EARLY DI DIAGNOSIS IS OF BRAIN DI DISEASES via liquid id biopsy psy, based sed on miRNA NA patterns erns in micr crogl glial ial micr crove vesi sicle cles
BrainDTech Team Dr. Fabio Bianco, PhD – Chief Executive Officer Dr. Pietro Conti, MD - Chief Financial Officer • Degree in Medicine & MBA • PhD in Pharmacology, Degree in Biotech • Director @several Health International • Founder of NeuroZone (President and CSO) Projects in UN agencies (UNDP, WHO, UNICEF) • CEO of BrainDTech • Founder and CEO of several startups • Director of Sanipedia Business Nursery • >10 yr in Biotech/Pharma with executive roles Dr. Ennio Ongini, PhD – Chief Scientific Officer Dr. Noemi Tonna, PhD – Lab Manager • PhD in Pharmacology • PhD in Pharmacology • Degree in Medical Biotechnology • 20 yrs Research Director Schering Plough • Lab Manager in NeuroZone • 15 yrs VP Research Nicox SA • >10 yr expertise in cell culturing/ in vitro drug • Member different evaluation Commitees discovery • >200 peer reviewed papers, H-index 38 Dr. Laura Iris Ferro, MD, MBA – Board Member Dr. Elisabetta Borello, PhD – Board Member • Degree in Medicine & Psychiatry, • • MBA @ Bocconi Univ., Milano Degree in Economics @ Bocconi Univ., Milano • • Top 10 most innovative women managers in Italy >30 years expertise in Healthcare Information • Founder and CEO of several biotechs , including Management Systems • Gentium, IPO at Nasdaq Founder & Board member of many biotechs • Board member in several companies (Sorin, Newronika , …)
The issue (need) Currently, diagnosis of brain diseases is carried out observi erving ng clini nical al sympt mptoms oms, which occur when most of the neurodegeneration has already ady occur ured ed 10 – 15 years Brain n INFLAM AMMA MATION TION Brain n DEGENER NERATI ATION CLINICAL AL SYMP MPTOM TOMS
BrainDTech proposal BrainDTe DTech ch represents a disrup upti tive ve approach ch to brain disease diagnosis because it detecs a signal (MicroRNA roRNA in micro rovesi vesicl cles es) released by microglia years s before ore any clinica ical manifestation festation. Brain n INFLAM AMMA MATION TION MICROVESI OVESICLES LES FROM OM MICROGL OGLIA Neuroinflammation activates MICROG ROGLI LIA Activated microglia produce MICROVES ROVESICLES CLES Microvesicles contain microR oRNA Microvesicles can be found in in LIQU QUID BIOPSY OPSY
BrainDTech added value Clinical data show that there are MICROVES ESICLE LES S more re Microv rovesic icles les in the e Cerebr rebros ospin pinal al Fluid id can be isolat ated ed of f Alzheimer’s Disea ease patien atients from liquid biops psies es with respect to pre-Alzheimer, or Mild Cognitive Impaired patients (Agosta et al ann Neurol 2014) We have observed that in different in vitro models, miRNAs miRNA A from om micro roglia glial micro rovesic icles les can be analyzed ed are e differ erent ntly ly up (gre reen) en) or down n (oran range ge) ) regu gulat lated ed, , in MICROVES ESIC ICLES LES creating pathology-specific patterns. We have observed that in each pattern there are miRNA patter erns ns spec pecif ific ic miRNA whic ich are e exclus lusiv ively ly up or down n are SPEC ECIFI IFIC regu gulat lated ed in a pathological model, thus creating for each PATH THOLO LOGY pathology specific patterns, which we have patented.
BrainDTech IP position We have submitted the following patent: "Methods for diagn agnos osis is, , prog ognosis nosis and nd treat reatment nt monit itoring ring of neur urolog ologic ical, neur urod odeg egene enera rativ ive e and d infla lammat ation ion – based disea eases via miRNA contained in micro roglia glial microv oves esic icle les" 2015/ 5/11 11 - Ital alian an paten ent submi bmissi ssion on (n.1020 n.102015 1500 0000 00748 4820 20) (AD, PD, ischem emia) a) 2016/ 6/07 07 - PCT paten ent exten ensi sion on (PCT/ T/EP20 2016 16/06 06194 940) 0) 2016/ 6/11 11 - Claim extension (Epilepsy, MS, Tourette Syndrome….+20 pathologies ) Our strategy is to: Develop pathology specific patterns to be Since miRNA control several biochemical patented and outlicenced processes, we plan to study the miRNA for early diagnosis or patterns obtained and identifty novel companion diagnostics in drug development therapeutical targets
The market: diagnostics in brain diseases BIOMAR MARKER KER MARKET KET FIGURES RES CURRENT T miR iRNA FOCUS AREAS GLOBAL BIOMA OMARKERS MARKET The market for miRNA diagnostics is at GLOBAL miRNA MARKET a starting point, currently only focused $1 $1 on cancer and cardiovascular diseases, $45,55 $24 $24 Bill llion Bill llion Bill llion by but expected to grow exponentially in in 2015 by 2020 2019 the upcoming years. CANCER CARDIO CURRENT ENT STATE ATE OF ART BEFOR ORE E CLINICAL AL AFTER ER CLINICAL AL MANIFEST STAT ATION MARKET APPLICATIONS MANIFEST STAT ATION 2012 12 2010 10 2014 14 2016 16 Lipid ipid test t for AD Acquisition of Avid Radiopharma: Acquisition of AD test from Memory Dx: in bloo lood imaging agent t for Abeta ta plaque Enable les diffe feren rentia tiatio tionAD vs vs dementia tia Nature dete tectio ction $18 million in equity shares • Methods 2014 Development milestone after phase 2 • $300 million cash • 9% royalties on sales • Up to $500 million in milestones • Recent market highlights in the field (Alzheimer as an example), refer to diagnostics that help to characterize the patient once the symptoms appear. BrainDTech fulfi lfill lls an an unmet nmet nee eed of pre-symptomatic diagnosis, as well as specific companion diagnostic in drug development
The market: competition CANCER ER Few innovative players in cancer diagnosis. One player (Diamir) in brain diagnosis, still in R&D (reached a research agreement with Janssen) focused on circu cula latin ting miRNA in plasma for detection of AD BRAIN The main issue with circulating miRNA – based approaches is lack of specificity, given miRNA can be produced by many different cell types BrainDTech approach is revolutionary because we isolate intact microvesicle from a specific cell type (microglia) and then analyze the content only of these organelles, thus significantly increasing specificity. BrainDTech approach is potentially breakthrough because recent scientific evidence (Plog et al J.Neurosci 2015) suggest that these vesicles could be present also in easily accessible biopsies such as plasma (this hypothesis is currently being validated in our lab).
BrainDTech Development plan CSF PoC human PoC AD vs PD AD vs PD clinical study AD vs pre-AD clinical study R&D plasma MV identification MV isolation miRNA analysis Services on MV isolation Revenue stream Support to R&D of international institutions Pathology specific licencing 2016 2017 2019 2018
BrainDTech info E. Ongini F. Bianco N. Tonna BrainD nDTec ech h srl OpenZone Via Ariosto 21 20091 Bresso – MI Italy Tel: +39-02-84269000 info@braindtech.com Brain n DTech srl www.braindtech.com Registr trat ation on date: e: 21/7/2016 VAT T number ber: : 09593150965 Shar are e capi pital al: 576 k €
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