Date: 2016-03-29
Type of information: Licensing agreement
Compound: INO-3112
Company: MedImmune (USA - global biologics arm of AstraZeneca (UK) Inovio Pharmaceuticals (USA - PA)
Therapeutic area: Cancer - Oncology - Infectious diseases
Type agreement: update licensing
Action mechanism: immunotherapy product. INO-3112 (VGX-3100 plus DNA-based immune activator encoded for IL-12) is a DNA immunotherapy targeting the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18 against HPV-caused cancers. This immunotherapy enables the body to produce E6 and E7 antigens in order to induce a stronger targeted immune response against HPV-associated diseases such as cervical cancer. This immunotherapy will be delivered intramuscularly followed by electroporation using Inovio's CELLECTRA® delivery device.
Disease: cancers caused by human papillomavirus (HPV) types 16 and 18
Details: * On August 10, 2015, AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases. 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 tumours. These HPV types are responsible for more than 70 per cent 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 tumour-specific T-cells. 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 commercialise. This 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. 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.
Financial terms: 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.
Latest news: * On March 29, 2016, Inovio Pharmaceuticals announced a clinical strategy update to take its INO-3112 HPV immunotherapy into human studies in combination with selected immunotherapy molecules from MedImmune, which is part of an existing partnership between the two companies. The companies intend to advance combination immunotherapies in populations with continued unmet need, the potential for a registrable endpoint, and an expedient clinical path. With these goals in mind, planned enrollment of a European Organization for Research and Treatment of Cancer (EORTC) trial to study cervical cancer patients with INO-3112 before and after chemoradiation in an adjuvant setting will not go forward. The EORTC collaboration was announced by Inovio prior to partnering with MedImmune in August 2015. INO-3112 is in phase I/II clinical trials for cervical and head and neck cancers. Inovio reported last November interim human data showing that its INO-3112 DNA-based immunotherapy generated robust HPV16/18 specific CD8+ T cell responses with cytolytic function and antibodies in all 10 tested head & neck cancer patients who received all treatments. A total of 21 patients have been treated in this study to date; further data will be reported in 2016.
