May 25, 2009
by Marie Daghlian, Assistant Editor
ImmunoVaccine Technologies (IVT) is partnering with FIT Biotech to advance the development of a therapeutic HIV vaccine, which will be a combination of FIT Biotech’s DNA plasmid therapeutic HIV vaccine MultiHIV with IVT's DepoVax vaccine delivery system. The companies will collaborate on pre-clinical studies in animal models, examining the novel vaccine's capabilities of inducing cell-mediated and humoral immunity against HIV virus.
Although the agreement between the two companies is just a research partnership at present, it could move in several different directions based on the results of the animal trials. "Based on the results of those trials we will see how to develop it further,
either as a partnership or whether we in-license their antigen or they in-license our delivery technology, we will see," said Dr. Marc Mansour, vice president of R&D at Halifax, Nova Scotia-based IVT.
According to Dr. Mansour, the company's proprietary delivery system makes it possible for a vaccine to stimulate an effective immune response in the individual with a single dose, eliminating the need for a series of shots and boosters.
"By testing DepoVax in combination with GTU MultiHIV plasmid, we are working towards developing a superior vaccine candidate for therapeutic use against HIV and AIDS," said Kalevi Reijonen, President and CEO at FIT Biotech.
The development of an HIV vaccine is complicated by the ability of the virus to mutate rapidly. FIT Biotech, based in Tampere, Finland and Tartu, Estonia has designed a synthetic DNA plasmid,known as GTU MultiHIV that covers the antigenic variability within HIV strains. GTU MultiHIV and is comprised of the multi-epitope/multivalent HIV antigens. As FIT Biotech's lead vaccine candidate,GTU MultiHIV has the potential to trigger an immune response that slows the progression of HIV
in infected individuals.
According to the company, the GTU technology can result in plasmid expression that is up to 100 times stronger than using conventional plasmids. FIT has already completed proof-of-concept Phase II trials of an early version of MultiHIV and is planning to submit an IND to the FDA to conduct its first U.S. trial.
The DepoVax platform uses liposomes to encapsulate a target antigen, like GTU MultiHIV, and adjuvant. DepoVax also relies on a hydrophobic carrier to create a depot effect that significantly enhances vaccine induced cell-mediated and humoral immunity. IVT's pre-clinical research has shown that DepoVax effectively delivers DNA plasmids into draining lymph nodes with as little as one dose.
"DepoVax will act as a vector to deliver FIT Biotech's GTU MultiHIV DNA vaccine and our goal is to develop a more sophisticated and efficient HIV vaccine candidate," commented Dr. Marc Mansour,Vice President R&D at IVT.
Both FIT's GTU technology and IVT's DepoVax delivery system have broad applications and can be used to develop vaccines against many different types of targets. FIT is currently developing vaccines against melanoma, diabetes, and hepatitis C, for example, all using GTU technology. IVT's first in-house immunotherapeutic is a cancer vaccine targeting prostate, breast, and ovarian tumors that will be going to the clinic in early 2010.
Privately-held ImmunoVaccine Technologies has an interesting history. The company was started in 2000 to commercialize vaccine delivery technology that originated at Dalhousie University in Halifax. According to Dr. Mansour, the technology was originally developed for an immuno-contraceptive vaccine for control of the seal population. "The problem with seals is that you can’t capture them again to deliver a booster immunization," said Dr. Mansour. "So this had to be a vaccine that would be effective with a single dose. That is how the concept was born."
The Dalhousie University researchers used liposomes to encapsulate the antigen that was combined with an oil depot. "This created a vaccine with long lasting immune responses because of combination of things," continued Dr. Mansour. "For one thing, it was a depot formulation which meant that when you injected it, it remained at the site of vaccination so it would be exposed to the immune system for a longer period of time than normal vaccines would be. But it also used liposomes to deliver the payload more efficiently to the immune system. And it also had some immune activators to make sure that the immune response was properly generated. The combination of all these things resulted in very strong immune responses that could be achieved with a single dose."
Although the vaccine developed at Dalhousie wasn't commercially viable, the technology could enhance any vaccine. IVT was founded with the idea to develop the technology for other types of vaccines and it started with developing animal health vaccines. In January 2008, IVT licensed its technology for the development of livestock vaccines to Pfizer Animal Health for undisclosed fees, milestones, and royalty payments.
Today, the company no longer works on animal health vaccines except to license the technology to others. It has shifted its focus entirely on human health vaccines, with a cancer immunotherapeutic vaccine as its lead candidate.
The DepoVax technology has broad application, not only for cancer but also for infectious disease vaccines. IVT has done studies with hepatitis B and has been able to show that it can reduce the number of doses required from a Hep B vaccine from three doses down to one dose. IVT has also done some work with pandemic influenza, a vaccine for which requires two doses. "They’re all two dose vaccines which means, in the case of a pandemic, you need to immunize people and then you have to ask them to come back in a month for a second shot before the vaccine is effective," says Dr. Mansour. "So we saw the value there and we tried combining a pandemic influenza antigen for target in our technology and we were able to show that we were able to get strong immune responses in as little as two weeks after a single immunization."
Although IVT has been able to show efficacy in proof of concept studies in the infectious disease arena, being a small company, they are focused on the cancer vaccine to bring it into the clinic as quickly as possible to show the safety and efficacy of the platform in humans. At the same time, they are continually looking at partnerships and collaborations to work on infectious disease applications because the technology is very broad. This has resulted in a number of recent collaborations, including one with the NIH for malaria and HIV vaccines, another with the La Jolla Institute for Allergy and Immunology in San Diego that is looking at influenza and arenavirus vaccines. and a collaboration with the Department of Defense in Canada looking at enhancing an anthrax vaccine because anthrax vaccines require six doses at present. FIT Biotech is the latest example where IVT is collaborating to enhance their DNA based HIV vaccine.
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CANADIAN BIOTECH NEWS, VOLUME 18 NUMBER 14