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
VGX-3100, INO-5412, and INO-3107. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
VGX-3100 FDA Regulatory Events
VGX-3100 is a drug developed by Inovio Pharmaceuticals for the following indication: High-grade Precancerous Cervical Dysplasia (HSIL).
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.
- Drug:
- VGX-3100
- Announced Date:
- May 21, 2026
- Indication:
- High-grade Precancerous Cervical Dysplasia (HSIL)
Announcement
INOVIO announced that its partner for VGX-3100 in China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100, INOVIO's investigational DNA immunotherapy being developed as a potential treatment for cervical dysplasia.
AI Summary
INOVIO said its partner in China, ApolloBio, reported positive topline results from a pivotal Phase 3 trial of VGX-3100, a DNA immunotherapy being studied for cervical dysplasia. The trial met its main efficacy goal and showed a favorable safety and tolerability profile, with no new major safety concerns.
VGX-3100 is designed to target high-risk HPV types 16 and 18 by helping the immune system clear persistent infection and encouraging abnormal cervical lesions to regress. INOVIO said the results provide important clinical support for ApolloBio’s planned regulatory filing in China.
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INO-5412 FDA Regulatory Events
INO-5412 is a drug developed by Inovio Pharmaceuticals for the following indication: Advance Novel Combination Therapy.
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.
- Drug:
- INO-5412
- Announced Date:
- March 4, 2026
- Indication:
- Advance Novel Combination Therapy
Announcement
INOVIO announced that they have entered into a clinical trial collaboration and supply agreement to evaluate INO-5412, INOVIO's DNA immunotherapy candidate, in combination with cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of GBM.
AI Summary
INOVIO announced a clinical trial collaboration and supply agreement with Akeso to evaluate INO-5412, INOVIO’s DNA immunotherapy candidate, in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). Under the agreement, INOVIO and Akeso will support the INSIGhT study by supplying their respective therapeutic products, while the investigative sponsors will manage day-to-day clinical operations. The collaboration will test whether the DNA immunotherapy can enhance anti-tumor immune responses when paired with dual PD-1/CTLA-4 blockade, with the goal of developing a new immune-based option for a cancer that has high unmet medical need.
INO-5412 is being evaluated alongside INOVIO’s broader GBM program, which includes INO-5401 (encoding SynCon antigens hTERT, WT1 and PSMA) and INO-9012 (encoding IL-12, a T-cell activator). The agreement lets both companies provide investigational medicines and logistical support as the INSIGhT trial progresses.
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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.
- Drug:
- INO-3107
- Announced Date:
- December 29, 2025
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
INOVIO 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. The review classification designated by FDA is Standard.
AI Summary
INOVIO announced that the U.S. Food and Drug Administration accepted its Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP). The FDA gave the application a Standard review classification and set a PDUFA action date of October 30, 2026. The agency indicated it is not currently planning to hold an advisory committee meeting to discuss the application.
INOVIO filed the BLA under the accelerated approval pathway, but the FDA’s initial review letter noted a potential issue: the agency preliminarily concluded that INOVIO has not submitted enough information to justify accelerated approval eligibility. INOVIO says it believes INO-3107 meets the criteria and plans to request a meeting with the FDA to discuss next steps. The company is not currently planning to seek approval under the traditional pathway.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- November 3, 2025
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
INOVIO announced that it has completed the rolling submission of its Biologics License Application (BLA) for its DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults.
AI Summary
INOVIO announced that it has completed the rolling submission of its Biologics License Application (BLA) for INO-3107, a DNA immunotherapy candidate for treating recurrent respiratory papillomatosis (RRP) in adults. The company submitted the application under the FDA’s Accelerated Approval program and has asked for priority review.
INOVIO expects the FDA to accept the BLA by the end of 2025. If the agency grants priority review, a decision could follow around mid-2026. Approval of INO-3107 would mark INOVIO’s first commercial product and the first DNA-based medicine available in the United States.
INO-3107 is intended to trigger a T-cell attack on HPV-6 and HPV-11, the viruses behind RRP. In a Phase 1/2 study, most patients had significantly fewer surgeries after treatment and experienced only mild side effects like injection site pain and fatigue. A successful launch could offer a new way to reduce surgery risks and help people with RRP.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- August 11, 2025
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
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)."
AI Summary
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.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- February 12, 2025
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- February 10, 2025
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
INOVIO announced that an abstract describing the immunological activity of INO-3107 will be presented as a poster at the following scientific conference:
AI Summary
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.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- December 3, 2024
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
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
AI Summary
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.
Read Announcement- Drug:
- INO-3107
- Announced Date:
- December 3, 2024
- Indication:
- For the Treatment of Recurrent Respiratory Papillomatosis
Announcement
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%.
AI Summary
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.
Read Announcement
