Inovio Pharmaceuticals, Inc. and its academic collaborators, including the University of Pennsylvania (UPenn), were awarded a new five-year $16 million Integrated preclinical/clinical AIDS Vaccine Development Programme grant from the National Institute of Allergy and Infectious Diseases (NIAID).

This five-year program grant was awarded based on the clinical successes of Inovio's Pennvax HIV vaccine program. The grant will fund research to expand Pennvax coverage of HIV strains as well as to further enhance antibody responses generated by the vaccine.

New Pennvax envelope constructs will be designed and tested with Inovio's DNA-based immune activator encoding novel cytokine genes and will be studied in a prime-boost strategy with recombinant HIV envelope proteins. The collaborators will assess different combinations in preclinical models with the goal of generating high levels of neutralizing antibodies mirroring the robust CD8+ T cell responses generated by Inovio's Pennvax-B DNA vaccine in previously published clinical studies. The overall goal of this project is to further build upon this important HIV vaccine approach as well to gain fundamental insight into new technologies to improve vaccination outcomes.

As part of this grant consortium, Inovio will couple its expertise in constructing, developing and manufacturing HIV vaccines with researchers from four world-leading academic institutions (University of Pennsylvania, Emory University, Duke University and the University of Massachusetts) along with VGXi, a contract DNA plasmid manufacturer, and Waisman Biomanufacturing, a contract protein manufacturer.

Dr J. Joseph Kim, president and CEO, said, "On behalf of our team of preeminent academic collaborators, we are honored to receive this significant new grant from the NIAID. Having completed the development of Pennvax-GP under a prior $25 million NIAID grant, we are on track to separately initiate a phase I study of this HIV vaccine. This additional NIAID funding allows us to immediately continue and expand the development of Pennvax vaccines. We have one of the most dynamic HIV programs in the world and we look forward to pursuing any and all scientific exploration to achieve an answer to this challenging disease using our novel DNA immunotherapy approach."

The NIAID previously awarded Inovio a $25 million grant to develop Pennvax-GP. UPenn was a collaborating partner on that award as well for the pre-clinical development activities. A phase I study of Pennvax-GP is expected to start in the first half of 2015.

Human immunodeficiency virus (HIV) is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia).

Inovio completed initial clinical studies of its HIV immunotherapy Pennvax-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon vaccine technology. In two published phase I studies, Pennvax-B immunization has been shown to generate high levels of activated, antigen-specific CD8+ killer T cells with proper functional characteristics. This ability uniquely positions Pennvax as an important product candidate for both preventing and treating HIV infections.

Using a $25 million grant from the NIH, Inovio designed its multi-clade, multi-antigen Pennvax-GP immunotherapy targeting viruses from clades A, B, C and D. Pennvax-GP is Inovio's lead preventive and therapeutic immunotherapy for HIV.