Monday, May 12, 2008

Drug developers use biomarkers to match patients, drugs

By Ryan McBride

Janusz Sowadski has spent most of the past 11 years in the life sciences industry with drug discovery firms, but now the Boston scientist wants to help drug developers find patients most likely to respond to their treatments.

To improve their chances of success in costly clinical trials, New England life sciences companies have invested heavily to mine for genetic information, or biomarkers, that can help match their drugs with appropriate patients. It's become a big business.

A bevy of local life sciences firms ­-- Aveo Pharmaceuticals Inc., Decision Biomarkers Inc. and Clinical Data Inc., to name a few -- have built different business models around tapping genetic biomarkers for clinical trials. And Sowadski is among the latest biotech entrepreneurs to join the hunt for such information, with a newly hatched Boston firm called Advanced Kinase Diagnostics Inc. (AKD).

Sowadski was cofounder of two Massachusetts biotech firms that were sold for more than $170 million combined. He launched AKD in February to help drug developers find the genes that can be used in tests to screen patients before they enter clinical trials for anti-kinase drugs for cancer.

"The goal here (at AKD) is to speed up the process of development of cancer drugs," said Sowadski, whose firm calls Boston its home but which also has labs in Houston.

Unreliable mice

Historically, pharmaceutical and biotech firms have decided whether to advance drugs into human clinical trials in part based on the effectiveness of treatments in mice or other animals in which cancer cells were implanted. Yet such animal studies have proved to be poor indicators of how some drugs will work in humans.

At Cambridge drug developer Aveo, mice are genetically engineered -- using methods developed by researchers at MIT and the Dana-Farber Cancer Institute in Boston -- to have mutated variations of common cancers found in people. By testing drugs in these mice, the firm discovers which mutated forms of a given tumor respond to its treatments. The data help identify biomarkers that are later matched to patients with certain genes for its clinical trials.

"Targeting the appropriate patients really gives you an advantage and can make the difference between a drug getting approved or not," said Murray Robinson, senior vice president of oncology at Aveo.

In fact, privately held Aveo inked a deal in late 2007 with Eli Lilly and Co. to provide its proprietary mice to help the Indianapolis-based drug giant discover biomarkers for use in human studies of an anti-cancer drug under development at Lilly.

Meantime, Clinical Data of Newton is in the midst of a Phase 3 clinical trial of a depression drug called vilazodone, in which genetic biomarkers are used to identify patients more likely to benefit from the treatment.

Yet while Clinical Data and Aveo both hunt down biomarkers, the process of identifying such genes or proteins in humans for clinical trials can be tricky. Decision Biomarkers, of Waltham, has recently begun sales of a system designed to screen patients' blood or serum for protein biomarkers at the site of clinical trials -- a process that takes hours rather than waiting days or weeks for results to come from central labs, company officials said.

"We think the opportunity worldwide for our (Avantra) system is well above $500 million," said Joseph Blanchard, the company's senior vice president of business development. He said the top five pharma companies are evaluating Decision Biomarkers' Avantra system, and the firm expects its product to be used at clinical trial sites by the end of this year or early next year.

Built on biomarkers

For Sowadski, the biomarkers themselves are the backbone of his startup, AKD, which is focused on genetic tests for developers of anti-cancer drugs that target kinase proteins. His firm has a database with genetic information and mortality figures for 20,000 cancer patients, a key tool to find biomarkers for its partners to use in the selection of patients in clinical trials, he said.

Though in the hot biomarker business, AKD is still in its infancy, and Sowadski said he hopes to raise $10 million in a Series A round of VC financing to fund the discovery of more biomarkers and to expand its labs in Houston.

Sowadski also cofounded and served as a senior executive of Kinetix Pharmaceuticals Inc., a Medford drug developer acquired by biotech giant Amgen Inc. of California for $170 million in 2000. His next venture, Pintex Pharmaceuticals Inc., of Watertown, raised $10.5 million in venture capital before it sold its scientific assets to British biotech firm Vernalis PLC.