Drugs / INO-3107
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04398433 | Oct 2020 → Dec 2022 | recurrent respiratory papillomatosis | Inovio Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-03-12 | Inovio Pharmaceuticals | Regulatory INOVIO Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights inovio.com ↗ |
| 2025-12-29 | Inovio Pharmaceuticals | Regulatory FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP) inovio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. |
| 2025-11-10 | Inovio Pharmaceuticals | Regulatory INOVIO Reports Third Quarter 2025 Financial Results and Recent Business Highlights inovio.com ↗
I'm very pleased to report that we've completed the rolling submission of our BLA for lead candidate INO-3107. |
| 2025-11-03 | Inovio Pharmaceuticals | Regulatory INOVIO Completes Rolling BLA Submission Seeking Accelerated Approval for INO-3107 as a Treatment for RRP in Adults inovio.com ↗ |
| 2025-08-26 | Inovio Pharmaceuticals | Regulatory INOVIO to Begin Rolling Submission of BLA for INO-3107 for the Treatment of RRP in Adults inovio.com ↗ |
| 2025-08-11 | Inovio Pharmaceuticals | Results Data Published in The Laryngoscope shows INO-3107 Resulted in Long-Term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP) inovio.com ↗
The data demonstrate that a majority of patients experienced continued improvement, as measured by the number of surgical procedures needed after treatment with INO-3107, beyond the initial 12-month study period of the previously published Phase 1/2 trial. |
| 2025-03-18 | Inovio Pharmaceuticals | Results INOVIO Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights inovio.com ↗
Announced durability data from retrospective study showing that 50% of patients achieved a Complete Response in the second 12-month period (year 2) with 86% of patients showing a reduction in surgery of 50% or greater in year 2 |
| 2025-02-12 | Inovio Pharmaceuticals | Results Clinical and Immunological Results from Phase 1/2 Study of INO-3107 as a Treatment for Recurrent Respiratory Papillomatosis Published in Nature Communications inovio.com ↗
In the trial, treatment with INO-3107 induced new populations of T cells in the blood that traveled to the airway and papilloma tissue and were correlated with a reduction in the number of post-treatment surgeries. |
| 2024-12-03 | Inovio Pharmaceuticals | Results New Retrospective Data Shows Half of RRP Patients Treated with INO-3107 Achieved a Complete Response When Evaluated 2 and 3 Years Following Initial Phase 1/2 Trial inovio.com ↗
In year three, the Complete Response rate had risen to 54%. |
| 2024-11-13 | Inovio Pharmaceuticals | Results Immunology Data Shows INOVIO's INO-3107 Induced Expansion of New Clonal T Cells That Infiltrate Airway Tissue and Correspond With Reduction of Surgeries for RRP Patients Observed in Phase 1/2 Trial inovio.com ↗
In the recent immunology study, INO-3107 induced the expansion of both existing and new clonal T cells that travel from the blood to the papilloma and airway tissues. |
| 2024-10-21 | Inovio Pharmaceuticals | Results INOVIO Announces New Data at Scientific Conferences for Lead Candidate, INO-3107, as a Potential Treatment for RRP inovio.com ↗
In the trial, INO-3107 was found to be well tolerated and immunogenic. |
| 2024-07-25 | Inovio Pharmaceuticals | Regulatory Inovio Receives Advanced Therapy Medicinal Product Certificate from European Medicines Agency for Quality and Non-Clinical Data for Lead Candidate INO-3107 inovio.com ↗ |
| 2024-07-11 | Inovio Pharmaceuticals | Regulatory INO-3107 Awarded the Innovation Passport Designation Under U.K. Government's Innovative Licensing and Access Pathway inovio.com ↗ |
| 2023-10-10 | Inovio Pharmaceuticals | Regulatory INOVIO Receives FDA Feedback that Data from Completed Phase 1/2 Trial of INO-3107 Can Be Used to Submit a BLA Under Accelerated Approval Program inovio.com ↗
The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial would not be required to support this submission. |
| 2023-09-07 | Inovio Pharmaceuticals | Regulatory INOVIO Announces U.S. FDA Breakthrough Therapy Designation Granted for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis inovio.com ↗
INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis (RRP). |
| 2023-05-23 | Inovio Pharmaceuticals | Regulatory INOVIO Announces Orphan Drug Designation for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis from the European Commission inovio.com ↗
INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Commission (EC) has granted orphan drug designation for INO-3107, the company's product candidate for the treatment of Recurrent Respiratory Papillomatosis (RRP). |
| 2023-05-10 | Inovio Pharmaceuticals | Results INOVIO Reports First Quarter 2023 Financial Results and Operational Highlights inovio.com ↗
Second cohort of trial showed 10 of the 11 (91%) patients saw a reduction in surgical interventions in the year following initial treatment |
| 2023-05-08 | Inovio Pharmaceuticals | Results New Data from Phase 1/2 Trial of INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis Presented at ABEA during COSM 2023 inovio.com ↗
Dr. Ted Mau, lead investigator and laryngologist at University of Texas Southwestern Medical Center, presented the new data during an oral presentation at the conference. |
| 2023-04-26 | Inovio Pharmaceuticals | Regulatory European Committee for Orphan Medicinal Products Provides Positive Opinion on INOVIO's Application for Orphan Drug Designation for INO-3107 inovio.com ↗
The opinion is now with the European Commission, which will provide a final decision on the application within 30 days. |
| 2023-02-16 | Inovio Pharmaceuticals | Results INOVIO Announces Positive Preliminary Results from Second Cohort of Phase 1/2 Trial with INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis inovio.com ↗ |
| 2022-10-13 | Inovio Pharmaceuticals | Results INOVIO Reports Positive Interim Phase 1/2 Results for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis inovio.com ↗ |
| 2020-07-29 | Inovio Pharmaceuticals | Regulatory INOVIO Receives Orphan Drug Designation From U.S. FDA for DNA Medicine INO-3107 To Treat Rare Disease Recurrent Respiratory Papillomatosis (RRP) inovio.com ↗
INOVIO (NASDAQ: INO) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP). |
| 2020-02-10 | Inovio Pharmaceuticals | Regulatory Inovio Receives Authorization from the U.S. FDA To Begin Phase 1/2 Clinical Trial for INO-3107, a DNA Medicine To Treat a Rare Disease -- Recurrent Respiratory Papillomatosis (RRP) inovio.com ↗
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for treatment of Recurrent Respiratory Papillomatosis or RRP. |
All press releases naming this drug 27 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | INO-3107 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04398433 ↗ |
| Modality | Other / unclassified | “INO-3107, a DNA immunotherapy designed to elicit targeted T-cell responses against human papillomavirus (HPV) types 6 and 11” PMID 37204106 ↗ May 2023 |
| Route | Intramuscular | “INO-3107 was administered by intramuscular (IM) injection followed by electroporation (EP)” PMID 37204106 ↗ May 2023 |