Download Oncology – companion diagnos`cs an other key market drivers

Oncology – companion diagnos0cs an other key market drivers Virtualisa0on of Drug Response Tes0ng for Personalised Medicine Applica0ons Session 3 European Business Development Conference Antwerp 23. to 24. November 2015 The Challenge: every pa+ent/tumour is different • 
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Different pa+ents respond to different cancer medica+ons Stra+fica+on a3empts have limited success Development of new drugs is s+ll inhibited by this Every second person will develop cancer -­‐ so we all need be3er treatment possibili+es www.alacris.de CANCER MEDICATION IS INEFFICIENT AND EXTREMELY EXPENSIVE Drug development cost of a cancer therapeu+c: 4.7 -­‐ 12 billion $ over 10 -­‐ 12 years Drug treatment cost
Extended median survival Ixempra: $ 4,200 / month Avas+n: $ 5,000 / month
Gleevec: $ 7,700 / month
Erbitux: $ 8,400 / month
Tasigna: $ 9,600 / month
Sprycel: $ 10,300 / month
Zaltrap: $ 11,000 / month
Yervoy: $ 39,000 / month 32 days 42 days years (life-­‐long treatment) 120 days 52 days not demonstrated 42 days 11 months www.alacris.de Stra+fica+on through biomarkers has limited success Zalcberg et al., NEJM 2008 Many colon cancer pa+ents with tumors with K-­‐ras wild type will respond posi+vely to treatment with EGFR receptor antagonists e.g. Cetuximab Pa+ents with tumors with K-­‐ras muta+ons do not: a 30.000 Euro treatment will show no effect on the tumor but will cause significant side effects on the pa+ent De Gramont et al., Nat Rev. Clinic. Oncol. 12, 2015 DEMAND FOR PERSONALISED MEDICINE AND DATA CHALLENGE NGS technics generate a wealth of data, however large amounts of data demand now efficient approaches for data interpreta0on and for op0mised therapy decision making 1 McKinsey & Company, Personalized Medicine, The Path Forward 2013 “Results unequivocally show that whenever we have sufficient informa6on to build a model it will perform be:er than most human experts” Daniel Kahneman -­‐ Nobel Price Winner in Economics 2002 www.alacris.de The Alacris Solu+on ModCellTM Virtual Patient Models
Virtual Clinical
Trials
Personalised
medicine
Biomarker
Discovery
Accelera+on and cost reduc+on of drug development Predic+on of op+mal therapy ID of treatment relevant biomarkers www.alacris.de The ModCellTM Plagorm INPUT Mechanistic drug data
Omics data (patient/tumour/cell lines/
tissues)
SIMULATION DATA ModCellTM platform
OUTPUT Molecular Readout
Drug Response Single /Combined APPLICATION & PRODUCTS •  in silico modelling plagorm •  Integrates and interprets (OMICS-­‐ and pathway) informa+on from +ssues, pa+ents, drugs and literature •  Predicts drug effects •  Iden+fies biomarkers •  Selects pa+ent responder (groups) •  Iden+fies op+mised therapies •  Guides clinicians, pa+ents and drug developers Existing cancer knowledge
Virtual Clinical
Trials
effec+ve trial & drug development cost savings by iden+fica+on of responder groups Functional Effects
on pathways
Virtual Patients
op+mised pa+ent Treatment n = 1 ModCellTM valida+on level • 
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Cell lines 3D cell models Xenograjs Clinical ModCellTM has a high (pre-­‐clinical) predic0ve accuracy rate (~75%) for a wide spectrum of different tumour types A prospec0ve clinical study started in September 2014 with 11 clinical partners www.alacris.de Applica0ons & Products www.alacris.de Alacris Products -­‐ I: “Virtual Pa+ent models” -­‐ confiden+al -­‐ Alacris Products -­‐ I: “Virtual Pa+ent models” Customer Product Customer Benefit Income Clinics, Oncology prac+ce Report to clinician specifying op+mized drug treatment: •  op+mized efficacy, •  poten+al