Biomarker-based diagnostics. Andras Apjok, CEO. Budapest, 17 February 2015 Innovation is GREAT Britain
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1 Biomarker-based diagnostics Andras Apjok, CEO Budapest, 17 February 2015 Innovation is GREAT Britain
2 Introduction: MDR and disease focus MDQuest is a spin off company of SOLVO Biotechnology (Hungary) MDQUEST is majority owned by SOLVO (73.72%) and minority owned by Széchenyi Capital Fund Management Zrt (26.28%) MDR (Multi Drug Resistance) is a widely known phenomenon related to protein pump function. MDR occurence is about 40% in cancer. Top selling cholesterol lowering, antidepressant and antiulcer drugs (e.g.: Lipitor, Nexium, Crestor, Zyprexa) are victims of MDR transporters. Standard chemotherapy drugs like MTX are are victims of MDR transporters. MDR pump activity can be measured in white blood cells. Elevated activity can be correlated with prognosis, drug efficiency and disease activity. MDR activity measurement is a relevant biomarker. Initial disease focus: hematologic malignancies & autoimmun disorders.
3 Vision and Mission MDQUEST intends to be the leading biomarker based diagnostics company developing diagnostic applications based on MDR protein function detection. MDQUEST s mission is to enable better therapy decisions regarding significant diseases, thus resulting in better survival rates, better quality of life, as well as reduced healthcare and disability costs.
4 The product : SOLVO MDQ Kit The SOLVO MDQ Kit is the first commercially available IVD CE approved clinical test for the detection of MDR protein function (MDR1, MRP1, and BCRP) by quantitative flow cytometry. Ready to use reagents Kit for 10 independent MDR1 / MRP1 / BCRP measurements carried out in triplicates Functional assay Compatible with white blod cell surface markers Highly selective inhibitors Different probe substrate for MDR1/MRP1 and BCRP Results are expressed in harmonised MDR activity factor (MAF) values
5 Target#1: Acute Myeloid Leukemia AML is the 2nd most common type of leukemia diagnosed Incidence: about 38,000 new cases/yr in the USA+EU combined 24,000 patients treated/yr in the USA+EU combined 40 50% of patients belong to CN (Cytogenetically Normal) group 25% five year survival MDR protein function is an independent biomarker MDR+ is a negative prognostic factor In CN-AML, testing of MDR pump function in white blood cells helps the physician to find the optimal therapy at start, which improves the patient s survival chances.
6 Target#2: Rheumatoid Arthritis 8.1M+ treated patients in the USA+EU combined High hospitalization costs High additional cost of disability No real cure, low disease activity is an acceptable goal MDR protein activity is a relevant biomarker No good disease activity marker is available on the market Timely information about disease activity allows better targeted therapy In RA, testing of MDR pump function in WB cells helps to find the optimal therapy earlier, which improves the patient s Qol, reduces health care costs and additional costs of disability.
7 Market potential Market potential is above 1 billion EUR The market for the SOLVO MDQ Kit can reach EUR 100 million No apparent direct competition The flow cytometry reagent market is growing in the EU+EFTA&USA at 7 12% yearly.
8 IP&Protection Six patents Proprietary technology Know how Trademarks Internet domains
9 The Team Dr András APJOK, MHSM MSc, CEO Péter SZERÉMY, MSc, Scientist Szilvia BOROS, Lab Technician Andrea FEJÉR, MA, Executive Assistant Dr Attila BALOGH, PhD, Consultant, Rheumatologist Dr Gergely TOLDI, PhD, Consultant, Pediatrician
10 Business strategy Building the market and beat home brew assays Initial market: EU+EFTA, the Arabic countries B2C Direct sales via opinion leaders, conferences, sales calls B2B Sales arrangements vith distributors Outlicensing is possible to global vendors Expansion to the USA, Canada requires FDA permission
11 How did we get here? Development of the SOLVO MDQ Kit Laboratory validation Clinical laboratory performance evaluation CE IVD Registration Investor negotiations SZTA Reference population Clinical Performance Evaluation Trial Hematological malignancies (AML, CLL) Pilot in CML Pilot in autoimmune diseases Autoimmune diseases RA study
12 Capital raise plan EUR 750,000 formarket development (USA, Canada, Asia Pacific) EUR 1,500,000 for product development and clinical validation studies EUR 1,000,000 for high throughput assay technology development
13 Exit plan Sales in 2018 can reach EUR 40 million In 2018 company value is expected over EUR 50 million Trade sale to a large diagnostics company 2018 onwards
14 SOLVO MDQ Kit - A Clinical Test for MDR Protein Function MDR protein activity measurement by quantitative flow cytometry Contact: Közép fasor 52. Szeged, Hungary H-6726 info@mdquest.hu
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