IMUGENE LIMITED - Investor Presentation 2017

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ASX:IMU

B Cell Based Antibodies for Immuno-Oncology

Leslie
Chong Chief
Executive
Officer 09-‐January-‐2017

Notice: Forward Looking Statements

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Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Imugene Limited’s control. Important factors that could cause actual results to differ materially from any assumptions or expectations expressed or implied in this brochure include known and unknown risks. As actual results may differ materially to any assumptions made in this brochure, you are urged to view any forward looking statements contained in this brochure with caution. This presentation should not be relied on as a recommendation or forecast by Imugene Limited, and should not be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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What Does Imugene Do?

We are developing cancer immunotherapy drugs based on antibodies

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IMU’s Value Proposition

ü Promising
science
with
impeccable
provenance in
the
hottest
area
of
cancer
today
– immuno oncology

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ü Broad
Pipeline:
HER-‐Vaxx &
Mimotopes

ü Breast
Cancer
clinical
trial
complete
&
on
the
cusp
of recruitment
on
our
second
Phase
1b/2
clinical
trial
in gastric
cancer

ü Tight
share
register
with
leading
Fund
Manager, Platinum
Asset
Management
ü Frequent,
rich,
quality
news
flow
ahead
ü Axel
Hoos Sr.
VP
of
immuno – oncology
at
GSK,
plus team
with
successful
track
record
in
drug development
ü Low
market
cap
-‐ undervalued
against
ASX
peers

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Imugene Operates in the most Promising area of Oncology Today…

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Imugene is
an
immunotherapy
company
developing B-‐cell
based
vaccines
in
the
most
promising
area
of oncology
today
– IMMUNO-‐ONCOLOGY

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What is Cancer Immunotherapy?

Immunotherapy
is
the
treatment
of cancer
with
substances
or
drugs
that stimulate
the
patient’s
immune response
– known
as
active immunisation
Unlike
chemotherapy, immunotherapy
drugs
do
not
target the
cancer
directly
Immunotherapy
helps
the
patient’s own
immune
system
recognise & attack
cancer
cells
Typical
immune
responses
are: – B
Cells
making
antibodies
to
attack the
cancer
T
Cells
developed
by
the
thymus
to attack
the
cancer

B
Cell

Antibody

T
Cell

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Two Compelling Antibody Programs and Commercial Opportunities

Imugene’s Pipeline
B
Cell
Peptide
technology

Peptides
produced
via computer
aided
programs: HER-‐Vaxx Vaccine

Peptides
identified
via mimotope technology

**Building

on
the
multi-‐levels
of
your
own
immune
system**

Identification
of
cancer
targets
for
variety
of
cancer
indications
Immune
responses
from
conjugates
and
adjuvants
B-‐Cell
Peptide
vaccines
against
checkpoint
targets

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What is an Antibody? A key Defense of the Immune System

Antibodies – Large
Y-‐shaped
protein.
They
are
exquisitely
made to
attach
themselves
to
a target
sitting
on
an
invading
organism

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There
are
2
ways
to
make
antibodies

In
a
factory

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For
example, Roche’s
Herceptin

Using
B
cells
in
your
own
body

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B
Cells – are
like
little
antibody factories
producing
millions
of antibodies
against
cancer
targets

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Advantages of B-Cell Based Antibodies

Issue	B-Cell Immunotherapy	Monoclonal Antibodies
Safety	• Stimulates the immune system to produce natural Abs, potentially safer, as demonstrated by HER-Vaxx	• Synthetic Ab, with side effects (including ventricular dysfunction, CHF, anaphylaxis, immune mediation)
Efficacy	• Polyclonal Ab response reduces risk of resistance and potentially increases efficacy	• Monoclonal Ab - single shot
Durability	• Antibodies continuously produced a lasting immune response to inhibit tumor	• Half life up to 12 days sometimes less
	recurrence
Usability	• Potentially low numbers of vaccinations required per year	• Requires regular infusion
Cost	• Low cost of production enables greater pricing flexibility facilitating combinations and opening up additional markets	• Expensive course of treatment >USD100K per year in the US

B-‐Cell
Vaccines
offer
a
unique
opportunity
to
intervene
at
multiple
points
in
the
immune
system and
create
immune
memory
which
enhances
durability
of
response.

