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GLS-5300

Phase 1

Healthy | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Last Updated: May 27, 2020

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03721718Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy VolunteersPHASE1 COMPLETED 60 — — Aug 28, 2018Apr 22, 2020May 27, 20202 South Korea
NCT02670187Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy VolunteersPHASE1 COMPLETED 75 — — Feb 1, 2016Sep 1, 2017Jan 9, 20191 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events
Day0 through up to 60 weeks

Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule

Administration (injection) site reactions
Day0 through up to 60 weeks

Administration (injection) site reactions described by frequency

Changes in safety laboratory parameters
Day0 through up to 60 weeks

Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.

Administration (injection) site pain
Administration (injection) site pain

Administration (injection) site pain as described by Visual Analog Scale (VAS)

Mean change from baseline in safety laboratory measures
Day0 through Week 60
Incidence of solicited adverse events after vaccination
Day0 through Week 60
Incidence of unsolicited adverse events after vaccination
Day0 through Week 60
Incidence of serious adverse events
Day0 through Week 60
Secondary Endpoints
Cellular Immune Responses
Day0 through up to 60 weeks
Binding antibody titers
Day0 through up to 60 weeks
Neutralizing antibodies
Day0 through up to 60 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
GLS-5300 with ID Cellectra electroporationEXPERIMENTALGLS-5300 at 0.3mg DNA/dose
GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporationEXPERIMENTALGLS-5300 at 0.3mg DNA/dose
GLS-5300 at 0.6mg DNA/dose (3 dose regimen)EXPERIMENTALGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
GLS-5300 at 0.6mg DNA/dose (2 dose regimen)EXPERIMENTALGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
GLS-5300EXPERIMENTALGLS-5300 at 0.67 mg DNA/dose
GLS-5300 at 2 mg DNA/doseEXPERIMENTALGLS-5300 at 2 mg DNA/dose
GLS-5300 at 6 mg DNA/doseEXPERIMENTALGLS-5300 at 6 mg DNA/dose
Interventions
NameTypeDescription
GLS-5300BIOLOGICAL\[Part A\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) \[Part B\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
Cellectra 2000 ElectroporationDEVICEGLS-5300 administered ID followed by Cellectra 2000 Electroporation
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Eligibility Criteria
Age Range19 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Age 19-70 years; 2. Able to provide consent to participate and having signed an Informed Consent Form (ICF); 3. Able and willing to comply with all study procedures; 4. Women of child-bearing potential agree to either remain sexually abstinent, use medically effective contrac...

Countries:South KoreaUnited States
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