Firalis Group. Legueux François, Project Leader. October 7th, 2016, Paris

Transcription

1 Firalis Group H2020 Success story SME RABIOPRED project A companion diagnostic for predicting the efficacy of anti TNFα biologics in patients of Rheumatoid Arthritis (RA) Legueux François, Project Leader October 7th, 2016, Paris 1

2 Presentation highlights 1 The SME Overview History Activities 2 The Story RABIOPRED project: A companion diagnostic for predicting the efficacy of anti TNFα biologics in patients of Rheumatoid Arthritis (RA) 3 The success Press Release HTG Les Echos 2

3 Group overview Created in 2008 Domain: Biomarkers based In Vitro Diagnostic (IVD) tools for Precision Medicine Fully integrated business model: >1600sqm of Shared platform for Service, R&D and Industrial activities Proprietary products for 3 high impact pathologies Heart Failure Alzheimer s Disease Rheumatoid Arthritis Four acquisitions since the inception About 70 people located in Paris, Strasbourg and Huningue 3

4 History

5 Organizational Structure 5

6 R&D and Service activities PRECISION MEDICINE MARKET R&D Coordination or contribution in numerous biomarker initiatives Innovative Medicines Initiative: SAFE T, BT Cure, PharmaCog Eurostars, ETB projects FP7: MitoCare, Imagint, Brainvector, Fibrotarget, Cardiosave, consortia Horizon2020, ADDIA, RABIOPRED, HeartPRIME.. Neurodegenerative Alzheimer s Disease CardioVascular Heart Failure DIVI Inflammatory Rheumatoid Arthritis In Vitro Diagnostic Products Services Biomarker Discovery Assay development & validation Bioanalytical testing, Biobanking Data management Multivariate data analysis Feeding with new candidate biomarkers Lipidomics, Metabonomics, Proteins & mabs arrays HTG, NGS platforms CE marking Manufacturing ISO13485 ISO17015 facilities for assay validation NFS Biobank Development of next generation Immunoassays : Multispec artificial mabs, Recombinant proteints, Multi analytes assays Connected POC devices Immediate revenues SHARED PLATFORM 6

7 Biomarker development flow chart The qualification of biomarkers requires close cross talks in numerous fields of expertise Firalis created a network of clinical centers of excellence, biobanks, biomarker laboratories, and statistic and data mining groups to accelerate the translation of biomarker candidates towards qualification in key contexts of use 7

8 Focus on three candidate diagnostic products Heart Failure post AMI About 1/3 of Acute Myocardial Infarction patients develop Heart Failure 50 70% patients with HF experience severe complications and death within 5 years No test available to predict HF development after AMI Urgent need for tool to stratify AMI patients before HF CardioSAVE test Alzheimer No cure for Alzheimer Disease But treatment available for symptoms and to slow down the progression Drugs only effective if prescribed in the early stages of the disease Diagnostics method currently long, painful and not reliable Urgent need to improve diagnostics method for AD ADDIA test Rheumatoid Arthritis RA is a chronic inflammatory condition causing severe pain and joint deformation Current treatments not effective for 30 40% of the patients treated No test to predict beforehand which patients are going to respond Urgent need for tool to stratify RA patients before treatment and in clinical trials RABIOPRED test 8

9 The Story: Rabiopred Project A companion diagnostic for predicting the efficacy of anti TNFα biologics in patients of Rheumatoid Arthritis (RA) Funded by Horizon2020 SME Instrument (European Commission) Tcland Expression Coordinator of the program European Centers of Excellence of Rheumatology on board Consortium: Strasbourg University Hospital, Strasbourg, France Institute of Rheomatology, Prague, Czech Republic Leiden University Medical Center, Netherlands IRMB Institute for Regenerative Medicine and Biotherapy Montpellier, France Tel Aviv Sourasky Medical Center, Israel Department of Rheumatology, Istanbul University Department of Rheumatology, Marmara University, Turkey RABIOPRED: Proprietary mrna signature for prediction of efficacy of anti TNFα biologicals. It is developed by Tcland Expression S.A, an affiliate of Firalis dedicated to companion diagnostics. Strong IP status: Four patents owned by discovery or in licensing for RA theranostic 9