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A Mimotope Produces a Copy of an Antibody

A
mimotope is
a
small
molecule,
often
a
peptide,
which
mirrors
the
structure
of
an epitope,
the
specific
target
an
antibody
binds
to.
Because
of
this
property
it
induces an
antibody
response
similar
to
the
one
elicited
by
the
epitope.
A
mimotope causes
your
B
cells
to
produce
an
antibody
copy
of
the
antibody
you want
to
“mimic”
Potential
tool
for
selecting
novel
vaccine
candidates
against
a
variety
of
tumors
Greatly
extends
IMU’s
oncology
franchise
and
pipeline.
Monoclonal
antibody
market
currently
at
US$60bn
annually
December,
2016
progressed
the
mimotope platform
with
filing
of
4
new
patent applications

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HER-Vaxx is a peptide vaccine being developed for HER2[+] gastric cancer

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ASX:IMU

HER-Vaxx: Mechanism of Action – How it Works

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P6
3
Peptides
P4
Tumor
Cell
P7
HER-‐Vaxx
Antibody
Secretion
HER-‐2/neu
B-‐cell
Activation
Via
helper
T-‐cells
HER-‐Vaxx attacks
the
HER-‐Vaxx B-‐Cell same
target
as
the
Immunotherapy
the
world’s
largest
selling
breast
cancer
drug
Herceptin
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Phase 1 in Breast Cancer, Completed at Medical University of Vienna

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Design

10
patients
All
late
stage
breast
cancer patients
HER-‐2
+/++
Life
expectancy

4
months
• Conducted
at
Medical University
of
Vienna

**Clinical

Endpoints**

❶ Safety
and Tolerability
❷ Immunogenicity: antibodies and cellular
responses

Results

Patients
developed
anti-‐HER-‐2
antibodies
Induction
of
cytokines
(Th1
biased;
IFNγ)
Induction
of
memory
T
&
B
cells
post vaccination
Reduction
in
T
reg cells
post
vaccination, indicating
strong
vaccine
response
Antibodies
induced
displayed
potent
anti-‐ tumor
activity
Promising
results
-‐ Patients
were
end
stage and
not
primary
target
group
Reviewed
in
Peer
Publication

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Wiedermann et.
al.,
Breast
Cancer
Res
Treat.
2010
Feb;119(3):673-‐83.

HER-Vaxx Has Been Considerably Optimised Since Phase 1a

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Ph1b/2
Formulation
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**First

Generation**

Three
separate
B
Cell epitopes
delivered
in virosomes (used
in Phase
1a).

Second Generation

incorporated the three B Cell epitopes into a single 49-mer peptide
2x increase in antibody response in vivo compared to three
single epitopes (extended patent life to 2030)

Third Generation

changed the delivery system from virosomes to CRM197 (which gave CD4 T-Helper response), and added a montanide adjuvant
20x increase in antibody response in vivo (potentially
extends patent life to 2036)

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HER-Vaxx Has Been Significantly Enhanced by the Carrier System and Adjuvant

Her-2/neu specific IgG kinetic, after last immunization

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1.60
1.40
1.20
1.00
0.80 3 w. after 3 doses vacc.
0.60 8 w. after 3 doses vacc.
0.40 16 w. after 3 doses vacc.
0.20 6 mo. after 3 doses vacc.
0.00 Pre-immunization
10 25 50
OD
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P467-CRM-Montanide (µg)

In the mouse model the new formulation sees circulating antibodies maintained for 6 months which equates to many years in humans.

