Post on 19-Apr-2018
1
ASX:IMU
B Cell Vaccines for Immunotherapy
Leslie Chong Chief Opera9ng Officer 11 January 2016
2
Notice: Forward Looking Statements
Any forward looking statements in this presenta9on have been prepared on the basis of a number of assump9ons which may prove incorrect and the current inten9ons, plans, expecta9ons and beliefs about future events are subject to risks, uncertain9es and other factors, many of which are outside Imugene Limited’s control. Important factors that could cause actual results to differ materially from any assump9ons or expecta9ons expressed or implied in this brochure include known and unknown risks. As actual results may differ materially to any assump9ons made in this brochure, you are urged to view any forward looking statements contained in this brochure with cau9on. This presenta9on should not be relied on as a recommenda9on or forecast by Imugene Limited, and should not be construed as either an offer to sell or a solicita9on of an offer to buy or sell shares in any jurisdic9on.
3
Why Imugene is Unique
Imugene (ASX: IMU) leading in B Cell vaccines for immunotherapy
…but B Cell vaccines are an open frontier for immunotherapy
T Cell vaccines have been exhaustively researched…
4
Who is Imugene?
• Leading immunotherapy company, working on B Cell pep9de vaccine technology developed at Medical University of Vienna, Austria
• Headquartered in Australia, publicly traded on Australian Securi9es Exchange (ASX:IMU)
• Lead product, HER-‐Vaxx, is a HER2 vaccine with Phase 1 in breast cancer completed
• HER-‐Vaxx moves to Phase 1b/2 in HER2+ gastric cancer in 2016
• Exci9ng mimotope pla^orm in development at Medical University of Vienna
• Seasoned management team led by Execu9ve Chairman Paul Hopper
• Market capitalisa9on (1/5/2016) only US$16.1m (A$22.5m) One of the world’s best value immunotherapy stocks
5
B Cell Peptide Vaccine Immunotherapy
• Imugene is one of the few biotech companies globally working on B Cell pep9de vaccines for immunotherapy
• Our colleagues at Medical University of Vienna (MUW) have created a HER2 B Cell pep9de vaccine, HER-‐Vaxx, capable of genera9ng a robust an9-‐cancer polyclonal an9body response
• Imugene and MUW’s work on B Cell pep9de vaccines is focused on discovering the poten9al to improve performance and cost effec9veness of monoclonal an9bodies
• In the Era of Immuno-‐Oncology, B Cell pep9de vaccines has a poten9al to play an important role
• We believe we have the management team to posi9on B Cell pep9de vaccines as a clinically relevant immunotherapy
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Why B Cell Vaccines?
• No HLA restric9on • Poten9al for higher affinity and specificity polyclonal an9bodies than monoclonals, depending on epitope conforma9on
• Poten9al for addi9onal and superior an9tumor effects through targe9ng different biologically relevant regions for the cancer in ques9on
• ADCC (An9body dependent cell mediated cytotoxicity) and CDC (complement dependent cytotoxicity) as per monoclonals, but at much lower cost
• T Help can come from vaccine formula9on
• Genera9on of immune memory
• Poten9ally less toxicity • Combining several B-‐cell epitopes into a single an9gen is synergis9c and results in a stronger immune response
B Cell
An9body
7
Why Our B Cell Peptide Vaccines?
• Target-specific antibodies with potent anti-tumor activity
• Reduction in Treg cells post-vaccination
• Induction of cytokines (Th1 biased, IFN-γ production)
• Induction of memory T & B cells
• Single peptide • CRM197 carrier system
easier to make
• Significantly higher antibody titre in vivo
• Allows most antigenic epitopes to be identified
Epitope discovery technologies
2010 - First generation vaccine performed very
well in the clinic
2016 - Third generation vaccine goes to clinic
8
Why Imugene?
