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INO-4800

Phase 1

Coronavirus Infection | Small molecule | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Jul 18, 2022

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 Enrollment199
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04447781Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19PHASE1 COMPLETED 79 — — Jul 15, 2020May 25, 2022Jul 18, 20222 South Korea
NCT04336410Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy VolunteersPHASE1 COMPLETED 120 — — Apr 3, 2020Feb 10, 2022Apr 15, 20223 United States
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Study Endpoints
Primary Endpoints
Primary Outcome Measures
Baseline up to Week 52

* Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays \[Immunogenicity\] * Incidence of adverse events among participants during the study period \[Safety and Tolerability\] * Percentage of Participants with Administration (Injection) Site Reactions \[Safety and Tolerability\] * Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period \[Safety and Tolerability\]

Percentage of Participants with Adverse Events (AEs)
Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Administration (Injection) Site Reactions
Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers
Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Change from Baseline in Antigen-Specific Cellular Immune Response
Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1 (Part A)EXPERIMENTAL* Number of Subjects: 20 subjects * ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Group 2 (Part A)EXPERIMENTAL* Number of Subjects: 20 subjects * ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Group 3 (Part B)EXPERIMENTAL* Number of Subjects: 90 subjects * ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Group 4 (Part B, Placebo)PLACEBO_COMPARATOR* Number of Subjects: 30 subjects * ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Group 1: INO-4800EXPERIMENTALParticipants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
Group 2: INO-4800EXPERIMENTALParticipants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
Group 3: INO-4800EXPERIMENTALParticipants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
Interventions
NameTypeDescription
INO-4800BIOLOGICAL\- Manufacturer: Inovio Pharmaceuticals Inc.
CELLECTRA® 2000DEVICE\- Manufacturer: Inovio Pharmaceuticals Inc.
Saline-sodium citrate (SSC) bufferOTHER\- Manufacturer: Inovio Pharmaceuticals Inc.
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Eligibility Criteria
Age Range19 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures * Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B) * Judged to be healthy by the Investigator on the basis of m...

Countries:South KoreaUnited States
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