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 didnâ€™t happen by accident, says GlobeImmune CEO Tim Rodell, M.D.
â€œFor a small company at the stage weâ€™re at, two mid-stage development products is a little unusual,â€ he concedes. â€œThe 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.â€
Itâ€™s not cheap or easy. GlobeImmuneâ€™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 â€˜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.)
â€œThe yeast is a vector to stimulate an immune response,â€ 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. GlobeImmuneâ€™s approach to hepatitis C can be applied to chronic and acute infectious diseases, he adds, such as influenza and fungal disease. GlobeImmuneâ€™s cancer therapy, GI-4000, â€œhas applications in colon, lung, melanoma cancersâ€ and more, says the CEO.
Thatâ€™s the kind of drug development platform that can deliver a multitude of drug candidates, and itâ€™s the kind of science that attracts other companies mining the same fields. So far, GlobeImmune has been advancing on investorsâ€™ funds, but Rodell knows that the day is fast approaching when new sources of financing will need to be tapped.
Just donâ€™t ask him to predict a date.
Says Rodell: â€œThere are two things I donâ€™t predict: When I get financing and when I get a partnership.â€
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.
â€œThe financing takes us to Phase II data in pancreas cancer and hepatitis C,â€ says Rodell. And a lot is riding on the outcome.
â€œPositive data on either candidate would give us a huge number of opportunities,â€ he adds. â€œIt would certainly drive a partnership, if there are none already in place.â€
An IPO is possible as well, says Rodell, who isnâ€™t ruling anything out at this stage. â€œThere are lots of routes to liquidity today. Weâ€™ve raised three sizeable venture rounds, but weâ€™ll probably be looking at something a bit different next time.â€