• Compelling science both for HER-‐Vaxx and mimotopes
• Leadership – Experienced management led by Execu9ve Chairman Paul Hopper (Polynoma, Viraly9cs); the board owns 6%
• Validated target for first product – HER-‐Vaxx targets same receptor as Roche's ~$8bn Hercep9n and Perjeta franchise
• Phase 1 completed – An9-‐HER2 an9body responses, T helper cytokines, Treg cells suppressed, therapy safe
• Robust IP – Exclusivity for HER-‐Vaxx un9l at least 2030 on granted US and EU patents -‐ further patent life extensions to 2036 and beyond underway
• News flow – Numerous milestone announcements and valua9on inflec9on points over next 12-‐24 months
9
ASX:IMU
B Cell Peptide Vaccines in the Era of ���Immuno-Oncology
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Imugene is an immunotherapy company developing B-‐cell based vaccines in the most promising area of oncology today – IMMUNO-‐ONCOLOGY
Imugene Operates in The Most���Promising Area of Oncology Today…
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2010 2011 2012 2015 2013 2014 2016 2017 2018 2019 2020 2021 2022
*Ci9group research note
The Immunotherapy Breakthroughs of the Last Five Years are Helping to Shape our Market Opportunity
Genera9on 2
MPDL3280A
Pembrolizumab
(checkpoint modulator)
(Cell Therapy)
Sipuleucel-‐T
Ipilimumab / CTLA-‐4
Genera9on 3
CAR-‐T
Genera9on 1
Mul9ple Therapies under Development
Blinotumumab
Nivolumab
Genera9on 1 and 2 predicted to generate
sales of $36bn by 2025*
MEDI 4736
Approved Under Inves9ga9on
12
ASX:IMU
HER-Vaxx – a Potential Breakthrough ���B Cell Peptide Vaccine
13 * $USD Source: Roche H1 Report hqp://www.roche.com/hy15e.pdf p12
HER-Vaxx Attacks the same Cancer Receptor the World’s Largest Cancer Franchise
Binding site of
Binding site of
Tumor cell
HER-‐2 Receptor
P4
P6
P7
HER-‐Vaxx: x3 polyclonal responses
Franchise sales annualising at nearly $8bn growing 13%*
P4
P6
P7
HER–Vaxx: 3 pep9des
Monoclonal response
14
HER-Vaxx is a Differentiated Product
• HER-‐Vaxx is a universal vaccine & can be used for all pa9ent types irrespec9ve of their “HLA haplotypes”, an issue which impacts T cell vaccines
• HER-‐Vaxx generates polyclonal responses that may be superior to treatment with a monoclonal an9body like Hercep9n
• Toxicity of HER-‐Vaxx is negligible • HER-‐Vaxx induces IFNγ produc9on that can influence the tumour micro environment and suppresses T Reg cells which are enhanced in cancer pa9ents & which assist tumor evasion mechanisms – thereby the efficacy of the HER-‐Vaxx might be enhanced
• Poten9al as an adjuvant therapy i.e., post surgery • HER-‐Vaxx is ac9ve immunisa9on and induces immunological memory – Hercep9n is passive immunisa9on, and its effec9veness depends upon frequent applica9ons
15 * Wiedermann et. al., Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Phase 1a in Breast Cancer, Conducted at Medical ���University of Vienna, Demonstrated Immunogenicity*
• n=10 • All metasta9c breast cancer pa9ents
• HER-‐2 +/++ • Life expectancy > 4 months
• Conducted at Medical University of Vienna
❶ Safety and Tolerability
❷ Immunogenicity: an9bodies/humoral and cellular responses
Clinical Endpoints
Design • Pa9ents developed an9-‐HER-‐2 Abs
• Induc9on of cytokines (Th1 biased; IFNγ)
• Induc9on of memory T & B cells post vaccina9on
• Reduc9on in T reg cells post vaccina9on, indica9ng strong vaccine response
• An9bodies induced displayed potent an9-‐tumor ac9vity
• Promising results -‐ Pa9ents were end stage and not primary target group
Results
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HER-Vaxx Has Been Considerably Optimised ���Since Phase 1a
First Genera9on
• (used in Phase 1a) was three separate B Cell epitopes delivered in virosomes
Third Genera9on • changed the delivery system from virosomes to CRM197 (which gave CD4 T-‐Help response), and added an adjuvant
• >10x increase in an9body response in vivo (poten9ally extends patent life to 2036)
Second Genera9on • incorporated the three B Cell epitopes into a single 49-‐mer pep9de
• > 2x increase in an9body response in vivo compared to three single epitopes (extended patent life to 2030)
17
* Data adjusted for comparison; original data generated for P467-‐30ug CRM197 generated with 1/20th of the concentra9on of comparable virosome formula9on. Adjustment may be subject to varia9on
NOTE: Actual an9body levels vary depending on number of immunisa9ons, dose used and characteris9cs of an9bodies under observa9on.
