www.glythera.com
February 2009
Limited
Corporate Presentation
www.glythera.com
Glythera Highlights
•
Glythera’s
Patented
Permalink
™
technology
allows
the
stable
linkage
of
PEG
or
Glycan
groups
to
proteins
or
peptides
in
vitro
,
while
Permacarb
™
technology
renders
carbohydrates
resistant
to
enzymatic
degradation
•
Glythera
technology
can
be
applied
to
peptide,
protein
and
antibody
based
therapeutics
•
In
combination,
these
technologies
allow
unprecedented
control
over
glycosylation,
greatly
enhancing
stability
and
homogeneity
•
Glythera
is
currently
working
in
partnership
with
a
leading
European
biotechnology
company
www.glythera.com
Company Overview
•
Glythera
is
a
spin
-
out
biotechnology
company
based
at
the
University
of
Bath
and
in
the
City
of
London
•
Glythera
expertise
rests
in
protein
chemistry
and
biochemistry
&
is
driven
to
add
value
to
marketed
biological
therapeutics
and
biologics
still
in
development
•
Glythera
adds
value
,
efficacy
and
novelty
to
new
biological
entities
and
provides
proprietary
uniform,
stable
and
controllable
PEGylation
linkers
•
Glythera
raised
its
first
round
of
investment
in
Autumn
2008
•
Glythera
is
an
IP
Group
PLC
portfolio
company
with
additional
investment
from
Bath
Ventures
and
research
funding
from
the
government
agency
SWRDA
www.glythera.com
Corporate Structure
Dr
Anthony
Baxter
-
Chairman
Dr
Baxter
was
formerly
the
founding
CEO
of
Argenta
Discovery
Ltd,
a
leading
drug
discovery
services
.
In
less
than
four
years
from
the
company's
start
-
up
in
1999
,
he
grew
services
revenue
to
over
£
9
million
which
included
building
a
pipeline
of
novel
therapeutic
programmes
.
Prior
to
this,
Dr
Baxter
was
Chief
Scientific
Officer
of
Oxford
Asymmetry
International
plc
and
helped
build
the
business
from
an
early
stage
company
to
its
flotation
on
the
LSE
and
then
to
its
eventual
merger
with
Evotec
for
£
316
million
.
Most
recently,
Dr
Baxter
lead
the
turnaround
of
deltaDOT
Ltd,
which
involved
fundraising
of
£
8
.
3
million
.
He
is
currently
a
Non
-
Exec
.
Chairman
of
Equinox
Ltd
.
,
and
the
CEO
of
Cyprotex
Plc,
which
has
recently
announced
better
than
expected
profits
to
Shareholders
.
Dr
Andrew
G
Watts
–
Founder
and
Executive
Director
Andrew
is
currently
a
Lecturer
in
Medicinal
Chemistry
with
over
10
years
experience
in
carbohydrate
research,
including
synthesis,
inhibitor
design,
mechanistic
enzymology
and
development
of
novel
technologies
.
After
completing
his
PhD
in
Western
Australia,
he
carried
out
Post
-
doctoral
research
in
Vancouver,
Canada
(UBC)
before
moving
to
the
UK
.
Dr
Amanda
MacKenzie
–
Founder
and
Executive
Director
Amanda
MacKenzie
is
a
Lecturer
in
Pharmacology
with
over
10
years
research
experience
in
field
of
ion
channels,
immunology
and
hematology
.
Her
experience
include
a
postdoctoral
fellowship
position
in
Glaxo
Wellcome
and
a
senior
fellowship
funded
by
AstraZeneca
mentored
by
Prof
.
Alan
North
.
She
has
authored
several
high
impact
research
papers
and
reviews
in
the
field
of
membrane
ion
channel
signalling
and
small
protein
cytokine
signalling
.
www.glythera.com
Corporate Structure
Simon Youlton
-
Business Development
Prof. William Baines
-
Non
-
Executive Director
Dr Alison Fielding, MBA
-
Executive Director
Alison
was
the
Chief
Operating
Officer
of
Techtran
Group
when
it
was
acquired
by
IP
Group
in
January
2005
.
Previously,
she
spent
five
years
at
McKinsey
&
Co
where
she
consulted
primarily
to
the
pharmaceutical
and
health
care
sectors
.
Prior
to
McKinsey,
Alison
spent
four
years
as
a
development
chemist
for
Zeneca,
performing
technical
roles
in
the
speciality
chemicals
and
agrochemicals
divisions
.
William is a scientist and entrepreneur. He has 15 years' experience in creating, valuing and
implementing new technology in start
-
up companies, including Ark Therapeutics and Vectura, and has
started 4 companies including Amedis Pharmaceuticals Ltd.. He is author of over 100 articles and
3 books, teaches entrepreneurship and company financing at Cambridge University.
Simon
has
a
15
year
career
in
sales
and
marketing
in
life
science
companies
and
a
ten
year
career
in
international
technology
transfer
.
This
has
included
being
a
Board
Member
of
several
life
science
companies,
being
a
Management
Team
Member
for
the
worlds
largest
cancer
charity
whilst
at
the
tech
transfer
and
drug
development
company
Cancer
Research
Technology
Ltd,
&
being
a
founding
member
of
the
CRUK
translational
funding
committee
set
up
to
receive
and
review
academic
translational
awards
and
review
the
drug
development
activities
of
CRT
.
www.glythera.com
The Glythera Approach
GLYTHERA’s
core
expertise
allows
the
functionalisation
of
biological
therapeutics
to
improve
properties
and
efficacy
of
glycoproteins
via
the
implementation
of
its
PermaLink
™
and
PermaCarb
™
technologies
.
