IND-enabling development for IN-002, an inhaled muco-trapping mAb against respiratory syncytial virus
IN-002 是一种针对呼吸道合胞病毒的吸入性粘膜捕获单克隆抗体,可进行 IND 开发
基本信息
- 批准号:10663797
- 负责人:
- 金额:$ 101.9万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-07-12 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAdsorptionAdultAffinityAgeAnimalsAntibodiesAntibody TherapyAntigensAntiviral TherapyApicalBackBindingBiologicalBiological AssayBronchiolitisCell LineCellsCessation of lifeChildChinese Hamster Ovary CellClinicClinicalClinical ResearchClinical TrialsContractsCotton RatsCoupledCritical PathwaysCyclic GMPDataDevelopmentDoseEffectivenessElderlyEngineeringEvaluationFDA approvedFormulationFunctional disorderGelGoalsGovernmentHospitalizationHumanImmuneImmunocompromised HostImmunoglobulin GIn VitroInfantInfectionInhalationInhalation TherapyInjectionsInterventionIntramuscular InjectionsInvestigationLegal patentLungMediatingModalityMolecular TargetMonoclonal AntibodiesMorbidity - disease rateMucinsMucociliary ClearanceMucous body substanceMusNebulizerNeonatalNeutrophil InfiltrationPalivizumabPersonsPhasePneumoniaPolysaccharidesPositioning AttributePregnancyPreventionRattusResearchRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesRespiratory SystemRespiratory syncytial virusRiskRunningSerumSideSiteSupportive careTherapeuticTissuesToxicologyTranslationsVaccine TherapyVaccinesViralViral Load resultViral load measurementViremiaVirionVirusVirus DiseasesVirus SheddingVulnerable PopulationsWorkairway epitheliumantiviral drug developmentcell bankcostcost effectivecost effective treatmentcross reactivitycrosslinkeffective therapyglycosylationhigh riskhigh risk infantimprovedlamb modelmeetingsminimal riskmortalitynecrotic tissuepathogenpharmacologicphase 1 studypre-Investigational New Drug meetingpre-clinicalprophylacticresearch clinical testingrespiratoryrespiratory pathogenside effecttechnology platformtransmission processvibration
项目摘要
Project Summary
Respiratory Syncytial Virus (RSV) is the leading cause of viral death in infants and young children, and is
also a major cause of respiratory illness in immune compromised adults and the elderly. Unfortunately, there is
currently no vaccine or effective therapy available for RSV. Synagis, a monthly intramuscular injection of the
monoclonal antibody (mAb) palivizumab, is the only FDA-approved intervention, but can only be used for
prevention and is given only to a very small subset of high-risk infants. Synagis is not effective at treating RSV
after infection has begun. Thus, for the tens of thousands hospitalized with RSV, only supportive therapy is
available; the resulting morbidity and mortality are substantial, particularly among the immunocompromised.
Interestingly, RSV spreads in the lung via shedding of virus exclusively into the airway; thus, RSV must
traverse the airway mucus (AM) before infecting other neighboring cells, and remains restricted to the airways
with little-to-no systemic viremia. This unique pathophysiology makes RSV difficult to target by systemically
dosed therapies. We believe an RSV-specific, safe and effective antiviral therapy that can be inhaled directly
into the respiratory tract would provide a powerful option addressing the current gap in pharmacological
interventions. To meet this goal, Inhalon has been advancing IN-002, developed using its proprietary and
patented “muco-trapping” mAb technology platform. IN-002 is a potent anti-F mAb with picomolar binding
affinity and neutralization potency, has minimal risk of viral escape, and possess suitable Fc N-glycosylation for
trapping RSV in AM. In turn, trapped RSV are quickly purged from the airways via natural mucociliary
clearance mechanisms. We have further formulated IN-002 to be stably nebulized using a vibrating mesh
nebulizer. By concentrating IN-002 directly at the site of infection, rather than delivering the mAb systemically,
we expect to enable efficacious and cost-effective treatment of RSV, with little risk of adverse side effects due
to limited systemic adsorption from pulmonary delivery. In a neonatal lamb model of RSV infection, daily
nebulized therapy with IN-002 initiated even at near peak viral titers in the lung was able to reduce infectious
RSV viral load in the lungs and BALF to almost non-detectible levels within 3 days. Inhalon is currently actively
engaging in cell line development for IN-002. To enable rapid translation into the clinic, we seek to complete
the cell line development in this proposal, and produce tox materials suitable for IND-enabling activities such
as Tissue Cross Reactivity studies, GLP pulmonary tox studies, and GLP nebulization characterization studies.
Together, the proposed work will support rapid advancement of IN-002 into clinical testing. Our work here with
RSV will also help pave the way for improved, molecularly-targeted, inhaled therapies for other respiratory
pathogens.
项目总结
项目成果
期刊论文数量(0)
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{{ truncateString('JEFF T HUTCHINS', 18)}}的其他基金
GMP manufacturing and IND Filing of IN-002, a potent inhaled muco-trapping antibody therapy for Respiratory Syncytial Virus
IN-002 的 GMP 生产和 IND 备案,这是一种针对呼吸道合胞病毒的有效吸入粘液捕获抗体疗法
- 批准号:
10761398 - 财政年份:2023
- 资助金额:
$ 101.9万 - 项目类别:
IND-enabling development for IN-002, an inhaled muco-trapping mAb against respiratory syncytial virus
IN-002 是一种针对呼吸道合胞病毒的吸入性粘膜捕获单克隆抗体,可进行 IND 开发
- 批准号:
10385558 - 财政年份:2022
- 资助金额:
$ 101.9万 - 项目类别:
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