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Calistoga Raises $30M to Develop Drugs for Cancer, Inflammation

Xconomy Seattle — 

Seattle-based Calistoga Pharmaceuticals has raised $30 million in a second round of venture capital to support its growing pipeline of drugs for cancer and inflammatory diseases. The venture financing is the second-biggest of the year in the Seattle life sciences cluster, behind the $40 million raised in March by Kirkland, WA-based Pathway Medical Technologies.

Calistoga got the vote of confidence from the same people who invested in its $21 million Series A round two years ago—Frazier Healthcare Ventures, Alta Partners, Three Arch Partners, and Amgen Ventures.

The company has been able to defy the gravity of the downturn because it is hitting its drug development milestones ahead of schedule, and it is pursuing one of the hottest targets in cancer biology of the moment. It’s called the PI3 kinase pathway, which controls critical cell processes like proliferation, migration, and cell survival. When these normal functions get flipped into an overactive mode, it’s a hallmark of cancer cells growing out of control as well as an immune system going haywire and attacking healthy tissue.

Calistoga was born in 2006 when it licensed technology from Bothell, WA-based Icos to develop drugs that hit this target. The company is up against some formidable competition in this cancer category, with GlaxoSmithKline, Novartis, Roche, and Exelixis, to name a few. Yet Calistoga claims to be different because its drugs are aimed to hit more specific types of PI3 kinase, including one known as the delta isoform. This means Calistoga’s drug may have a better profile for blood cancers that express this variety of the PI3 kinase, and it may have milder side effects that would make this drug useful for chronic conditions like inflammatory diseases, says CEO Carol Gallagher.

“This will give us some wind in our sails as we advance these programs,” Gallagher says. “It’s great in a difficult financing environment to get a signal from our investors that they have confidence.”

The financing enables Calistoga to keep building up a pipeline of experimental drugs, so that a year from now it expects to have three different drugs in clinical trials. The new financing means Calistoga has enough cash to operate through 2010, although Gallagher wouldn’t be more specific because the cash burn rate will depend on how fast it decides to push drugs through clinical trials. Calistoga, which has 22 employees, is planning to conserve this capital carefully from the start—it doesn’t plan to hire more staff right away, Gallagher says.

Calistoga’s lead product these days is called CAL-101. The company has completed a Phase I clinical trial that looked at multiple doses of the product in a dozen patients, and data from the study will be presented in a few weeks at the American Society of Clinical Oncology meeting, Gallagher says. The trial will expand to four more groups of a dozen patients each: people who have chronic lymphocytic leukemia, slow-growing non-Hodgkin’s lymphoma (NHL), aggressive NHL, and acute myeloid leukemia. The first look at data on safety and initial indicators of effectiveness ought to be ready by December, at the meeting of the American Society of Hematology, Gallagher says.

The company’s second program is now going by the name of CAL-263. This is a different compound made to block the same PI3 kinase delta isoform, albeit in a way that could be useful for chronic inflammatory diseases, specifically asthma and rheumatoid arthritis, Gallagher says. This product should be ready to advance into Phase II trials for both asthma and rheumatoid arthritis—a pair of potentially big markets—in early 2010, she says.

The newest compound working through the Calistoga pipeline is CAL-120. This drug is made a bit differently, to block both delta and another flavor of PI3 kinase known as beta. That means it should work better against a range of solid tumors, not just blood cancers, Gallagher says. It also allows Calistoga to remain differentiated from competitors, who have pan-PI3 blockers that hit a third variety of this popular pathway, that goes by the name alpha. Calistoga has stayed away from that variation because it sees potential for such a drug to disrupt sugar metabolism and insulin sensitivity, which might bring unacceptable side effects, Gallagher says. CAL-120 ought to be in clinical trials in 2010, she says.

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