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Phase 1b/2, in Gastric Cancer

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**Phase

1b
lead-‐in Phase
2**

Open
label
- Open
  label
•
~18
patients
in
3
cohorts ~68
patients
from
sites of
up
to
6
pts
per
cohort in
Asia
•
Combination
with
chemo Combination
with
chemo
•
Endpoints: Randomized – Recommended
Phase
2 • Primary
Endpoints:
Dose
of
HER-‐Vaxx –
– Overall
Survival Safety:
any
HER-‐Vaxx – Progression-‐Free
Survival
toxicity
•
Immunogenicity
(anti-‐ Secondary
endpoint: HER-‐2
antibody
titres)) – Immune
response

✓ 08-‐Nov,
2016:
Phase
1b/2
Commences Q1,
2017:
Patient
Enrolled Q1-‐Q2,
2017:
Early
Patient
Data
Available Q3
2017:
Interim
Ph1b
Patient
Data
Available Q4
2017:
Final
Ph1b
Patient
Data
Available

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Huge Gastric Market Opportunity

Gastric
cancer
is
the
second
leading
cause
of
cancer mortality
in
the
world
&
its
management,
especially in
advanced
stages,
has
evolved
relatively
little
• ~20%
patients
with
metastatic
gastric
cancer
are HER-‐2
positive
Surgery,
chemotherapy,
radiation
&
Herceptin
are the
key
treatments
In
many
countries,
particularly
Asia,
chemotherapy such
as
capecitibine and
5-‐FU,
is
the
standard
of care,
not
Herceptin
Asia
is
the
largest
market
for
gastric
cancer
globally

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Chemotherapy

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Monoclonal
antibody

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2015 Big Pharma Antibody Deals

20%

of
the
top
10
Big
Pharma deals
in
2015
were
in
the
antibody
space

Top
ten
2015
licensing
transactions
by
announced
total
size

		Licensee	Licensor	Total Size	Upfront	Subject	Stage	Primary
				(US $M)	(US $M)			Rx Area
	1	Sanofi	Hanmi	$4,266	$445	Sanofl to develop Hanmi's Portfolio (specifically 3	Reformulation	Endo/Meta
						assets) of long-acting diabetes treatment
	2	AstraZeneca	lonis	$4,090	$65	Discovery and development of antisense therapies	Discovery	Diversified
			(fka Isis)			for cardiovascular, metabolic and renal diseases
	3	Vertex	CRISPR	$2,625	$75	Vertex and CRISPR to use CR1SPR-cas9 gene editing	Discovery	Diversified
						technology to discover and develop new treatment
						for genetic diseases
	4	Gilead	Galapagos	$2,075	$300	Gilead Sciences to develop and commercialize	Phase II	Al/lnflam
						Galapagos' filgotlnlb against rheumatoid arthritis
	5	Pfizer	Heptares	$1,890	Undisclosed	Heptares and pfizer to develop novel drugs targeting	Discovery	Diversified
						GPCR against multiple therapeutic indications
$350M up-front Phase 1	6	BMS	Five Prime	$1,740	$350	BMS to develop and commercialize Flve Prime's CSFlR antibody program, including FPA-008 for immunology and oncology	Phase I	Diversified
	7	Sanofi	Lexicon	$1,730	$300	Sanofi to develop and commercialize Lexicon's	Phase III	Endo/Meta
						sotagliflozin against diabetes, with an option to
						license
	8	Amgen	Xencor	$1,702	$45	Amgen to develop and commercialize Xencor's	Preclinical	Diversified
						bispecific cancer immunotherapy and inflammation
						programs
$640M up-front Phase 1	9 10	Sanofi Ultragenyx	Regeneron Arcturus	$1,665 $1,570	$640 $10	PD-1 inhibitor and other new immuno-0ncology antibodies, with an option Arcturus and Ultragenyx to discover and develop	Phase I Discovery	Cancer Diversified
						mRNA therapeutics using UNA Oligomer chemistry
						and LUNAR nanoparticle delivery platform

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What Could an IMU Deal Look Like? Top

