Washington Editor

CFD Therapeutics Inc. is open for business as a new therapeutic drug company, complete with a large cache of cancer-related intellectual property and all-important venture capital backing.

The newly minted South San Francisco-based firm was spun out of diaDexus Inc., also of South San Francisco, and a biotech concern that plans to focus exclusively on diagnostics going forward. CFD, which is receiving most of its initial funding from the Biotechnology Value Fund LP, essentially inherited diaDexus' therapeutic operations and will work to develop therapeutic monoclonal antibodies against ovarian, pancreatic, breast, colon, prostate and lung cancer targets.

"For a really small company, it's a lot to juggle," said Jackie Papkoff, CFD's chief scientific officer, referring to diaDexus' diagnostic and therapeutic divisions. Previously, she served as diaDexus' executive vice president of discovery and therapeutics, largely overseeing target discovery and validation. "It makes a lot more sense for each activity to now be pursued independently."

That thought was echoed by David Raksin, CFD's director of business development, who said the company's streamlined focus would make it easier to establish future partnerships. He declined to comment on the amount of early funding that has gone into CFD, except to acknowledge that the investment made by the San Francisco-based Biotechnology Value Fund gave it a majority ownership stake. In addition, diaDexus retains an interest in the spinout.

Importantly, the former gave the latter solid footing for its early portfolio: an exclusive license from diaDexus to its entire set of therapeutic targets and associated monoclonal antibodies. As a result, CFD's programs will leverage over eight years and more than $100 million of target discovery and antibody development efforts carried out at diaDexus.

"Since we were early in the genomics sandbox," Papkoff said of diaDexus, "we had a lot of information to zip through."

Through its founding partnership with Incyte Genomics almost a decade ago and its own discovery program, diaDexus identified genes that are highly overexpressed in cancerous relative to normal tissue. "The less normal tissue expression you have," Papkoff explained, "the better."

Starting from thousands of genes, diaDexus identified about 20 promising candidates to move into preclinical development as therapeutic antibody targets, and several of them appear to have significantly greater cancer and tissue specificity than well-known therapeutic targets such as HER-2 and EGFR. Papkoff attributed that potential to the fact that they exhibit "very little normal expression."

CFD will use its initial funding to advance antibodies directed against the two most promising targets in that pipeline of about 20 through preclinical development. Papkoff said the company would complete animal efficacy studies this year on that pair of undisclosed targets, which she said are highly expressed on cell-surface proteins.

CFD now owns full rights to those two programs, while other select pipeline candidates will be co-developed under an existing partnership with Medarex Inc., of Princeton, N.J. That original agreement dates back three years, and was broadened 18 months later. Its focus is on targets for lung, ovarian and other cancers. (See BioWorld Today, Sept. 17, 2004.)

A group of eight diaDexus scientists, with competencies in preclinical development and validation of targets and therapeutic antibodies, have transferred into CFD's operations at the outset.

In terms of additional support, diaDexus is providing start-up infrastructure such as labs, equipment and other services, including access to protein and monoclonal antibody production teams. "They are intimately involved in the ongoing activities of CFD," Papkoff said, further noting that CFD's access to diaDexus' capabilities and infrastructure will be key to furthering CFD's focus.

Both she and Raksin make up its current management team. Raksin previously worked at diaDexus, as well, although most recently he was on the banking side of the business.

For its part, diaDexus now will focus its efforts on diagnostics, particularly the commercialization of the FDA-approved PLAC blood test for measuring the risk of coronary heart disease and ischemic stroke. Privately held diaDexus was founded in 1997 as a joint venture by the former SmithKline Beecham, now London's GlaxoSmithKline plc, and what is today Incyte Corp., of Wilmington, Del. SmithKline granted diaDexus an exclusive license to certain diagnostic intellectual property, and Incyte contributed free access to its databases.

To date, diaDexus has raised well in excess of $100 million.