Early diagnosis of brain diseases

Early diagnosis of brain diseases

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Description: Currently, diagnosis of brain diseases is carried out observing clinical symptoms, which occur when most of the neurodegeneration has already occurred. For example, Parkinson ‘s Disease symptoms (tremor) manifest when over 70% of dopaminergic neurons are dead (Parkinson Disease Foundation 2013). Before neuronal degeneration, there is a sustained inflammatory brain activity, which results in exacerbated neuroinflammation leading to cell death.

The onset of this inflammatory reaction can occur even 10-15 years before the actual symptoms manifest (Lull et al Neurotherapeutics 2010).

 
Author: Fabio Bianco PhD, Ennio Ongini PhD, Pietro Conti MD, Noemi Tonna PhD, Filippo Martinelli Boneschi   | Visits: 384 | Page Views: 537
Domain:  Medicine Category: Therapy 
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Contents:
EARLY DIAGNOSIS OF BRAIN DISEASES
via liquid biopsy,
based on miRNA patterns
in microglial microvesicles

BrainDTech team
Dr. Fabio Bianco, PhD – Chief Executive Officier






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

Dr. Ennio Ongini, PhD – Chief Scientific Officer






PhD in Pharmacology
20 yrs Research Director Schering
Plough
15 yrs VP Research Nicox SA
Member of different evaluation
Commitees
>200 peer reviewed papers, H-index 38

Dr. Elisabetta Borello, MBA – 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

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. Filippo Martinelli Boneschi, MD – Scientific Advisor






Degree Medicine, Residency Neurology
Master Epidemiology & Biostats @
Columbia University
PhD in Neuroscience @ HSR
Neurologist, Head of Laboratory of
Genetics @ HSR Institute
> 120 peer-reviewed papers, PI of
National and EU funded grants

The issue (need)
10 – 15 years
Brain INFLAMMATION

Brain DEGENERATION

CLINICAL SYMPTOMS



Currently, diagnosis of brain diseases is carried out observing clinical symptoms,
which occur when most of the neurodegeneration has already occurred.



For example, Parkinson ‘s Disease symptoms (tremor) manifest when over 70%
of dopaminergic neurons are dead (Parkinson Disease Foundation 2013).



Before neuronal degeneration, there is a sustained inflammatory brain activity,
which results in exacerbated neuroinflammation leading to cell death.



The onset of this inflammatory reaction can occur even 10-15 years before the
actual symptoms manifest (Lull et al Neurotherapeutics 2010).

BrainDTech proposal

Brain INFLAMMATION

MICROVESICLES FROM MICROGLIA

Bianco et al,
EMBO J 2009






Neuroinflammation activates MICROGLIA
Activated microglia produce MICROVESICLES
Microvesicles contain microRNA
Microvesicles can be found in LIQUID BIOPSY

BrainDTech represents a disruptive approach to brain disease diagnosis because
it detects a signal (MicroRNA) contained in microvesicles released by microglia
(the immune cells of the brain) years before any clinical manifestation.

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
We have submitted the following patent:
"Methods for diagnosis, prognosis and treatment monitoring
of neurological, neurodegenerative and inflammation – based diseases
via miRNA contained in microglial microvesicles"




2015/11 - Italian patent submission (n.102015000074820) (AD, PD, ischemia)
2016/07 - PCT patent extension (PCT/EP2016/061940)
2016/11 - Claim extension (Epilepsy, MS, Tourette Syndrome….+20 pathologies)

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

The market: Diagnostics in brain diseases
BIOMARKER MARKET FIGURES
CURRENT miRNA
FOCUS AREAS

GLOBAL BIOMARKERS MARKET

$24
Billion
in 2015

GLOBAL miRNA MARKET

$1
Billion
by
2019

$45,55
Billion
by 2020

CANCER

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.

CARDIO

MARKET APPLICATIONS

CURRENT STATE OF ART
BEFORE CLINICAL
MANIFESTATION
2016

AFTER CLINICAL MANIFESTATION
2012
2010

2014
Lipid test for AD
in blood

Nature
Methods 2014

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

Acquisition of Avid Radiopharma:
imaging agent for Abeta plaque
detection



$300 million cash
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 fulfills an unmet need of pre-symptomatic diagnosis,
as well as specific companion diagnostic in drug development

The market: competition
CANCER

Few innovative players in cancer diagnosis.
One player (Diamir) in brain diagnosis,
still in R&D (reached a research agreement with Janssen)
focused on circulating 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

R&D
We are currently running the proof of concept in
humans, testing AD patients in order to confirm
data so far obtained in in vitro models.
Then we will compare 2 indications (AD and PD),
then we will proceed in stratifying patients.
In parallel, we are testing the possibility of
isolating microglial microvesicles from plasma.

CSF

PoC human

PoC AD vs PD
MV isolation

plasma MV identification

AD vs PD clinical study
miRNA analysis

Revenue stream
Services on MV isolation

BrainDTech expects to obtain first revenue from
pathology specific pattern licencing
starting from 2019.

Support to R&D

In the meantime, drug discovery service activity
to third parties with proprietary know how on
microvesiclce isolation can be provided

Pathology specific
licencing

2016

2017

2018

2019

BrainDTech info
E. Ongini
F. Bianco
N. Tonna

BrainDTech srl
OpenZone
Via Ariosto 21
20091 Bresso – MI Italy
Tel: +39-02-84269000
Brain DTech srl
Registration date: 21/7/2016
VAT number: 09593150965
Share capital: 576 k€

info@braindtech.com
www.braindtech.com