20
Licenses
with
Upfront
Payments

$50m

Licensee	Licensor	Upfront($M)	Equity($M)	Stage	Rx Area
Sanofi	Regeneron	$640		Phase I	Cancer
Celgene	Med Immune / AZ	$450		Phase III	Cancer
Sanofi	Hanmi	$445		Reformulation	Endo/Meta
Bristol-Myers Squibb	Five Prime	$350		Phase I	Diversified
Astellas	lmmunomic	$300		Discovery	Al/lnflam
Gilead	Galapagos	$300	$425	Phase II	Al/lnflam
Sanofi	Lexicon	$300		Phase III	Endo/Meta
Medlmmune / AZ.	Innate	$250		Phase II	Cancer
Allergan	Merck	$250		Phase II	Neurology
Novartis	Aduro	$200	$25	Preclinical	Cancer
Celgene	Juno	$150	$850	Phase II	Diversified
Celgene	Nurix	$150		Discovery	Diversified
MerckKGaA	lntrexon	$115		Discovery	Cancer
Celgene	Lycera	$105		Phase I	Cancer
Janssen	Hanmi	$105		Phase I	Endo/Meta
Bayer	lonis (fka ISIS)	$100		Phase II	Cardiovascular
DiaVax	Cityof Hope	$100		Phase I	Viral Infection
Bayer	lonis (fka ISIS)	$100		Phase II	Hematologic
Merck	NGM	$914	$106	Preclinical	Endo/Meta
Vertex	Parion	$80		Phase II	PuIm/Resp

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Highlights
indicate
Phase
I
Licensing Source:
Thomson
Reuters
11
Jan
16,
“Life
Sciences
Dealmaking 2015”

Valuation and Licensing Deals in Immuno-Oncology

	Valuation of Companies Licensing Deals Company Valuation (USDm) Development Stage of lead drug Agios Pharmaceuticals, Inc. $1.829 Phase 3 Karyopharm Therapeutics, Inc. $288 Phase 2 Dicerna Pharmaceuticals, Inc. $68 Phase I Immune Design Corp. $167 Phase 2 Heat Biologics, Inc. $14 Phase 2 Loxo Oncology, Inc. $514 Phase I Epizyme, Inc. $597 Phase 2 Kite Pharma, Inc. $2,609 Phase 1/2 Idera Pharmaceuticals, Inc. $185 Phase 1/2 Ignyta, Inc. $213 Phase 1/2 Inovio Pharmaceuticals, Inc. $716 Phase 2 Five Prime Therapeutics, Inc. $1.150 Phase I OncoMed Pharmaceuticals,Inc. $387 Phase 2 Mean $672
Licensing Deals	Licensing Deals

Valuation of
Companies
Licensing Deals
Company
Valuation (USDm)
Development Stage of lead drug
Agios Pharmaceuticals, Inc.
$1.829
Phase 3
Karyopharm Therapeutics, Inc.
$288
Phase 2
Dicerna Pharmaceuticals, Inc.
$68
Phase I
Immune Design Corp.
$167
Phase 2
Heat Biologics, Inc.
$14
Phase 2
Loxo Oncology, Inc.
$514
Phase I
Epizyme, Inc.
$597
Phase 2
Kite Pharma, Inc.
$2,609
Phase 1/2
Idera Pharmaceuticals, Inc.
$185
Phase 1/2
Ignyta, Inc.
$213
Phase 1/2
Inovio Pharmaceuticals, Inc.
$716
Phase 2
Five Prime Therapeutics, Inc.
$1.150
Phase I
OncoMed Pharmaceuticals,Inc.
$387
Phase 2
Mean
$672

Licensing Deals

Licensing Deals	Upfront (includes equity& cash)USDm	Milestone payments (USDm)	Upfront Payment as % ofTotal	Total deal size
High	999.8	1835	100%	2,012.3
Mean	87.6	433	22.9%	514.6
Median	35.0	309	10.3%	363.5
Low	1.0	0	0.7%	1.0

The average total deal size is $514.6m, and the median deal size is $363.5m

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Sample News Flow in the next 12 Months

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ü Patent
filings
on
mimotopes (2H,
2016)
ü Patients
dosed
in
the
Phase
1b/2
trial
in
gastric cancer
(1H,
2017)
ü Recruitment
progress
and
interim
Phase
1b/2
data (1H,
2017)

