Patient Stratification and Precision Medicine in Pancreatic Cancer

Transcription

1 Patient Stratification and Precision Medicine in Pancreatic Cancer 12èmes Journées November the 24th 2016 Piquemal David

2 Core Business: RNA diagnostics A state of art platform & a 17-year expertise in Genomics and Bioinformatics & Biostatistics: Discovery Services Clinical Assays: A portfolio of Companion Diagnostics in clinical development dedicated to Personalized Medicine RNA-based diagnostics have the potential to significantly improve patient stratification, which is at the heart of precision medicine Unique RNA technology paired with big data analytics Page 2

3 Core Business: Blood diagnostics A blood test as Companion Diagnostic CDx to stratify patients in cancer Drug Toxic Patients diagnosed with Cancer Drug not toxic but not beneficial to patient Drug not toxic and beneficial Page 3

4 Pancreatic Cancer Case Study Page 4

5 Pancreatic cancer Epidemiology The 4th and 5th most common cancer in men and women, respectively. It accounts for more than 110,000 new cases and 95,000 cancer-related deaths each year. About 90% of pancreatic tumors are adenocarcinomas. Diagnosis The diagnosis and staging of pancreatic cancer are accomplished through imaging tests and pathologic diagnosis. Page 5

6 Pancreatic cancer: Diagnosis The tumor Difficult to access Cells heterogeneity Page 6

7 Pancreatic cancer: Liquid Biopsy A molecular biomarkers blood-based strategy meeting the final expected diagnosis/prognosis test A non-invasive test The sampling (collection, stabilization, and transport) is standardized (PAXgene Blood RNA system, FDA 510(k) Application - K082150) Page 7

8 Pancreatic cancer: Clinical Trial Study based: A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer Group 1 Control Gemcitabine 1000mg/m² Group 2 Treated Gemcitabine 1000mg/m² Masitinib (9 mg/kg/day) Retrospective clinical evaluation using 120 patients of differing ages (40 to 79 years old), sex & ethnic origins (France, USA, Eastern Europe) ClinicalTrials.gov: NCT Page 8

9 Workflow of the OMICS-Based Development Process Discovery and Validation step Page 9

10 Pancreatic cancer: Biomarkers selection The RNAseq approach: Targeted Sequence: Long RNA, Coding and non-coding RNA MARS: Friday 25th by Fabien Pierrat Targeted Processes : Expression Splicing SNPs, InDels in exon sequences Page 10

11 Pancreatic cancer: Biomarkers validation GemciTest is a quantitative real-time PCR assay, developed to identify pancreatic cancer patients having a higher potential survival rate of the gemcitabine-based treatments Under review with FDA qpcr 96-well plate Page 11

12 Pancreatic cancer: GemciTest Page 12

13 Pancreatic cancer: GemciTest Drug Toxicity Price Page 13

14 Pancreatic cancer: GemciTest Page 14

15 Pancreatic cancer: GemciTest 65% GemciTest + gemcitabine 12% Page 15

16 The RNA Team Laurent Manchon Fabien Pierrat Roman Bruno Pascal Laurent Bernadette Trentin Florian Noguier Marine Morent Partner: AB SCIENCE, Bull, CNRS / Paris V UMR8147, ENS Cachan UMR8113 et INSERM U891 Page 16

17 ACOBIOM Tel: +33 (0) Web: Developing a win-win collaboration On new therapeutics associated with Companion Dx / Pharmacogenomics studies On innovative diagnostics/biomarkers in unmet medical fields of applications Page 17