INOVIO's BLA for INO-3107 for RRP on track for 2H25 FDA acceptance.

INOVIO announced that the FDA agreed to its rolling submission timeline for the Biologics License Application (BLA) for INO-3107 as a treatment for Recurrent Respiratory Papillomatosis (RRP). The submission is expected to be completed in the coming months and accepted by the FDA by the end of 2025, with the goal of receiving priority review.

INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) has received FDA approval to proceed with its rolling submission of the Biologics License Application (BLA) for INO-3107, an investigational DNA medicine designed to treat Recurrent Respiratory Papillomatosis (RRP) in adults. The submission is expected to be completed in the coming months, with the goal of achieving FDA file acceptance by the end of 2025.

The FDA's agreement to INOVIO's rolling submission timeline is a significant step forward in the company's efforts to bring a potentially life-changing therapeutic option to patients suffering from RRP. The condition, characterized by the development of small, wart-like growths in the respiratory tract, can cause severe airway obstruction and significantly impact patients' quality of life. Current standard of care involves surgery to remove papillomas, but the growths often recur, posing risks of permanent vocal cord damage and additional costs.

INO-3107, which has received both Orphan Drug and Breakthrough Therapy designations, is designed to elicit an antigen-specific T cell response against HPV-6 and HPV-11 proteins, potentially preventing or slowing the growth of new papillomas. In clinical trials, the drug showed promising results, with 72% of patients experiencing a 50-to-100% reduction in surgeries after one year of treatment. A retrospective study involving 28 participants showed that 86% of patients required no surgeries after two years, with half of them experiencing no surgeries at all.

The FDA's accelerated approval program allows INOVIO to submit its BLA using data from its completed Phase 1/2 trial, which demonstrated the drug's safety and efficacy. INOVIO is leveraging its Breakthrough Therapy designation to expedite the approval process, aiming to bring INO-3107 to market as quickly as possible.

INOVIO's DNA medicines platform, which includes precisely designed DNA plasmids and a proprietary delivery device called CELLECTRA, is designed to optimize the design and delivery of innovative DNA medicines. The company's technology aims to teach the body to manufacture its own disease-fighting tools, offering a unique approach to treating various conditions, including HPV-related diseases, cancer, and infectious diseases.

References:
[1] https://www.prnewswire.com/news-releases/inovio-to-begin-rolling-submission-of-bla-for-ino-3107-for-the-treatment-of-rrp-in-adults-302538344.html
[2] https://www.marketscreener.com/news/inovio-to-begin-rolling-submission-of-bla-for-ino-3107-for-the-treatment-of-rrp-in-adults-ce7c50d9db88f62c