WILEX was founded in September 1997 by a team of clinical oncologists from the Technical University of Munich led by Professor Olaf Wilhelm. The founders had many years of experience in basis and clinical research on the uPA system and its role in tumour growth and tumour metastasis. This group was joined in 1999 by Professor Sven Warnaar of University of Leiden, Netherlands, who served until his retirement in 2003 as WILEX’s Chief Scientific Officer. In the early 1990s, Professor Warnaar and his team had discovered the G250 antibody (today: RENCAREX®*) and the G250 (MN/CA IX) antigen as the therapeutic target of RENCAREX®.

The company started operations in July 1998 after raising EUR 3 million in a financing round with a fund advised by Apax Partners as lead investor. To-date WILEX has raised EUR 68 million in four private financing rounds from various institutional and private investors including Apax, Earlybird, Merlin, TVM, Karolinksa Investment Fund and silent partners.

The funds were used to advance the clinical anti-cancer product portfolio of the company and to build up pre-clinical research projects including academic collaborations. In particular, the clinical Phase I and Phase II study program with the antibody RENCAREX® in renal cell cancer (RCC) were successfully completed and a Phase III study, which is currently ongoing, initiated. A new antibody based diagnostic imaging agent REDECTANE®* has been developed. It demonstrates 100 % positive predictive accuracy in feasibility study. In the uPA inhibitor program, the two drug candidates WX-UK1 and MESUPRON®* were brought from research into clinical development in cancer patients. Efficient and sustainable corporate infrastructures were built up as well as an internationally experienced management team with broad expertise from the international pharmaceuticals and biotech industry in cancer drug research and development, regulatory affairs and corporate finance.

In September 2003, WILEX was awarded the first “Biotechnology Clinical Partnership Award” from the U.S. Department of Defense (DoD) Breast Cancer Research Program in support of the clinical development of WX-UK1 in patients with breast cancer. The grant in the amount of USD 5 million will contribute to fund the clinical trials of WX-UK1 in the United States being conducted in collaboration with the Fox Chase Cancer Center. In May 2004, WILEX received an Investigational New Drug (IND) approval from the U.S. regulatory authority FDA to conduct a pivotal Phase III trial with RENCAREX® in patients with non-metastatic RCC. The study is currently recruiting patients. In April 2004 a first co-development and marketing agreement on RENCAREX® was signed with the Spanish pharmaceutical company Laboratorios del Dr. Esteve S.A. (Esteve), Barcelona, for certain countries in Southern Europe.

* temporary name while under development