EA EARLY DI Y DIAG AGNOSI SIS S OF F BR BRAI AIN DISE SEAS - - PowerPoint PPT Presentation

EA EARLY DI Y DIAG AGNOSI SIS S OF F BR BRAI AIN DISE SEAS ASES ES

via liquid id biops psy, base sed d on miRNA NA patter erns ns in micr crogli glial al micr crovesic vesicles les

Fabio Bianco, CEO fbianco@braindtech.com www.braindtech.com

Te Team

• Medicine & MBA
• Founder/CEO several startups
• Director Health Int’l Projects @UN
• Board Member
• Dr. Pietro Conti, MD, MBA – President
• Dr. Fabio Bianco, PhD – Chief Executive Officer
• Medical Biotech, Pharmacology
• President/CSO @NeuroZone
• +10yr in Biotech/Pharma
• Board Member
• Pharmacology
• 20 yrs R&D Director Schering Plough
• 15 yrs VP Research Nicox SA
• +200 peer reviewed papers
• Dr. Ennio Ongini, PhD – Chief Scientific Officer
• Dr. Noemi Tonna, PhD – Lab Manager
• Medical Biotech, Pharmacology
• Lab manager @NeuroZone
• +10yr in drug discovery
• Dr. Laura Ferro, MD, MBA – Board Member
• Medicine & Psychiatry
• MBA @ Bocconi Univ., Milano
• Top 10 innovative women managers in Italy
• Founder /CEO several biotechs (including Gentium, IPO at

Nasdaq)

• Dr. Carlo Frati, MBA – Board Member
• Economics - Bocconi Univ; MBA, INSEAD
• McKinsey & Co. (2000-2016): Partner
• Capital Shuttle S.p.A. (2016): CEO
• Banca Consulia (2017-present): CFO
• Dr. Elisabetta Borello – Board Member
• Economics-Bocconi Univ., Milano
• +30 yrs in Healthcare Information Management Systems
• Founder /Board member many biotechs

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

Th The issu sue (need need)

Brain DEGENERA ERATI TION Brain INFLAM AMMA MATION TION Clinical al SYMP MPTOM TOMS

10 10 – 15 15 years ars

Brain INFLAM AMMA MATION TION

Br BrainDTech Tech propos

• sal

al

 Neuroinflammation activates MICROG OGLI LIA  Activated microglia produce MICROVESICLES OVESICLES  Microvesicles contain microR

• RNA

 Microvesicles can be found in LIQU QUID BIOPSY OPSY MICROVES ROVESICLES CLES FROM OM MICR CROGL OGLIA

BrainDTe DTech ch represents a disrup upti tive ve approach ch to brain disease diagnosis because it detects a signal (MicroR

• RNA

A in microvesicles rovesicles) released by microglia years s before

• re any clinica

ical manifestation festation

Br BrainDTech Tech added added value ue

miRNAs are PATH THOLO LOGY Y SPE PECIFIC FIC miRNAs in MICROVES ESICLE LES

High expression Low expression

MICROVES ESICLE LES S in liqui uid biops psies es

(Agosta et al Ann Neurol 2014)

Healthy subjects Alzheimer’s patients

Methods for diagnosi

• sis,

, progno nosi sis and treatme atment nt monitoring toring

• f neurologi

logical cal, , neurodegenera rative tive and inflamma lammatio tion – based diseases ses via miRNA A inside microg

• glia

ial microve

• vesi

sicle cles

• Disease staging
• Early diagnosis / companion diagnostics
• Non-invasive liquid biopsies

Market et Opportu rtuni nity ty: : diagn gnostic

• stics in brain

n diseases ases

“miRNA diagnostics fastest growing segment

• f global microRNA market”

(Persistence market research)

$45,5 ,5 B

(2020)

+$ +$ 1 B

$45,5 B +$1 B

BEFORE CLINICAL MANIFESTATION AFTER CLINICAL MANIFESTATION

Ba Barrier ers to Competition tition

PATHOLO OLOGY GY-SPEC SPECIFIC PATTER ERNS DEVELO ELOPM PMEN ENT NOVEL EL THERAPEU APEUTIC TARGET GETS IDENTIFICAT ATION ON EARLY LY DIAGN AGNOSI OSIS COMPAN PANION DIAGN GNOST OSTICS

PATENT STRATEGY

 2015/1 /11 - Itali lian pate tent t submissi ission (AD, , PD, isch chemia) ia)  2016/0 /07 - PCT pate tent t exte tensio sion  2016/1 /11 - Claim im exte tensio sion (+20 path thologie ies) s)  2017/0 /06 – EU pate tent t submissi ission

PATENT 1 –miRNA from microglia MVs

 2017/0 /09 - Itali lian pate tent t submissi ission  2018/0 /01 – exp xpecte cted PCT pate tent t exte tensio sion  2018/0 /04 –exp xpecte cted EU pate tent submissi ission

PATENT 2 –new blood-based biomarker

2 years 21

Patterns

EPIL vs ctrl 240 – 240 EPIL 60 EPIL vs ctrl 80 – 80 10

Patterns

PD vs ctrl 240 – 240 PD 60 PD vs ctrl 80 – 80 2 years

Fr From platfo tform rm tech chnol

• log
• gy … to big data

CSF BLOOD

MCI

2019-20 CSF 2018 CSF 2017 CSF AD – MCI – MS 80 – 80 – 80 AD – MCI – MS 60 – 60 – 60 AD – MCI – MS 240 – 240 – 240 AD vs Healthy 60 – 20

MS AD vs MS AD vs MCI MCI vs MS

6

Patterns AD

2 years 15

Patterns

NP vs ctrl 240 – 240 NP 60 NP vs ctrl 80 – 80 Observational Study 1 (OS1) Perspective non-interventional Validation Discovery OS 2 miRNA pattern Licensing

DATABASE: access to big data

Before neurodegenerative diseases can be treated, they must be detected… Fabio Bianco

fbianco@braindtech.com www.braindtech.com

…the earlier the better