HER-Vaxx 3G Registers Markedly Increased Antibody Titres
-‐
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
Virosomes P467-‐30ug virosomes Adj P467-‐30ug CRM197*
Very significant increase seen a]er x4 immunisa9ons
OD of An9
-‐P467 An
9bod
y Titres In
Mice A]
er 4
Immun
isa9
ons for H
ER-‐Vaxx Form
ula9
ons
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Phase 1b/2, Starting 2016 Under an IND, in HER2+ Gastric Cancer
• Open label • 15 pa9ents, x3 groups of
5 pa9ents
• Combina9on with chemo
• Endpoints: – RP2D (Recommended Phase 2
Dose) of HER-‐Vaxx – Safety: any HER-‐Vaxx toxicity – Immunogenicity (an9-‐HER-‐2
an9body 9tres) – Test booster schedule
(q 4 weeks or 8 weeks)
Phase 1b lead-‐in Phase 2
• Open label • ~68 pa9ents from sites in Asia
• Combina9on with chemo
• Randomized
• Primary Endpoints: – Overall Survival – Progression-‐Free Survival
• Secondary endpoint: – Immune response
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Phase 1b/2 Trial Design���Gastric Cancer
Design Phase 1b/2 IND Submission Q1, 2016
Final Protocol Q1, 2016
N Phase 1b =15; Phase 2 = 68
# Sites 18-‐20
Enrollment Dura9on 36 months: Phase 1b=12 months; Phase 2 = 24 months
FPI Q2, 2016
End Points PFS, OS and Immune response
Vendors Central Lab
Phase 1b Phase 2
R A N D OM I Z E Cohort 1 5
Cohort 2 5
Cohort 3 5
Advanced Adenocarcinoma of the Stomach
n=68
No crossover treatment interim PFS analysis
Con9nuous Immune response monitoring 1:1
SOC: Cispla9n + 5FU or Capcitabine
Her-‐Vaxx + Cispla9n + 5FU or Capcitabine
Treat un9l PD
Follow for OS RP2D
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ASX:IMU
Mimotopes – Delivering on the Promise of B Cell Peptide Vaccines
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With our mimotopes technology, we can reverse-engineer monoclonal antibodies
• Our colleagues at Medical University of Vienna have developed cu}ng edge proprietary techniques to select pep9des that would mimic monoclonal an9bodies
• Imugene has acquired an op9on to develop mimotope vaccines with MUW.
