AI assistant
IMUGENE LIMITED — AGM Information 2016
Nov 1, 2016
65124_rns_2016-11-01_6011b6fe-e10a-4c23-a368-fa14dc330de3.pdf
AGM Information
Open in viewerOpens in your device viewer
==> picture [227 x 41] intentionally omitted <==
ASX:IMU
==> picture [720 x 246] intentionally omitted <==
B Cell Antibodies for Immuno-Oncology
Leslie Chong Chief Operating Officer AGM November 2, 2016
1
Notice: Forward Looking Statements
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.
==> picture [90 x 16] intentionally omitted <==
2
Company Overview
Developing B-cell based immuno-oncology therapies
-
Mimotope Platform Technology: B cells to produce an antibody copy of the antibody you want to “mimic”
-
HER-Vaxx: Completed a Phase 1 trial in patients with HER-2+/++ breast cancer
-
The Phase 1b/2 gastric cancer trial to begin this week (initiation starts this week)
-
Technology originates from the Medical University of Vienna, one of Europe’s leading cancer institutes
-
Technology identified in 2012 by Dr Axel Hoos (Sr. VP at GSK)
-
Public listing on ASX in December 2013 via reverse merger into listed shell, Imugene Ltd - Axel Hoos joins the Board – his only Board worldwide
==> picture [74 x 68] intentionally omitted <==
==> picture [121 x 49] intentionally omitted <==
==> picture [90 x 16] intentionally omitted <==
3
What is an Antibody? A key defense of the immune system
Antibodies – look like the letter “Y” and are made of proteins. They are exquisitely made to attach themselves to one target only sitting on an invading organism which the body doesn’t like .
==> picture [51 x 47] intentionally omitted <==
There are 2 ways to make antibodies
==> picture [112 x 44] intentionally omitted <==
In a factory
==> picture [204 x 135] intentionally omitted <==
==> picture [55 x 96] intentionally omitted <==
For example, Roche’s Herceptin for breast cancer
==> picture [94 x 44] intentionally omitted <==
Using B cells in your own body
==> picture [150 x 103] intentionally omitted <==
- B Cells – are like little antibody factories producing millions of antibodies to target “nasties” entering the body
==> picture [90 x 16] intentionally omitted <==
4
Two Compelling Antibody Programs and Commercial Opportunities
Imugene’s Pipeline B Cell Peptide technology
==> picture [167 x 123] intentionally omitted <==
----- Start of picture text -----
Peptides produced
via computer
aided programs:
HER-Vaxx Vaccine
----- End of picture text -----
==> picture [167 x 123] intentionally omitted <==
----- Start of picture text -----
Peptides identified
via mimotope
technology
----- End of picture text -----
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
==> picture [90 x 16] intentionally omitted <==
5
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”
-
Mimotopes to be part of the next wave of the immuno-oncology revolution against cutting edge oncology targets
-
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 pa
==> picture [192 x 121] intentionally omitted <==
==> picture [156 x 141] intentionally omitted <==
==> picture [90 x 16] intentionally omitted <==
6
Advantages of Mimotopes Immunotherapy
Issue Mimotope 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 Half life up to 12 days a lasting immune response to inhibit sometimes less tumor recurrence
-
•
-
Usability Potentially low numbers of Requires regular infusion vaccinations required per year
Cost
-
•
-
Low cost of production enables greater Expensive course of treatment pricing flexibility facilitating combinations >USD100K per year in the US and opening up additional markets
==> picture [90 x 16] intentionally omitted <==
7
HER-Vaxx Attacks the Same Cancer Receptor the World’s Largest Cancer Franchise
==> picture [675 x 438] intentionally omitted <==
----- Start of picture text -----
HER–Vaxx:
3 peptides P6
P4
P7
Binding site of
P4
HER-Vaxx: x3 Monoclonal
polyclonal P6 response
Binding site of
responses P7
Franchise sales annualising at
nearly $8bn growing 13%
HER-2
Receptor
Tumor cell
Click to view Mechanism
Of Action
$USD Source: Roche H1 Report http://www.roche.com/hy15e.pdfhttp://www.roche.com/hy15e.pdf p12
----- End of picture text -----
- $USD Source: Roche H1 Report http://www.roche.com/hy15e.pdfhttp://www.roche.com/hy15e.pdf p12
8
Phase 1b/2, in 2016 in Gastric Cancer
Trial to be done under a IND
-
Open label
-
15 patients, x 3 groups of 5 patients
- Open label - ~68 patients from sites in Asia - Combination with chemo -
Combination with chemo
-
Endpoints:
-
Recommended Phase 2 Dose of HER-Vaxx
-
Safety: any HER-Vaxx toxicity
-
Immunogenicity (anti-HER-2 antibody titres)
-
Test booster schedule
- (q 4 weeks or 8 weeks)
-
Randomized
-
Primary Endpoints:
-
Overall Survival
-
Progression-Free Survival
-
Secondary endpoint:
-
Immune response
==> picture [90 x 16] intentionally omitted <==
9
Leadership – Extensive Drug Development Experience
==> picture [72 x 72] intentionally omitted <==
Leslie Chong
Chief Operating Officer
-
Over 19 years of oncology experience in Phase I - III of clinical program development
-
Leadership role involvement in 2 marketed oncology products
==> picture [72 x 72] intentionally omitted <==
Prof Ursula Wiedermann Chief Scientific Officer
-
Co-inventor of Her-Vaxx; inventor of mimotope platform technology
-
Professor of Vaccinology at Medical University of Vienna
-
Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco
==> picture [72 x 72] intentionally omitted <==
==> picture [72 x 72] intentionally omitted <==
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
==> picture [72 x 72] intentionally omitted <==
==> picture [72 x 72] intentionally omitted <==
Dr Nick Ede
Chief Technology Officer
-
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
==> picture [90 x 16] intentionally omitted <==
10
Strong News Flow in the next 12 months
Report Phase 2 results 2H 2019 Recruit for Phase 1b mimotope trial 2H 2018 US FDA IND allowed for mimotope 1H 2018
Recruit and run randomized controlled Phase 2 trial 2H 2017 Report Phase 1b trial results late 2H 2017 IND enabling GLP, Safety, Tox results of mimotope 2H 2017 Recruitment Progress and dose selection on Phase 1b 1H-2H 2017 Preclinical in vivo, in vitro results for 1[st] mimotope 1H 2017 Other Mimotopes Identified 1H 2017 1[st] mimotope candidate 1H 2017 First Patient In Phase 1b trial 2H 2016 Phase IB Study initiated/Started 2H 2016
Announce preclinical toxicology results (WIL) 2H 2016 Announce preclinical immunologic results (Charles River) 2H 2016 First regulatory and ethic board package submission 1H 2016 Appoint principal investigator 1H 2016 Her-Vaxx GMP clinical batch complete 1H 2016
mimotope HER-Vaxx
==> picture [90 x 16] intentionally omitted <==
11
Thank you
Leslie Chong Chief Operating Officer [email protected] +61 458 040 433
Paul Hopper Executive Chairman [email protected] +61 406 671 515
==> picture [90 x 16] intentionally omitted <==
12