An Immunoprotectant for Argentine Hemorrhagic Fever
阿根廷出血热的免疫保护剂
基本信息
- 批准号:8692502
- 负责人:
- 金额:$ 120.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-04-21 至 2019-03-31
- 项目状态:已结题
- 来源:
- 关键词:AcademiaAcuteAddressAnimal ModelAntibodiesArenavirusBenchmarkingBindingBiological AssayBiological ProductsBiological Response Modifier TherapyBiological WarfareCategoriesCaviaCenters for Disease Control and Prevention (U.S.)ChemistryClinical ManagementClinical ResearchCollaborationsCommunicable DiseasesComplementControlled StudyCoupledDevelopmentDiagnosisDiseaseDisease OutbreaksDrug FormulationsEpitopesExposure toFDA approvedFutureGlycoproteinsGoalsHealth protectionHumanIndividualIndustryInfectionInternationalInvestigational DrugsInvestigational New Drug ApplicationJunin virusKentuckyLeadMapsMedicalMethodsModelingMonoclonal AntibodiesMorbidity - disease rateNational SecurityNaturePerformancePharmaceutical PreparationsPharmacology and ToxicologyPhasePlantsPopulationPreclinical TestingPreventionPreventiveProductionPublic HealthResearch InstituteRiskRodentSafetySerumSymptomsSystemTestingTexasTherapeuticTreatment EfficacyUniversitiesViral Hemorrhagic FeversVirusX-Ray Crystallographyantibody-dependent cell cytotoxicitybioprocesscGMP productioncost effectivedisorder preventiondrug developmenthemorrhagic fever virusimprovedin vivomanufacturing process developmentmembermortalityneutralizing monoclonal antibodiespreventproduct developmentpublic health relevance
项目摘要
DESCRIPTION (provided by applicant): Junin virus, the causative agent of Argentine hemorrhagic fever, is an arenavirus identified by the Centers for Disease Control and Prevention (CDC) as a Category A agent, or "high-priority agent ... that pose(s) a risk to national
security." There are currently no FDA approved drugs available for preventing or treating infections with Junin. There is a clear unmet need for a Junin immunoprotectant to address the threat of biowarfare as well as for public health protection during regular naturally occurring outbreaks. We have identified highly potent neutralizing monoclonal antibody (mAbs) that bind the Junin glycoprotein (GP). Clinical studies using polyclonal sera have demonstrated a clear relationship between neutralization and therapeutic efficacy, providing excellent proof-of-concept support for this effort. The goal of this proposed effort is the development of an immunoprotectant for Junin virus, manufactured in a rapid and cost-effective plant system (RAMP: Rapid Antibody Manufacturing Platform), for prevention and post-exposure treatment of infection.
The Specific Aims of this proposed effort are:
Specific Aim 1. Determine therapeutic window of lead product candidate.
The guinea pig model will be used to identify the therapeutic window of the product candidate.
Specific Aim 2. Elucidate structural and functional activities of the mAb and Junin virus.
The epitope of MJ-01 will be mapped by X-ray crystallography and its potency quantified by neutralization assays (with and without complement), and antibody dependent cellular cytotoxicity (ADCC). An understanding of the mechanism of action is required for the future Investigational New Drug submission (Aim 4).
Specific Aim 3. Humanize the Junin immunoprotectant and manufacture drug product using a versatile and inexpensive GMP platform. The lead product candidate will be humanized and then produced using the RAMP system. A stable formulation will be identified, and Good Manufacturing Practices (GMP) performed to supply the drug product for IND-enabling studies.
Specific Aim 4. Complete Investigational New Drug (IND) enabling studies
All IND-enabling pharmacology, toxicology, and Chemistry, Manufacturing and Controls (CMC) studies will be performed, with a final goal of filing an IND application to support a Phase 1 human safety trial.
描述(由申请人提供):朱宁病毒是阿根廷出血热的病原体,是一种沙粒病毒,被美国疾病控制与预防中心(CDC)认定为a类病原体,或“高优先级病原体”。这对国民经济构成了威胁
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)
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Larry Zeitlin其他文献
Larry Zeitlin的其他文献
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{{ 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:
$ 120.45万 - 项目类别:
Core B - MappBiopharmaceutical, Inc.
核心 B - MappBiopharmaceutical, Inc.
- 批准号:
10581494 - 财政年份:2019
- 资助金额:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 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:
$ 120.45万 - 项目类别:
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