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INO-3107

Phase 1

Respiratory Papillomatosis | Small molecule | ENT |Inovio Pharmaceuticals, Inc.|Last Updated: Apr 14, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

ACCELERATED_APPROVALPRIORITY_REVIEWORPHAN_DRUGBREAKTHROUGH_THERAPY

Clinical trial landscape

INO-3107 · 1 trial · 1 indication

Phase 1 1
NCT04398433INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)Respiratory Papillomatosis
COMPLETED32 Analytics
PHASE1COMPLETED
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
Respiratory Papillomatosis
NCT0439843332
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Study Endpoints

Primary Endpoints

Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
From first dose of study drug through 30 days following the last dose (approximately up to Week 13)

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.

Secondary Endpoints

Change in Number of Recurrent Respiratory Papillomatosis (RRP) Surgical Interventions in One Year Following Day 0, Compared to One Year Prior to Day 0
Up to Week 52
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
Up to Week 52
Change From Baseline in RRP Staging Assessment Scores Over Time
Baseline, Weeks 6, 11, 26, and 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INO-3107: Group 1EXPERIMENTALParticipants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
INO-3107: Group 2EXPERIMENTALParticipants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
INO-3107: Group 3EXPERIMENTALParticipants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.

Interventions

NameTypeDescription
INO-3107DRUGINO-3107 administered by IM injection.
CELLECTRA® 2000DEVICECELLECTRA® 2000 device used for EP following IM delivery of INO-3107.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: * Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma or documentation of low-risk positive HPV using a Sponsor approved HPV-6/11 type-specific assay * Requirement for frequent RRP intervention to remove or resect respiratory papilloma, as defined as at...

Countries:United States
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Frequently asked questions about INO-3107

What is INO-3107 used for in Respiratory Papillomatosis?

INO-3107 is an investigational small molecule being developed for the treatment of Respiratory Papillomatosis, a condition characterized by recurrent growths in the respiratory tract. It is specifically studied in patients with HPV-6- and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The drug is administered with electroporation to enhance delivery.

What does INO-3107 target?

INO-3107 is designed to target HPV-6 and HPV-11, the viral types associated with recurrent respiratory papillomatosis. By addressing these viral targets, the therapy aims to treat the underlying cause of the condition. The drug is administered with electroporation, a technique that uses electrical pulses to improve cellular uptake.

Who makes INO-3107?

INO-3107 is developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical research on this investigational therapy for Respiratory Papillomatosis.

What phase is INO-3107 in?

INO-3107 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials. The drug has received several FDA designations, including accelerated approval, priority review, orphan drug, and breakthrough therapy, reflecting its potential significance.

What clinical trials is INO-3107 in?

INO-3107 has been studied in one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT04398433. This trial enrolled 32 participants with HPV-6- and/or HPV-11-associated recurrent respiratory papillomatosis in the United States. The study was controlled but not randomized or double-blinded, and it included adults aged 18 years and older.

Is INO-3107 the same as any other drug?

INO-3107 is the primary name for this investigational therapy developed by Inovio Pharmaceuticals. No alternative names have been reported for this drug in the available clinical trial information. It is being studied specifically for the treatment of Respiratory Papillomatosis associated with HPV-6 and HPV-11 infections.