HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPY - A PARADIGM SHIFT IN PLAY NICHOLAS EDE, PHD CHIEF TECHNOLOGY OFFICER WHOLESALE INVESTORS SEPTEMBER 7 ...
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ASX:IMU
HARNESSING B-CELLS FOR
v
CANCER IMMUNOTHERAPY
A Paradigm Shift in Play
Nicholas Ede, PhD
Chief Technology Officer
Wholesale Investors
September 7 /2018
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
Imugene Limited about future events are subject to risks, uncertainties and other
(ASX:IMU) factors, many of which are outside Imugene Limited’s control.
Important factors that could cause actual results to differ materially
Level 3, 62 Lygon Street,
from any assumptions or expectations expressed or implied in this
Carlton VIC 3053
brochurev include known and unknown risks. As actual results may
Dr Nick Ede differ materially to any assumptions made in this brochure, you are
Chief Technology Officer
urged to view any forward looking statements contained in this
m: +61 (0) 400 642 254 brochure with caution. This presentation should not be relied on as a
e: nede@imugene.com recommendation or forecast by Imugene Limited, and should not be
w: imugene.com construed as either an offer to sell or a solicitation of an offer to buy
or sell shares in any jurisdiction.
2
Imugene develops vaccines to boost and direct
the body’s immune vsystem to specifically
target and attack cancer cells
3
A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER?
In a facility: Using B-cells in your body
VS
v
B-cells are cells in
the human body
that naturally
produce millions of
antibodies
For example, Merck’s PD-1 inhibitor Keytruda Teaching B-cells to make antibodies using peptide
antigens
4
Why go for active immunization against
cancer ?
Difference between passive
immuno-therapy and active
vaccination
v
5
ASX:IMU
Importance of differentiation
v
in an
increasingly crowded market
6
STRATEGIC ACQUISITION
Ohio State University and Mayo Clinic B-cell peptide vaccine portfolio
• Opportunity to create the pre-eminent, dominant position globally in B-cell peptide vaccines
and therapeutics. A catalyst for value creation.
• Professor Kaumaya’s work in the area of check-point inhibitors and tumor-associated
antigens such as Her-2, is highly complementary to Imugene’s existing platform and portfolio.
v
- Six patent families including composition of matter and method of use patents covering
PD-1, Her-1, Her-2, Her-3, VEGF, IGF-1R, CD28 peptide vaccines and therapeutics.
- Commercially attractive upfront payment; royalty rate in low single digit royalty on sales;
exclusive, world-wide and sub-licensable until expiry of the last patent.
• Broadens and accelerates key Imugene Research and Clinical programs
- PD-1 and HER2 + PD-1 combination programs accelerate by 24+ months
7
OSU
WORLDWIDE, EXCLUSIVE
LICENSE
v Her-
Ongoing Six additional Three year
Six patent IND ready PD- 2 clinical clinical candidates R&D contract
families, 1 clinical trial Her-1, Her-2, Her- with access to
trial 3, VEGF, IGF-1R Ohio
22 patents (Phase 1) (Phase 2) CD28 translational labs
Access to experience and expertise with Prof. Pravin
Kaumaya and team
8
WHY SELECT AND TARGET PD-1 FOR B-CELL VACCINATION?
Monoclonal antibody immunotherapies Whilst acknowledging the rapid rise in
Keytruda® (Merck) and clinical trials involving PD-1 and their
Opdivo® (BMS) targeting PD-1 sold combination with other treatments*, a PD-1
USD$3.8B and $4.9B, B-cell vaccination approach represents a
respectively, in 2017. paradigm shift in cancer immunotherapy.
* Tang etal. Comprehensive analysis of the clinical immuno-
v oncology landscape, Annals of Oncology,
. 2017
In industry-recognized mouse cancer
models (colon cancer), the PD-1
targeting B-cell vaccine is The combination of the PD-1 vaccine
more superior than the gold standard with the acquired Phase II Her-2 vaccine
mouse PD-1 monoclonal antibody significantly inhibits tumor growth
(used in preclinical model testing for c/w mAb control in a Her-2+ model of
Keytruda and Opdivo). colon cancer.
