DNA Immunotherapy Candidate for Head & Neck Cancer Part of New Pharma Collaboration

August 14, 2015
Erin Wallace

AstraZeneca’s MedImmune has entered into a licensing agreement and collaboration with Inovio Pharmaceuticals, whereby MedImmune was given exclusive rights to Inovio’s INO-3112 immunotherapy.

1Last year, Inovio began a phase I/IIa clinical trial, following positive results from the phase I VGX-3100 trial, to evaluate safety, immunogenicity, and clinical responses of INO-3112 for the treatment of human papillomavirus (HPV)-associated head and neck cancer.2

INO-3112 combines VGX-3100, an investigational DNA immunotherapy candidate designed to treat precancers and cancers caused by HPV, with INO-9012, a DNA-based immune activator encoded for IL-12, and targets E6 and E7 oncogenes of HPV types 16 and 18 against HPV-based cancers, such as cervical and head and neck.

The open-label HPV-005 study will include up to 20 adults with HPV-positive head and neck squamous cell carcinoma (HNSCC). These patients will be treated with INO-3112 and followed for safety, as well as for immune and clinical responses.

In the second part of the study, up to 10 patients will be treated with the INO-3112 after completion of chemotherapy and radiation therapy. Both treatments will include a combination of 6 mg of VGX-3100 and 1 mg of INO-9012 delivered together intramuscularly with Inovio’s CELLECTRA electroporation delivery device.2

This study, conducted at the Abramson Cancer Center in the Perelman School of Medicine at the University of Pennsylvania, will also analyze T-cell immune responses to INO-3112 and will analyze pre- and postimmunotherapy tumor tissue to assess infiltration of T cells into the tumor and tumor bed. The study will also look at clinical responses characterized by antitumor effects, using RECIST criteria, and will measure progression free survival (PFS).2

As part of the agreement, MedImmune, which is to fund all developmental costs, will pay $27.5 million up front to Inovio, and agrees to make future payments, totaling up to $700 million based on development and commercial milestones.1

Following the collaboration, MedImmune and Inovio hope to develop up to two additional DNA-based cancer vaccine products that are not already included in Inovio’s current product pipeline. MedImmune will have exclusive rights to develop and advertise the products, and Inovio will be eligible to receive royalties on worldwide net sales.1

“[The] 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 immunooncology 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,” said David Berman, senior vice president and head of the Oncology Innovative Medicines Unit, MedImmune, in a press release.1

In the same press release1, J. Joseph Kim, president and CEO, Inovio, concluded, “Our licensing partnership with MedImmune represents an important step in executing our immunooncology 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.”

References:

1. AstraZeneca. MedImmune enters into strategic cancer vaccine collaboration and license agreement with inovio pharmaceuticals.http://www.astrazeneca.com/Media/Press-releases/Article/20150810--medimmune-enters-into-cancer-vaccine-collaboration. Accessed on August 14, 2015.

2. Inovio. INO-3112 immunotherapy for head & neck cancer.http://www.inovio.com/products/cancer-vaccines/hpv/head-neck-cancer. Accessed on August 14, 2015.