Biotechnology company INOVIO Pharmaceuticals Inc (NASDAQ: INO) announced on Wednesday that it intends to submit a Biological License Application (BLA) for INO-3107, a potential Recurrent Respiratory Papillomatosis (RRP) treatment, in H2 2024. The company will seek Rolling Submission and Priority Review from the U.S. Food and Drug Administration (FDA) under an accelerated approval program. INOVIO aims for expedited review, anticipating a 2025 launch for INO-3107.

Following discussions with the FDA, INOVIO is confident in its path to BLA submission under the accelerated approval program. The company plans to request a Priority Review, potentially shortening the FDA's review period to around six months compared to the standard 10 months. If approved, INO-3107 would be the first DNA medicine available to RRP patients in the U.S., marking a significant milestone for INOVIO.

INO-3107, designed for an antigen-specific T cell response against HPV-6 and HPV-11 proteins, showed promising results in a Phase 1/2 clinical trial. The treatment demonstrated a decrease in surgical interventions and generated a robust immune response. INO-3107 aims to address the debilitating effects of RRP, a rare disease caused by HPV-6 and/or HPV-11, characterised by respiratory tract papillomas.

The DNA medicines platform of INOVIO comprises precisely designed DNA plasmids delivered by the company's proprietary investigational medical device, CELLECTRA. This technology facilitates the production of specific proteins to combat diseases, with INOVIO's delivery devices ensuring optimal efficacy without chemical adjuvants or nanoparticles.

INOVIO focuses on developing and commercialising DNA medicines to combat HPV-related diseases, cancer and infectious diseases, offering innovative solutions for disease prevention and treatment.