9
PD-1/Her-2 vaccine combination active in model of colorectal
cancer with no signs of toxicity
% Cancer growth inhibition in Colorectal cancer model • All mice vaccinated over a period of 9
weeks showed no signs of scruffiness,
lesions, and lethargy
PD-1 vaccine plus Her-2 vaccine 90%
• Organs (spleen, liver, heart, lung, kidney,
and tumor) from the Balb/c mice
PD-1 vaccine vaccinated with combination peptides
65%
(HER-2 and PD-1) were collected from
v mice and submitted for analysis
PD-1 mAb 39% • No significant lesions were noted in any
of the organs submitted for histologic
evaluation.
Control (PBS) 0% • There were also no overt biochemical
abnormalities noted.
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Inhibition of cancer growth 16 days after infusion of cancer cells
10PD-1 “KEY-VAXX” VACCINE PHASE 1 DEVELOPMENT PATH 2018-2019
Finalise
PD-1 Formal regulatory IND 2019:
CMC Commence
candidate vaccine manufacturing pre-clinical submissions
Phase 1
Identified May,
2018
v
Proposed Adaptive Phase 1/2
Expansions Assumption
PD-1 Vaccine Design
Cohort 3 3-6 Indication
OBD
Expansion
Dose Finding (12-20 patients)
Signal Seeking Proof of
Cohort 2 3-6 Expansion Concept
*Safety
*Immunogenecity
Indication Expansion
*Tumor PD (12-20 patients)
Cohort 1 3-6
11IMMUNO-ONCOLOGY COMBINATIONS DRIVING VALUE
• Combining drugs for better I/O outcomes is driving value
creation presently
• Big Pharma are looking for novel combinations or “elusive
blends” that;
v
• Combine without increasing toxicity
• Combine with minimal cost increase
• Combine for better response rates and efficacy
• Imugene’s cancer vaccines potentially tick all three boxes
1
2Combination example
• July 2018, FDA approves Opdivo plus Yervoy combination for a certain subset of patients with
metastatic colorectal cancer
• The FDA approval of combination Opdivo and Yervoy provides a novel therapeutic option with
a higher response rate than that from monotherapy immunotherapy, BUT
v
• Unfortunately, more significant toxicity is noted with the combination, and diligence is needed
to monitor these immune-mediated side effects
• Although early in development, Imugene’s PD-1 and Her-2 cancer vaccines potentially provide
efficacy and response rate with minimal toxicity
13PROFESSOR PRAVIN KAUMAYA & DR. TANIOS BEKAII SAAB
For reprint orders, please contact: reprints@futuremedicine.com
Could precision-engineered
Editorial
Future Oncology
peptide epitopes/vaccines be the
key to a cancer cure?
v
“Combination cancer vaccines with peptide
mimics have the potential to treat existing cancer
and prevent its recurrence.”
Pravin TP Kaumaya
The Ohio State University, Department of Obstetrics & Gynecology, Suite 316 Medical Research Facility,
420 W. 12th Ave., Columbus, OH 43210, USA n kaumaya.1@osu.edu
The combination of different vaccine and thera- or the receptors themselves and small-molecule
peutic strategies to target specific molecular path- inhibitors that target the intracellular kinase
ways that are dysregulated in tumors may create domains of RTKs [4–6] . 1
clinical breakthroughs for safe and efficacious 4A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT
Leslie Chong (Sydney, Australia) Dr Nick Ede (Melbourne, Australia)
Managing Director & Chief Executive Officer Chief Technology Officer
• Over 20 years of oncology experience in Phase I – III of • Over 25 years peptide vaccine and drug development
clinical program development
• Former CEO Adistem, CEO Mimotopes
• Leadership role involvement in two marketed oncology
products • VP Chemistry Chiron (now Novartis), Research Fellow CRC
Vaccine Technology
• Previously Senior Clinical Program Lead at Genentech, Inc.,
in San Francisco
Dr Axel Hoos (Philadelphia, U.S.A.) Dr Anthony Good (Sydney, Australia)
Non-Executive Director Vice President of Clinical Research
• Senior Vice President and Head of Oncology at GSK • Over 20 years global clinical development experience.
