One target for biomarker R&D is the development of a companion diagnostic for a personalized medicine, and Basiliea is taking this route with the discovery of a biomarker for its experimental cancer therapeutic, BAL27862, with data presented at this year's American Association for Cancer Research (AACR) annual meeting in Chicago.
BAL27862 is a small-molecule drug, given in a prodrug form (known as BAL101553), that destabilizes the formation of microtubules, which leads to cell death. These are structures that help maintain cell structure, and the drug is most effective in patients with a specific type of microtubule. In order to find a biomarker that might help pick these patients out, Basiliea and German Cancer Research Center researchers screened cells and found a gene coding for a protein called BubR1. In lab bench studies, cells with low levels of this protein were more likely to be resistant to treatment with BAL27862.
"The identification of BubR1 as a potential predictive biomarker, based on the demonstrated correlation between BubR1 expression and sensitivity of cancer cells to BAL101553, is a result of Basilea's strategy to ultimately optimize treatment of cancer patients by selecting as early as possible those most likely to benefit from this novel drug," said Dr. Laurenz Kellenberger, Basilea's chief scientific officer.
BAL101553 has moved into Phase I clinical trials in people with advanced solid tumors. The biomarker could help researchers stratify patients into groups who are more of less likely to respond, speeding the route of the drug through clinical trials to market and avoiding putting patients through treatment schedules (and potential side effects) from which they would receive no benefit. Both, though, are still in early-stage research and, as with all early-stage studies, there are no guarantees of success.
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