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IMUGENE LIMITED — AGM Information 2008
Nov 27, 2008
65124_rns_2008-11-27_8d7e3e63-c1a4-48cf-b139-2ac5a63f92a3.pdf
AGM Information
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ASX RELEASE
28 November 2008
Company Announcements Platform Australian Stock Exchange Level 4 20 Bridge Street SYDNEY NSW 2000
By e-Lodgement
Dear Sir/Madam
AGM PRESENTATION
Please find attached a copy of the presentation given to shareholders at the 2008 Annual General Meeting of Imugene Limited (ASX: IMU) this morning in Sydney.
Yours faithfully IMUGENE LIMITED
Julie Foster Company Secretary
Perth Office
Level 20, Allendale Square 77 St Georges Terrace Perth WA 6000 Tel: +61 8 9440 2660 Fax: +61 8 9440 2699
ABN: 99 009 179 551
www.imugene.com
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IMUGENE LIMITED Advanced Vaccine Technologies Disease control in pigs and poultry Annual General Meeting 28 November 2008
Dr Warwick Lamb Managing Director
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- Developer of Pig & Poultry vaccines
• Platform adenoviral vector delivery of desired antigens or cytokines
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Fowl Adenovirus & Porcine Adenovirus
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Patents granted in major regions (US & Europe)
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5 vaccines through proof of concept
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3 vaccines currently in animal trials
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3 additional vaccines ready for animal trials
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Development strategy on track
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An early stage developer of adenoviral vaccines
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• Spent 3 years improving science & patents
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• Has completed several proof of concept trials, mostly in the US
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Laboratory at La Trobe Uni – Melbourne, Australia
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Products for large markets
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poultry – 50 billion birds produced pa
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– i 1 billi i
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p gs – on p gs pa
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Value of markets >U$4 billion
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individual vaccines sales target >U$100m
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Proof of concept achieved for two big animal health disease targets
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Coccidiosis vaccine for broiler chickens
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PRRS vaccine for pigs
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POC achieved in animal trials – high dose of disease used to ‘challenge’ animals
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P d rogresse
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US Regulatory processes
– Commercial Development Strategy
- Patents – progress in expanding coverage
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Proof of Concept – achieved
– Poultry
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Coccidiosis
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Avian Influenza – H5N1
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Gamma Interferon – immune & growth enhancer
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Pigs
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Porcine Reproductive and Respiratory Syndrome
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Classical Swine Fever
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Proof of Concept – required
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Poultry
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Infectious Bursal Disease
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Classical strain
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Very virulent Strain
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Chicken Anemia Virus
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Avian Influenza - H7 and H9
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Pigs
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Porcine Circovirus
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Cytokine based immune system & growth enhancer
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Flexible Administration – cost effective
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water, aerosol, in ovo, injection
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Inexpensive to manufacture
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Delivers key genetic information
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Does not cause disease
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Ubiquitous in poultry and swine
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Safe - no residue
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Limited or no shedding
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• No genetic modification o an mat i l
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Marker vaccine (DIVA)
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• Platform delivery system for large product portfolio
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PAV patent family
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Granted in US, Europe, China, Australia & others
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Initial patents expiry 2018
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Successfully underwent Interference in the US – claims interfered with VIDO & Uni of Saskatchawan – resulted in Imugene receiving assignment of patents
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FAV patent family
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Granted in US, Europe, Australia & others
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Initial patents expiry 2014
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Additional FAV and PAV patents recently filed to extend product life
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• Coccidiosis – Broiler vaccine
Initial Trial results – ABIC/University of Technology, Sydney
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Blinded trial 24 groups of 20 broilers per group
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Successful groups had 2 oral doses (day 1 and 14)
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Emeria maxima challenge on day 28
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The best performing vaccine group’s results are: Lesion scoring:
