1.
OSE
PHARMA
A
NEW
PLAYER
IN
PHASE
III
IN
LUNG
CANCER
WITH
AN
INNOVATIVE
CANCER
THERAPEUTIC
VACCINE
Orphan
Synergy
Europe-­‐
Pharma
(OSE
Pharma
Paris),
is
preparing
fundraising
focused
on
an
international
clinical
phase
III
for
a
cancer
therapeutic
vaccine
fighting
lung
cancer.
Paris,
France,
July
2,
2012
-­‐
Dominique
Costantini,
M.D,
and
Emile
Loria,
M.D,
health
experienced
professionals,
announce
the
creation
of
OSE
Pharma,
an
innovative
new
biopharmaceutical
company
developing
advanced
phase
III
clinical,
first-­‐
in-­‐class,
breakthrough
innovative
products
for
Orphan
severe
lung
diseases.
OSE
Pharma
has
in-­‐licensed
a
cancer
therapeutic
vaccine
program
for
international
development
and
European
rights
in
lung
cancer,
the
main
cause
of
mortality
by
cancer
in
the
world
(cf
p2).
Recognized
internationally
in
the
Biopharma
industry,
who
they
have
acquired
a
complementary
expertise,
Dominique
Costantini
and
Emile
Loria
have
respectively
successfully
created,
managed
business
operations
in
public
companies,
in
Europe
the
company
BioAlliance
(Euronext)
and
the
US
company
Epimmune
(Nasdaq).
“Starting
this
new
venture,
is
based
first
on
the
interest
of
this
therapeutic
vaccine
targeting
simultaneously
various
Tumor
antigens,
an
important
choice
when
we
know
the
heterogeneity
of
these
antigens.
The
clinical
phase
II
results
conducted
in
severe
advanced
lung
cancer
(mainly
metastatic
Non
Small
Cell
lung
cancer
with
failure
of
previous
lines
of
treatment)
established
correlation
between
survival
and
immune
response
covering
more
than
one
Tumor
Antigens
(John
Neimunatis
-­‐
Mary
Crowley
oncology
hospital
-­‐Dallas-­‐
and
the
other
US
investigators
of
the
phase
2
trial) commented Dominique Costantini, M.D. CEO
of OSE-Pharma. The
EP2101
safety
and
the
long
term
survival
are
very
interesting
when
the
need
of
new
treatment
options
is
clearly
established
for
advanced
lung
cancer.
This
phase
III
priority
is
the
basis
of
our
financing
round”.
Company’s
lead
product
EP2101
is
an
active
cancer
immunotherapy
or
a
cancer
therapeutic
“vaccine”.
It
is
based
on
proprietary
10
multi-­‐epitopes
(small
peptides)
targeting
5
main
Tumor
Associated
antigens
expressed
in
various
tumors.
Emile
Loria
was
conducting
this
epitope
program
until
clinical
phase
II.
OSE-­‐
Pharma
has
established
an
US
epitopes
expert
team
preparing
the
phase
III
program.
The
original
EP2101
combination
provides
Cytotoxic
T
lymphocytes
responses
and
synergic
immune
responses
versus
the
5
Tumor
Associated
Antigens.
EP2101
overcomes
“tolerance”
(tolerance
is
an
immune
response
failure
because
tumor
antigens
are
often
shared
with
normal
tissues).
These
selected
epitopes
are
a
combination
of
wild
type
and
modified
analogs
increasing
binding
to
receptors
(HLA
A2)
and
then
becoming
able
to
attack
cancer
tumor
cells
of
HLA
A2
patients.
The
Cytotoxic
T
Lymphocytes
response
is
dependent
of
HLA
A2
tissue
binding
and
EP2101
patient
responders
are
HLA
A2
positive.
OSE Pharma
Société anonyme à Conseil d’Administration au capital social de 526 500 euros
Siège social : Pépinière Paris Santé Cochin - 29bis rue du Faubourg Saint Jacques 75 014 Paris
RCS Paris 479 457 715

2.
OSE
PHARMA
A
NEW
PLAYER
IN
PHASE
III
IN
LUNG
CANCER
WITH
AN
INNOVATIVE
CANCER
THERAPEUTIC
VACCINE
COMPANY
PROFILE
:
OSE
Pharma
an
innovative
clinical
stage
(Phase
III
status)
biopharmaceutical
company
has
established
its
corporate
headquarters
in
Paris
Hospital
Cochin
(Pépinière
Paris
Santé
Cochin),
France.
OSE
Pharma
founded
in
May
2012,
is
focused
on
targeting
severe
and
orphan
pulmonary
diseases,
this
medico-­‐economic
model
is
based
on
protection
and
acceleration
of
development
for
drugs
significantly
improving
treatment
options
for
patients
with
unmet
medical
needs.
OSE
lead
product
EP2101
has
completed
a
Phase
II
clinical
trial
in
non-­‐small
cell
lung
cancer
HLA
A2
positive
patient
responders.
The
multi-­‐epitopes
cancer
vaccine
(small
peptides)
are
tumor-­‐specific
CTL
(cytotoxic
T
Lymphocytes)
epitopes
selected
from
5
tumor-­‐associated
antigens
(HER2/neu;
P53;
CEA;
MAGE2;
MAGE3).
These
5
Tumor
associated
antigens
are
for
poor
prognosis
when
overexpressed
alone
and
increasing
when
associated.
The
OSE
epitopes
platform
benefits
also
of
clinical
phase
I/II
results
in
colon
cancer
and
could
be
applied
for
other
cancers
with
the
same
Tumors
antigens.
The
company
is
also
preparing
a
new
independent
clinical
project
in
Cystic
fibrosis,
an
orphan
genetic
disorder
with
progressive
lung
damages.
Lung
cancer
Lung
cancer
is
the
leading
cause
of
cancer
death
in
the
world.
More
people
die
of
lung
cancer
than
of
colon,
breast
and
prostate
cancers
combined.
According
to
the
World
Health
Organization,
lung
cancer
(non-­‐small
cell,
NSCLC,
and
small
cell
type)
affects
more
than
1.2
million
patients
a
year,
with
around
1.1
million
deaths
annually
and
around
500,000
in
the
U.S.,
Europe
and
Japan.
About
85
percent
of
all
lung
cancers
are
the
non-­‐small
cell
type.
Further,
only
about
15
percent
of
people
diagnosed
with
NSCLC
survive
this
disease
after
five
years.
The
majority
of
patients
are
with
advanced
stage
disease
at
diagnosis:
stage
IIIB
invasive
or
Stage
IV
metastatic).
Despite
aggressive
treatments,
the
5-­‐year
relative
survival
rates
are
about
24%
for
patients
with
regional
disease
and
less
than
4%
for
patients
with
distant
disease.
Contacts
OSE Pharma SA H&B Communication
Dominique Costantini, CEO Florence Portejoie
dominique.costantini@osepharma.com +33 1 58 18 32 58 / +33 6 88 84 81 74
Mob +33 6 13 20 77 49 f.portejoie@hbcommunication.fr
Anne Hardy
+33 1 58 18 32 51 / +33 6 13 56 23 96
a.hardy@hbcommunication.fr
OSE Pharma
Société anonyme à Conseil d’Administration au capital social de 526 500 euros
Siège social : Pépinière Paris Santé Cochin - 29bis rue du Faubourg Saint Jacques 75 014 Paris
RCS Paris 479 457 715