PIPELINE
Additional Prophylactic Vaccines

Clinical-Stage Prophylactic Vaccines:
HIV
A phase 1 trial of the GeneVax® prime/VesiculoVax™ boost HIV vaccine has completed testing (HVTN 087) for safety and immunogenicity in normal healthy adults.

Program Status:
Phase 1. Pre-clinical studies have demonstrated a GeneVax® prime/VesiculoVax™ boost vaccine delivering the envelope from the clade C isolate 1086.C to be highly effective in the induction of antibodies to the V1/V2 region of HIV. With funding from the NIH Division of AIDS, a VesiculoVax™ vectored 1086.C envelope vaccine has completed manufacture and will enter the clinic in October 2014.

Unmet Medical Need:
The WHO and UNAIDS estimate that worldwide 2.3 million people are infected with HIV annually. A recent clinical trial demonstrated that it is possible to achieve partial protection against HIV infection with a prime/boost vaccination strategy. The Profectus GeneVax® prime/VesiculoVax™ boost prophylactic HIV vaccine is designed to provide a more robust immune response and improved protection.

Preclinical-Stage Prophylactic Vaccines:
HIV
As part of its comprehensive HIV vaccine program, Profectus is collaborating with the Institute of Human Virology to develop a subunit vaccine called the Full Length Single Chain (IHV001). The vaccine is composed of the HIV envelope glycoprotein complexed with its primary receptor CD4 that triggers a structural rearrangement of the envelope to reveal a conserved structures that are exposed as the virus enters the target cell. The structures then become targets for an immune response that could protect against HIV infection.

Program Status:
Immunogenicity and protection studies in non-human primates are complete. IHV001 has been manufactured with grant support from the NIH Division of AIDS awarded to Profectus, as well as grants from the US Army, and the Bill and Melinda Gates Foundation awarded to the Institute of Human Virology. A phase 1 clinical trial will initiate in 2015.

Unmet Medical Need:
The WHO and UNAIDS estimate that worldwide 2.3 million people are infected with HIV annually. A recent clinical trial demonstrated that it is possible to achieve partial protection against HIV infection with a prime/boost vaccination strategy. IHV001 is designed to provide a robust and durable antibody response that could improve protection against HIV infection.

Nipah / Hendra
As part of its comprehensive Public Health and Biodefense vaccine franchise, Profectus is developing a subunit vaccine composed of the envelope glycoprotein of Nipah/Hendra virus.

Program Status:
With support from NIAID, immunogenicity studies in small animals have been completed.

Unmet Medical Need:
The natural reservoir for these closely related viruses are bats historically found in Australia. However, the range of this bat species is steadily increasing and bringing the threat of infection to millions of people in Southeast and Central Asia.

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