Inovio Gets Advanced Therapy Certificate from EMA for INO-3107

INOVIO, a biotechnology company dedicated to developing DNA medicines for treating HPV-related diseases, cancer, and infectious diseases, announced that the European Medicines Agency's Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for its primary candidate, INO-3107. This candidate is aimed at treating Recurrent Respiratory Papillomatosis (RRP). The certification verifies that INOVIO's data complies with the standards necessary for evaluating a European Marketing Authorization Application.

Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs, hailed this regulatory milestone as a validation of the company's efforts to provide INO-3107 to patients globally. She emphasized the progress the cross-functional development team has made in meeting high standards.

The CAT's role includes assessing and certifying advanced therapy medicinal products (ATMPs) being developed by small enterprises. This certification process helps identify any development issues before a Marketing Authorization Application is submitted.

INO-3107 is designed to provoke an antigen-specific T cell response against HPV-6 and HPV-11 proteins, targeting infected cells to potentially prevent or slow the growth of papillomas. In a Phase 1/2 clinical trial, 81.3% of patients experienced a reduction in surgical interventions in the year following INO-3107 administration compared to the previous year. Notably, 28.1% of patients required no surgical intervention during or after the dosing period. Before receiving INO-3107, patients had a median of four surgeries in the prior year; post-dosing, there was a median decrease of three surgeries. The trial also revealed that INO-3107 induced a strong immune response, generating activated CD4 and CD8 T cells with lytic potential. These T-cell responses persisted up to Week 52, indicating long-term cellular memory. The treatment was well-tolerated, with mostly low-grade side effects like injection site pain and fatigue.

Similar to other DNA medicines, INO-3107 has shown the capability to produce antigen-specific T cells without being affected by anti-vector immunity, a common issue for other T-cell generating platforms like viral vectors. This unique feature is anticipated to allow INO-3107 to sustain its T cell response and overall efficacy, potentially making it a vital therapeutic option for RRP patients.

The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and suggested that INOVIO could submit its Biologics License Application (BLA) under the accelerated approval program using data from the completed Phase 1/2 trial. The European Commission has similarly granted Orphan Drug designation to INO-3107 and assigned a CE marking to INOVIO's delivery device, CELLECTRA®, certifying its compliance with European Union safety, health, and environmental standards. The United Kingdom has awarded INO-3107 the Innovation Passport, an entry point to the Innovative Licensing and Access Pathway (ILAP), aimed at accelerating market access and patient availability.

Recurrent Respiratory Papillomatosis (RRP) is a rare and debilitating disease primarily caused by HPV-6 and HPV-11, characterized by the appearance of wart-like growths in the respiratory tract. While generally benign, these growths can cause severe airway obstruction and respiratory complications, significantly affecting the patient's quality of life. Surgery remains the standard treatment, but the papillomas often recur, posing additional risks of permanent vocal cord damage.

INOVIO's DNA medicines platform consists of precisely designed DNA plasmids delivered via the proprietary CELLECTRA® device. These plasmids are engineered to produce specific proteins to combat diseases. CELLECTRA® optimally delivers these DNA medicines without requiring chemical adjuvants or lipid nanoparticles, avoiding the historical issues related to viral vector platforms.

INOVIO continues to focus on optimizing the design and delivery of DNA medicines to help the body manufacture its own disease-fighting tools, contributing to advancements in treating HPV-related diseases, cancer, and infectious diseases.