Inovio Pharmaceuticals (INO) FDA Approvals

Inovio Pharmaceuticals' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Inovio Pharmaceuticals (INO). Over the past two years, Inovio Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as INO-3107. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

INO-3107 FDA Regulatory Timeline and Events

INO-3107 is a drug developed by Inovio Pharmaceuticals for the following indication: For the Treatment of Recurrent Respiratory Papillomatosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Peer-reviewed data - August 11,2025

• Drug: INO-3107
• Announced Date: August 11, 2025
• Indication: For the Treatment of Recurrent Respiratory Papillomatosis

INOVIO nnounced that peer-reviewed data from a retrospective study investigating the long-term clinical and safety response of patients treated with INO-3107 were published online in The Laryngoscope under the title "DNA Immunotherapy (INO-3107) Results in Long-term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP)."

INOVIO announced that peer-reviewed data from a retrospective study of INO-3107 were published online in The Laryngoscope under the title “DNA Immunotherapy (INO-3107) Results in Long-term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP).” The study collected data on 28 patients over a median follow-up of 2.8 years after their initial treatment.

Results showed continued improvement beyond the first year of treatment. The overall response rate (patients with a 50–100% drop in surgeries) rose to 86% at the end of the second 12-month period (Year 2), up from 72% after Year 1. The complete response rate (zero surgeries per year) increased to 50% in Year 2 from 28% in Year 1.

Patients also needed fewer surgeries: the average fell from 4.1 per year before treatment to 1.7 in Year 1 and then to 0.9 in Year 2. Early data into Year 3 continued to show fewer surgeries, and INO-3107 was well tolerated with no serious adverse events reported.

Peer-reviewed data - February 12,2025

Phase 1/2

• Drug: INO-3107
• Announced Date: February 12, 2025
• Indication: For the Treatment of Recurrent Respiratory Papillomatosis

INOVIO announced that peer-reviewed data from its Phase 1/2 clinical trial with INO-3107 as a potential treatment for recurrent respiratory papillomatosis (RRP) were published online in Nature Communications under the title DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107.

INOVIO announced that peer-reviewed data from its Phase 1/2 clinical trial of INO-3107 were published online in Nature Communications. The study focused on using this DNA immunotherapy to treat recurrent respiratory papillomatosis (RRP), a condition caused by HPV-related infections. Results showed that INO-3107 stimulated new T cell populations that traveled from the blood to affected airway and papilloma tissues. These targeted T cells were linked to improved clinical outcomes, with 81% of patients needing fewer surgeries after treatment compared to the year before. The findings underline how INO-3107 engages both the innate and adaptive immune systems to fight HPV-6 and HPV-11. Overall, the data provide strong support for INO-3107’s potential to become a significant therapeutic option for RRP patients by reducing the need for repeated surgeries.

Abstract - February 10,2025

• Drug: INO-3107
• Announced Date: February 10, 2025
• Indication: For the Treatment of Recurrent Respiratory Papillomatosis

INOVIO announced that an abstract describing the immunological activity of INO-3107 will be presented as a poster at the following scientific conference:

INOVIO Pharmaceuticals announced that an abstract about the immunological activity of its DNA medicine INO-3107 will be presented as a poster at an upcoming scientific conference. The poster, titled "Loss of Detectable HPV-6 Following Induction of Emergent T cells in Patients with Durable Complete Clinical Response to Treatment for Recurrent Respiratory Papillomatosis using INO-3107," will be featured at the American Association for Cancer Research’s Immuno-Oncology Discovery and Innovation in Cancer Immunology meeting scheduled for February 23-26, 2025.

The abstract explains how treatment with INO-3107 helped some patients with Recurrent Respiratory Papillomatosis by reducing detectable levels of HPV-6 and by generating specific T cells. The detailed findings will be available on INOVIO’s website after the conference, highlighting important advancements in DNA medicine and immunotherapy research.

Provided Update - December 3,2024

• Drug: INO-3107
• Announced Date: December 3, 2024
• Indication: For the Treatment of Recurrent Respiratory Papillomatosis

INOVIO announced data from a retrospective trial showing that the number of RRP patients meeting the criteria for a Complete Response increased to 50% by the end of the second year following initial treatment with INO-3107 in a previously reported Phase 1/2 52-week trial where the Complete Response rate was 28%.

INOVIO announced promising retrospective trial results for its investigational DNA medicine INO-3107 in treating Recurrent Respiratory Papillomatosis (RRP). Data showed that the percentage of patients who achieved a Complete Response—meaning no need for surgery—increased significantly over time. In a previously reported Phase 1/2 52‐week trial, 28% of patients reached a Complete Response. However, in the retrospective study, this rate grew to 50% by the end of the second year and further to 54% by the third year. Additionally, most patients maintained or improved their overall response, with 95% sustaining it at year two and 86% into year three. These durable responses support the potential of INO-3107 to reduce or eliminate the need for surgery, offering a long-term, non-surgical treatment option for patients with this chronic condition.

Data - December 3,2024

• Drug: INO-3107
• Announced Date: December 3, 2024
• Indication: For the Treatment of Recurrent Respiratory Papillomatosis

INOVIO announced data from a retrospective trial showing that the number of RRP patients meeting the criteria for a Complete Response increased to 50% by the end of the second year following initial treatment with INO-3107 in a previously reported Phase 1/2 52-week trial where the Complete Response rate was 28%. I

INOVIO announced positive new data from a retrospective trial of its DNA medicine INO-3107 for treating Recurrent Respiratory Papillomatosis (RRP). The study shows that by the end of the second year after the initial treatment, 50% of patients met the criteria for a Complete Response, compared to 28% seen in the earlier 52-week Phase 1/2 trial. In the third year, the Complete Response rate further increased to 54%. These results suggest that INO-3107 may offer a more durable treatment option, potentially reducing the need for repeated surgeries that many RRP patients currently face. The findings, based on longer-term follow-up, may help determine optimal re-dosing strategies and support the continued clinical development of INO-3107 as a non-surgical therapy for this challenging disease.

Inovio Pharmaceuticals FDA Events - Frequently Asked Questions

Has Inovio Pharmaceuticals received FDA approval?

As of now, Inovio Pharmaceuticals (INO) has not received any FDA approvals for its therapy in the last two years.

What drugs has Inovio Pharmaceuticals submitted to the FDA?

In the past two years, Inovio Pharmaceuticals (INO) has reported FDA regulatory activity for INO-3107.

What is the most recent FDA event for Inovio Pharmaceuticals?

The most recent FDA-related event for Inovio Pharmaceuticals occurred on August 11, 2025, involving INO-3107. The update was categorized as "Peer-reviewed data," with the company reporting: "INOVIO nnounced that peer-reviewed data from a retrospective study investigating the long-term clinical and safety response of patients treated with INO-3107 were published online in The Laryngoscope under the title "DNA Immunotherapy (INO-3107) Results in Long-term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP).""

What conditions do Inovio Pharmaceuticals' current drugs treat?

Currently, Inovio Pharmaceuticals has one therapy (INO-3107) targeting the following condition: For the Treatment of Recurrent Respiratory Papillomatosis.