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INO-4700

Phase 2

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) | Small molecule | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Jan 22, 2026

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04588428Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy VolunteersPHASE2 COMPLETED 192Jun 21, 2021Jan 19, 2023Jan 22, 20266 Jordan, Kenya +1
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Study Endpoints
Primary Endpoints
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
From the first dose of the study drug up to the end of the study (up to 48.7 weeks)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with treatment. TEAEs: AEs with onset after administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. TEAEs were graded based on the Toxicity Grading Scale for Healthy Adult \& Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration \[FDA\] Guidance for Industry), as Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Prevents daily activity/requires medical intervention \& Grade 4: Emergency room visit/hospitalization. A causally related AE is one judged by the Investigator to have a possible, probable, or definite relationship to the administration of an investigational product (IP).

Part 1: Percentage of Participants With Injection Site Reactions
From the first dose of the study drug up to the end of the study (up to 48.7 weeks)

Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.

Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs)
From Screening to the end of the study (up to 48.7 weeks)

An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate.

Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6
At Week 6

Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.

Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6
At Week 6

Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.

Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10
At Week 10

Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.

Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10
At Week 10

Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.

Part 1: Percentage Neutralizing Antibody Responders at Week 6
At Week 6

The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was \>20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.

Part 1: Percentage Neutralizing Antibody Responders at Week 10
At Week 10

The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was \>20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.

Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6
At Week 6

Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was \> baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.

Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10
At Week 10

Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was \> baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.

Part 2: Percentage of Participants With Adverse Events
From the first dose of the study drug up to the end of the study (up to 68 weeks)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have causal relationship with treatment.

Part 2: Percentage of Participants With Injection Site Reactions
From the first dose of the study up to the end of the study (up to 68 weeks)

Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (FDA Guidance for Industry, September 2007). Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.

Part 2: Percentage of Participants With Adverse Events of Special Interest (AESIs)
From Screening up to the end of the study (up to 68 weeks)

An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate. These included respiratory distress syndrome, pneumonia, neurologic, hematologic, immunologic, and other events (including local or systemic SAEs, acute renal failure, SARS-CoV-2 infection, or death). In addition, anxiety and pain related to the EP procedure were monitored.

Part 2: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody
At Week 12

Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination were to be assessed.

Part 2: Percentage Neutralizing Antibody Responders
At Week 12

The immune responses to INO-4700 were to be measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were to be collected at serial timepoints.

Part 2: Percentage of Antigen Specific Cellular Immune Responders
At Week 12

Assessments of cellular immune responses to INO-4700 were to be performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs).

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part 1: INO-4700 Group AEXPERIMENTALParticipants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Part 1: INO-4700 Group BEXPERIMENTALParticipants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Part 1: INO-4700 Group CEXPERIMENTALParticipants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Part 1: INO-4700 Group DEXPERIMENTALParticipants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Part 1: INO-4700 Group EEXPERIMENTALParticipants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Part 1: Placebo Group FPLACEBO_COMPARATORParticipants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Part 1: Placebo Group GPLACEBO_COMPARATORParticipants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Part 1: Placebo Group HPLACEBO_COMPARATORParticipants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Part 1: Placebo Group IPLACEBO_COMPARATORParticipants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Part 2: Parts 2A and 2BEXPERIMENTALParticipants were planned to receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants were planned to receive a third dose).
Interventions
NameTypeDescription
INO-4700DRUGINO-4700 was administered ID.
PlaceboDRUGSterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000DEVICEEP using the CELLECTRA™ 2000 device was administered following ID drug administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites6

Key Inclusion Criteria: * Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening; * Able and willing to comply with all study procedures; * Screening laboratory results within normal limits; * Negative tests for Hepatiti...

Countries:JordanKenyaLebanon
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