10 Rheumatoid Arthritis and its socio economic impact Prevalence of selected autoimmune diseases Millions of RA patients are currently treated with anti TNFα biologics, one of the 2 nd line RA treatments The global pharmaceutical market of biologics in RA is currently estimated at $15.5 billion, of which ~73% is held by anti TNFα agents including Remicade, Humira and Enbrel* The projected market size for these biologics is to grow to >$21 billion by 2022** These biologics are not effective in 30 40% of patients. Identification of non responders will avoid several months of unnecessary treatment and very significant health care costs. *Decision Resources 2013 **PharmaPoint, Feb

11 Current therapeutic strategy of RA management & need for a companion diagnostic 1 st line treatment of RA is classical DMARDs 1 st line RA treatment On Classical DMARDs Patients Respond Maintain treatment 2 nd line treatment is biologics mainly anti TNFα among others 1 st line RA treatment On Classical DMARDs In 30 40% patients, suboptimal response or intolerance 2 nd line RA treatment Switch to Biologics (anti TNF) 30 40% of these patients do not respond to anti TNFα biologics impacting higher treatment costs. Unmet need for a precision medicine tool to predict treatment response such as RABIOPRED 11

12 RABIOPRED a theranostic tool for Rheumatoid Arthritis RABIOPRED test will stratify Rheumatoid Arthritis patients, eligible for an anti TNF biologics, to responders and non responders. Anti TNFα therapy RABIOPRED Test Negative (Responders) Test Positive (Non responders) Alternative therapy (other than anti TNFα) 12

13 Technology of RABIOPRED assay HTG EdgeSeq platform The technology is a combination of nuclease protection assay (qnpa) and next generation sequencing for targeted sequencing to provide accurate and sensitive measurement of the expression of more than 2000 genes simultaneously. Property of Tcland Expression 13

14 RABIOPRED Current Development Stage Development & analytical validation Assay Design Completed Analytical validation initiated Assay Development Completed CE Marked RABIOPRED 3Q Q q 1Q Tcland proprietary/ exclusive license RA panels RA genes from literature and IP databases with good predictive value RA genes from KOLs Today RABIOPRED RABIOPRED RA genes from other specialized knowledge bases which predict treatment efficacy of anti TNF alpha biologicals Highly relevant RA related mrna targets Property of Tcland Expression 14

15 RABIOPRED Clinical Performance Validation Study arms, number of patients, objectives Infliximab (Remicade ) 90 patients Adalimumab (Humira ) 90 patients RABIOPRED Etanercept (Enbrel ) Golimumab (Simponi ) Certolizumab Pegol (Cimzia ) Remsima / Inflectra Benepali 90 patients 90 patients 90 patients 90 patients 90 patients Total patients recruited: 720 Anti TNFα biologic treatment RABIOPRED RABIOPRED Qualified IVD tool to predict treatment response of all anti TNFα biologics in RA patients Flixabi 90 patients Inclusion Initiation of the Biologic anti TNFα Blood sampling, Data collection First assessment 12 to 14 weeks Blood sampling, Data Collection EULAR response criteria ACR response criteria Second assessment 22 to 24 weeks / treatment switch Blood sampling, Data Collection EULAR/ACR remission criteria Property of Tcland Expression 15

16 RABIOPRED Clinical Performance Validation Timeline RABIOPRED A theranostic tool for predicting responders & non responders to anti TNFα therapy in patients of Rheumatoid Arthritis Property of Tcland Expression 16

17 The Success Joint press release withhtg Bringing national and international Echo 17 17

18 Acknowledgements Firalis Team Institutional support Investors NEPTISSIMO FINANCIERE DE L INTENDANCE 18

19 Thank you! 19