Approval Probability
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INO-3107 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| INO-3107: Group 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| INO-3107 | DRUG | INO-3107 administered by IM injection. |
| CELLECTRA® 2000 | DEVICE | CELLECTRA® 2000 device used for EP following IM delivery of INO-3107. |
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...
INO-3107 is being developed for recurrent respiratory papillomatosis, also called RRP, a condition in which benign growths form in the airway. It is an investigational therapy from Inovio Pharmaceuticals and has not been approved by the FDA. The clinical program has studied it in adults with HPV-6 and/or HPV-11 associated RRP.
INO-3107 is being developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker INO. The company has advanced the asset to the NDA/BLA stage for recurrent respiratory papillomatosis. It has received FDA designations including Breakthrough Therapy, Orphan Drug, and Accelerated Approval pathways.
INO-3107 is at the NDA/BLA stage of development, meaning Inovio Pharmaceuticals has moved toward a regulatory filing for recurrent respiratory papillomatosis. The supporting clinical work was a Phase 1 study. The drug remains investigational and has not been approved by the FDA.
INO-3107 has been evaluated in one completed clinical trial, NCT04398433, titled INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP). The Phase 1 study enrolled 32 participants in the United States, was controlled, and included adults 18 years and older. No trials are currently active.
INO-3107 has received three FDA designations for recurrent respiratory papillomatosis: Breakthrough Therapy, Orphan Drug, and Accelerated Approval. These designations are intended to support and expedite development of therapies for serious conditions. The drug is still investigational and has not been approved by the FDA.
The INO-3107 clinical program enrolled a total of 32 participants across one completed trial, NCT04398433. That Phase 1 study was conducted in the United States and enrolled adults aged 18 years and older with HPV-6 and/or HPV-11 associated recurrent respiratory papillomatosis. No additional trials are currently active.