Pharma Focus Asia

INOVIO Receives European Commission Orphan Drug Designation for INO-3107

Tuesday, May 23, 2023

INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases.

INO-3107 is INOVIO's clinical-stage DNA medicine product candidate being developed as a potential treatment for RRP. INO-3107 is designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types responsible for causing RRP among other HPV-related diseases. These targeted T cells are designed to seek out and kill infected cells, with the aim of potentially preventing or slowing the growth of new papillomas.

RRP is a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterised by the development of small, wart-like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications.

INO-3107 received orphan drug designation from the U.S. Food and Drug Administration (FDA) in July 2020, making it the first RRP product candidate to receive designations from both U.S. and EU regulatory bodies.

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