• We believe mimotopes will be part of the next wave of the Immuno-‐oncology Revolu9on
• In conjunc9on with the MUW team we are now selec9ng novel vaccine candidates against a variety of cancer targets
• This greatly extends the Imugene’s oncology franchise and pipeline
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ASX:IMU
The Imugene value proposition���
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Compelling science and���commercial opportunity
HER-‐Vaxx
• Strong an9body response • T Regs down • Tumor growth inhibi9on in vivo
• Induc9on of cytokines, inc. IFNγ • Induc9on of memory T & B cells post vaccina9on
• IP life out to 2030 and beyond • Exis9ng HER2 franchise now US$8bn and growing
Mimotopes
• Various proprietary technologies allows suitable B cell epitopes to be iden9fied
• Monoclonal an9body market now >US$60bn pa
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Leslie Chong – Chief OperaEng Officer • Appointment as COO in August 2015 • Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco
Paul Hopper – ExecuEve Chairman • Interna9onal & ASX biotech capital markets experience par9cularly in immuno-‐oncology & vaccines • Head of Life Sciences Desk & Australia Desk at Los Angeles-‐based investment bank, Cappello Group • Director Prescient Therapeu9cs, Chairman Viraly9cs, former Director pSivida, Somnomed & Fibrocell Science
Dr Axel Hoos – Non-‐ExecuEve 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 Consor9um; Imugene is his only Board seat worldwide
Dr Nick Ede – Head of Manufacturing • Former CTO Consegna, CEO Adistem Ltd, CEO Mimotopes P/L, COO EQiTX Ltd (ZingoTX & VacTX) • VP Chemistry Chiron (now Novar9s), Research Fellow CRC Vaccine Technology
Leadership – ���Extensive Drug Development Experience
Prof Ursula Wiedermann – Chief ScienEfic Officer • Co-‐inventor of technology • Prof of Vaccinology at Medical University of Vienna
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0
50
100
150
200
250
Attractive Valuation
Median US$66m
US$m m
arket cap
as a
t 5 Ja
n. 2016
Imugene US$13m
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Our Stock Has Stabilised���Since Mid-2015
• Company spent 2014 and 2015 preparing second and third genera9on HER-‐Vaxx
HOWEVER
• We are now going to the clinic in 2016
• We expect strong news flow
• There is poten9al for strong progress with our mimotopes program
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110
130
150
170
190
210
Oct-‐13
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Feb-‐14
Mar-‐14
Apr-‐14
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4
Aug-‐14
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5
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Nov-‐15
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23 Octob
er 2013 = = 100
Imugene (USD) Nasdaq Biotechnology Index
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Strong News Flow
US FDA IND allowed 1H 2016
Appoint Principal Inves9gator 1H 2016
Announce preclinical toxicology results (WIL) 2H 2015
Announce preclinical immunologic results (Charles River) 1H 2016
Recruit and run lead in Phase 1b trial 1H 2016
Recruit and run randomized controlled Phase 2 trial 2H 2017
Report Phase 1b trial results late 1H 2017
Report Phase 2 results 2H 2019
Her-‐Vaxx GMP clinical batch complete 2H 2015
Iden9fica9on of 1st mimotope 1H 2016
Preclinical in vivo, in vitro results for mimotope 2H 2016
IND enabling GLP, Safety, Tox results of mimotope 1H 2017
US FDA IND allowed for mimotope 1H 2017
Recruit for Phase 1b mimotope trial 1H 2017
Four mimotopes Iden9fied 1H, 2016
Report on dose escala9on progress and status of Ph1b 2H 2016
Report Progress and dose selec9on on Phase 1b 1H 2017
mimotope Her-‐Vaxx
28
ASX:IMU
B Cell Vaccine Immunotherapy
@TeamImugene
imugene.com
29
Op9ons on issue (as at Jan. 2016) Substan9al holders as at Jan. 2016
ASX:IMU, ISIN: AU000000IMU9
* Average
Our Stock
No of op9ons
Exercise Price Expiry
Listed (IMUO) 371,177,356 $0.015 31-‐Mar-‐17
Unlisted 109,000,000 $0.0173* 30-‐Oct-‐17*
TOTAL 480,177,356 $0.0155* 18-‐May-‐17*
Market Cap (1/52016) $22.5M AUD, $16.5M USD
Ordinary Shares 1.73 billion
12 month price range 0.8 cents – 1.7 cents AUD
Avg daily volume 2.28M shares (last three months)
Public Equity Invested to date $9.00M
Cash & Equivalents $4.3M (as at Sep ‘16, include 3.0M raise)
No. of Shares % Capital
Oqo Buqula 107,000,000 6.2
Tom Henderson 89,666,666 5.2
Paul Hopper 71,196,875 4.1
30
Thank you
Leslie Chong Chief Operating Officer leslie.chong@imugene.com
+61 458 040 433
Stuart Roberts Head of Corporate Development sroberts@imugene.com
+61 447 247 909
Paul Hopper Executive Chairman receptogen@earthlink.net
+61 406 671 515
31
ASX:IMU
Appendix – HER-Vaxx Phase 1 Results���
Wiedermann et. al., Breast Cancer Res Treat. 2010 Feb;119(3):673-83.
