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GLS-5700

Phase 1

Healthy | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Dec 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02887482GLS-5700 in Dengue Virus Seropositive AdultsPHASE1 COMPLETED 160 — — Aug 1, 2016Jun 1, 2018Jan 20, 20223 Puerto Rico
NCT02809443GLS-5700 in Dengue Virus-Naïve AdultsPHASE1 COMPLETED 40 — — Jul 1, 2016Dec 1, 2017Dec 24, 20243 United States, Canada
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Study Endpoints
Primary Endpoints
Mean change from baseline in safety laboratory measures
Day 0 through Week 14
Incidence of solicited adverse events after vaccination
Day 0 through Week 14
Incidence of unsolicited adverse events after vaccination
Day 0 through Week 14
Incidence of serious adverse events
Day 0 through Week 14
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
Day 0 through Week 60
Secondary Endpoints
Binding antibody titers to Zika envelope
Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
Day 0 through Week 60 following first dose
T cell response
Day 0 through Week 60 following first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboEXPERIMENTALPlacebo at 0 mg DNA/dose
GLS-5700EXPERIMENTALGLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
GLS-5700 at 1 mgEXPERIMENTALDNA/dose
GLS-5700 at 2 mgEXPERIMENTALDNA/dose
Interventions
NameTypeDescription
GLS-5700BIOLOGICALGLS 5700 at 2 mg DNA/dose
PlaceboBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age 18-65 years; * Able to provide consent to participate and having signed an Informed Consent Form (ICF); * Able and willing to comply with all study procedures; * Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier me...

Countries:Puerto RicoUnited StatesCanada
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