Emerging Drug Developer: Synta Pharmaceuticals

Synta rings in New Year with a new deal

The folks at Synta Pharmaceuticals know how to end a year with a bang.

While most people were preparing for the Christmas and New Year's holiday bash, Synta was finalizing a development deal worth potentially $1 billion with Roche. Significantly, the deal covers some of its preclinical work and will include up to three compounds targeting calcium release-activated calcium modulator channels aimed at inflammatory diseases.

For the Lexington, MA-based developer, the news capped a solid string of triumphs in 2008. And the deal served as a fresh reminder of the potential of the company's chemical compound library. All of Synta's five publicly revealed development programs have been generated in-house.

Up until now, most of the news surrounding Synta has centered on its late-stage cancer work.

Synta's lead program is an on-going Phase III trial of elesclemol in metastatic melanoma. In mid-December, the company announced that it had earned a $15 million milestone payment from GlaxoSmithKline, which partnered on the drug in a pact worth up to $585 million in pre-commercial milestones. And that check came just two months after a $25 million payday in mid-October. Altogether the GSK deal is worth up to $1 billion.

Enrollment for the Phase III is expected to wrap up later this month or next. And Synta says that it will conduct the primary endpoint analysis for progression-free survival shortly after that point. Meanwhile, researchers are conducting a Phase I/II clinical trial of elesclomol in combination with docetaxel in hormone refractory metastatic prostate cancer.

"This is a confirmatory Phase III trial, which is quite unusual in oncology development," CEO Safi R. Bahcall, Ph.D told a group in New York last December. The late-stage trial, he explained, is designed exactly the same way the company's Phase IIb elesclomol trial was run. And that trial squarely hit its primary endpoint.

Elesclomol is designed to elevate the oxidative stress levels in cancer cells, triggering programmed cell death. And they're going after metastatic melanoma initially, giving the company a shot at creating a first-line therapy for an aggressive cancer where there is none now.

"With a positive outcome we would expect this drug to become the first choice for all patients around the world with metastatic melanoma," said Bahcall. Several other cancers offer the same target for the therapy, and Bahcall noted that a trial for ovarian cancer would get underway this year.

Synta also has a small Phase IIa trial underway for apilimod, a small molecule drug candidate that inhibits the production of the cytokines interleukin-12 and interleukin-23, which are believed to regulate biological processes underlying certain autoimmune and inflammatory diseases. And there are two Phase I trials underway for STA-9090, a synthetic, small-molecule inhibitor of heat shock protein 90, or Hsp90, for the treatment of cancer.

"We are looking at dosing at this stage," says Rob Kloppenburg, vice president of investor relations, adding that a third Phase I trial for STA-9090 is planned. That program is un-partnered and likely to stay that way - at least for the U.S. market, he adds. If elesclomol proves as successful as Synta believes it can be, their deal with GSK allows the company commercialization rights that would open the door to developing a marketing arm that could also handle STA-9090 following an approval.

Synta currently employs about 200 people, more than half of them scientists.

Bahcall already had a reputation as a deal-maker ahead of the Roche pact. His $1 billion development deal with GlaxoSmithKline stands as one of the largest of its kind for a single therapy. And now Roche is adding to the biotech's cash reserves with another deal that could fetch a billion dollars.

At the end of September, Synta reported that it had $83 million in cash on the books, and that was before GSK's $15 million milestone arrived. With the Roche deal, Synta gets $25 million up front, including $9 million for research costs. On top of that there's $245 million in development milestones for the first product, $122.5 million for each of the next two products along with $170 million in commercial milestones for each of the programs. 

Given the bleak outlook in biotech over the last 90 days, investors were understandably cheered by the big numbers involved. This helps prove once again that good science can still earn a large reward.

Emerging Drug Developer: Synta Pharmaceuticals
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