INO-3107 Receives Innovation Passport Under U.K. Licensing Pathway

PLYMOUTH MEETING, Pa., July 11, 2024 – INOVIO, a biotechnology firm focused on DNA medicines for HPV-related diseases, cancer, and infectious diseases, has announced that its leading DNA medicine candidate, INO-3107, has been recognized as an innovative medicine by the UK's Innovative Licensing and Access Pathway (ILAP). This recognition, known as the Innovation Passport, was awarded to INO-3107 for treating Recurrent Respiratory Papillomatosis (RRP), a chronic and rare respiratory disease caused by HPV-6 and HPV-11.

Dr. Jacqueline Shea, President and CEO of INOVIO, expressed that the Innovation Passport designation underscores the potential of INO-3107 to significantly improve treatment options for RRP patients. Dr. Shea highlighted the importance of this recognition in facilitating enhanced interactions with regulators and access to development resources that could expedite the regulatory approval process in the UK. She emphasized the company's commitment to working with ILAP partners to bring this promising treatment to patients swiftly.

The Innovation Passport represents the initial step in ILAP, which aims to streamline the regulatory approval process and expedite patient access to new medicines in the UK. This designation provides a unified framework for regulatory approval and development milestones, granting recipients access to various development tools and opportunities for enhanced regulatory consultations. Specific advantages of ILAP include a potentially faster Marketing Authorization Application (MAA) assessment in 150 days, rolling review, and continuous benefit-risk evaluation. ILAP is a collaborative effort by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), the All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence, and the Scottish Medicines Consortium.

About INO-3107

INO-3107 is engineered to trigger an antigen-specific T cell response against HPV-6 and HPV-11 proteins, targeting and eliminating infected cells to potentially prevent or slow papilloma growth. In a Phase 1/2 clinical trial, INO-3107 demonstrated significant efficacy, with 81.3% of patients experiencing a reduction in surgical interventions within a year of treatment compared to the previous year. Notably, 28.1% of the patients required no surgical intervention during or after the treatment period. The trial also indicated a robust immune response, with activated CD4 and CD8 T cells observed, suggesting a persistent cellular memory response. INO-3107 was generally well tolerated, with most adverse effects being low-grade, such as injection site pain and fatigue.

The U.S. FDA has granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, allowing INOVIO to submit a Biologics License Application (BLA) using data from the completed Phase 1/2 trial under the accelerated approval program. The European Commission has also granted Orphan Drug designation for INO-3107. Additionally, INOVIO's delivery device, CELLECTRA®, has received CE marking, indicating compliance with European Union safety, health, and environmental standards.

About RRP

Recurrent Respiratory Papillomatosis (RRP) is primarily caused by HPV-6 and HPV-11 and is characterized by the growth of benign but potentially obstructive papillomas in the respiratory tract. These growths can lead to severe airway obstruction and respiratory complications, significantly impacting patients' quality of life. The current standard treatment is surgical removal of the papillomas, but the growths often recur, necessitating repeated surgeries that carry risks of permanent vocal cord damage. INOVIO's research highlights the critical need for reducing surgical interventions, as each surgery poses substantial risks.

About INOVIO's DNA Medicines Platform

INOVIO's platform comprises precisely designed DNA plasmids delivered by its proprietary investigational device, CELLECTRA®. The technology allows the body's cells to produce specific proteins to target diseases without requiring chemical adjuvants or lipid nanoparticles. This platform eliminates the risk of anti-vector responses seen with viral vector platforms and maintains the efficacy of T cell responses.

About INOVIO

INOVIO is dedicated to developing DNA medicines to treat and protect against HPV-related diseases, cancer, and infectious diseases. The company leverages its technology to design and deliver DNA medicines that enable the body to produce disease-fighting tools.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!