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Profectus BioSciences, Inc. Awarded $3.5M National Institutes of Health (NIH) SBIR Grants To Advance Therapeutic Vaccines Against HIV



7/29/2014 9:19:06 AM

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BALTIMORE, Md., July 29, 2014 – Profectus BioSciences, Inc., a clinical-stage vaccine platform company developing novel PBS Vax™ vaccines for the treatment and prevention of infectious diseases, announced today the award of two Small Business Innovative Research (SBIR) grants totaling $3.5 million from the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Profectus will use the awards to support the optimization and testing of a novel DNA therapeutic vaccine strategy against simian immunodeficiency (SIV) infection of macaques, the prevailing animal model for human immunodeficiency virus (HIV), in collaboration with Dr. Deborah Fuller, Associate Professor in Microbiology at the University of Washington and Washington National Primate Research Center.

The effort exploits a key observation published by Dr. Fuller that a skin-delivered therapeutic DNA vaccine co-formulated with a novel adjuvant-stimulated mucosal T cell response in SIV-infected macaques led to durable viral suppression in these animals after ceasing standard antiretroviral therapy.1 As a component of the National Institutes of Health's HIV "Cure Agenda,” this collaboration aims to improve this outcome by using more potent adjuvants from Profectus’s portfolio and a novel DNA delivery device that more efficiently delivers DNA into the skin.

About Profectus Biosciences

Profectus BioSciences is a clinical-stage vaccine platform company developing novel vaccines for the prevention and treatment of infectious diseases and related cancers based on the company’s proprietary Prime/Boost System of Vaccines (PBS Vax™) platform. The PBS Vax system enables the “tailoring” of immune response to a specific disease target to achieve greatly enhanced immunogenicity and comprises VesiculoVax™ vaccines vectored with replication-competent vesiculoviruses and GeneVax® DNA vaccines enhanced by the co-administration of GeneVax IL-12® and electroporation delivery. Clinical studies of PBS Vax have demonstrated a favorable safety profile and that the platform enhances immune responses in new ways. Profectus is using the PBS Vax discovery engine to create a pipeline of differentiated new vaccines that have the potential to be first-in-class or best-in-class products to treat and prevent disease. The company’s lead product candidate, a therapeutic and prophylactic vaccine for HIV, is in human clinical studies and is currently being used in the clinic as part of the National Institutes of Health's HIV "Cure Agenda.” The company’s biodefense vaccine franchise for the Ebola and Marburg viruses is in late-stage preclinical development and was shown to provide 100 percent protection of monkeys against lethal challenge with these agents when tested by the U.S. government. For more information, please visit www.profectusbiosciences.net

1 Fuller DH, Rajakumar P, Che JW, Narendran A, Nyaundi J, et al. (2012). “Therapeutic DNA Vaccine Induces Broad T Cell Responses in the Gut and Sustained Protection from Viral Rebound and AIDS in SIV-Infected Rhesus Macaques.” PLoS ONE 7(3): e33715. doi:10.1371/journal.pone.0033715

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