INO-3107 and the PAPZIMEOS precedent · INO-3107 · Mar – Aug 2026
How do INOVIO and Precigen describe each other's product?
Precigen names INOVIO its main competitor and notes INO-3107 is under FDA review. INOVIO calls PAPZIMEOS's approval “unexpected”, contrasts its dosing, and from July 2026 says its 24-month complete response rate “was only 43%”.
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
Precigen's 10-K names INOVIO as its main competitor and describes INO-3107 as under FDA review. INOVIO's 10-K calls the PAPZIMEOS approval “unexpected”, says INO-3107 would be a second entrant, and contrasts the products' dosing; its August 2026 10-Q adds that PAPZIMEOS's 24-month complete response rate “was only 43%”.
What the evidence shows
Precigen, March 25, 2026: We believe our main competitor in the field is INOVIO Pharmaceuticals
10-K · Mar 25, 2026. The BLA for INO-3107 is currently under review by the FDA
10-K · Mar 25, 2026.
INOVIO, March 12, 2026: For RRP, Precigen received an unexpected traditional approval for PAPZIMEOS in August 2025
10-K · Mar 12, 2026; Unlike INO-3107, PAPZIMEOS requires additional surgery prior to the third and fourth doses if visible papilloma are present to maintain minimal residual disease as part of the treatment regimen
10-K · Mar 12, 2026.
INOVIO, August 12, 2026: In a single-arm, open-label Phase 1/2 study of PAPZIMEOS in patients with RRP requiring three or more surgical procedures per year, 24-month complete response rate was only 43%
10-Q · Aug 12, 2026. The FDA's figure for the same timepoint: a 24-month complete response rate of 43% (15/35; 95% CI 26% to 61%)
FDA · Aug 14, 2025 · p. 5.
The FDA's review of PAPZIMEOS does not discuss INO-3107: The FDA's Summary Basis for Regulatory Action for PAPZIMEOS does not mention INO-3107, INOVIO or electroporation. FDA · searched What each trial measured: Do the PAPZIMEOS and INO-3107 trials measure the same thing?
Follow the thread
- What evidence did the FDA accept when it approved PAPZIMEOS?The FDA's review does not mention INO-3107
- What did INOVIO say the PAPZIMEOS approval meant for INO-3107?“Second entrant”
- 51% vs. 28.1%: the FDA decision behind two RRP treatments43% at 24 months
The documents, by date
The passages quoted
FDA Summary Basis for Regulatory Action, August 14, 2025
The FDA's Summary Basis for Regulatory Action for PAPZIMEOS does not mention INO-3107, INOVIO or electroporation.
Open the document →FDA Summary Basis for Regulatory Action, August 14, 2025 · page 5
The primary endpoint, complete response (CR) rate at 12 months, defined as the percentage of subjects with no clinically indicated surgical interventions during the 12 months following treatment, was achieved in 51% of patients (18/35; 95% CI 34% to 69%). Furthermore, 15 patients maintained complete response at 2 years yielding a 24-month complete response rate of 43% (15/35; 95% CI 26% to 61%).Open at the source →
INOVIO Form 10-K, filed March 12, 2026
For RRP, Precigen received an unexpected traditional approval for PAPZIMEOS in August 2025 and launched the product commercially in the U.S. later in the year. As a result, we may be at a potential competitive disadvantage in this indication, if approved, as INO-3107 would be a second entrant.Open at the source →
INOVIO Form 10-K, filed March 12, 2026
Unlike INO-3107, PAPZIMEOS requires additional surgery prior to the third and fourth doses if visible papilloma are present to maintain minimal residual disease as part of the treatment regimen.Open at the source →
Precigen Form 10-K, filed March 25, 2026
We believe our main competitor in the field is INOVIO Pharmaceuticals. INOVIO is developing their investigational DNA vaccine INO-3107, which is delivered via use of an electroporation device and targets HPV6 and HPV11 antigens. The BLA for INO-3107 is currently under review by the FDA.Open at the source →
INOVIO Form 10-Q, filed August 12, 2026
In August 2025, PAPZIMEOS, a gorilla adenoviral vector-based immunotherapy, was approved for the treatment of adults with RRP. PAPZIMEOS is administered as adjuvant treatment following surgical debulking. Unlike INO-3107, PAPZIMEOS requires additional surgery prior to its third and fourth doses if visible papilloma are present to maintain a state of minimal residual disease as part of its treatment regimen. In a single-arm, open-label Phase 1/2 study of PAPZIMEOS in patients with RRP requiring three or more surgical procedures per year, 24-month complete response rate was only 43%.Open at the source →