INO-3107 and the PAPZIMEOS precedent · INO-3107 · Aug 2025 – Aug 2026
Where does INO-3107's confirmatory trial stand in INOVIO's filings?
In August 2025 INOVIO said it would need to start a confirmatory trial before submitting. Its filings since describe the trial as planned, with a protocol still to be submitted and the FDA's feedback on the design “forthcoming”. None says the trial has started.
EphemerisX Research · Published · 5 source documents · 1 min read
Short answer
Planned, by INOVIO's filings. In August 2025 it said accelerated-approval submission required starting a confirmatory trial first. The 10-K and later filings call it “our planned confirmatory trial”; the August 2026 10-Q says the protocol is still to be submitted and that the FDA's feedback on its design would be forthcoming. That 10-Q does not say the trial has started.
What the evidence shows
August 12, 2025: As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission
10-Q · Aug 12, 2025.
March 2026, the 10-K: such as our planned confirmatory trial of INO-3107 for the treatment of RRP, we may encounter difficulties in recruiting a sufficient number of patients to enroll in the trial due to the small number of patients with the disease
10-K · Mar 12, 2026. May 2026 adds: and the recent availability of an approved immunotherapy
10-Q · May 13, 2026.
August 2026: INOVIO will update its IND in conjunction with submitting our confirmatory trial protocol for INO-3107, which will be subject to further FDA review
10-Q · Aug 12, 2026. From the July meeting: The FDA stated that feedback on the confirmatory trial design would be forthcoming
10-Q · Aug 12, 2026. INOVIO's 10-Q for the quarter to June 30, 2026 does not say that the confirmatory trial of INO-3107 has started. 10-Q · searched
For PAPZIMEOS, Precigen's 10-K says that with traditional approval a confirmatory clinical trial is no longer required
10-K · Mar 25, 2026. How that came about: How did PAPZIMEOS go from an accelerated-approval application to a traditional approval?
Follow the thread
- How did PAPZIMEOS go from an accelerated-approval application to a traditional approval?No confirmatory trial required for PAPZIMEOS
- What did INOVIO say the PAPZIMEOS approval meant for INO-3107?“An approved immunotherapy” and enrollment
- What has INOVIO disclosed about the FDA's review since December 2025?Design feedback “forthcoming”
The documents, by date
The passages quoted
INOVIO Form 10-Q, filed August 12, 2025
As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission.Open at the source →
INOVIO Form 10-K, filed March 12, 2026
With respect to clinical trials of product candidates for rare diseases, such as our planned confirmatory trial of INO-3107 for the treatment of RRP, we may encounter difficulties in recruiting a sufficient number of patients to enroll in the trial due to the small number of patients with the disease.Open at the source →
Precigen Form 10-K, filed March 25, 2026
In August 2025, FDA granted full approval to Papzimeos for the treatment of adults with RRP. The Papzimeos approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP. We completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos full approval. As a result of Papzimeos receiving full FDA approval, a confirmatory clinical trial is no longer required.Open at the source →
INOVIO Form 10-Q, filed May 13, 2026
With respect to clinical trials of product candidates for rare diseases, such as our planned confirmatory trial of INO-3107 for the treatment of RRP, we may encounter difficulties in recruiting a sufficient number of patients to enroll in the trial due to the small number of patients with the disease and the recent availability of an approved immunotherapy.Open at the source →
INO-3107 and the PAPZIMEOS precedent Form 10-Q, filed August 12, 2026
INOVIO's 10-Q for the quarter to June 30, 2026 does not say that the confirmatory trial of INO-3107 has started.
Open the document →INOVIO Form 10-Q, filed August 12, 2026
By early August 2026, the FDA had completed its mid- and late-cycle review meetings for the BLA and all scheduled pre-licensure inspections. In July 2026, the FDA conducted the previously agreed to informal meeting, during which we presented the totality of data supporting INO-3107's safety and efficacy, its highly differentiated approach to treating RRP, and the rationale for accelerated approval eligibility. We also discussed the current standard of care and the ongoing need for additional therapeutic options. During the informal meeting, the FDA did not discuss its preliminary commentary in the file acceptance letter regarding accelerated approval eligibility. The FDA stated that feedback on the confirmatory trial design would be forthcoming.Open at the source →
INOVIO Form 10-Q, filed August 12, 2026
in conjunction with submitting our confirmatory trial protocol for INO-3107, which will be subject to further FDA review.Open at the source →