ApolloBio Licenses Inovio’s Late-Stage HPV DNA Immunotherapeutic for China – Genetic Engineering & Biotechnology News

Chinese biomed ApolloBio negotiated exclusive rights to develop Inovios lead DNA immunotherapeutic for human papillomavirus (HPV), VGX-3100, within China, Hong Kong, Macao and Taiwan. The collaboration and licence agreement covers development of VGX-3100 for treating and/or preventing pre-cancerous 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.

$12 million of near-term payments will be made to Inovio when FDA lifts the existing VGX-3100 Phase III pre-initiation 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 non-surgical treatments for persistent HPV infection or cervical dysplasia. Commenting on the deal with Inovio, Dr. Weiping Yang, ApolloBios CEO, said, We are delighted to begin 2017 with a strategic collaboration with Inovio. VGX-3100 is the worlds first therapeutic vaccine being developed for HPV pre-cancers. 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 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.

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ApolloBio Licenses Inovio's Late-Stage HPV DNA Immunotherapeutic for China - Genetic Engineering & Biotechnology News