Money will be used to study genetic adjuvants and recombinant Vesicular Stomatitis Virus technology.

Profectus BioSciences received $6.25 million in NIAID grants and contracts. This includes three SBIR grants from the Division of AIDS of the NIH totaling $2.9 million focused on optimizing the company’s genetic adjuvants. It also includes $2.75 million in continued contract support from the Division of AIDS to develop the firm’s recombinant Vesicular Stomatitis Virus (rVSV) platform as an HIV vaccine.

Also, on October 5, Profectus BioSciences was awarded a Fast Track SBIR from the Division of AIDS for $3.1 million to support development of its Transition State Vaccine (TSV) technology for a prophylactic HIV vaccine.

Profectus BioSciences is dedicated to harnessing the immune system to treat and prevent viral diseases and cancers through the delivery of proprietary prime/boost vaccines. “Along with IL-12, our portfolio of genetic adjuvants provides us with a toolbox of options to optimize our heterologous prime/boost vaccines,” says John Eldridge, CSO.

One of the adjuvant approaches exploits the enzymatically active A1 subunit of cholera toxin (CTA1), which can be expressed from DNA, RNA, and viral vectors. In a recently completed phase 1 SBIR, expression of the CTA1 adjuvant from a pDNA-based vector demonstrated promise in small animal models.

The phase 2 SBIR supports the continued evaluation and optimization of CTA1 in nonhuman primates in conjunction with the Profectus BioSciences’ HIV pDNA vaccine. Additional adjuvants supported by this funding utilize other cell-signaling pathways to stimulate the body’s innate but potentially powerful and adaptive immune system.

Additionally, under its contract with the Division of AIDS, the company will leverage its rVSV technology in the development of an HIV vaccine. VSV is a negative-strand, nonsegmented RNA virus from the order Mononegavirales that has been redesigned to enable delivery of vaccine immunogens. It is a particularly attractive candidate for this purpose because its genome can potentially host more than one foreign gene, and it contains its own toll-like receptor activating adjuvant, Profectus BioSciences explains.

Since replication is cytoplasmic, and the genome comprises RNA, rVSV is incapable of integrating within the genome of infected host cells, a highly desirable safety feature. Unlike adenovirus and other viral vector vaccines employed today, human infection with VSV is very rare, so the general population is free of pre-existing, virus-neutralizing immunity. Profectus BioSciences is utilizing this technology along with its pDNA platforms to develop effective therapeutic vaccines against HCV, HPV, HSV, and HIV.

The $3.1 million funding received two days ago from the Division of Aids will be used along with $1.3 million received through collaborative grants awarded to Robert Gallo, M.D., director of the Institute of Human Virology (IHV) of the University of Maryland School of Medicine. Originally developed at the IHV, the TSV strategy targets the adaptive immune response to the most protected portions of HIV envelope spikes that are considered the Achilles heel of all HIV isolates.

TSV is being developed as a subunit protein and also for delivery utilizing the company’s plasmid DNA and rVSV vaccine vectors. Thus far, the TSV approach has generated significant protective responses in several nonhuman primate models for HIV, the company says.

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