Inovio, a biotechnology company focused on developing and commercialising DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, has announced that its partner for VGX-3100 in China, ApolloBio, declared positive topline results from its pivotal phase 3 trial of VGX-3100, Inovio’s investigational DNA immunotherapy being developed as a potential treatment for cervical dysplasia.
The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favourable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future regulatory submission of VGX-3100 in China.
According to the terms of the ApolloBio Agreement, Inovio is entitled to receive up to an aggregate of $20.0 million, less required income, withholding or other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in specified territories. In the event that VGX-3100 is approved for marketing, Inovio will be entitled to receive royalty payments based on a tiered percentage of annual net sales.
ApolloBio announced that the trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favourable safety and tolerability profile, with no new significant safety risk signals observed. The positive outcome of this study provides important clinical evidence to support ApolloBio’s future regulatory submission of VGX-3100 in China.
