EARLY DI DIAGNOSIS IS OF BRAIN DI DISEASES via liquid id biopsy - - PowerPoint PPT Presentation

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EARLY DI DIAGNOSIS IS OF BRAIN DI DISEASES via liquid id biopsy - - PowerPoint PPT Presentation

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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.

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SLIDE 1

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

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SLIDE 2

BrainDTech Team

  • Dr. Laura Iris Ferro, MD, MBA – Board Member
  • Dr. Ennio Ongini, PhD – Chief Scientific Officer
  • Dr. Elisabetta Borello, PhD – Board Member
  • Degree in Economics @ Bocconi Univ., Milano
  • >30 years expertise in Healthcare Information

Management Systems

  • Founder & Board member of many biotechs
  • Dr. Pietro Conti, MD - Chief Financial Officer
  • Degree in Medicine & MBA
  • Director @several Health International

Projects in UN agencies (UNDP, WHO, UNICEF)

  • Founder and CEO of several startups
  • PhD in Pharmacology
  • 20 yrs Research Director Schering Plough
  • 15 yrs VP Research Nicox SA
  • Member different evaluation Commitees
  • >200 peer reviewed papers, H-index 38
  • Degree in Medicine & Psychiatry,
  • MBA @ Bocconi Univ., Milano
  • Top 10 most innovative women managers in Italy
  • Founder and CEO of several biotechs , including

Gentium, IPO at Nasdaq

  • Board member in several companies (Sorin,

Newronika, …)

  • Dr. Noemi Tonna, PhD – Lab Manager
  • PhD in Pharmacology
  • Degree in Medical Biotechnology
  • Lab Manager in NeuroZone
  • >10 yr expertise in cell culturing/ in vitro drug

discovery

  • Dr. Fabio Bianco, PhD – Chief Executive Officer
  • PhD in Pharmacology, Degree in Biotech
  • Founder of NeuroZone (President and CSO)
  • CEO of BrainDTech
  • Director of Sanipedia Business Nursery
  • >10 yr in Biotech/Pharma with executive roles
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SLIDE 3

Currently, diagnosis of brain diseases is carried out observi erving ng clini nical al sympt mptoms

  • ms,

which occur when most of the neurodegeneration has already ady occur ured ed

The issue (need)

Brain n DEGENER NERATI ATION Brain n INFLAM AMMA MATION TION CLINICAL AL SYMP MPTOM TOMS

10 – 15 years

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SLIDE 4

Brain n INFLAM AMMA MATION TION

BrainDTech proposal

 Neuroinflammation activates MICROG ROGLI LIA  Activated microglia produce MICROVES ROVESICLES CLES  Microvesicles contain microR

  • RNA

 Microvesicles can be found in in LIQU QUID BIOPSY OPSY MICROVESI OVESICLES LES FROM OM MICROGL OGLIA

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

  • re any clinica

ical manifestation festation.

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SLIDE 5

BrainDTech added value

MICROVES ESICLE LES S can be isolat ated ed from liquid biops psies es

Clinical data show that there are more re Microv rovesic icles les in the e Cerebr rebros

  • spin

pinal al Fluid id

  • f

f Alzheimer’s Disea ease patien atients with respect to pre-Alzheimer,

  • r Mild Cognitive Impaired patients

(Agosta et al ann Neurol 2014)

miRNAs can be analyzed ed in MICROVES ESIC ICLES LES

We have observed that in different in vitro models, miRNA A from

  • m micro

roglia glial micro rovesic icles les are e differ erent ntly ly up (gre reen) en) or down n (oran range ge) ) regu gulat lated ed, , creating pathology-specific patterns.

miRNA patter erns ns are SPEC ECIFI IFIC for each PATH THOLO LOGY

We have observed that in each pattern there are spec pecif ific ic miRNA whic ich are e exclus lusiv ively ly up or down n regu gulat lated ed in a pathological model, thus creating pathology specific patterns, which we have patented.

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SLIDE 6

BrainDTech IP position

 2015/ 5/11 11 - Ital alian an paten ent submi bmissi ssion

  • n (n.1020

n.102015 1500 0000 00748 4820 20) (AD, PD, ischem emia) a)  2016/ 6/07 07 - PCT paten ent exten ensi sion

  • n (PCT/

T/EP20 2016 16/06 06194 940) 0)

  • 2016/

6/11 11 - Claim extension (Epilepsy, MS, Tourette Syndrome….+20 pathologies)

We have submitted the following patent: "Methods for diagn agnos

  • sis

is, , prog

  • gnosis

nosis and nd treat reatment nt monit itoring ring

  • f neur

urolog

  • logic

ical, neur urod

  • deg

egene enera rativ ive e and d infla lammat ation ion – based disea eases via miRNA contained in micro roglia glial microv

  • ves

esic icle les" Our strategy is to:

Develop pathology specific patterns to be patented and outlicenced for early diagnosis or companion diagnostics in drug development Since miRNA control several biochemical processes, we plan to study the miRNA patterns obtained and identifty novel therapeutical targets

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SLIDE 7

The market: diagnostics in brain diseases

GLOBAL BIOMA OMARKERS MARKET $24 $24 Bill llion in 2015 $45,55 Bill llion by 2020 CURRENT T miR iRNA FOCUS AREAS CANCER CARDIO $1 $1 Bill llion by 2019 GLOBAL miRNA MARKET

2010 10

Acquisition of Avid Radiopharma: imaging agent t for Abeta ta plaque dete tectio ction

  • $300 million cash
  • Up to $500 million in milestones

2012 12

Acquisition of AD test from Memory Dx: Enable les diffe feren rentia tiatio tionAD vs vs dementia tia

  • $18 million in equity shares
  • Development milestone after phase 2
  • 9% royalties on sales

2014 14

Lipid ipid test t for AD in bloo lood Nature Methods 2014

AFTER ER CLINICAL AL MANIFEST STAT ATION

CURRENT ENT STATE ATE OF ART

BEFOR ORE E CLINICAL AL MANIFEST STAT ATION MARKET APPLICATIONS 2016 16

BIOMAR MARKER KER MARKET KET FIGURES RES

The market for miRNA diagnostics is at a starting point, currently only focused

  • n cancer and cardiovascular diseases,

but expected to grow exponentially in the upcoming years. 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

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SLIDE 8

The market: competition

CANCER ER BRAIN

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

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).

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SLIDE 9

BrainDTech Development plan

2016 2017 2018 2019

PoC AD vs PD PoC human CSF MV isolation MV identification plasma miRNA analysis AD vs PD clinical study

R&D Revenue stream

Services on MV isolation Support to R&D of international institutions AD vs pre-AD clinical study Pathology specific licencing

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SLIDE 10

BrainDTech info

BrainD nDTec ech h srl OpenZone Via Ariosto 21 20091 Bresso – MI Italy Tel: +39-02-84269000 info@braindtech.com www.braindtech.com Brain n DTech srl Registr trat ation

  • n date:

e: 21/7/2016 VAT T number ber: : 09593150965 Shar are e capi pital al: 576 k€

  • F. Bianco
  • N. Tonna
  • E. Ongini