By Allan Maurer
ORLANDO, FL–Are you a man or a mouse? That question takes on new meaning when applied to clinical testing of experimental drugs, says William Warren, president, CEO and co-founder of Orlando’s VaxDesign. Many drugs tested in mice fail at later, expensive stages of clinical development because, “We know animal models do not translate to human responses,” Warren says.
VaxDesign has developed an artificial immune system that mimics human responses to drugs. Research and Development magazine described it as “essentially a clinical trial in a test tube.”
Warren tells TechJournal South, “When we started a few years ago, we wanted to develop our own drugs, but needed a way to distinguish ourselves. Every cancer vaccine company thinks it has a cure for cancer. They have to think that.
“So we asked ourselves, where’s the bottleneck in drug development? You hear about drugs failing at Phase I, Phase II and Phase III clinical tests and that’s why it costs a billion dollars to get a drug to the marketplace. We need better preclinical data.”
Huge market for the device
Normally, drug companies use animal models to test their experimental treatments, but, Warren says, “Animal models of treatments for HIV to psoriasis and flu are not representative of human responses. But there was no alternative. The mouse was the best you could do. So, you could cure a disease in a mouse, but not in a human.”
That’s why the VaxDesign founders decided to create a device that would replicate human immune responses and help get better drugs to market. The market for the device could be huge. As many as 50 million animal studies of drugs are conducted annually. “That’s a big market opportunity,” says Warren.
Creating a device rather than drugs also offered numerous business advantages. The company would not need FDA approval, a ten-year, billion-dollar venture. They could get to market much faster and indeed, already have customers using their device.
One of the things that happens in any immune system, your body or in vitro (out of the body, usually referring to in the test tube) is that it generates antibodies to neutralize the virus or invader. In our system, we create monoclonal antibodies at the same time we do tests, so we’re looking at therapeutic opportunities.
Disease specific approach
The company is also looking into creating a treatment for Crohn’s disease, an autoimmune problem that causes inflammation of the bowels and affects as many as 600,000 Americans yearly. Treatments for autoimmune diseases, where the body attacks its own cells, often take a sledgehammer approach, says Warren. “The treatments weaken your whole immune system. We’re trying to make our treatment disease specific rather than take a sledgehammer approach.”
Founded in 2003 as a spinout of Oklahoma City technology incubator Sciperio, VaxDesign started out with something a lot of biotech companies would like to have: a $40 million contract from the Defense Advanced Research Projects Agency (DARPA). The company has just begun seeking grants from other government agencies and is in the early stages of raising a venture round in the $10 million range, says Warren.
The company’s artificial immune system (AIS) can rapidly simulate a clinical trial such as evaluating the effect of a vaccine on human population subgroups. The tests require human white blood cells drawn from a group of volunteers who mirror age, gender, and ethnic diversity found in the general population.
The tests cluster results in groups that distinguish reactions of the different sub groups or show results representative of 95 percent of the human population.
The data helps drug developers design full human clinical trials less likely to fail due to a lack of accurate preclinical data on human responses.
Robots do the tests
“We think it replicates the human response in a representative and predictable way,” says Warren.
The entire testing process is automated and carried out by robots, Warren says. “That’s actually more accurate and efficient than if humans did the tests. The robots don’t get tired or bored doing repetitive tasks.”
The company plans to use its “Mimic” (Modular Immune in vitro Constructs) technology to develop a predictive model for testing autoimmune drug candidates and for testing vaccine effectiveness.
The 38-employee company collaborates with the University of Central Florida, the University of Florida, and the University of Miami, Florida Blood Centers, Florida Hospital and M.D. Anderson Cancer Center in Orlando, among many others.
The company’s Web site (see below) includes detailed explanations of the VaxDesign technology, including articles from industry publications and even a movie.
On the Web: www.vaxdesign.com
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