Chinese biomed ApolloBio negotiated exclusive rights to develop Inovio’s lead DNA immunotherapeutic for human papillomavirus (HPV) VGX-3100 within China, Hong Kong, Macao, and Taiwan. The collaboration and license agreement covers development of VGX-3100 for treating and/or preventing precancerous HPV infections and HPV-driven dysplasias and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants.
Under terms of the deal, ApolloBio will fund all clinical development costs for VGX-3100 within its licensed geographies. Inovio will earn $15 million in up-front and near-term payments and could receive another $20 million in regulatory milestones, plus double-digit sales royalties.
Near-term payments of $12 million will be made to Inovio when FDA lifts the existing VGX-3100 Phase III preinitiation clinical hold, which has been in place since October 2016. The agency refused to allow the start of the proposed Phase III VGX-3100 trial because it wanted additional data on the shelf-life of disposable parts of the Cellectra® 5PSP immunotherapy delivery device.
ApolloBio has separately agreed to invest up to $35 million in Inovio, after the clinical hold has been lifted. The firms said that the aggregate investment may be kept below an amount that would make ApolloBio the largest shareholder in Inovio.
The firms claim that there are currently no approved nonsurgical treatments for persistent HPV infection or cervical dysplasia. Commenting on the deal with Inovio, Dr. Weiping Yang, ApolloBio’s CEO, said, “We are delighted to begin 2017 with a strategic collaboration with Inovio. VGX-3100 is the world’s first therapeutic vaccine being developed for HPV precancers. This collaboration, license, and equity investment marks our determination to introduce late-stage innovative new drugs to meet severely unmet medical needs within the Greater China region.”
Inovio is exploiting its SynCon® DNA plasmid technology and electroporation delivery platform to develop DNA immunotherapeutics against multiple cancers and infectious diseases, including human immunodeficiency virus (HIV) and hepatitis. VGX-3100 is designed to activate functional, antigen-specific CD8 T cells to clear persistent HPV 16/18 infection and to reverse the development of precancerous cervical dysplasia.