Calistoga Pharmaceuticals - 2009 Fierce 15

FierceBiotech 2009 Fierce 15 winner

Based: Seattle, WA
Founded: 2007
CEO: Carol Gallagher (photo)

The Scoop: Calistoga Pharmaceuticals is an ambitious player in one of the hottest arenas in cancer research: PI3 kinase inhibitors. In particular, the developer is focused on a particular niche: delta isoform-selective PI3 inhibitors. CAL-101 is aimed at hematological malignancies. A second cancer program, CAL-120, is being studied for solid tumors. And Calistoga's pipeline includes CAL-263, which is being studied for big-market inflammatory diseases like asthma, COPD and rheumatoid arthritis.

What Makes it Fierce: Anyone looking for signs of market potential in the inhibition of Phosphoinositide-3 kinase, or PI3K, need only look back a few weeks to the announcement of a $1 billion pact Exelixis signed with Sanofi-Aventis. Calistoga is aimed at the same sweet spot in drug research.

Calistoga has narrowed its approach to PI3K and is starting to see hard data that the developer is on the right track. Preliminary data from a Phase I safety and efficacy trial demonstrated that six of the 12 evaluable patients in the trial-an impressive 50 percent rate--had a partial response after a one-month evaluation. Partial response is a minimum 50 percent decrease in tumor burden.

Researchers are now taking doses of interest into broader groups, says Calistoga CEO Carol Gallagher, for several cancer types. "Out of 24 patients we have a 50 percent response rate. And most of these are at the first month, the first evaluation."

By specifically targeting the delta isoform of PI3 kinase, Calistoga's science team believes that their therapy has a solid shot at proving itself as a safer, more efficacious approach to blood cancers, steering clear of some of the side effects that plague the current generation of oncology drugs.

A program for inflammatory disease is headed for mid-stage tests next year-which Gallagher expects to partner ahead of Phase III. And another PI3 kinase, this one focused on beta to attack solid tumors, will move into the clinic next year.

Calistoga has the money to pursue its dreams. In early May the developer reported snaring a $30 million Series B from an impressive array of top tier venture groups.

What to Look For: By the fourth quarter of this year Calistoga will have data on 70 to 80 cancer patients, "some still early, so we won't have a full picture of durability," says the CEO. "Given what we're seeing now with single-agent activity, we think we could start Phase II in 2010, with Phase II registration in a refractory, relapsed population." The right Phase II data in that group could possibly pave the way to an approval with a product ready for the market by late 2012.

Given the kind of money needed for late-stage trials, Gallagher fully expects to get a partner lined up. "It's likely that by the beginning of next year we'd go to the FDA and talk about registration plans. A partner would want to be involved in those discussions, if we decide on the right partner."

Venture backers: Frazier Healthcare, which helped found the company, along with Alta Partners, Amgen Ventures, and Three Arch Partners.

Calistoga Pharmaceuticals - 2009 Fierce 15

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