$INO Collaboration and License Deal with ApolloBio for Greater China

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    Blog Coverage Inovio Inks Collaboration and License Deal with ApolloBio for Greater China

    One of Inovio Pharma’s competitors within the Biotechnology space, Bio-Techne Corp. (NASDAQ: TECH), reported on February 07, 2017, its financial results Q2 ended December 31, 2016. AWS will be initiating a research report on Bio-Techne in the coming days.

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    Agreement Details

    As per terms of the agreement, Inovio will receive $15 million in upfront and near-term payments comprising an initial $3 million signing fee and a $12 million milestone upon lifting of the VGX-3100 phase-3 pre-initiation clinical hold by the FDA since October 2016. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US, China, and Korea, and double digit royalties on net sales of VGX-3100.

    Under a separate equity agreement, ApolloBio will invest in Inovio’s common stock, once the hold on clinical trial is lifted at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. Inovio stated that the investment will not exceed $35 million and is structured in a way that the amount may be lowered in order to ensure that ApolloBio will not be the largest shareholder in Inovio. The agreements are subject to People’s Republic of China (PRC) corporate and regulatory approvals and payments are subject to PRC’s currency approvals.

    This collaboration on VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias, and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants.

    Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said: “As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the US and European countries, this agreement opens up Greater China for our lead program and first phase-III product. 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.”

    Details about the Product – VGX-3100

    Inovio’s VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 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. In a phase-II trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure.

    About HPV and Cervical Dysplasia

    As per the official press release, HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally, the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million.

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