PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO), a biotechnology company, presented new data from a Phase 1/2 trial of INO-3107 (NCT:04398433) for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis (RRP) on May 5th as part of the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The COSM is a major national meeting of otolaryngologists/head and neck surgeons and incorporates the scientific programs of eight participating professional societies including the ABEA.
Dr. Ted Mau, lead investigator and laryngologist at >University of Texas Southwestern Medical Center, presented the new data during an oral presentation at the conference.
“The additional data on INO-3107 presented demonstrate immunogenicity and potential for efficacy,” said Dr. Mau. “INO-3107 reduced the need for surgical interventions for most trial participants – arguably the most important potential clinical benefit to patients living with this disease.”
Dr. Jeffrey Skolnik, INOVIO’s Senior Vice President of Clinical Development added: “The data set we’ve analyzed from this trial indicate that INO-3107 could potentially provide a life-changing alternative to the current standard of care for RRP. We are focused on moving this candidate forward as quickly as possible to realize its potential for patients globally.”
In , INOVIO announced positive preliminary results from the second (side port needle) cohort of its Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-associated RRP in adults. Positive results from the first (standard needle) cohort were shared in October 2022. At COSM, Dr. Mau presented combined safety and immunogenicity data from both cohorts.
Safety highlights:
- INO-3107 was well-tolerated, with the most frequently reported treatment-emergent adverse events (TEAEs) related to administration, and all related TEAEs were low-grade
- Most commonly reported TEAEs: injection site pain (31%), fatigue (16%), and headache (13%)
- No treatment-related SAEs and no TEAEs led to treatment discontinuation
Immunological data highlights:
- Treatment with INO-3107 induced cellular responses against both HPV 6 and HPV 11, inducing both CD4+ and CD8+ T cells, including cytotoxic CD8 cells thought to be important for clearance of virally infected cell
- All 32 participants demonstrated an increase in at least one peripheral T cell assessment to one or more antigens in INO-3107 above levels prior to treatment
- T-cell responses against HPV 6 and HPV 11 were still observed at Week 52, which was 43 weeks after treatment with INO-3107, indicating persistent cellular memory response
- Additional analysis is ongoing to determine possible relationships between CD4+ and CD8+ T cell phenotypes and clinical outcome
Overall, 81.3% (26/32) patients had a decrease in surgical interventions in the year after INO-3107 administration versus the prior year, including 28.1% (9/32) that required no surgical intervention. Patients had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95% confidence interval -3, -2). In the trial, patients received four doses of INO-3107 on Day 0, and Weeks 3, 6, and 9. At the outset of the study (Day 0), patients could have RRP tissue surgically removed, but any surgery performed after Day 0 during the dosing window was counted against the efficacy endpoint.
The data presented at ABEA were also included in a peer-reviewed manuscript accepted for publication by The Laryngoscope under the title “Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP.” The Laryngoscope, in publication since 1896, is the official journal of the Triological Society (TRIO), the American Laryngological Association (ALA), and the ABEA.
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