drug resistance, •  side effect profile -­‐  Pa+ents: quickest route to effec+ve therapy, less side effects -­‐  Clinicians: op+mized treatment schedules -­‐ Payers: cost savings through more effec+ve treatment, op+mal drug selec+on -­‐ payment through private pa+ents (current) -­‐ reimbursement ajer cer+fica+on www.alacris.de Comparison to Different Analysis & Treatment Approaches increasing molecular complexity of tumour analysis and more personalised treatment Empirical Biomarker Tumor Panel every pa+ent is treated according to standard (pathological) disease classifica+ons biomarkers are sta+s+cally correlated to previous treatment outcomes pa+ents are stra+fied according to ac+onable variants every pa+ent is treated according to individual molecular changes in tumour & pa+ent trial and error treatment improved success rate but majority of pa+ents treated incorrectly further improved success rate but majority of pa+ents treated incorrectly individualised treatment of every pa+ent -­‐ confiden+al -­‐ ModCellTM transcriptome & genome & omics n = 1 www.alacris.de I n p u t Alacris Products -­‐ II: “Virtual Clinical Trials” Drug Data binding-­‐/dissocia+on-­‐ ModCellTM data, kD-­‐value, IC50 •  disease types •  biomarkers Responders Non-­‐Responders (Pa0ent Cohort / Groups of Cell Lines) O u t p u t Drug-­‐specific www.alacris.de Alacris Products: “Virtual Clinical Trials” Customers Products Customer Benefit Income Pharmaceu+cal, Biotech and CRO Industries, Investors (project financing), diagnos+cs companies -­‐ iden+fica+on of responder groups -­‐ relevant biomarkers for prognos+cs or companion diagnos+cs -­‐ drug response data on thousands of virtual pa+ents à virtual trialling -­‐ smaller and more efficient, targeted trials -­‐ product differen+a+on -­‐  drug development cost savings -­‐  project rescue -­‐  biomarker sale/licence fees -­‐  FTE remunera+on, technology access fees, milestone payments and success fees www.alacris.de Alacris -­‐ Company Background •  Spin-­‐off company of the Max Planck Ins+tute for Molecular Gene+cs, Berlin, ac+ve since September 2011. •  Currently 19 employees, next genera+on sequencing lab for clinical applica+ons, large IT infrastructure and extensive bioinforma+cs exper+se. •  Alacris works together with clinics and industry leaders in the fields of personalised medicine, biomarker applica+on, IT and drug development (Charité, Med. Univ. Graz, Qiagen, SAP, GSK, .....) and is part of highly qualified na+onal and interna+onal research networks (IMI, Horizon2020..). •  Alacris’ mission is to transform the fields of personalised medicine and targeted drug discovery and development, significantly improving success rates, via its predic+ve modelling plagorm -­‐ ModCellTM. •  Alacris was awarded the dis+nguished “Deutsche Innova+onspreis” (2015). www.alacris.de Summary ModCellTM • 
streamlining the drug development process, biomarker discovery and personalised medicine applica+ons • 
proof-­‐of-­‐principle data available for cell lines, 3D cell models, animal models and ini+al clinical data • 
high accuracy rate of ~75% for predic+ng drug response • 
more efficient drug development and early decision making in clinical trials through iden+fica+on of responder and non-­‐responder cohorts (retrospec+vely and prospec+vely) and significant reduc+ons in +me and costs. • 
iden+fica+on of efficient drug combina0ons with real addi+ve effects • 
drug reposi0oning, expanding the applicability of drugs to a larger number of pa+ents e.g. for different tumor types • 
Biomarker iden0fica0on for companion diagnos+cs www.alacris.de contact PD Dr. Bodo Lange -­‐ CEO Alacris Theranos+cs [email protected] www.alacris.de