BioWorld International Correspondent

MUNICH, Germany - Wilex AG began a licensing and research collaboration with San Raffaele Biomedical Science Park in Milan, Italy, to examine the therapeutic and diagnostic use of the cleaved uPA receptor of the urokinate-type plasminogen activator (uPA) system.

This receptor plays a role in cell migration and in the metastasis of several types of solid tumors. Wilex believes that it offers a new target for a range of cancers.

Under the terms of the agreement, Wilex, of Munich, receives exclusive, worldwide rights to the intellectual property covering the cleaved uPA receptor in the fields of tumors and inflammatory diseases. Within the next two years, Wilex and San Raffaele plan to develop antibodies against the receptor that are to be evaluated in cell and animal models. Furthermore, the receptor will be tested to predict patients' response to Wilex's current lead product in its ongoing Phase Ib/IIa trial.

"This partnership expands our intellectual property and broadens our basis for the uPA system in general," Olaf Wilhelm, CEO of Wilex, told BioWorld International. "Plus, we wanted to work with Francesco Blasi," a professor at the Universit Vita-Salut San Raffaele. "He is one of the top people in the field," Wilhelm said.

"Our goal," Wilhelm said, "is to develop antibodies and select one that we can take into preclinical testing. The research plan has clear milestones and well-defined go/no-go' inflection points." The agreement calls for the collaboration to last a minimum of two years, with options to extend it if criteria are met.

Wilhelm added, "There is nice intellectual property around the agreement as well. The business payoff is that it broadens our pipeline and improves our position in the uPA field in general."

The uPA program is one major component of Wilex's research pipeline. The company was founded in September 1997, but the involvement of its leaders with uPA dates back to the mid-1980s. They were looking for ways to identify the approximately 30 percent of cancer patients who have relapses after treatment. Research with both tumor cells and long-term surveys found that if the uPA system is overexpressed in cancer patients, they had a high chance of relapse. Indeed, Wilhelm said that uPA overexpression was the highest prognostic marker of all they examined.

Wilex's strategic choice to explore the uPA system is part of what Wilhelm characterized as a paradigm shift in cancer treatment: addressing many cancers as systemic diseases, and changing treatments from "seek-and-destroy" approaches to controlling its spread and thus increasing the clinical benefit to patients.

Wilhelm and co-founders Manfred Schmitt and Viktor Magdolen, both of the Technical University of Munich, are positioning the company between late lead optimization and full clinical development, all the way to registration. Basic research is done through academic and other alliances, such as the one with San Raffaele. The company currently has four compounds in clinical testing, and three more in development.

Wilhelm is not overly worried about the difficult market conditions facing biotechnology companies in Germany. "We raised money at the end of 2000, because it was a good time to do so," he said. "We have high flexibility and a low burn rate. We have done five R&D projects on €18 million. Moreover, we are generating cash through partnering."