EU Consortium Established to Enable Biomarker-Driven Clinical Trials of Colon Cancer Drugs

Horizon Discovery and researchers at the University of Torino School of Medicine in Turin will share about $4.4 million in European Commission FP7 grant funding for their participation in the recently established Coltheres (Colon Cancer and Therapeutics) consortium. The four-year, €6.5 million Coltheres initiative was established to identify new drug resistance biomarkers and to design and carry out biomarker-driven clinical trials of targeted cancer drugs. Studies will be based on the use of molecularly defined colon cancers as a testing ground to define specific biomarkers of response or resistance to signaling pathway agents. The consortium will be open to any pharmaceutical developer looking to evaluate their drugs in proof-of-concept trials.

Horizon Discovery has been awarded $1.6 million in Coltheres funding to develop X-Man™ cell lines incorporating new predictive biomarkers of drug response to help provide insights into drug resistance mechanisms and identify the most beneficial drugs and drug combinations. The biomarkers will be identified through the consortium’s profiling of clinical trial patient cohorts. Horizon says it expects the program will lead to about 100 new genetically defined X-Man cell lines that can be used to support drug discovery research and development. The firm will retain ownership of the new cell lines.

$2.8 million in funding has been awarded to researchers at the University of Torino School of Medicine, led by Alberto Bardelli, Ph.D., who co-founded Horizon and is lead investigator for the Coltheres consortium. Professor Bardelli’s team will carry out patient tumor profiling of resistance biomarkers and screens to help identify rational drug combinations that reverse resistance.

“Personalized cancer medicine based on the genetic milieu of individual tumors has long been postulated,” he remarks. “Coltheres is designed to translate this concept into clinical practice using colorectal tumors as a paradigmatic model.”

The European Commission sets out a number of goals for the Coltheres intiiative. These include: the building and screening of predictive in vitro models based on this data to enable the rapid and empirical determination of drug resistance biomarkers; the use of these models and of the clinical studies to prospectively screen for genes mediating resistance and sensitivity to targeted therapies in CRCs; the building of new algorithms to significantly accelerate the design of rational therapies by integrating more predictive models, assays, and biomarkers into all phases of drug discovery; including novel Phase 0 (xenopatients) studies; the design of innovative and focused biomarker-driven Phase II trials based on knowledge gathered within the project. 

Other participants in the consortium include Dutch firm Agendia and academic researchers in Spain, Switzerland, Belgium, the Netherlands, and the U.K.