BOULDER, Colo.--Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced the presentation of initial results of their proteomic analysis of GlobeImmune’s Phase 2 clinical trial in pancreas cancer at the European Society of Medical Oncology’s, 14th World Congress on Gastrointestinal Cancer in Barcelona, Spain on 27 June 2012. This marks the first presentation of data resulting from a corporate partnership to explore development of a new diagnostic test based on Biodesix’ technology. The analysis was presented by Donald A. Richards, M.D., Ph.D as part of the GlobeImmune study.
The Phase 2 Adjuvant Trial of GlobeImmune’s GI-4000 Plus Gemcitabine vs. Gemcitabine Alone in Ras Mutation+ Resected Pancreas Cancer, was designed to evaluate the impact of GI-4000 on patients’ recurrence-free survival. The companies collaborated to evaluate Biodesix’ ProTS® mass spectrometry-based technology platform in the identification of a proteomic signature that could identify patients who were more likely to have good outcomes following GI-4000 therapy. The collaboration was also a demonstration of ProTS’ ability to rapidly identify clinically meaningful signatures based on analysis of patient blood-derived samples.
The GlobeImmune study enrolled subjects with Ras mutant positive adenocarcinoma of the pancreas post resection randomized 1:1 to GI-4000 plus gemcitabine or placebo plus gemcitabine (stratified by R0 or R1 resection status). Results of this clinical study demonstrated a 2.6 month improvement in median overall survival in R1 subjects treated with GI-4000 in combination with gemcitabine (17.2 months) versus subjects treated with gemcitabine and placebo (14.6 months), a 16% advantage in 1 year survival (72% vs. 56%), and a 1 month advantage in median RFS (9.6 vs. 8.5 months).
Exploratory proteomic analysis using MALDI ToF mass-spectrometry and ProTS was performed by Biodesix on baseline plasma samples from patients in the study. This analysis revealed a proteomic signature that was associated with improved clinical outcomes in the GI-4000 treated group, but not in the placebo group. The exploratory proteomic signature was observed in approximately half of tested study subjects (16 of 44 in the GI-4000 group and 26 of 46 in the placebo group). The specific proportion of patients could change with further development of the diagnostic test. This signature could, if prospectively validated, have the potential for use as an enrichment marker in future clinical trials.
“We are delighted to work with GlobeImmune to develop a personalized approach to therapy for pancreatic cancer patients,” said Heinrich Röder, D. Phil., Biodesix’ Chief Technology Officer. “We are encouraged by these preliminary results and look forward to continuing the validation work for this program.”
David Apelian, M.D., Ph.D., Senior Vice President Research & Development and Chief Medical Officer of GlobeImmune added, “Biodesix’ approach revealed a potential avenue to select patients who are more likely to benefit from GI-4000 therapy, and we are pleased to continue this work with them.”
Biodesix is a fully integrated molecular diagnostics company advancing the development of products for personalized medicine. Biodesix developed, validated and commercialized VeriStrat®, a serum proteomic test currently available to help physicians guide therapy for patients with advanced non-small cell lung cancer. The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs) using a simple blood draw. Samples are processed in Biodesix’ CLIA –certified laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat is based on ProTS®, proprietary technology which harnesses the power of mass spectrometry and enables the discovery of specific molecular profiles that characterize a patient’s condition or likely outcome in response to therapy. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.