Friday, September 08, 2023
INOVO, a biotechnology firm specializing in the development and commercialization of DNA-based medications for HPV-related illnesses, cancer, and infectious diseases, has disclosed that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INO-3107 as a potential therapy for individuals afflicted by Recurrent Respiratory Papillomatosis (RRP). This designation is intended to accelerate the advancement and assessment of medications designed to treat severe or life-threatening disorders when preliminary clinical data suggest substantial enhancements compared to existing therapies.
Dr. Jacqueline Shea, INOVO's President and Chief Executive Officer, emphasized the importance of this designation and its potential impact on the lives of RRP patients. Kim McClellan, President of the Recurrent Respiratory Papillomatosis Foundation, also expressed enthusiasm for the attention and optimism this treatment could bring to individuals with RRP.
INO-3107 is an experimental DNA medication designed to induce a precise T cell response against HPV-6 and HPV-11, the HPV strains responsible for RRP and other HPV-related diseases. The Breakthrough Therapy designation follows Orphan Drug designations granted by the European Commission in May 2023 and the FDA in 2020.
Subject to FDA approval, INOVIO plans to initiate a pivotal trial for INO-3107 in the first quarter of 2024, with the support of prominent Clinical Research Organizations and key opinion leaders in the field.
The Breakthrough Therapy designation is based on data from a Phase 1/2 multicenter trial evaluating INO-3107's safety, tolerance, immunogenicity, and effectiveness in RRP patients. The study demonstrated a reduction in surgical interventions following INO-3107 administration, with a noteworthy proportion of patients requiring no surgical intervention during or after treatment.
RRP is a rare disease primarily caused by HPV-6 and HPV-11, characterized by papillomas in the respiratory tract. The standard treatment involves surgical removal of these growths, but they frequently reoccur due to the underlying HPV infection.
INO-3107 presents potential as a treatment for RRP by specifically targeting and eliminating infected cells. This encouraging development signifies progress in addressing a challenging and debilitating condition.a