• Former Medical Lead for Yervoy, the first survival improving v • Integral to the development of significant new medicines
medicine in Immuno-Oncology
• Chairman of the BoD of the Sabin Vaccine Institute including Viagra, Revatio, Lipitor, and Somavert.
• Co-Chair of the Cancer Immunotherapy Consortium Think-Tank • Ex Pfizer Global Research and Development, Ex Covance
Clinical Services.
Paul Hopper (Sydney, Australia) Dr Mark Marino (San Diego, U.S.A.)
Executive Chairman Chief Medical Officer
• International & ASX biotech capital markets experience • Leads the Company’s global clinical development,
particularly in immuno-oncology & vaccines regulatory and medical monitoring activities
• Former Chairman of Viralytics, Founder & Director of • Previously held CMO positions at Daiichi-Sankyo,
Prescient, Founder of Imugene & Polynoma LLC, former Hoffman-La Roche AG, and Novartis
Director pSivida, Somnomed & Fibrocell Science • Dr Marino holds a Medical Doctor degree from the
Albert Einstein College of Medicine
15Imugene Scientific Advisory Board
Professor Peter Schmid (Barts Cancer Inst., Prof Ursula Wiedermann (Vienna, Austria)
London) Chief Scientific Officer
Chair of Cancer Medicine, Queen Mary Hospital London • Co-inventor of HER-Vaxx
• Expertise in breast and lung cancer, cancer immunotherapy • Professor of Vaccinology at Medical University of Vienna
and early drug development
• Leads the Centre of Experimental Medicine at Barts Cancer
Institute
Dr Yelina Janjigian (MSKCC, U.S.A.) Dr Neil Segal (MSKCC, U.S.A.)
Medical Oncologist Medical Oncologist
• Expertise in esophageal and stomach (gastric) cancer • Expertise in GI, Colon, Pancreatic cancers
• Active in GI clinical trials testing combinations of Her-2 and
v • Active clinical immuno-oncology researcher
checkpoint inhibitor therapies
• Clinical lead in several trials using PD-L1 inhibitors
Our competition is cancer, and in that fight, we’re collaborating with an
outstanding team of medical researchers and oncologists
16FINANCIAL SUMMARY
ASX:IMU
Options on issue (as at July 2018)
No. of options Exercise Price Expiry
Market Cap (31/Jul/18): $79.2M AUD, $58.9M USD Listed:
242.5M $0.026 30/11/2020
(IMUOA)
Listed:
Ordinary Shares: 3.559 billion 248.3M $0.04 30/11/2021
(IMUOB)
Unlisted: 79.5M $0.024* 09/03/2020*
12 month price range: 1.3 cents – 3.9 cents AUD
Total: 570.3M $0.03* 01/07/2020*
9.5M shares * Average
Avg daily volume: v Top 5 shareholders (as at July 2018)
(April-July 2018)
No. of Shares % Capital
~$42.5M (public)
Investment to Date: National Nominees Limited 240,906,746 6.69%
~$ 5.5M (VC)
HSBC Custody Nominees
165,986,536 4.61%
$25.8M Limited
Cash & Equivalents:
(as at 31 July 2018) Dr. Nicholas Smith 86,000,000 2.39%
J P Morgan Nominees
79,957,741 2.22%
Australia Limited
Paul Hopper
75,678,722 2.10%
Executive Chairman
17EXECUTIVE SUMMARY
• Imugene B-cell vaccine pipeline: Broadened and strengthened clinical programs
globally, brings the Imugene platform and technology into US and European focused
clinical trials
• Synergistic technology acquisition from Ohio State University and The Mayo
Clinic: Full spectrum of indications and targets to choose from, including check
point inhibitors and combination therapies. Accelerates and advances Imugene
v
PD-1 vaccine program by 24 months
• Experienced management & board: Meeting milestones and successful M&A
activity
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