Fledgling firm GeoVax Inc. hopes to change the world, and it hopes to do so in a hurry.
Formed early last year, the Atlanta-based AIDS vaccine start-up is planning to begin clinical trials this quarter with its first candidate. Before the end of the year, GeoVax expects the HVTN (HIV Vaccine Trials Network), a unit of the National Institutes of Health in Bethesda, Md., to begin enrollment.
"It really is an exciting project," GeoVax CEO Don Hildebrand said. "It's something that's so desperately needed; there's such a huge problem with AIDS worldwide. It's a worthy cause, and what more important project could one be working on?"
HVTN will incur costs associated with the trial, which will be run independent of GeoVax. Using a small cohort of patients, the U.S.-based trial will be designed to determine the vaccine's safety over the course of up to a year. The Phase I study for the DNA prime portion of the vaccine for subtype B is scheduled for this quarter, with the corresponding Phase I trial for the MVA boost portion following shortly thereafter.
The vaccine candidate, based on T-cell and plasmid vector technology, will be prime/boost DNA/MVA monovalent HIV-1 vaccines containing either subtype B, subtype AG or subtype C immunogens.
"It involves two vaccine components," Hildebrand said. "The first is a DNA vaccine, used to prime the immune response of the individual who receives it. The second vaccine is MVA, a modified vaccinia ancara strain of virus in which we inserted genes to coat the proteins and the antigens of the AIDS virus."
The vaccine candidate was developed by Harriet Robinson, a faculty member at Emory University in Atlanta, in collaboration with the Centers for Disease Control and Prevention, also in Atlanta, and the National Institutes of Health.
"This combination of giving DNA followed by the recombinant vaccinia virus booster has been extremely successful in stimulating a high level of T-cell immunity in these particular vaccinates," Hildebrand said. "When they are challenged with a virus that causes AIDS, this holds the virus level down to a very low level that is slightly detectable or not detectable in the individual. And as long as that virus that causes AIDS stays at this very low level, there is no clinical sign of AIDS."
He pointed to preclinical work that includes more than two and a half years of studies in monkeys, which has shown 100 percent protection in monkeys given a full dose of the vaccine.
"We're confident that these are some of the very best results anybody has ever demonstrated in an AIDS vaccine," he said. "These vaccines look exceptionally promising in preventing disease in humans."
With a clear market objective for developing such a product, the six-employee firm is not the only company working to create such a vaccine. Hildebrand said that while others also are developing vaccines by combining DNA with a vaccinia virus booster, the GeoVax product is differentiated by its multiprotein expression.
"We get expressions to several of the proteins that are found in the AIDS virus," he said. "And this gives a very broad spectrum of immunity in an individual, rather than a narrow or small amount of immunity."
GeoVax said it eventually intends to develop a trivalent vaccine containing a combination of B, AB and C immunogens, as well as monovalent vaccines that could be effective in North America, Europe, Australia and Japan. Down the road, GeoVax expects to develop other combination vaccines to broadly protect populations elsewhere in the world, with eventual clinical studies planned for Africa.
But in the near term, the company also remains focused on its business needs. GeoVax, which obtained seed funding from Emory as well as funding through grants, expects to complete its first round of financing in the coming year.
"We're just starting to go out and raise some additional financing from individual investors," Hildebrand said. "And very shortly, we're going out to raise some significant money - we're looking in the $10 million to $20 million range - to support some of the contract manufacturing requirements to make vaccines for these human trials, and also to conduct certain human trials."