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ü First
mimotope drug
candidate
identified
(1H, 2017)

ü Preclinical in
vivo/vitro results
(2H,
2017) ü Final
Phase
1b/2
trial
readout
(2H,
2017)

HER-‐Vaxx mimotope

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IMU broadens pipeline with acquisition from Baker IDI

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ü Exclusive
agreement
with
Baker
IDI

ü Oncology
rights
to
develop
a
portfolio
of
small
molecule
arginine modulators
for
cancer
treatment

ü Arginine
is
a
critical
amino
acid
for
the
health
of
cancer
fighting
T-‐cells
and depletion
of
it
limits
the
effectiveness
of
T-‐cells
to
fight
tumors ü Baker
IDI
compounds
increase
the
availability
of
arginine
in
the
cellular environment

ü Minimal
cost
and
resources
required
for
POC
in
2017

ü New
patent
filed
to
protect
compounds
in
the
field
of
cancer
and
immuno-‐ oncology,
including
combination
with
checkpoint
inhibitors

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A Team with Track Record in Drug Development

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**Leslie

Chong**

_Chief

Executive
Officer_

Over
19
years
of
oncology
experience
in
Phase
I
-‐ III
of
clinical
program
development
Leadership
role
involvement
in
2
marketed
oncology
products
Previously
Senior
Clinical
Program
Lead
at Genentech,
Inc.,
in
San
Francisco

**Dr Axel

Hoos**

_Non-‐Executive

Director_

Currently
Vice
President
Oncology
R&D
at GlaxoSmithKline
Previously
Clinical
Lead
on
Ipilumimab at
Bristol-‐Myers
Squibb
Co-‐Director
of
the
think-‐tank
Cancer Immunotherapy
Consortium; Imugene is
his only
Board
seat
worldwide

**Paul

Hopper**

_Executive

Chairman_

International
&
ASX
biotech
capital
markets
experience particularly
in
immuno-‐oncology &
vaccines
Chairman
of
Viralytics,
Director
of
Prescient,
Founder
of
Polynoma LLC,
former
Director
pSivida, Somnomed &
Fibrocell Science
Head
of
Life
Sciences
Desk
&
Australia
Desk
at
Los Angeles-‐based
investment
bank,
Cappello Group

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Prof
Ursula
Wiedermann Chief
Scientific
Officer

Co-‐inventor
of
Her-‐Vaxx;
inventor
of
mimotope platform
technology
Professor
of
Vaccinology at
Medical
University of
Vienna

**Dr Nick

Ede**

Chief
Technology
Officer

Over
25
years
peptide
vaccine
and
drug development
Former
CTO
Consegna,
CEO
Adistem Ltd,
CEO Mimotopes P/L,
COO
EQiTX Ltd
(ZingoTX & VacTX)
VP
Chemistry
Chiron
(now
Novartis),
Research Fellow
CRC
Vaccine
Technology

**Dr Anthony

Good**

_Clinical

Program
Manager_

Over
15 years
oncology
&
immunology experience
in
global clinical development programs.
Integral
to
the development
of
significant
new
medicines including
Viagra,
Revatio,
Lipitor, Selzentry and
Somavert.
Ex Pfizer
Global
Research
and
Development, Covance
Clinical
and
Periapproval Services and
Western
Sydney
University

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Business Strategy and Partnering Opportunities

2017 2017-‐2018

2017-‐2018?

