Inovio Pharmaceuticals Advances DNA Medicine for Rare Respiratory Disease
Inovio Pharmaceuticals is spearheading the development of DNA-based treatments, targeting a spectrum of diseases including human papillomavirus (HPV), various cancers, and a range of infectious conditions. The organization’s proprietary technology is designed to enhance plasmid configuration and administration, with the aim of transforming the approach to disease management. Currently, the entity’s primary therapeutic candidate, INO-3107, is in the developmental phase for the treatment of recurrent respiratory papillomatosis (RRP), a rare disorder characterized by benign tumor growths within the respiratory pathways, which can lead to significant complications and potentially fatal blockages of the airways.
INO-3107, an experimental DNA medicine, is being developed to provoke a specific T cell response against HPV types 6 and 11, which are implicated in the onset of RRP and other associated conditions. The objective of its is to eradicate the infection and potentially inhibit or diminish the development of new papillomas. The firm has disclosed plans to submit a biologics license application (BLA) for INO-3107 to the US Food and Drug Administration (FDA) under an expedited approval process in the latter half of 2024. This announcement follows a productive Type B meeting with the FDA, where consensus was reached on the regulatory approach for INO-3107.
Following the BLA submission, the entity aims to seek Priority Review designation from the FDA, which, if granted, could reduce the review timeline to approximately six months from the date of acceptance, a significant decrease from the standard 10-month evaluation period. The investigational candidate has already been granted Orphan Drug and Breakthrough Therapy designations in the United States for RRP, and has also received Orphan Drug designation within the European Union for the same indication.
The firm has reported favorable outcomes from a phase III trial assessing INO-3107’s safety, tolerability, immunogenicity, and effectiveness in patients with RRP linked to HPV-6 and/or HPV-11. The primary measure of success in the study was the reduction in surgical procedures needed post-administration, compared to the year preceding treatment. Based on these positive results, the FDA recommended forgoing a pivotal phase III trial for INO-3107, suggesting that the completed study suffice for a BLA submission under the accelerated approval framework. Nevertheless, the company is preparing to commence a confirmatory study of INO-3107 for RRP ahead of the BLA submission.
Moreover, the company has forged a clinical collaboration and supply agreement to assess a combination therapy involving INO-3112 and Coherus BioSciences’ Loqtorzi (toripalimab-tpzi) for the treatment of locoregionally advanced, high-risk HPV-related oropharyngeal squamous cell carcinoma (OPSCC), a form of throat cancer. Loqtorzi, a PD-1 inhibitor by Coherus BioSciences, has received FDA approval for use in recurrent or metastatic nasopharyngeal carcinoma. This partnership underscores a mutual conviction in the potential clinical advantage of integrating INO-3112 with a PD-1 inhibitor for the management of HPV-related head and neck cancers.
Inovio Pharmaceuticals is making significant strides in the field of DNA medicine, with its lead candidate INO-3107 showing promise in the treatment of RRP. The company’s commitment to advancing its proprietary technology and therapeutic candidates reflects its dedication to addressing unmet medical needs. The potential approval marks a milestone in providing new treatment options for patients suffering from this rare respiratory disease. As the company continues its research and development efforts, the healthcare community anticipates the outcomes of its innovative approaches to combating challenging diseases.
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