32 * Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Study Design*
Pa9ent inclusion criteria • Metasta9c breast cancer • HER2 +, ++ • ER/PR pos. • Life expectance > 4 mo
Primary endpoint • Safety & Tolerability Secondary endpoint • Immunogenicity
– Specific an9bodies – Cellular responses
Administra9on & Readout Schedule
Blood draw Vaccina9on with 10μg of each pep9de an9gen
D0 D28 D56 D84
33 * Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Patient Characteristics – Aged 55-84 *
Pa9ent ID Age Metas. disease since Prior chemotherapy Current an9hormonal 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
34 * Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Safety and Tolerability - Few Grade 1 Local Reactions, None Systemic*
Pa9ent ID Local vaccina9on reac9on grade Systemic grade 3/4 toxicity
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
35
c.
29
Phase I - Secondary Endpoint: Immunologic Responses
kappa IgG lambda IgG0
1
2
3
Her
-2/n
eu a
b tit
er in
crea
se
pre- post- pre- post- pre- post-0
1020304050607080
P4 P6 P7
pept
ide
ab ti
ter
pre- post-0
100200300400500600700800
IFN
- γγ γγ p
g/m
l
pre- post-0
100200300400500600700800
TNF-αα αα
pg/
ml
pre- post-0
20
40
60
80
100
120
140
IL-2
pg/
ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide 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 titers (HHT)16
* Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Phase 1 Secondary Endpoint – Immunologic Responses
• 8/10 developed significant an9-‐pep9de an9body levels • In all but one the an9bodies were also directed against Her-‐2/neu • The majority also showed a 4-‐fold increase in influenza 9tres (HI)
c.
29
Phase I - Secondary Endpoint: Immunologic Responses
kappa IgG lambda IgG0
1
2
3
Her
-2/n
eu a
b tit
er in
crea
se
pre- post- pre- post- pre- post-0
1020304050607080
P4 P6 P7
pept
ide
ab ti
ter
pre- post-0
100200300400500600700800
IFN
- γγ γγ p
g/m
l
pre- post-0
100200300400500600700800
TNF-αα αα
pg/
ml
pre- post-0
20
40
60
80
100
120
140
IL-2
pg/
ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide 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 titers (HHT)16
c.
29
Phase I - Secondary Endpoint: Immunologic Responses
kappa IgG lambda IgG0
1
2
3
Her
-2/n
eu a
b tit
er in
crea
se
pre- post- pre- post- pre- post-0
1020304050607080
P4 P6 P7
pept
ide
ab ti
ter
pre- post-0
100200300400500600700800
IFN
- γγ γγ p
g/m
l
pre- post-0
100200300400500600700800
TNF-αα αα
pg/
ml
pre- post-0
20
40
60
80
100
120
140
IL-2
pg/
ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide 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 titers (HHT)16
Cellular responses show Th2 profile
c.
29
Phase I - Secondary Endpoint: Immunologic Responses
kappa IgG lambda IgG0
1
2
3
Her
-2/n
eu a
b tit
er in
crea
se
pre- post- pre- post- pre- post-0
1020304050607080
P4 P6 P7
pept
ide
ab ti
ter
pre- post-0
100200300400500600700800
IFN
- γγ γγ p
g/m
l
pre- post-0
100200300400500600700800
TNF-αα αα
pg/
ml
pre- post-0
20
40
60
80
100
120
140
IL-2
pg/
ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide 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 titers (HHT)16
36 * Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Reduction in Regulatory T Cells*
• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumour pa9ents than healthy controls
• Vaccina9on significantly reduced T reg cells in both groups
c.
