Recombinant Hyperimmune Gammaglobulin for Primary Immunodeficiency
重组超免疫丙种球蛋白治疗原发性免疫缺陷
基本信息
- 批准号:9139000
- 负责人:
- 金额:$ 75.02万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2016
- 资助国家:美国
- 起止时间:2016-07-01 至 2018-06-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAdultAffectAmericanAntibioticsAntibodiesAntibody RepertoireAntigensBacteriaBindingBiochemistryBiological AssayCLIA certifiedCapitalCellsChronicChronic lung diseaseClinicalCohort StudiesCongenital DisordersCytomegalovirusDNA LibraryDataDiagnosticDiagnostic testsDoctor of PhilosophyDrug KineticsEuropeExclusionFDA approvedFailureFamilyFlow CytometryGenomicsHemophilusHigh Pressure Liquid ChromatographyImmuneImmune System DiseasesImmunocompromised HostImmunologistIn VitroInfectionInfluenzaIntravenous ImmunoglobulinsIon ExchangeLibrariesLight-Chain ImmunoglobulinsLungMethodsMicrofluidicsMorbidity - disease rateOutcomePatientsPharmaceutical PreparationsPhasePlasmaPneumoniaProphylactic treatmentProteinsRecombinantsRecurrenceRodentScientistSequoiaSerumSmall Business Innovation Research GrantSpecialistStreptococcusTestingTherapeuticTimeToxicologyTransplant RecipientsUnited States National Institutes of HealthVaccinatedVirusWest Nile virusWorkX-Linked Agammaglobulinemiaantibody librariescombatcongenital immunodeficiencyimprovedmeetingsmonomermortalitynew technologynovel strategiespathogenpolyclonal antibodypreclinical efficacyproduct developmentprophylacticpublic health relevanceresponseseropositivetranscriptome sequencing
项目摘要
DESCRIPTION (provided by applicant): The Specific Aim of this SBIR direct-to-Phase II project is to develop natural repertoire recombinant intravenous immunoglobulin (rIVIg) "hyperimmunes" against common pathogens for patients with primary immune deficiency (PID). PID is a diverse family of congenital disorders, including common variable immune deficiency (CVID) and X- linked agammaglobulinemia (XLA), which are characterized by significantly reduced antibody titers. Immunologists treat humoral PID with prophylactic intravenous immunoglobulin (IVIg), which is a pool of proteins isolated from the plasma of thousands of donors. Still, 40% of patients suffer recurrent pneumonia, and 36% die from lung failure due to chronic lung disease. Most PID patients with recurrent infections receive prophylactic antibiotics to address chronic infection. Hyperimmunes are plasma-derived gammaglobulins that are enriched for activity against a particular pathogen. Unfortunately, the nine FDA-approved hyperimmunes do not address the pathogens that are most responsible for morbidity and mortality in PID patients. Previously, we developed GigaLink(tm), which uses microfluidics and multiplexed PCR to build massively polyclonal DNA libraries from antibody repertoires, with native heavy and light chain immunoglobulin (Ig) pairing intact. In our preliminary work, we leveraged GigaLink(tm) to produce and characterize hyperimmune influenza rIVIg with >40× enriched binding activity. In this SBIR direct-to-Phase II project, we will add hyperimmunes for two more pathogens of critical importance to PID outcomes, manufacture several test batches of rIVIg, and perform toxicology, pharmacokinetic, and pathogen binding studies. Though PID is the primary clinical indication, these drugs could be used for other kinds of immunocompromised patients, such as transplant recipients. Finally, our therapeutic approach will be useful to combat emerging pathogens, i.e., for West Nile rapid response.
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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David Scott Johnson其他文献
David Scott Johnson的其他文献
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{{ truncateString('David Scott Johnson', 18)}}的其他基金
Commercialization of an Advanced Technology for T Cell Receptor Analysis and Engineering
T 细胞受体分析和工程先进技术的商业化
- 批准号:
9193662 - 财政年份:2016
- 资助金额:
$ 75.02万 - 项目类别:
Recombinant Hyperimmune Gammaglobulin for Primary Immunodeficiency
重组超免疫丙种球蛋白治疗原发性免疫缺陷
- 批准号:
9304957 - 财政年份:2016
- 资助金额:
$ 75.02万 - 项目类别:
Production Technology for Recombinant Intravenous Immunoglobulin
重组静脉免疫球蛋白生产技术
- 批准号:
8976337 - 财政年份:2015
- 资助金额:
$ 75.02万 - 项目类别:
Recombinant Hyperimmune Gammaglobulin for Pneumococcal Disease
用于治疗肺炎球菌疾病的重组超免疫丙种球蛋白
- 批准号:
8979450 - 财政年份:2015
- 资助金额:
$ 75.02万 - 项目类别:
Next-Generation Antibody Discovery and Development Technology
下一代抗体发现和开发技术
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9174883 - 财政年份:2014
- 资助金额:
$ 75.02万 - 项目类别:
Therapeutic Antibody Discovery from Pancreatic Cancer B Cell Repertoires
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- 批准号:
8832750 - 财政年份:2014
- 资助金额:
$ 75.02万 - 项目类别:
B Cell Repertoire Molecular Platform for Antibody Drug Discovery
用于抗体药物发现的 B 细胞库分子平台
- 批准号:
8756836 - 财政年份:2014
- 资助金额:
$ 75.02万 - 项目类别:
Cloud-Based Bioinformatics for Immune Repertoire Analysis
用于免疫谱分析的基于云的生物信息学
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8642691 - 财政年份:2012
- 资助金额:
$ 75.02万 - 项目类别:
Cloud-Based Analysis of TCR Repertoire Sequencing Data
基于云的 TCR 谱库测序数据分析
- 批准号:
8394673 - 财政年份:2012
- 资助金额:
$ 75.02万 - 项目类别:
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