Inovio Pharmaceuticals has received authorisation from the US Food and Drug Administration (FDA) to conduct a Phase I/II clinical trial of its DNA drug, INO-3107, to treat recurrent respiratory papillomatosis (RRP).
RRP is a rare disease that develops due to human papillomavirus (HPV) types 6 and 11 infections. It leads to non-cancerous tumour growths and airway obstructions, and may progress to cancer.
The disease currently lacks a cure and is treated with surgery for temporary airway restoration. However, the tumour recurs and requires repetitive surgery, usually several times a year.
During the open-label, multi-centre Phase I/II trial, INO-3107’s safety, efficacy, tolerability and immunogenicity will be assessed in a total of 63 HPV 6 and/or 11-related RRP patients.
The trial will enrol adult patients who needed a minimum of two surgeries a year for the last three years to remove associated papilloma(s).
For the trial, participants will initially undergo surgery for papilloma(s) removal, followed by four INO-3107 doses, one every three weeks.
The primary efficacy endpoint will be a twofold increase or more in the time between surgical interventions after the first INO-3107 dose compared with the frequency before study therapy.
Positive safety and potential efficacy data in adults is expected to support the expansion of the trial for paediatric patients and a potential booster regimen.
Inovio Pharmaceuticals Clinical Development vice-president Jeffrey Skolnik said: “Inovio’s investigational DNA medicine INO-3107 is designed to destroy and clear tumours caused by HPV 6 and 11 infections from the body exactly where they are hiding.
“We believe this DNA medicine has the potential to provide people living with RRP a long-term, if not life-long, improvement in their disease, especially as an alternative to often successive and debilitating surgeries that may temporarily remove HPV growths from the airways but do not address the underlying recurring virus.”
The company intends to seek the FDA orphan disease designation for INO-3107.
In May last year, Inovio started dosing in a Phase I clinical trial of its DNA vaccine, INO-4500, to prevent a Lassa virus infection.