Emerging Drug Developer: S*BIO

S*BIO readies new venture round as it moves into Phase II

After several years of early-stage work in the oncology sphere, Singapore-based S*BIO is preparing to take the next big step in its development.

In a matter of weeks, says CEO Jan-Anders Karlsson, the developer plans to announce a new venture round of about $30 million. The Phase I study of its lead compound--an HDAC inhibitor--will wrap with new data available in October and a mid-stage study should be ready to launch next year. The company also just announced that it has started a Phase I trial of its second therapy--an oral JAK2 inhibitor.

S*BIO still has a long way to go. Like others in the cancer space, one study will lead to others as the developer explores various cancer types. The upcoming mid-stage study will be the first of several for SB939. The first Phase II data is likely to start flowing in 2010. SB1518, meanwhile, is entering a 60-patient, dose-escalating Phase I trial in the U.S. for leukemia and certain other types of lymphoma.

The developer has yet to announce the new venture round, and Karlsson wasn't releasing the list of investors, yet. He did note that a number of new European investors were preparing to back the company and would be joining the board of directors.

"We think this (venture round) will take us to the second half of 2009," says Karlsson. "With that we will come closer to Phase II data for the HDAC inhibitor and JAK2 compound (SB1518). "We'll at least have started Phase II studies. The real value inflection point probably comes in the first half of 2010, the middle of 2010, when we will have Phase II data on the two compounds."

To get to that point, he adds, the company will likely either raise a new venture round or look to "limited partnering" to supply new funds.

Depending on the data, S*BIO may opt to pursue a Phase IIb trial for solid tumors--something that Karlsson says would require a partner. If the company chooses a hematology indication, there's an option of going it alone.

S*BIO got started with the considerable support available from the Singapore Economic Development Board, which years ago started to craft a program designed to make the city-state a leader in the biopharma world. That backing (Chiron was a member of the original joint venture that launched S*BIO) has spawned a company with a vision of growing into a sizeable force of its own.

S*BIO doesn't plan to try and copy the standard biotech development model established in the U.S. and Europe, says the CEO. Instead, it has kept one foot planted in the U.S. clinical development world while eyeing a role for itself as a trailblazer in Asian markets.

"We are close to India," says Karlsson. "We are certainly close to China." And with their small molecule focus in the cancer space, "there are many opportunities for us to be a leading biotech in this part of the world."

Ultimately, says Karlsson, who joined the company in 2005, S*BIO hopes to be able to pursue "a mix of marketing ourselves and partnering. We need some risk mitigation so we don't take on all the risk ourselves."

The biotech company has about 50 people on staff, most in Singapore with a clinical development team in place in Redwood City, CA. The California operation keeps the company in the FDA's orbit while staying close to U.S. colleagues working in the development sphere.

Karlsson doesn't expect the number of staffers to grow dramatically.

"We stay as we are," he says, "moving a little from research and discovery to more competence in clinical development and regulatory."

As Karlsson notes, this is his first small venture. His development pedigree stretches back to big firms in Germany and Japan - he was executive vice president, global research of Bayer Pharma--a different world from the small team building S*BIO.

"We have a very short decision making point," says Karlsson. "We have few committees. We are very close to decisions--all small and big strategic decisions--and be accountable for it."