个重要的问题。
未满足的公共卫生需求。
由于其高效力和特异性,以及其出色的临床安全性和有效性记录,
单克隆抗体(mAbs)是抗病毒治疗的一个有吸引力的平台。超过50个mAb
经美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)批准,
mAb药物开发的制造、配制和监管挑战是众所周知的。的
抗体的效用,无论是天然存在的还是被动应用的,对于预防和治疗后,
暴露治疗传染病已经有超过世纪的历史了。
目前已有三种具有抗亨尼帕病毒活性的高效先导候选治疗mAb,
允许开发活动在CETR工作启动时立即开始。核心B将侧重于
优化这些候选物,向下选择主导产品形式(单一mAb与混合物),以及
推进产品的临床评价和开发。为了实现这些目标,我们建议
具体目标:1。优化3种先导mAb的个体体内效力; 2.评价
优化的mAb组合以鉴定先导产物候选物; 3.进行新药试验
(IND)-使能工作。5年的努力将以进行IND前会议的最后一个里程碑而告终
和食品药物管理局
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Larry Zeitlin其他文献
Larry Zeitlin的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Larry Zeitlin', 18)}}的其他基金
Core B - MappBiopharmaceutical, Inc.
核心 B - MappBiopharmaceutical, Inc.
- 批准号:
10362728 - 财政年份:2019
- 资助金额:
$ 64.29万 - 项目类别:
Development of highly potent human monoclonal for RSV immuno-prophylaxis
开发用于 RSV 免疫预防的高效人单克隆抗体
- 批准号:
10208698 - 财政年份:2018
- 资助金额:
$ 64.29万 - 项目类别:
Development of highly potent human monoclonal for RSV immuno-prophylaxis
开发用于 RSV 免疫预防的高效人单克隆抗体
- 批准号:
10080251 - 财政年份:2018
- 资助金额:
$ 64.29万 - 项目类别:
Development of highly potent human monoclonal for RSV immuno-prophylaxis
开发用于 RSV 免疫预防的高效人单克隆抗体
- 批准号:
10447760 - 财政年份:2018
- 资助金额:
$ 64.29万 - 项目类别:
Rapid Response Agents Against Filovirus Outbreaks Using Vectored Immunoprophylaxis
使用载体免疫预防针对丝状病毒爆发的快速反应剂
- 批准号:
9200868 - 财政年份:2016
- 资助金额:
$ 64.29万 - 项目类别:
An Immunoprotectant for Argentine Hemorrhagic Fever
阿根廷出血热的免疫保护剂
- 批准号:
8840490 - 财政年份:2014
- 资助金额:
$ 64.29万 - 项目类别:
An Immunoprotectant for Argentine Hemorrhagic Fever
阿根廷出血热的免疫保护剂
- 批准号:
8692502 - 财政年份:2014
- 资助金额:
$ 64.29万 - 项目类别:
An Antibody Immunoprotectant for Category B Toxins
B 类毒素的抗体免疫保护剂
- 批准号:
8484785 - 财政年份:2012
- 资助金额:
$ 64.29万 - 项目类别:
An Antibody Immunoprotectant for Category B Toxins
B 类毒素的抗体免疫保护剂
- 批准号:
9067312 - 财政年份:2012
- 资助金额:
$ 64.29万 - 项目类别:
相似海外基金
Development of a new generation of antiviral agents that are effective against drug-resistant viruses and prevent serious illness and sequelae.
开发新一代抗病毒药物,可有效对抗耐药病毒并预防严重疾病和后遗症。
- 批准号:
23K18186 - 财政年份:2023
- 资助金额:
$ 64.29万 - 项目类别:
Grant-in-Aid for Challenging Research (Exploratory)
A versatile structure-based therapeutic platform for development of VHH-based antitoxin and antiviral agents
一个多功能的基于结构的治疗平台,用于开发基于 VHH 的抗毒素和抗病毒药物
- 批准号:
10560883 - 财政年份:2023
- 资助金额:
$ 64.29万 - 项目类别:
Genetically encoded bicyclic peptide libraries for the discoveryof novel antiviral agents
用于发现新型抗病毒药物的基因编码双环肽库
- 批准号:
10730692 - 财政年份:2021
- 资助金额:
$ 64.29万 - 项目类别:
Design and synthesis of nucleosides to develop antiviral agents and oligonucleotide therapeutics
设计和合成核苷以开发抗病毒药物和寡核苷酸疗法
- 批准号:
21K06459 - 财政年份:2021
- 资助金额:
$ 64.29万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Genetically encoded bicyclic peptide libraries for the discoveryof novel antiviral agents
用于发现新型抗病毒药物的基因编码双环肽库
- 批准号:
10189880 - 财政年份:2021
- 资助金额:
$ 64.29万 - 项目类别:
Computer-aided identification and synthesis of novel broad-spectrum antiviral agents
新型广谱抗病毒药物的计算机辅助鉴定和合成
- 批准号:
2404261 - 财政年份:2020
- 资助金额:
$ 64.29万 - 项目类别:
Studentship
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10222540 - 财政年份:2020
- 资助金额:
$ 64.29万 - 项目类别:
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10669717 - 财政年份:2020
- 资助金额:
$ 64.29万 - 项目类别:
Association between sedentary lifestyle and liver cancer development in hepatitis C patients treated with direct-acting antiviral agents
接受直接抗病毒药物治疗的丙型肝炎患者久坐的生活方式与肝癌发展之间的关系
- 批准号:
20K10713 - 财政年份:2020
- 资助金额:
$ 64.29万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10174522 - 财政年份:2020
- 资助金额:
$ 64.29万 - 项目类别: