Emerging Drug Developer: GlobeImmune

GlobeImmune reaches the crossroad of drug discovery

Most small biotech companies are doing well when they reach the point where they have one Phase II clinical trial underway. GlobeImmune will soon have two studies at the mid-stage point; one for a pancreas cancer therapy and another for a product in development for hepatitis C.

That didn’t happen by accident, says GlobeImmune CEO Tim Rodell, M.D.

“For a small company at the stage we’re at, two mid-stage development products is a little unusual,” he concedes. “The thinking is that both of these products, and others in preclinical studies, are based on a single proprietary platform. We felt early on that it was important to investigate the platform in more than one target area, since the risk and upside in both areas are likely to be different.”

It’s not cheap or easy. GlobeImmune’s Phase II trial for GI-4000 is underway in 50 sites in the U.S. and two in India, focusing on its impact on progression-free survival for early-stage pancreas cancer. That trial should be fully enrolled by the early part of 2008, with data scheduled to land by the end of next year. A separate trial for hepatitis C is preparing to launch, with data from that study also being released before the end of next year.

Louisville, CO-based GlobeImmune was founded in the late ‘90s on the research developed by scientists at the University of Colorado. Its researchers have been using recombinant yeast--Saccharomyces cerevisiae--that is genetically modified to express a protein that triggers a killer T cell response directed at diseased cells. These targeted therapies are called Tarmogens (from Targeted Molecular Immunogens.)

“The yeast is a vector to stimulate an immune response,” says Rodell. That immune response in hepatitis C patients caused viral loads to drop in a Phase Ib trial. And the same approach can be brought to bear against a variety of ailments. GlobeImmune’s approach to hepatitis C can be applied to chronic and acute infectious diseases, he adds, such as influenza and fungal disease. GlobeImmune’s cancer therapy, GI-4000, “has applications in colon, lung, melanoma cancers” and more, says the CEO.

That’s the kind of drug development platform that can deliver a multitude of drug candidates, and it’s the kind of science that attracts other companies mining the same fields. So far, GlobeImmune has been advancing on investors’ funds, but Rodell knows that the day is fast approaching when new sources of financing will need to be tapped.

Just don’t ask him to predict a date.

Says Rodell: “There are two things I don’t predict: When I get financing and when I get a partnership.”

Some of the short-term mystery went out of the financing picture on Wednesday, though, when GlobeImmune announced a $41.2 million Series C, a venture round that included the likes of Biogen Idec, which has programs in oncology and several others categories, and Celgene, which concentrates on cancer and inflammatory conditions. Wexford Capital led this latest round, which may be enough to move a third program into the clinic.

“The financing takes us to Phase II data in pancreas cancer and hepatitis C,” says Rodell. And a lot is riding on the outcome.

“Positive data on either candidate would give us a huge number of opportunities,” he adds. “It would certainly drive a partnership, if there are none already in place.”

An IPO is possible as well, says Rodell, who isn’t ruling anything out at this stage. “There are lots of routes to liquidity today. We’ve raised three sizeable venture rounds, but we’ll probably be looking at something a bit different next time.”

Emerging Drug Developer: GlobeImmune
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