Tiziana Life Sciences has announced that it has entered into an exclusive license agreement with TTFactor S.r.l. ("the Licensor", acting on behalf of the FIRC (the Italian Foundation for Cancer Research) Institute for Molecular Oncology (IFOM), and the European Institute of Oncology (IEO)), covering the use of twenty defined stem cell markers (the "TOP 20") for patient stratification in breast cancer.
The TOP 20 model is a gene expression signature capable of predicting disease aggressiveness and prognosis in breast cancer patients. It is different from all other signatures available today because it is derived from cancer stem cells and therefore it predicts cancer behaviour based on its stem cell content.
The TOP 20 genes have been defined based on published expression profiles of breast stem cells, and further selected based on their levels of expression and likelihood of reduction into practice for patient stratification in breast cancer.
The inventor of the TOP 20 model, Professor Pier Paolo Di Fiore, a physician and specialist in molecular oncology and cell biology, is a consultant to Tiziana and a member of Tiziana's Scientific Advisory Board.
Under the terms of the licensing agreement, Tiziana will pay the Licensor €600,000 over 4 years to fund research to create or enhance technologies to assist in the development and commercialization of products and services derived from the TOP 20 genes.
In return for an exclusive license to patents on the TOP20 genes, Tiziana will pay the Licensor inter alia a royalty rate of 1.5% based on commercial sales of any products developed under the license agreement.
Gabriele Cerrone, Executive Chairman of Tiziana, said: "We are very excited to be developing a diagnostic test with IEO, one of Europe's leading breast cancer institutes. This agreement gives us access to cutting edge stem cell technology as the TOP 20 model is synergistic with our existing therapeutic focus and enables us to enhance our franchise in breast cancer treatment.
"Stem cells are the "engine" of cancer and, therefore, laboratory tests based on stem cells are more likely to be helpful in patients' management both from the diagnostic and therapeutic viewpoint. Stratification of patients according to their clinical prognosis is an important goal in cancer research as it allows oncologists to better personalize patient treatment."
Professor Pier Paolo Di Fiore said: "I believe that Tiziana's elite and world-renowned oncology researchers provide the perfect platform to commercialize the TOP 20 model. I look forward to working closely with Dr Napoleone Ferrara, Dr Riccardo Dalla-Favera and the rest of the Tiziana team to offer this new diagnostic test for breast cancer patients."