PermaLink
™
is
a
biologically
stable
linker
which
attaches
functional
groups
such
as
carbohydrates
and
PEGs
to
cysteine
residues
on
proteins
and
peptides
.
PermaCarb
™
technology
renders
carbohydrates
resistant
to
enzymatic
degradation,
maximising
their
biological
effects
in
vivo
.
Our modular approach enables the stable
attachment of PermaCarb
™
s using PermaLink
™
to
create drugs with improved plasma half
-
life,
biological stability and therapeutic efficacy.
www.glythera.com
Problems which can be addressed:
Biologics and Biosimilars
•
Biological therapeutics can be heterogeneous.
•
Chemical heterogeneity is a concern for regulatory compliance and often
necessitates multiple purification steps.
•
Current production methods can result in heterogeneity of post
-
translational
modification patterns, particularly glycosylation, which can effect the PK
properties:
-
eg
Bioavailability, biological activity, solubility (including the propensity
for aggregation) and immunogenicity
.
•
Glycans are degraded by glycosidases
in vivo
, which can increase rate of
clearance and reduce plasma half
-
life.
•
Glythera’s patented technologies
minimises these risks by providing a
‘better designed’, homogeneous and stable product.
www.glythera.com
PermaLink
™
•
PermaLink
™
uses novel chemistry to functionalise surface cysteine residues
through a thio
-
ether bond,
stable
to biological and chemical degradation.
•
Range of reagents
customized
for different sized
proteins
or
peptides
.
•
Improved selectivity and control of PEGylation over maleimide methodology.
•
High yields (>95%) for glycosylated/PEGylated peptides with the Glythera process.
Customized
functional group
Carbohydrate, PEG,
Affinity tag
Linker Group
Chemistry modulates reactivity
www.glythera.com
PermaCarb
™
•
PermaCarb’s are novel glycosylation groups
resistant
to enzymatic
degradation by exo
-
glycosidases (during production and
in vivo
)
•
Glycans can be added synthetically to modify protein function: such as
improved plasma half
-
life, enhanced efficacy and solubility
•
Can be used in combination with Permalink
™
for stable attachment to
proteins and peptides at defined locations
•
Wide range of endogenous glycosylation patterns are available
Linker
Reactive
Flexibility and Control
Synthesis of the carbohydrate
prior to conjugation assures
homogeneity and efficiency.
Engineered Resistance
Unique ability to introduce
resistance to enzymatic degradation
ensuring maximum benefit from
glycosylation is conferred to the
therapeutic.
www.glythera.com
Application of Glythera Technologies
•
Pegylated PermaLink can be used to replace Maleimide based methods of Pegylation
•
PermaLink targets cysteine residues similar to Maleimide, but provides greater specificity and
increased stability without needing to make changes to the target protein
Companies currently using Pegylation
•
PermaCarb technology can be applied
directly
to endogenously glycosylated therapeutics produced
in cell
-
based systems
•
Glycosylated therapeutics can be modified with PermaCarb to produce homogenous glycoforms
which are then inert to enzymatic degredation
in vivo
, thus improving half
-
life
Companies currently using cell
-
based glycosylation methods
•
The Pegylation of small peptides, or introduction of natural glycosylation sequences into peptides,
can result in loss of functional activity.
•
The application of PermaLink to small peptides requires only a single a.a. substitution (Ser, Thr, Ala
→Cys) to allow functionalisation by low molecular weight PermaCarb
Companies developing peptide
-
based therapeutics
www.glythera.com
Glythera PARTNERSHIPS
•
Glythera supplies know
-
how to produce homogeneous glycoforms with stable
glycosylation for biologicals manufactured in bacterial, yeast or mammalian cell based
systems, to enhance pharmacokinetic properties.
•
Glythera can introduce chemical stability and/or glycosidase resistance to your drug.
•
Novel substitutions allow the controlled and stable linkage of PEG’s without the need for
maleimide chemistry.
•
IDF
™
-
Improved Drug Functionality : through the ability to incorporate novel glycan
modification points.
www.glythera.com
Glythera Internal Projects
•
We will be moving certain exemplar peptides and protein
biotherapeutics in to Proof
-
of
-
Concept animal models at
the end of this year
•
Such agents will include Permalink
™
and Permacarb
™
modified G
-
CSF, an HIV peptide protein fusion inhibitor
and Interferon
β
1a
•
Preliminary data on PEGyltated
Interferon
β
1a using
Permalink has given encouraging results
www.glythera.com
Glythera PARTNERSHIPS
Partner delivers test
peptide or protein
•
We welcome enquiries for all types of biological therapeutics
•
We will help you in the first steps to make
Permalink
™
and
Permacarb
™
variants
for you to perform biological evaluation
Glythera delivers sample of
partner peptide/protein after
functionalisation/protection
Partner evaluates
Glythera version of
peptide/protein cf
original form
www.glythera.com
Summary
•
Our two patented technologies
–
Permalink
™
and
Permacarb
™
are both
applicable to functionalising proteins, peptide and antibody based biologicals
•
Functionalisation can:
•
improve stability and serum half
-
life through stable glycosylation
•
provide homogeneous glycosylation
•
We can PEGylate proteins without Maleimide and in a more defined and
controlled manner, producing a chemically stable product
•
New formulations, biomanufacture methods and novel IP allow for extensions of
class lifespan and market penetration for follow
-
on biologics
•
We are a young company ‘hungry’ for partners
www.glythera.com
Thank you
For further information regarding
Glythera Limited
,
please contact:
•
Simon Youlton on +44 (0)7588 410868
(
s.youlton@Glythera.com
)
Glythera Limited, 24 Cornhill, London, EC3V 3ND, Registered Number 6433235
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