early diagnosis of brain diseases · dr. ennio ongini, phd –chief scientific officer dr. noemi...
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EARLY DIAGNOSIS OF BRAIN DISEASES via liquid biopsy, based on miRNA patterns
in microglial microvesicles
Fabio Bianco, [email protected]
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 observing clinical symptoms,
which occur when most of the neurodegeneration has already occured
The issue (need)
Brain
DEGENERATION
Brain
INFLAMMATION
Clinical
SYMPTOMS
10 – 15 years
Brain
INFLAMMATION
BrainDTech proposal
Neuroinflammation activates MICROGLIA
Activated microglia produce MICROVESICLES
Microvesicles contain microRNA
Microvesicles can be found in LIQUID BIOPSY
MICROVESICLES FROM MICROGLIA
BrainDTech represents a disruptive approach to brain disease diagnosis
because it detects a signal (MicroRNA in microvesicles)
released by microglia years before any clinical manifestation
BrainDTech added value
miRNAs are
PATHOLOGY SPECIFIC
miRNAs
in MICROVESICLES
High expression Low expression
MICROVESICLES
in liquid biopsies
(Agosta et al Ann Neurol 2014)
Healthysubjects
Alzheimer’spatients
Methods for diagnosis, prognosis and treatment monitoring
of neurological, neurodegenerative and inflammation – based diseases
via miRNA inside microglial microvesicles
o Disease stagingo Early diagnosis / companion diagnosticso Non-invasive liquid biopsies
Market Opportunity: diagnostics in brain diseases
“miRNA diagnostics fastest growing segment
of global microRNA market”(Persistence market research)
$45,5 B(2020)
+$
1
B
$45,5 B
+$1 B
BEFORE CLINICAL MANIFESTATION
AFTER CLINICAL MANIFESTATION
o
o
o
o
o
o
o
o
Barriers to Competition
PATHOLOGY-SPECIFIC PATTERNS
DEVELOPMENT
NOVEL THERAPEUTIC TARGETS
IDENTIFICATION
EARLY DIAGNOSIS
COMPANION DIAGNOSTICS
PATENT STRATEGY
2015/11 - Italian patent submission (AD, PD, ischemia)
2016/07 - PCT patent extension
2016/11 - Claim extension (+20 pathologies)
2017/06 – EU patent submission
PATENT 1 –miRNA from microglia MVs
2017/09 - Italian patent submission
2018/01 – expected PCT patent extension
2018/04 –expected EU patent submission
PATENT 2 –new blood-based biomarker
2 years
21Patterns
EPIL vs ctrl
240 – 240
EPIL
60
EPIL vs ctrl
80 – 80
10Patterns
PD vs ctrl
240 – 240
PD
60
PD vs ctrl
80 – 80
2 years
From platform technology … 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 6Patterns
AD
2 years
15Patterns
NP vs ctrl
240 – 240
NP
60
NP vs ctrl
80 – 80
ObservationalStudy 1 (OS1)
Perspectivenon-interventional
Validation
Discovery
OS2
miRNA pattern Licensing
DATABASE: access to big data
Before neurodegenerative diseases can be treated,they must be detected…
Fabio [email protected]
www.braindtech.com
…the earlier the better