early diagnosis of brain diseases · 2017. 3. 28. · brain few innovative players in cancer...
TRANSCRIPT
EARLY DIAGNOSIS OF BRAIN DISEASES via liquid biopsy,
based on miRNA patterns
in microglial microvesicles
BrainDTech Team
Dr. Fabio Bianco, PhD – Chief Executive Officer
• Medical Biotech, Pharmacology• President/CSO @NeuroZone• +10yr in Biotech/Pharma• Board Member
Dr. Noemi Tonna, PhD – Lab Manager
• Medical Biotech, Pharmacology• Lab Manager@NeuroZone• +10yr in drug discovery
Dr. Pietro Conti, MD, MBA – President
• Medicine & MBA• Founder/CEO several startups• Director Health Int’l Projects @UN• Board Member
Dr. Elisabetta Borello, PhD – Board Member
• Economics-Bocconi Univ., Milano• +30 yrs in Healthcare Information
Management Systems • Founder /Board member many biotechs
Dr. Ennio Ongini, PhD – Chief Scientific Officer
• Pharmacology• 20yrs R&D Director Schering Plough• 15 yrs VP Research Nicox SA• +200 peer reviewed papers
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
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 DEGENERATIONBrain INFLAMMATION CLINICAL SYMPTOMS
10 – 15 years
Brain INFLAMMATION
BrainDTech proposal
BrainDTech represents a disruptive approach to brain disease diagnosis
because it detecs a signal (MicroRNA in microvesicles)
released by microglia before clinical manifestation.
Neuroinflammation activates MICROGLIA
Activated microglia produce MICROVESICLES
Microvesicles contain microRNA
Microvesicles can be found in LIQUID BIOPSY
MICROVESICLES FROM MICROGLIA
Bianco et al EMBO J 2009
BrainDTech added value
MICROVESICLES
can be isolated
from liquid biopsies
Clinical data show that there are
more Microvesicles in the Cerebrospinal Fluid
of Alzheimer’s Disease patients
with respect to pre-Alzheimer,
or Mild Cognitive Impaired patients(Agosta et al ann Neurol 2014)
miRNAs
can be analyzed
in MICROVESICLES
We have observed that in different in vitro models,
miRNA from microglial microvesicles
are differently up (green) or down (orange) regulated,
creating pathology-specific patterns.
miRNA patterns
are SPECIFIC
for each PATHOLOGY
We have observed that in each pattern there are
specific miRNA which are exclusively up or down
regulated in a pathological model, thus creating
pathology specific patterns,
which we have patented.
BrainDTech IP position
Pathology specific patterns to be outlicenced
for early diagnosis or companion diagnostics
in drug development
Since miRNA control several biological processes,
we plan to study the miRNA patterns obtained
and identifty novel therapeutical targets
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)
PATENTS
The market: Diagnostics in brain diseases
GLOBAL BIOMARKERS MARKET
$24
Billion
in 2015
$45,55
Billion
by 2020
CURRENT miRNA
FOCUS AREAS
CANCER CARDIO
$1
Billion
by
2019
GLOBAL miRNA MARKET
2010
Acquisition of Avid Radiopharma:
imaging agent for Abeta plaque
detection• $300 million cash
• Up to $500 million in milestones
2012
Acquisition of AD test from Memory Dx:
Enables differentiationAD vs dementia• $18 million in equity shares
• Development milestone after phase 2
• 9% royalties on sales
2014
Lipid test for AD
in blood
Nature Methods 2014
AFTER CLINICAL MANIFESTATION
CURRENT STATE OF ART
BEFORE CLINICAL
MANIFESTATION
MA
RK
ET A
PP
LIC
ATI
ON
S
BIOMARKER MARKET FIGURES
The market for miRNA diagnostics is at
a starting point, currently only focused
on 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 fulfills an unmet need of pre-symptomatic diagnosis,
as well as specific companion diagnostic in drug development
2016
The market: competition
CANCER
BRAIN
Few innovative players in cancer diagnosis.
Brain solutions are currently focusing on
circulating miRNA in plasma for detection of AD
The main issue with circulating miRNA –based approachesis lack of specificity, given miRNA can be produced
by many different cell types
BrainDTech approach is revolutionarybecause 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 breakthroughbecause recent scientific evidence (Plog et al J.Neurosci 2015)
suggest that these vesicles could be present alsoin easily accessible biopsies such as plasma
(this hypothesis is currently being validated in our lab).
PoC AD vs MS Clinical PoC AD clinical study
2017 2018 2019
Cerebrospinal Fluid
Microvesicle isolationMicrovesicleidentification
miRNA analysis
Revenue stream
Blood
Pathology specificlicencing
2
Access to DATABASE
3
Outlicencing of non-core knowhow (microvesicle handling)
1
BrainDTech Development plan
BrainDTech info
BrainDTech srl
OpenZone
Via Ariosto 21
20091 Bresso – MI Italy
Tel: +39-02-84269000
www.braindtech.comBrain DTech srl
Registration date: 21/7/2016
VAT number: 09593150965
Share capital: 576 k€
F. Bianco
N. Tonna
E. Ongini