74% of birds had a score of 1 lesion (control group 6%) 11% of birds had a score of 3 lesions or more (control group 44%) Oocyst scoring:
Group max daily oocyst count <68,000 (control >350,000) – reduction 80% Group total oocyst count <139,000 (control group >668,000) – reduction 79%
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• 3 groups, 15 piglets (21 day old)
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Virus Isolation from sera in control and vaccinated pigs
(challenge on Day 28)
80%
70%
60%
50%
T1
40% T2
T3
30%
20%
10%
0%
Day 28 Day 32 Day 35 Day 38 Day 42
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Average Lung Scores
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10
8
6
Control
IM
4
Oral
2
0
Day 42
ge
ogy
a l
Percent g Patho
verage otal Lu n
A T
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PRRS Virus Isolation from Pig Lungs
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80
70
60
50
Control
40
IM
30
Oral
20
10
0
Day 42
ion
sitive for t
Pigs Po us Isola r
ntage of RRS Vi
e P
Perc
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Percentage of PRRS Antibody Positive Pigs
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100
90
80
70
60
50
40 Control
30
IM
20
Oral
10
0
Day of PRRSV challenge
age
t
Percen
08 08 08 08 08
8/7/20
3/07/20 17/07/20 31/07/20 14/08/20
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• Broiler Productivity Enhancer (gamma interferon)
– Significant Trial results - rFAdV-CMV-IFNg vaccine
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Double Blinded 900 broiler trial (group size 50 birds):
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Feed conversion improved by up to
- 11 . 7% compared to Ross Index & 9 . 2% compared to medicated control group
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Weight gains improved by up to
- 15.6% compared to Ross Index & 13.75% compared to medicated control group
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Effective with or without antibiotics in feed
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18 groups – doses ranged from 2 dose to 4 dose – Day 0 to day 28
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Dosage & stability – required
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Manufacturing – production technique required (cell line,
eggs)
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Proof of concept H5N1 – in ovo & oral – passed in 2007
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Additional suite – H7 & H9 – constructs available for trial
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Diagnostic – matched to each vaccine
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H5N1 trial results
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Conducted by Benchmark in the US
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2 dose group (in ovo & oral at day 7) challenge at day 21
- 100% survival (8 birds) control group 12.5% survival (1 out of 8 birds)
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1 dose group (in ovo) challenge at day 14
- 82 % survival (9 out of 11 birds) control group 37.5% survival (3 out of 8 birds)
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Platform suitable to make vaccines against other avian influenza viruses
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Heterologous challenge model (challenge – Asian Strain)
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Dosage, stability & manufacturing – required
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Infectious Bursal Disease
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– Recombinants made for 2 strains
• Class cai l
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Very virulent
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Freedom to operate with VP2 genes
– Vaccine candidates ready for trialling – Proof of concept designed and approved – Classical version - POC trials underway
- Proof of concept designed and approved
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– Recombinant constructed and verified in lab
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Vaccine candidates ready for trialling
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Freedom to operate
– Proof of concept trial designed and approved – POC trials underway
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Porcine Circovirus PCV
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• Recombinant constructed
• Laboratory verified
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Ready to proceed to trials
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• First POC trial planned in US to complete 1[st] qtr 2009
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Directors & management
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Graham Dowland – Chairman
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Warwick Lamb – CEO
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Roger Steinepreis – Director
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Mike Sheppard – Chief Scientific Officer
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Shares on issue
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Options – Dec 09, 25c
143 6 m. 4.3 m
- Options – Mar 11, 20c
3.0 m
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Ownership:
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Board, management & their associates
14 %
- No debt, Minimal overhead, Cash 30 Sep 08 $1.4 m
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- Focus on proven products
• Alliances with International Industry
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US & Europe
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• Continue regu al tory processes
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Lab will focus on existing range
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Complete trials on range extension products
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By 1[st] qtr 2009
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Commence evaluation of contract manufacturing for vaccine range
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Products meet demand in large global markets
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Large range of important vaccines – proved
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Commercial advantages based on platform vectors
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Secure patent position – being expanded
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International industry validation & interest
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Regulatory & manufacturing progression occurring
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Commercial Strategy Implementation on track
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