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IND-enabling studies for eCD4-Ig as a long-acting recombinant protein therapeutic
NIHUS FederalResearch GrantFY2025AIDS VirusAb-dependent cellular cytotoxicityAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAlpha-FucosyltransferasesAmino Acid SequenceAnimal ModelAnimal Models and Related StudiesAnimalsAntibodiesAntibody ResponseAntiseraAssayBindingBioassayBiological AssayBlood CellsBlood PlasmaBlood leukocyteBody TissuesBody WeightCNS Nervous SystemCardiac ToxicityCardiotoxicCardiotoxicityCell BodyCell LineCellLineCellsCentral Nervous SystemCirculationClinicClinicalClinical ChemistryClinical TrialsClottingCoagulationCoagulation ProcessCrab-Eating MacaqueCrab-Eating MonkeyCynomolgus MonkeyCynomolgus macaqueDNA mutationDataDevelopmentDoseDrug KineticsDrugsEarly-Stage Clinical TrialsFamilyFcRnFcRn neonatal transfer proteinFeedbackFemaleFucosyltransferaseFundingGenetic ChangeGenetic defectGenetic mutationGerm LinesGrantHIVHIV Envelope Glycoprotein gp120HIV Envelope Protein gp120HIV InfectionsHIV ReceptorsHIV env Protein gp120HTLV-III InfectionsHTLV-III ReceptorsHTLV-III gp120HTLV-III-LAV InfectionsHalf-LifeHistopathologyHumanHuman Immunodeficiency VirusesHuman T-Lymphotropic Virus Type III InfectionsIND FilingIND applicationIND packageIND submissionIg Somatic HypermutationImmune SeraImmunoglobulin Somatic HypermutationInjectableInvestigational DrugsInvestigational New Drug ApplicationInvestigational New DrugsKnock-outKnockoutLAV-HTLV-IIILaboratoriesLength of LifeLeukocytesLeukocytes Reticuloendothelial SystemLife ExtensionLongevityLymphadenopathy-Associated VirusLymphatic cellLymphocyteLymphocyticM fascicularisM. fascicularisMacacaMacaca cynomolgusMacaca fascicularisMacaca irusMacaqueMarrow leukocyteMediatingMedicationModern ManMolecular InteractionMutationNeuraxisPBMCPeripheral Blood CellPeripheral Blood Mononuclear CellPersonsPharmaceutical PreparationsPharmacokineticsPharmacologyPhasePhase 1 Clinical TrialsPhase I Clinical TrialsPlacebosPlasmaPlasma SerumPopulationPre IND FDA meetingPre-IND mtgPrimary Protein StructurePropertyProtein EngineeringProteinsReceptor ProteinRecombinant ProteinsRecombinantsRegimenReportingReticuloendothelial System, Serum, PlasmaRodentRodentiaRodents MammalsSBIRSafetySham TreatmentSmall Business Innovation ResearchSmall Business Innovation Research GrantStrains Cell LinesStructureSubcutaneous InjectionsSurfaceSynthetic antigen binderTherapeuticTissuesToxic effectToxicitiesToxicokineticsToxicologyUrinalysisVirusVirus-HIVWhite Blood CellsWhite CellWorkWritingantibody dependent cell mediated cytotoxicityantibody dependent cytotoxicityantibody mediated cellular cytotoxicityantibody mimeticsantibody-dependent cell cytotoxicityantibody-dependent cellular cytotoxicityantibody-like binderantibody-like moleculeantibody-like proteinantibody-like reagentantibody-mediated cytotoxicitybiophysical characteristicsbiophysical characterizationbiophysical measurementbiophysical parametersbiophysical propertiescross reactivitycultured cell linecytokinedevelopmentaldrug/agentexperiencefirst in manfirst-in-humanfood Ingestionfood consumptiongenetic protein engineeringgenome mutationgp120gp120 ENV Glycoproteingp120(HIV)immune serumimmunotoxicityin vitro Assayinsoluble aggregatelong-tailed macaquelymph cellmalemanufacturemeetingmeetingsmimeticsmodel of animalmouse modelmurine modelnative protein drugneonatal Fc receptorneutralizing antibodynew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapypharmaceutical proteinphase I protocolpre-IND consultationpre-IND discussionpre-IND meetingpre-Investigational New Drug meetingpre-clinicalpreclinicalpreventpreventingprotein aggregateprotein aggregationprotein designprotein drug agentprotein sequenceprotein-based drugreceptorrespiratorysafety testingsham therapysomatic hypermutationsubcutaneoussubdermalsubdermal injectionsulfotyrosinesynthetic antigen binding reagenttherapeutic proteinthermolabilitythermostabilitytoxic reaction in immunologytyrosine O-sulfatetyrosine sulfatevirtualwhite blood cellwhite blood corpuscle♀♂
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Description preview
ABSTRACT
This FastTrack SBIR grant will support pre-clinical IND-enabling studies for recombinant eCD4-Ig protein,
ahead of a first-in-human (FIH) Phase 1 clinical trial. eCD4-Ig is an antibody-like therapeutic for HIV
consisting of parts of HIV’s receptor and coreceptors fused to the constant Fc region of an antibody. Due to
being comprised of…
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