US-based biotechnology firm Inovio Pharmaceuticals has received the US Food and Drug Administration (FDA) approval to start Investigational New Drug (IND) clinical trial of its DNA medicine INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP).
RRP is a rare disease characterised by the growth of tumours in the respiratory tract, caused by a type of human papillomavirus (HPV) infection. The growth of a noncancerous tumour leads to airway obstructions and can progress to cancer in rare cases.
The disease currently has no treatment options other than surgery, which temporarily restores the airway by removing the tumour, which eventually recurs, and the surgery is repeated multiple times in a year.
Inovio 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.”
Inovio intends to include paediatric patients and potential booster regimen in the study
The open-label, multicentre Phase 1/2 clinical study of INO-3107 is planned to enrol approximately 63 subjects with HPV 6 and/or 11-associated RRP in the US, to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107.
Inovio said that the adult subjects in the study will be first subjected to surgical removal of papillomas, followed by administering four doses of INO-3107, one in every three weeks.
The primary efficacy endpoint of the study includes doubling or more in the time between surgical interventions after the first dose of INO-3107, relative to the frequency prior to study therapy.
The company intends to expand the study to include paediatric patients along with a potential booster regimen, after obtaining sufficient safety and potential efficacy data in adults.
Inovio president and chief executive officer J Joseph Kim said: “Our mission at Inovio is to rapidly provide patients with urgent health needs access to our novel DNA medicines.
“We are pleased the FDA has authorized our INO-3107 clinical trial, and look forward to working closely with the RRP patient and medical community to drive recruitment as quickly as possible.”
