INOVIO’s Significant Progress Towards Submitting a Biologics License Application (BLA) for INO-3107 and DNA-Encoded Monoconal Antibodies (DMAb)
INOVIO, a biotechnology company specializing in DNA medicines for HPV-related diseases, cancer, and infectious diseases, reported its financial results and operational highlights for the fourth quarter and full year ended December 31, 2024. The company also provided an update on its progress towards submitting a Biologics License Application (BLA) for INO-3107 as a potential treatment for recurrent respiratory papillomatosis (RRP) and announced promising results from its ongoing proof-of-concept Phase 1 trial of DMAb targeting COVID-19.
Resolution of Manufacturing Issue and Progress on BLA Submission for INO-3107
INOVIO resolved the previously announced manufacturing issue concerning the single-use array component of the CELLECTRA device. The company also completed the drafting of all non-device BLA modules for INO-3107. INOVIO is on track to begin the rolling submission of the BLA in mid-2025 and aims to request priority review, with a goal of completing the submission in the second half of 2025 and receiving acceptance of the submission by the end of the year.
Durability Data from Retrospective Study
The company announced durability data from a retrospective study of INO-3107, which showed that 50% of patients achieved a Complete Response in the second 12-month period (year 2), with 86% of patients showing a reduction in surgery of 50% or greater in year 2. These data will be included in the BLA submission.
Promising Interim Results from Ongoing Proof-of-Concept Phase 1 Trial of DMAb
INOVIO announced promising interim results from its ongoing proof-of-concept Phase 1 trial of DMAb targeting COVID-19. The data showed that the DMAb were well tolerated and exhibited long-lasting in vivo production. This technology has the potential to overcome traditional monoclonal antibody production challenges, such as short half-life and anti-drug immune responses, making it a potentially promising platform for a broad range of diseases.
Impact on Individuals and the World
For individuals with RRP, the progress towards the submission of a BLA for INO-3107 represents a potential breakthrough in the treatment of this debilitating disease. The durability data from the retrospective study indicates that INO-3107 could provide long-term relief from the need for repeated surgeries, improving their quality of life. Moreover, the promising interim results from the Phase 1 trial of DMAb targeting COVID-19 hold great promise for the development of effective and long-lasting treatments for various diseases, including infectious diseases like COVID-19 and diseases with missing or defective proteins.
On a global scale, the advancements made by INOVIO in DNA medicine technology could significantly impact the healthcare landscape. DNA medicines have the potential to provide long-term production of therapeutic antibodies and deliver a broad spectrum of therapeutic proteins, offering a more sustainable and versatile approach to treating various diseases. This could lead to more effective and accessible treatments for individuals worldwide, reducing the burden of chronic diseases and improving overall global health.
Conclusion
INOVIO’s progress towards submitting a BLA for INO-3107 as a potential treatment for RRP and the promising interim results from its ongoing Phase 1 trial of DMAb targeting COVID-19 represent significant milestones for the company and the field of DNA medicine. These advancements have the potential to improve the lives of individuals with RRP and offer a more sustainable and versatile approach to treating various diseases. As INOVIO continues to develop and commercialize DNA medicines for HPV-related diseases, cancer, and infectious diseases, the impact on individuals and the world could be substantial.
- INOVIO made significant progress towards submitting a BLA for INO-3107 as a potential treatment for RRP
- Resolution of manufacturing issue and completion of non-device BLA modules
- Rolling submission of BLA on track for mid-2025 with priority review and acceptance by end of the year
- Durability data from retrospective study showed 50% of patients achieved Complete Response in year 2
- 86% of patients showed a reduction in surgery of 50% or greater in year 2
- Promising interim results from ongoing proof-of-concept Phase 1 trial of DMAb targeting COVID-19
- Well tolerated and exhibited long-lasting in vivo production
- DNA medicine technology has the potential to provide long-term production of therapeutic antibodies
- Delivers a broad spectrum of therapeutic proteins for treating diseases with missing or defective proteins
- Significant impact on individuals and the world through more effective and accessible treatments
