Human Therapies » HIV Vaccine

The goal of any vaccine is to teach an immune system to recognize a foreign pathogen in the body, and enable the host to mount a robust response against infection. Many companies, academic institutions, NGOs and governmental agencies have spent billions of dollars developing over 100 different HIV vaccine candidates over the last 20 years. In this process only a few of the vaccine candidates have shown very modest success - most have completely failed. Clearly a different strategy is required.

VIRxSYS’ HIV vaccine candidate, VRX1023, uses the Company’s HIV-based lentiviral vector technology refined during the development of VRX496. VIRxSYS has performed extensive work in mice and in non-human primates with this vaccine candidate. The Company’s studies in these animal models indicate immunogenicity levels that compare very favorably to the previous “gold standards” for HIV vaccines. The immunological profile to date is very encouraging, and we are excited about the sustainability of those responses.

Over the last two years VIRxSYS has performed a prophylactic HIV vaccine study in non-human primates, administering VRX1023 three times to monkeys. The monkeys were then injected with a strong infectious dose of SIV (the simian version of HIV) as a “challenge” to determine the ability of the VIRxSYS vaccine candidate to protect the animals against the virus. The results are very encouraging. It is difficult to compare these results to the data obtained by other groups testing other vaccine candidates without performing “head-to-head testing.” However, based on our evaluation of the data we have to date, we believe our results are extremely strong. We also have shared the data with a number of internationally recognized HIV vaccine experts, each of whom indicated they viewed the data very favorably as well. Our data will be presented at upcoming scientific meetings and submitted for publication in the near future.

The Company intends to meet with the FDA to discuss our plan to conduct clinical trials, first using VRX1023 as a therapeutic vaccine. In such a trial, VRX1023 would be administered to patients already infected with HIV to determine the antiviral and immunological benefits derived from the vaccine. VIRxSYS also intends, at a later date, to investigate VRX1023 in a prophylactic setting.

VIRxSYS also has held discussions with a number of commercial, governmental and philanthropic entities regarding partnership for the further development of, and clinical trials for, VRX1023. We have received preliminary signals of interest from a number of these entities, and with the data from the monkey study, the Company has initiated steps to broaden its search for development and clinical partners. The eventual goal is to secure a strategic commercial partner for this product.