Marked for survival
MONTPELLIER, France—In the category of "good things come in small packages," genomic and pharmacogenomic company Skuldtech and fellow French company AB Science, a Paris-based pharma specializing in the development of tyrosine kinase inhibitors, say that from a simple drop of blood, they were able to identify biomarkers that are predictive of pancreatic cancer survival associated with masitinib treatment.
The recently announced discovery comes out of a Phase III clinical trial focusing on pancreatic cancer treated with masitinib that was managed by AB Science. The purpose of the trial was to "evaluate the therapeutic efficiency of a new treatment combining masitinib and gemcitabine as compared with the current standard pancreatic cancer treatment of gemcitabine only," according to the two companies, but based on Skuldtech's technology for associating gene sequencing with the company's proprietary bioinformatics tools and gene profiling studies, they came up with something more. They were able to identify specific transcriptome markers that reportedly can distinguish between the different populations treated during the Phase III study and select the predictive markers for higher pancreatic cancer survival associated with masitinib treatment.
"AB Science has been the sponsor of the clinical trials and managed the Marketing Authorization Application filing. Skuldtech has been in charge of the biomarker identification on the basis of the blood samples collected during the masitinib Phase clinical trials III," Skuldtech CEO Didier Ritter tells ddn. "AB Science and Skuldtech worked closely together to give clinical sense to the biomarkers data generated by Skuldtech to meet regulatory authorities requirements for filing. Skuldtech has managed the entire wet lab analysis for biomarkers identification. Skuldtech identified the biomarkers and validated the selected genes. AB Science and Skuldtech worked closely together in order to select the last set of genes matching the masitinib Phase III clinical results."
This is the first time that Skuldtech and AB Science have worked together, Ritter notes, but after this biomarker discovery, they have decided "to collaborate on other masitinib applications."
These newly discovered biological markers "will pave the way for market authorization of a companion diagnostic test associated with this drug," the companies say. The predictive markers for survival associated with masitinib treatment and identified in this Phase III clinical trial are the joint property of AB Science and Skuldtech, and the companies have filed patents have been filed to protect the markers, which are also associated with the masitinib Marketing Authorization Application already filed with regulatory authorities by AB Science.
If and when masitinib obtains market authorization for treating pancreatic cancer, however, AB Science will retain all of the rights related to masitinib itself.
"To the best of our knowledge, this is the first time that new biological markers have been discovered during a Phase III clinical trial," Ritter noted in the news release about the discovery. "These markers are both specific to the drug being developed and associated with positive patient response. Faced with the 'patent cliff' and a challenging economic context, the pharmaceutical industry is seeking new solutions for achieving successful Phase III clinical trials, and also new vectors for growth. The concept of personalized medicine or personalization of treatments therefore represents a source of hope both for patients and the medical industry."
Pancreatic cancer is an aggressive cancer with poor prognosis—the survival rate after five years is only 5 percent—and the cancer comes in at about 110,000 new cases per year in industrialized countries. Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells as well as a limited number of kinases that play key roles in various cancers. Because it inhibits certain kinases that are essential in some oncogenic processes, it is hoped that masitinib will have an effect on tumor regression, alone or in combination with chemotherapy. Masitinib received orphan drug designation in the treatment of pancreatic cancer from both the U.S. Food and Drug Administration and the European Medicines Agency.