Plymouth Meeting, US-based Inovio announced new data from a Phase I/II trial investigating INO-3107 in patients with HPV-associated recurrent respiratory papillomatosis (RRP).
INO-3107 elicits a targeted T-cell response against HPV-6 and HPV-11 which are responsible for causing RRP or other HPV-related diseases. In July 2020, INO-3107 received orphan drug designation from the FDA.
The additional immunological data analysis showed that INO-3107 induced CD4+ and CD8+ T-cells resulting in cellular responses against both HPV-6 and HPV-11. All 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.
Additionally, INO-3107 decreased the need for surgical interventions in the year after administration compared to the previous year. 81.3% of the patients required fewer surgeries, including 28.1% that required none.
Lead investigator Dr Ted Mau said that the reduction in surgical interventions is “arguably the most important potential clinical benefit to patients living with this disease”
As for safety, INO-3107 was well tolerated and the most frequently reported treatment-emergent adverse events (TEAEs) were related to administration, such as injection site pain, fatigue, and headache.
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The primary endpoint of the trial is measuring the percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). So far, no treatment-related SAEs and no TEAEs led to the discontinuation of treatment.
The open-label trial (NCT04398433) recruited 32 patients with HPV-6 and/or HPV-11-associated RRP to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107. Patients received four doses of INO-3107 on Day 0, and weeks three, six, and nine.
At the onset of the trial, patients could have RRP tissue surgically removed, but any surgical intervention performed after Day 0 during the dosing window was counted against the efficacy endpoint.
The trial enrolled 21 patients into the first cohort where subjects were dosed with a standard needle. The second cohort included 11 patients who received the drug by an exploratory side portal needle. In February 2023, Inovio announced positive preliminary results from the second cohort.
However, the company plans to use the standard needle in the next trial with INO-3107. According to the ClinicalTrials.gov listing, the estimated study completion date is July 2023.
RRP is a rare disease characterised by the development of small, wart-like growths, also known as papillomas, in the respiratory tract. RRP is primarily caused by HPV-6 and/or HPV-11, and while the papillomas are generally benign, they can lead to life-threatening airway obstruction.
Last month, Inovio also announced early data from another DNA vaccine targeting the Ebola virus. The results showed that INO-4201 can elicit strong humoral and cellular responses, restoring antibody titers to protect against Ebola.