On August 10, 2015 Inovio Pharmaceuticals (Nasdaq:INO) reported that it has entered into a license agreement and collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (Press release, Inovio, AUG 10, 2015, View Source [SID:1234507147]).

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Under the agreement, MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.

MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.

Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.

Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

Dr. David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: "Today’s collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovio’s T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients."

Dr. J. Joseph Kim, President and CEO, Inovio, said: "Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio’s cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune’s recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration."

Today’s agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.

About INO-3112

Inovio’s SynCon DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio’s HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovio’s VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.

Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA immunotherapy.

Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia to early stage or no disease, meeting the study’s primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.