West Coast Editor

To move its preclinical "tailor-made" protease programs along, Catalyst Biosciences Inc. raised $10.3 million in a Series A financing.

"We could be in the clinic in approximately two years, but it's really hard to tie that down," said Ed Madison, vice president of research for South San Francisco-based Catalyst.

With a partner, of course, things could move much more quickly.

"We haven't actively looked [for one] but we're going to start early next year," Madison said.

Founded in 2003, Catalyst has seven full-time employees and plans to increase to about 20 over the next nine months or so. Six or seven proteases - depending on whether you count second-generation products as stand-alones - already are on the market, including Activase (alteplase) tissue-plasminogen activator, also known as T-PA, from Catalyst's South San Francisco neighbor Genentech Inc.

Another is Indianapolis-based Eli Lilly and Co.'s Xigris (activated drotrecogin alfa). Proteases even have a cosmetic application - the wrinkle treatment Botox (botulinum toxin) from Allergan Inc., of Irvine, Calif., is a member of the class.

"There are also some blood-clotting factors," Madison said, noting that has been a major area of focus.

"People have worked on maybe one protease for, say, myocardial infarction, always using it to cleave its natural substrate," he said. "We're viewing proteases as a platform comparable to monoclonal antibodies."

Specifically, the firm's technology couples mutagenesis techniques with proprietary screens to select for proteases from large libraries of variants. The hunt is for proteases that preferentially cleave a unique amino acid sequence. Variants move through the cycle as many times as necessary, and Catalyst can generate proteases with the sought-after specificity in a matter of weeks.

The company has a program in oncology and another in inflammatory bowel disease. The former is an engineered protease and the latter is natural. Madison said the company will work with both.

"Many of them will be engineered, but we're going to have a balanced approach," he said, pointing out that the number of possible candidates is "almost infinite, when you begin to engineer them" for advantage.

"T-PA is a good example," Madison said. "The natural one worked, but you had to give it as a bolus injection followed by infusion." The engineered version (i.e., Activase), allows for a single bolus injection.

He declined to say how long the company can operate on the money gained from the Series A.

"We haven't really disclosed that, and it depends on the ramp-up," he said. "Right now, we could operate for quite a while with seven employees."

Sofinnova Ventures, of San Francisco, led the financing, which also included Burrill and Co., also of San Francisco; RCT Bioventures, of Menlo Park, Calif.; and Novartis Venture Fund in San Diego.