Licensing and collaboration agreement provides exclusive rights to HPV immunotherapeutic.
Providing exclusive rights to develop and commercialize its DNA immunotherapy VGX-3100, Inovio Pharmaceuticals disclosed it had recently entered into an amended agreement with Chinese biomedical company ApolloBio Corporation to develop and commercialize its human papillomavirus (HPV) immunotherapeutic across greater China, including Hong Kong, Macao and Taiwan.
According to Inovio, ApolloBio will issue an up-front payment of $23 million (which amends the previously announced $15 million agreement) and sets the stage for another $20 million in payments if certain milestones are met, as well as royalty payments based on sales.
Inovio’s President and Chief Executive Officer Dr. J. Joseph Kim noted ApolloBio will bring significant capabilities and expertise to product development, as well as an understanding of the Chinese healthcare marketplace and regulatory landscape across the region. “We are pleased to move forward with an agreement that preserves the best interest for our shareholders,” he said, explaining that in addition, “this collaborative agreement … could potentially accelerate our overall global VGX-3100 efforts by accessing clinical study patients in China. We expect this deal to close in the first quarter of 2018.”
Designed to treat pre-cancers caused by HPV, the VGX-3100 is a first-in-class treatment for pre-cancerous HPV infections and HPV-driven dysplasias, including cervical, vulvar and anal pre-cancers. VGX-3100 studies have shown promising results. The immunotherapeutic, explained Inovio, works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia.
During its Phase IIb trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated among trial participants without the side effects and obstetric risks associated with surgery. According to Inovio, there are currently no approved treatments for persistent HPV infection or cervical dysplasia and that the primary treatment involves excising the pre-cancerous lesion as well as a healthy margin of cervical tissue.
These surgeries can produce pain and cramping, a significant risk of post-surgical bleeding as well as other complications including infection, pre-term delivery and miscarriages during future pregnancies. Evan after surgery women with persistent HPV infection remain at high risk for cervical cancer: “Because surgical excision does not treat the underlying HPV infection that causes cervical dysplasia,” said Inovio, “there is a 10-16% risk of disease recurrence.”
