West Coast Editor

Having "set the tone" for valuing its tumor antigen technology in the deal entered four years ago with then-IDEC Pharmaceuticals Corp., Caprion Pharmaceuticals Inc. signed another, this time with Johnson & Johnson's Centocor Research and Development Inc., said Lloyd Segal, Caprion's president and CEO.

Segal's Montreal-based firm will deliver targets found with its CellCarta proteomics platform, and Centocor, of Radnor, Pa., will keep exclusive worldwide rights to develop and sell monoclonal antibodies or other drugs against any target chosen.

Terms of the Centocor deal were not disclosed, but the deal with IDEC (which since has become Biogen Idec Inc.) carried a $4 million equity investment in Montreal-based Caprion, as well as a technology access fee and research funding that together totaled $7 million. (See BioWorld Today, Sept. 18, 2002.)

Centocor is "very much like biotech - entrepreneurial, fairly fast moving, very focused," Segal said. "There's a sense of urgency that reminds us of [ourselves]." Caprion uses proteomics not only to find new targets - this is the more lucrative area - but also to ransack collaborators' clinical-trial samples for potentially relevant biomarkers.

"We're correlating protein expression to different states of the same form of sample," Segal said. "We've done plasma, we've done whole blood, and we're doing a urine [project] right now."

Recently gained partners - all for biomarker discovery - include Cambridge, Mass.-based Vertex Pharmaceuticals Inc., entered in March; Berlex Inc., of Wayne, N.J. (an affiliate of Germany's Schering AG), begun in January; and Bothell, Wash.-based ICOS Corp., also a January deal.

"Existing partners tend to sign up for small deals and come back for bigger ones," Segal said.

Caprion develops its own drugs, too. The firm last month reported positive data from a 40-patient Phase I trial with Shigamabs, its dual antibody for Shigatoxin-producing E. coli infections, awarded fast-track status by the FDA. Shigamabs is designed to work against strains including O157:H7, the culprit in the recent spinach-related outbreak.

"In the case of Shigatoxin-producing E. coli, the bacteria never really leave the gut," Segal said. "They adhere to the wall of the gut and secrete toxins."

Caprion plans to move the anti-toxin Shigamabs into a pivotal trial in 2007.

On its way to Phase II trials in pancreatic cancer and melanoma is Caprion's CAP-232, a synthetic cyclic peptide in-licensed from Expergen Inc., of Madison, Wis., that acts on the glycolytic pathway regulating energy production in tumor cells. An exploratory Phase IIa trial in a dozen refractory-melanoma patients showed clinical response in 30 percent of patients, and reaffirmed CAP-232's safety profile.

Privately held Caprion filed for an initial public offering in May, aiming to raise an undisclosed amount, but withdrew the IPO at the end of July because of adverse market conditions. (See BioWorld Today, May 10, 2006.)

IPO aside, Segal expects to grow the biomarker effort more during the next few years.

"Five years ago, every [scientific] meeting was a high throughput-screening meeting," Segal said. "Three years ago, it was genomics. Now, everybody is talking about biomarkers."

Even skeptical regulators have eased up somewhat. An FDA white paper about a year ago "signaled for the first time in a policy statement that they were going to be open to functional genomic data" in making trial-design decisions, Segal said.

"Statistical correlation didn't satisfy them [in the past], they wanted to know the biology," he said. "You can't always explain it."