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Phase
1b
Gastric
Study
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Big
Pharma?
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License
/Partner

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Our Stock

ASX:IMU, ISIN: AU000000IMU9

Market Cap	$32.5M AUD, $23.5M USD
(22/Dec/16)
Ordinary Shares 12 month price range	2.17 billion 0.7 cents – 2.1 cents AUD
Avg daily volume	10.5M shares (last three months)
Investment to Date	~$12.2 m
Cash & Equivalents	$3.82M as of 22/Dec/2016

Options on issue (as at Dec. 2016)

	No of options	Exercise Price	Expiry
Listed (IMUO)	371,166,262	$0.015	31-Mar-17
Unlisted	49,000,000	$0.0173*	30-Oct-17*
TOTAL	420,166,262	$0.0155*	18-May-17*

Substantial holders (as at Dec. 2016)

	No. of Shares	% Capital
Platinum Asset	213,846,553	9.88%
Management
Webinvest Pty Ltd	101,000,000	4.66%

National Nominees Limited	66,424,732	3.07%
Tisia Nominees	65,666,666	2.39%
Sarah Cameron	51,817,073	1.39%

Average

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IMU’s Value Proposition

ü Promising
science
with
impeccable
provenance in
the
hottest
area
of
cancer
today
– immuno oncology

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ü Broad
Pipeline:
HER-‐Vaxx &
Mimotopes

ü Breast
Cancer
clinical
trial
complete
&
on
the
cusp
of recruitment
on
our
second
Phase
1b/2
clinical
trial
in gastric
cancer

ü Tight
share
register
with
leading
Fund
Manager, Platinum
Asset
Management
ü Frequent,
rich,
quality
news
flow
ahead
ü Axel
Hoos Sr.
VP
of
immuno – oncology
at
GSK,
plus team
with
successful
track
record
in
drug development
ü Low
market
cap
-‐ undervalued
against
ASX
peers

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Contact

Leslie
Chong Chief
Executive
Officer [email protected] +61
458
040
433

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ASX:IMU

Appendix

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Imugene Science Advisory Board

Christoph Zieliniski

Director, Clinical Division of Oncology and Chairman, Department of Medicine at Medical University Vienna, Austria.
Coordinator of the Comprehensive Cancer Center at Medical University Vienna and the General Hospital in Vienna, Austria.
President, Central European Cooperative Oncology Group (CECOG).

Ursula Wiedermann

MD, PhD

Chief Science Officer
Professor of Vaccinology and Head of the Institute of Specific Prophylaxis and Tropical Medicine of the Medical University Vienna.
Speaker of the newly founded Centre for Geographic Medicine at the Medical University Vienna

Neil Segal

MD, PhD

Oncologist at the Memorial Sloan Kettering Cancer Center.
He holds a Doctorate of Medicine and Philosophy from University of the Witwatersrand in South Africa.

Yelena Janjigian

Medical
oncologist
at
the
Memorial
Sloan
Kettering
Cancer
Specializes
in
the
treatment
of
malignancies
of
the
gastrointestinal
tract, including
esophagus
and
stomach
cancers.

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Phase Ia Study Design*

Administration & Readout Schedule

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----- Start of picture text -----

D0 D28 D56 D84
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Blood draw

Vaccination with 10μg of each peptide antigen

**Patient

inclusion criteria**

Metastatic breast cancer
HER2
+,
++
ER/PR
pos.
Life
expectance >
4
mo

**Primary

endpoint**

Safety &
Tolerability

Secondary endpoint

Immunogenicity
Specific antibodies
Cellular responses
Breast
Cancer
Res
Treat.
2010
Feb;119(3):673-‐83.

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Patient Characteristics – Ages 55-84 *

Patient ID	Age	Metas. disease since	Prior chemotherapy	Current antihormonal therapy
1	55	Oct. 2006	no	Anastrozol
2	66	May 2004	yes (1 adj)	Fulvestrant
3	84	Mar. 1999	no	Anastrozol
4	79	Sept. 2003	no	Anastrozol
5	67	Apr. 2004	no	Fulvestrant
6	69	Sept. 2004	no	Anastrozol
7	60	Aug. 2002	yes (3 met)	Fulvestrant
8	76	Apr. 1999	no	Fulvestrant
9	63	Jun. 2006	yes (1 met)	Exemestan
10	70	Apr. 2008	No	Anastrozol

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Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

Safety and Tolerability – Few Grade 1 Local Reactions, None Systemic*

Patient ID	Local vaccination reaction grade	Systemic grade
1	1	no
2	0	no
3	0	no
4	1	no
5	1	no
6	0	no
7	0	no
8	0	no
9	1	no
10	0	no

Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

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Phase 1 Secondary Endpoint – Immunologic Responses

Cellular responses show Th2 profile

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----- Start of picture text -----

80 3
70
60 1 2 3 4
2
50
40 185 kDa
30 1
20
10
0 0
pre- post- pre- post- pre- post- kappa IgG lambda IgG
P4 P6 P7
140 P<0.05 800 800
120 700 700
600 600
100
500 500
80
400 400
60
300 300
40 200 200
20 100 100
0 0 0
pre- post- pre- post- pre- post-
eptide ab titer
p
H er-2/neu ab titer increase
pg/ml pg/ml
α γ
IL-2 pg/ml TNF- IFN-
----- End of picture text -----

8/ ~~10 developed significant anti-p~~ ep ~~tide antibody levels~~
In
all
but
one
the
antibodies
were
also
directed
against
Her-‐2/neu
The
majority
also
showed
a
4-‐fold
increase
in
influenza
titres (HI)
Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

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Reduction in Regulatory T Cells*

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pre-vaccination post-vaccination
p=0.033 Data.026
10.0 p=0.007 60.841.06 29.788.32 65.780.86 25.797.58
7.5 Pat 01
5.0
1 0 [0] 10 [1] 10 [2] 10 [3] 10 [4] 10 [0] 10 [1] 10 [2] 10 [3] 10 [4]
10 [0] 10 [1] CD25 PE10 [2] 10 [3] 10 [4]
2.5
2.29 6.21 1.31 4.36
64.26 27.24 73.22 21.10
0.0
pre- post- pre- post- Pat 02
patients normal donors
10 [0] 10 [1] 10 [2] 10 [3] 10 [4] 10 [0] 10 [1] 10 [2] 10 [3] 10 [4]
0.77 2.51 0.94 2.12
• 87.16 9.56 88.74 8.20
Significantly
higher
number
of
Normal
CD4+Foxp3+
regulatory
T
cells
in
tumour patients
than
healthy
controls donor
•
Vaccination
significantly
reduced
T
reg CD4+CD25+
cells
in
both
groups
p
CD4+Foxp3+
%CD4+CD25+Foxp3+
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Vaccination
significantly
reduced
T
reg cells
in
both
groups
Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

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Excellent Immunogenicity, even at low dose, and in Patients ages up to 84 years, with no Cardiotoxicity

Antibody and cellular responses in human

Pat. 1 2 3	#	Peptide- specific ab P4, P6, P7 ↑ ↑↑ ↑ ↑ ↑ ↑ ↑ ↑	HER2- specific ab ↑ ↑ ↑ (+/-)	Infl. HIT - ↑ -	IL-2, IFNγ, TNF - - - ↑ ↑ ↑ ↑ - -	T reg ↓ ↓ ↓
4 5		↑ ↑ ↑ ↑ ↑ ↑	↑ ↑	↑ ↑	- ↑ ↑ ↑ ↑ ↑	↓ ↓
6 7 8 9 10		- - - ↑ ↑ ↑ ↑ ↑ ↑ ↑ +/- +/- - - -	- ↑ ↑ (+/-) ↑ -	- ↑ ↑ ↑ -	↓ ↓ ↓ - - - ↑ ↑ - ↑ ↑ ↑ +/- ↓ +/-	↓ ↓ ↑ ↓ ↓

Strong
immunogenicity
in
8/10 patients
in
Phase
1
study
with 10
μg of peptide antigen
Good
correlation
with
cellular responses
(cytokines)
Safe
and
well
tolerated,
in particular
no
cardiotoxicity
Protective
efficacy
of
peptides demonstrated
in
preclinical tumor
model
in
mice
showing delay
of
onset
and
reduced tumor
growth

HER-Vaxx breast cancer vaccine – Phase 1 trial 10 μg group

Breast
Cancer
Res
Treat.
2010
Feb;119(3):673-‐83.

