Its sights set high, ChemoCentryx Inc. is heading into the New Year with one clinical program under way and several others nearing human studies. Such progress reflects the five-year-old firm's push to progress preclinical development as quickly as possible.

The San Carlos, Calif.-based company is developing therapeutics to treat autoimmune and inflammatory disorders, cancer, infectious diseases and transplant rejection. To that end, ChemoCentryx is developing small molecules to inhibit the activity of the chemokine system, which regulates immune response.

"We have used our knowledge and drug discovery tools pretty quickly and efficiently, because five years into the development of the company, we have one program in clinical development and three others knocking on the door of clinical development," ChemoCentryx President and CEO Thomas Schall told BioWorld Today. "I think it's safe to say that we'll take at least one of those into the clinic this year. And we have a fairly robust pipeline - all of it from our in-house discovery and technology efforts."

He founded the company on the basis of his work in cell migration. Schall said regulating the trafficking of immune cells through the chemokine system presented the business opportunity ChemoCentryx aims to exploit.

"If we can understand which receptors are important in which specific diseases - whether it be arthritis, multiple sclerosis or asthma - then maybe we can create drugs that block those receptors specifically," Schall said. "And if we can block those receptors specifically, then we can stop the trafficking of lymphocytes to the brain, in the case of multiple sclerosis, and have a therapeutic endpoint that is beneficial."

To achieve such a goal, ChemoCentryx developed its EnabaLink technology suite, a drug discovery system designed to allow the company to analyze the chemokine system with its assays. Schall said the company has designed its process to cut in half a typical seven-year-plus preclinical cycle.

The first fruit of ChemoCentryx's efforts entered clinical trial studies three months ago, just under four years after the program began. The oral anti-inflammatory drug candidate, T487, is being developed in partnership with South San Francisco-based Tularik Inc. The small molecule, being studied in a 30-patient, dose-escalating trial to evaluate its safety, efficacy and pharmacokinetics, targets a specific cell surface receptor and is expected to reduce inflammation in a variety of conditions, including rheumatoid arthritis, inflammatory bowel disease and psoriasis.

Under terms of the collaboration, which began in 1999, Tularik will retain worldwide commercialization rights to the compound, while ChemoCentryx will receive payments based on its development and any eventual commercialization.

ChemoCentryx still has full rights to all of its other late-stage preclinical candidates, small molecules designed to treat inflammatory bowel disease, rheumatoid arthritis, cancer, viral disease and cardiovascular inflammation. Schall said the company plans this year to enter human studies with one of the candidates to treat gut disease, a program that has grown from inception to clinical development in just over three years.

"In this space - the chemokine receptors and leukocyte trafficking area - I think that we will continue to deliver on reducing the preclinical cycle time considerably," Schall said. "That is how we are leveraging our assets - our expertise assets, our technology assets and now our small-molecule drug candidates."

While the majority of ChemoCentryx's work is designed to create orally active small molecules, the company also is developing two immunostimulant biologics programs called ProDendryx. They have been funded, in part, by two awards from the Defense Advanced Research Projects Agency.

Collaborations could become key to further development of some of ChemoCentryx's other programs. The company expects to partner at some point with pharmaceutical companies, with discussions under way in some undisclosed programs, though Schall said ChemoCentryx plans to progress one or two programs independently as well.

"We believe that while partnerships are very important and part of our business strategy, we're not in the business of just coming up with early stage discovery and development and then partnering it all away," he said. "We want to stage these programs so that we have a diversified portfolio with some programs partnered, and others moving along independently."

Tularik, ChemoCentryx's sole partner to date, also gained an equity stake in the company after providing a measure of funding in its February 2001 Series B round of financing. ChemoCentryx reported as recently as a year ago $37 million in total funding.

Schall said the 60-person company continues to plan its growth based on the progress of its development programs.

"All of our focus now is continuing to push the discovery programs into clinical development," he said. "At the same time we understand the fundamental importance of keeping the drug discovery engine churning and continuing to fill the pipeline to create new opportunities. Clearly, the funding environment affects us all, but the market understands quality, and I think that the market understands that although valuation can be ephemeral, value creation is eternal. We've started discussions with a new round of investors, and we're getting very good feedback on our programs. They like to see how the investment to date has paid off, and how we've hit all our major goals and milestones."