Products in Development

Onyvax's lead products are being developed for the treatment of prostate and colorectal cancers, two of the most common cancers today. Onyvax believes its therapies will be able to prolong life for cancer patients while helping to maintain a high quality of life.

Product Cancer Type Status Cell Vaccines     Onyvax-P Prostate Phase II Onyvax-O Ovarian Preclinical Onyvax-L Lung Preclinical Onyvax-M Myeloma Preclinical Onyvax-R Renal Preclinical       Other     Onyvax-105 (monoclonal antibody) Multiple Phase I

Onyvax-P is a Cell Vaccine being developed for prostate cancer treatment. It is being evaluated in a randomised Phase IIb study in patients who have failed hormone therapy but who do not have radiologically detectable disease. This study follows the successful completion of a Phase IIa trial in which almost half of the patients showed significant decreases in their PSA velocity. In addition, the time to disease progression was lengthened relative to that normally expected in a population at this stage of the disease (Clinical Cancer Res (2005) 11:4469-4478).

Onyvax-P consists of a combination of three inactivated cell lines that are representative of different stages of the disease.

Onyvax-O (ovarian). Onyvax has entered into a collaborative license agreement with the Mayo Clinic granting Onyvax exclusive worldwide rights to develop and commercialise a cancer vaccine for ovarian cancer. The ovarian carcinoma cell lines were developed by the Mayo Clinic for use as human therapeutics.

Onyvax-105 is a monoclonal antibody that mimics the molecule CD55, which is over-expressed in many common cancers. CD55 is interesting not only as a cancer marker, but because it appears to be produced by cancer cells in order to protect them from immune attack. By vaccinating patients with Onyvax-105, tumors that express CD55 become targets for a powerful immune response. Two Phase I clinical studies are copmplete in colorectal cancer and pediatric osteosarcoma respectively (Br J Cancer (2005) 92:1358-65). Results will be used to further develop a second-generation antibody to enter preclinical trials.

Antigen discovery: The combination of novel cell lines and data from Onyvax clinical trials provides a unique platform for identifying clinical relevant tumor antigens. This program is being pursued in collaboration with academic centers of excellence