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Tumor Growth Inhibition in vivo *

Time to disease progression

Days after randomization

Preclinical study with tetanus toxoid–conjugated peptide antigens

d
65 d
170 d
235

Prolonged
time
to disease
progression
Immunization of c-‐neu transgenic mice (recognized HER2
cancer model)
with tetanus toxoid-‐conjugated peptides P4,
P6
and P7
Vaccinated animals show significant delay in
tumor onset and reduced growth kinetics
Co-‐administration
of IL-‐12 further improves the vaccine performance
Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

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No toxicity, in Particular No Cardiotoxicity

Rat cardiomyocytes

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Repeat
dose
toxicity
study
with TT-‐conjugated
peptides
in
mice
Repeat
dose
toxicity
study
with HER-‐Vaxx
in
rats
Local
tolerability
&
immuno-‐ genicity
study
with
HER-‐Vaxx
in rabbits
In
vitro
toxicity
study
with purified
serum
from
immunized animals
on
rat
cardiomyocytes

In vitro toxicity study on rat cardiomyocytes

Breast Cancer Res Treat. 2010 Feb;;119(3):673-83.

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Contact

Leslie
Chong Chief
Executive
Officer [email protected] +61
458
040
433

==> picture [227 x 41] intentionally omitted <==

ASX:IMU

AI assistant

IMUGENE LIMITED — Investor Presentation 2017

65124_rns_2017-01-08_e14a32bb-f6e3-481e-8b0f-fcbe6502ea5f.pdf

ASX:IMU

Notice: Forward Looking Statements

What Does Imugene Do?

IMU’s Value Proposition

Imugene Operates in the most Promising area of Oncology Today…

What is Cancer Immunotherapy?

Two Compelling Antibody Programs and Commercial Opportunities

**Building

What is an Antibody? A key Defense of the Immune System

Advantages of B-Cell Based Antibodies

A Mimotope Produces a Copy of an Antibody

HER-Vaxx: Mechanism of Action – How it Works

Phase 1 in Breast Cancer, Completed at Medical University of Vienna

Design

**Clinical

Results

HER-Vaxx Has Been Considerably Optimised Since Phase 1a

**First

Second Generation

Third Generation

HER-Vaxx Has Been Significantly Enhanced by the Carrier System and Adjuvant

Her-­2/neu specific IgG kinetic, after last immunization

Phase 1b/2, in Gastric Cancer

**Phase

Huge Gastric Market Opportunity

2015 Big Pharma Antibody Deals

20%

What Could an IMU Deal Look Like? Top

Valuation and Licensing Deals in Immuno-Oncology

Sample News Flow in the next 12 Months

IMU broadens pipeline with acquisition from Baker IDI

A Team with Track Record in Drug Development

**Leslie

_Chief

**Dr Axel

_Non-­‐Executive

**Paul

_Executive

**Dr Nick

**Dr Anthony

_Clinical

Business Strategy and Partnering Opportunities

2017-­‐2018?

Our Stock

ASX:IMU, ISIN: AU000000IMU9

Substantial holders (as at Dec. 2016)

IMU’s Value Proposition

Contact

Appendix

Imugene Science Advisory Board

Christoph Zieliniski

Ursula Wiedermann

Neil Segal

Yelena Janjigian

Phase Ia Study Design*

Administration & Readout Schedule

**Patient

**Primary

Secondary endpoint

Patient Characteristics – Ages 55-84 *

Safety and Tolerability – Few Grade 1 Local Reactions, None Systemic*

Phase 1 Secondary Endpoint – Immunologic Responses

Cellular responses show Th2 profile

Reduction in Regulatory T Cells*

Excellent Immunogenicity, even at low dose, and in Patients ages up to 84 years, with no Cardiotoxicity

Antibody and cellular responses in human

Tumor Growth Inhibition in vivo *

Time to disease progression

No toxicity, in Particular No Cardiotoxicity

Rat cardiomyocytes

Contact

More from IMUGENE LIMITED

IMUGENE LIMITED Investor Presentation 2017

Her-2/neu specific IgG kinetic, after last immunization

_Non-‐Executive

2017-‐2018?