California-based Inovio Pharmaceuticals has licensed its pre-cancer human papilloma virus (HPV) immunotherapy to Chinese biomedical company ApolloBio.
ApolloBio now has exclusive rights to develop and commercialise VGX-3100 for the treatment and/or the prevention of pre-cancerous HPV infections and HPV-driven dysplasias (abnormal growths).
As part of the agreement, Inovio will receive up to $50 million in upfront costs and near-term payments and equity investment, broken down into an initial $15 million payment and $35 million in aggregate investment.
ApolloBio will fund all clinical development of VGX-3100 and will pay Inovio $20 million based on the achievement of specific regulatory milestones in the US, China and Korea.
“As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the U.S. and European countries, this agreement opens up Greater China for our lead program and first phase 3 product,” said Joseph Kim, president and chief executive officer of Inovio. “We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China.”
VGX-3100 is a non-surgical treatment for high-grade cell dysplasia. The treatment is a type of DNA immunotherapy that activates a class of immune cells called CD-8 T-cells which help clear cells infected with HPV 16 and 18 variants. Combined, these two variants cause 70% of all cervical cancer cases.
In a phase 2 trial, VGX-3100 demonstrated clinical efficacy and was well tolerated by trial participants.
The therapy is a first-in-class, HPV-specific immunotherapy that specifically targets the underlying cause of cervical dysplasia. Currently, there are no approved medical treatments for persistent HPV infection or cervical dysplasia with standard treatment consisting of surgical excision of pre-cancerous lesions.
This technique is not always successful with around 10-16% of all cervical dysplasia cases treated this way coming back. The treatment is also associated with pain, cramping and post-surgical bleeding.