30
• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumor patients than healthy controls
• Vaccination significantly reduced T reg cells in both groups
pre- post- pre- post-0.0
2.5
5.0
7.5
10.0
patients normal donors
p=0.007
p=0.033
%C
D4+
CD
25+F
oxp3
+
Phase I - Regulatory T cells:Cancer Patients vs.Healthy Controls
0.94 2.1288.74 8.20
100 101 102 103 104
post-vaccinationpre-vaccination
CD4+CD25+
100 101 102 103 104
2.29 6.2164.26 27.24
0.77 2.5187.16 9.56
Pat 01
Pat 02
Normal donor
100 101 102 103 104
1.31 4.3673.22 21.10
100 101 102 103 104
0.86 7.58 65.78 25.79
Data.026
100 101 102 103 104CD25 PE
1.06 8.32 60.84 29.78
CD
4+Fo
xp3+
c.
30
• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumor patients than healthy controls
• Vaccination significantly reduced T reg cells in both groups
pre- post- pre- post-0.0
2.5
5.0
7.5
10.0
patients normal donors
p=0.007
p=0.033%
CD4+
CD25
+Fox
p3+
Phase I - Regulatory T cells:Cancer Patients vs.Healthy Controls
0.94 2.1288.74 8.20
100 101 102 103 104
post-vaccinationpre-vaccination
CD4+CD25+
100 101 102 103 104
2.29 6.2164.26 27.24
0.77 2.5187.16 9.56
Pat 01
Pat 02
Normal donor
100 101 102 103 104
1.31 4.3673.22 21.10
100 101 102 103 104
0.86 7.58 65.78 25.79
Data.026
100 101 102 103 104CD25 PE
1.06 8.32 60.84 29.78
CD4+
Foxp
3+CD
4+Foxp3+
CD4+CD25+
37
Excellent Immunogenicity, even at low dose, and in Patients aged up to 84 years, with no Cardiotoxicity
• Strong immunogenicity in 8/10 pa9ents in Phase 1 study with 10 μg of pep9de an9gen
• Good correla9on with cellular responses (cytokines)
• Safe and well tolerated, in par9cular no cardiotoxicity
• Protec9ve efficacy of pep9des demonstrated in preclinical tumor model in mice showing delay of onset and reduced tumor growth
* Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Pat. # Pep9de-‐specific ab P4, P6, P7
HER2-‐ specific
ab
Infl. HIT
IL-‐2, IFNγ, TNF
T reg
1 ↑ ↑ ↑ ↑ -‐ -‐ -‐ -‐ ↓
2 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓
3 ↑ ↑ ↑ ↑ (+/-‐) -‐ ↑ -‐ -‐ ↓
4 ↑ ↑ ↑ ↑ ↑ -‐ ↑ ↑ ↓
5 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓
6 -‐ -‐ -‐ -‐ -‐ ↓ ↓ ↓ ↓
7 ↑ ↑ ↑ ↑ ↑ -‐ -‐ -‐ ↓
8 ↑ ↑ ↑ ↑ (+/-‐) ↑ ↑ ↑ -‐ ↑
9 ↑ +/-‐ +/-‐ ↑ ↑ ↑ ↑ ↑ ↓
10 -‐ -‐ -‐ -‐ -‐ +/-‐ ↓ +/-‐ ↓
HER-‐Vaxx breast cancer vaccine – Phase 1 trial 10 μg group
An9body and cellular responses in human
38
Tumor Growth Inhibition in vivo*
• Prolonged 9me to disease progression
• Immuniza9on of c-‐neu transgenic mice (recognized HER2 cancer model) with tetanus toxoid-‐conjugated pep9des P4, P6 and P7
• Vaccinated animals show significant delay in tumor onset and reduced growth kine9cs
• Co-‐administra9on of IL-‐12 further improves the vaccine performance
* Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Days a�er randomiza9on
Preclinical study with tetanus toxoid–conjugated pep9de an9gens
d 170 d 235 d 65
Time to disease progression
Cumula9
ve propo
r9on
tumor-‐free
39
No toxicity, in particular no cardiotoxicity
• Repeat dose toxicity study with TT-‐conjugated pep9des 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
* Breast Cancer Res Treat. 2010 Feb;119(3):673-‐83.
Rat cardiomyocytes
In vitro toxicity study on rat cardiomyocytes
40
ASX:IMU
B Cell Vaccine Immunotherapy
@TeamImugene
imugene.com Leslie Chong Chief Operating Officer leslie.chong@imugene.com
+61 458 040 433