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H2020 ‐ Success story SMERABIOPRED project
A companion diagnostic for predicting the efficacy of anti‐TNFαbiologics in patients of Rheumatoid Arthritis (RA)
Legueux François, Project LeaderOctober 7th, 2016, Paris
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Firalis Group
1‐ The SMEOverviewHistoryActivities
2‐ The StoryRABIOPRED project:A companion diagnostic for predicting the efficacy of anti‐TNFα biologics in patients of Rheumatoid Arthritis (RA)
3‐ The successPress Release HTGLes Echos
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Presentation highlightsPresentation highlights
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Created in 2008Domain: Biomarkers‐based In Vitro Diagnostic (IVD) tools for “Precision Medicine”Fully integrated business model:
>1600sqm of Shared platform for Service, R&D and Industrial activitiesProprietary products for 3 high impact pathologies
• Heart Failure• Alzheimer’s Disease• Rheumatoid Arthritis
Four acquisitions sincethe inceptionAbout 70 people located inParis, Strasbourg and Huningue
Group overviewGroup overview
HistoryHistory
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Organizational StructureOrganizational Structure
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PRECISION MEDICINE MARKET
CardioVascular Heart Failure‐DIVI
Inflammatory Rheumatoid Arthritis
NeurodegenerativeAlzheimer’s Disease
• 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 ..
R&D
In VitroDiagnostic
Prod
ucts
Services
• Biomarker Discovery
• Assay development & validation• Bioanalytical testing, • Biobanking• Data management • Multivariate data analysis
Feeding with new candidate biomarkersLipidomics, Metabonomics, Proteins & mAbs‐arraysHTG, NGS platforms
CE marking‐ManufacturingISO13485‐ISO17015‐facilities for assay validationNFS96 900 Biobank
Development of next generation Immunoassays : Multispec artificial mAbs,Recombinant proteints, Multi‐analytes assaysConnected POC devices
Immed
iate
revenu
es
SHARED PLATFORM
R&D and Service activitiesR&D and Service activities
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Biomarker development flow chartBiomarker 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
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• 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 AMIH
eart Failure
post AMI Urgent need for
tool to stratify AMI patients before HF
CardioSAVE test
• 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 respondRh
eumatoid
Arthritis
Urgent need for tool to stratify RA patients before treatment and in clinical trials
RABIOPRED 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
Focus on three candidate diagnostic productsFocus on three candidate diagnostic products
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The Story: Rabiopred ProjectThe Story: Rabiopred ProjectA companion diagnostic for predicting the efficacy of anti‐TNFα biologics in patients of Rheumatoid Arthritis (RA)
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
Funded by Horizon2020 SME Instrument (European Commission) Tcland Expression – Coordinator of the program European Centers of Excellence of Rheumatology on board
Tel Aviv Sourasky Medical Center,Israel
IRMB Institute for RegenerativeMedicine and BiotherapyMontpellier, France
Department of Rheumatology,Istanbul University
Department of Rheumatology,Marmara University, Turkey
Strasbourg University Hospital,Strasbourg, France
Institute of Rheomatology,Prague, Czech Republic
Leiden University Medical Center, Netherlands
Consortium:
Rheumatoid Arthritis and its socio‐economic impact
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 2013
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Millions of RA patients are currently treated with anti‐TNFα biologics, one of the 2nd 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, Humiraand Enbrel*
The projected market size for these biologics is to grow to >$21 billion by 2022**
Prevalence of selected autoimmune diseases
• 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
Current therapeutic strategy of RA management & need for a companion diagnostic
PatientsRespond Maintain treatment
In 30‐40% patients,suboptimalresponseor intolerance
Switch toBiologics(anti‐TNF)
2nd line RA treatment
• 1st line treatment of RA is classical DMARDs
• 2nd line treatment is biologics mainly anti‐TNFα among others
On ClassicalDMARDs
1st line RA treatment
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On ClassicalDMARDs
1st line RA treatment
RABIOPRED ‐ a theranostic tool for Rheumatoid Arthritis
Test Negative(Responders)
Test Positive(Non responders)
Anti‐TNFα therapy
Alternative therapy(other than anti‐TNFα)
RABIOPRED
RABIOPRED test will stratify Rheumatoid Arthritis patients, eligible for an anti‐TNF biologics, to responders and non‐responders.
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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.
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Property of Tcland Expression
RABIOPRED Current Development StageDevelopment & analytical validation
3Q 2016 4Q 2016 1q 2017
Analytical validation initiatedAssay Design Completed
Assay Development Completed
CE Marked RABIOPRED
RABIOPRED
Tcland proprietary/ exclusive license RA panels
Tcland proprietary/ exclusive license RA panels
RA genes from KOLsRA genes from KOLs
RA genes from literature and IP databases with good predictive
value
RA genes from literature and IP databases with good predictive
value
RA genes from other specialized knowledge‐bases which predict treatment
efficacy of anti‐TNF alpha biologicals
Highly relevant RA related mRNA targets
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RABIOPRED
1Q 2017
Property of Tcland Expression
Today
RABIOPRED Clinical Performance Validation Study arms, number of patients, objectives
First assessment
12 to 14‐weeks
First assessment
12 to 14‐weeks
Inclusion
Initiation of the Biologic anti‐TNFα
Inclusion
Initiation of the Biologic anti‐TNFα
Second assessment
22 to 24‐weeks / treatment switch
Second assessment
22 to 24‐weeks / treatment switch
RABIOPRED ‐ Qualified IVD tool to predict treatment response of all anti‐TNFα biologics in RA patients
Infliximab (Remicade®) 90 patients
Adalimumab (Humira®)
Etanercept (Enbrel®)
Golimumab (Simponi®)
Certolizumab Pegol(Cimzia®)
Remsima®/ Inflectra®
Benepali®
Total patients recruited: 720Total patients recruited: 720
Flixabi®
RABIOPRED
90 patients
90 patients
90 patients
90 patients
90 patients
90 patients
90 patients
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Property of Tcland Expression
Anti‐TNFα biologic treatmentAnti‐TNFα biologic treatment RABIOPRED
Blood sampling, Data collection Blood sampling, Data Collection• EULAR response criteria
• ACR response criteria
Blood sampling, Data Collection
• EULAR/ACR remission criteria
RABIOPRED Clinical Performance ValidationTimeline
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Property of Tcland Expression
RABIOPRED• A theranostic tool for predicting responders & non‐responders to anti‐TNFα therapy in patients of Rheumatoid Arthritis
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The SuccessThe Success
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Joint press release with HTGBringing national and international Echo
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AcknowledgementsAcknowledgements
Institutional support
Firalis Team
Investors
NEPTISSIMO
FINANCIERE DE L’INTENDANCE
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Thank you!Thank you!