PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) reported new peer-reviewed findings demonstrating that its investigational DNA immunotherapy, INO-3107, continues to deliver long-term clinical benefits for patients with recurrent respiratory papillomatosis (RRP). The retrospective study, published in The Laryngoscope, showed that patients treated with INO-3107 experienced fewer surgical procedures over time, with clinical responses improving beyond the initial 12-month Phase 1/2 trial period.
RRP, a rare disease caused by human papillomavirus (HPV), is marked by the growth of noncancerous tumors in the airways, often requiring repeated surgeries to maintain breathing and vocal function.
In the initial Phase 1/2 open-label trial (RRP-001), 32 patients demonstrated a significant reduction in the number of surgeries required in the year following treatment with INO-3107 compared to the year prior. The new retrospective analysis (RRP-002) tracked 28 of those patients over an extended period, with a median follow-up of 2.8 years.
The data revealed sustained and improving clinical outcomes:
- Overall Response Rate (50–100% reduction in surgeries) rose from 72% at the end of Year 1 to 86% at the end of Year 2.
- Complete Response (no surgeries required) increased from 28% in Year 1 to 50% in Year 2.
- The mean number of surgeries dropped from 4.1 annually before treatment to 1.7 in Year 1, and further to 0.9 in Year 2.
- Partial data from Year 3 indicated continued improvement, reinforcing the long-term durability of treatment benefits.
Importantly, INO-3107 was well tolerated, with no serious adverse events or long-term safety issues reported.
“The majority of patients experienced a reduction in surgeries following initial treatment with INO-3107, and almost all maintained or improved their response two years later,” said Dr. Aaron Friedman of the University of Cincinnati Medical Center, one of the trial’s principal investigators. “These findings suggest INO-3107 has the potential to change the trajectory of this disease.”
INOVIO’s CEO, Dr. Jacqueline Shea, underscored the therapy’s potential impact on quality of life. “Every surgery matters to patients. Seeing durable reductions in surgical need validates our belief that INO-3107 could become the preferred treatment option for the RRP community, if approved,” she said.
The results strengthen the case for INO-3107 as a potential new standard of care for RRP, offering a long-term, less invasive alternative for managing this debilitating condition.
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