HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPY - v Leslie Chong Managing Director & Chief Executive Officer September /2018
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ASX:IMU
v
HARNESSING B-CELLS FOR
CANCER IMMUNOTHERAPY
Leslie Chong
Managing Director & Chief Executive Officer
September /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 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.
v
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 in which it would be a contravention of
applicable law.
2
EXECUTIVE SUMMARY
• Experienced management & board: Meeting milestones and successful
M&A activity
• Imugene B-cell vaccine pipeline: Broadened and strengthened clinical
programs globally, include U.S. and European centres
• HER-Vaxx milestones of Phase v1b recruitment completed; Phase 2
activity commences
• KEY-Vaxx pre-clinical work started
• Synergistic technology licensed from Ohio State University and The Mayo
Clinic: Full spectrum of indications and targets to choose from, including
check point inhibitors and combination therapies
3
A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT
Leslie Chong (Sydney, Australia) Prof Ursula Wiedermann (Vienna, Austria)
Managing Director & Chief Executive Officer Chief Scientific Officer
• Over 20 years of oncology experience in Phase I – III of • Co-inventor of HER-Vaxx
clinical program development
• Leadership role involvement in two marketed oncology • Professor of Vaccinology at Medical University of Vienna
products
• Previously Senior Clinical Program Lead at Genentech, Inc.,
in San Francisco
Dr Axel Hoos (Philadelphia, U.S.A.) Mr. Charles Walker (Brisbane, Australia)
Non-Executive Director Non-Executive Director
• Senior Vice President and Head of Oncology at GSK • Experienced listed biotech CEO and CFO (ASX;ACL and ASX:IMU)
• Former Medical Lead for Yervoy, the first survival improving • Experienced in financial markets including executing 55
medicine in Immuno-Oncology international tech corporate transactions
• Chairman of the BoD of the Sabin Vaccine Institute
• Clinical experience includes managing pipeline of drugs in all
• Co-Chair of the Cancer Immunotherapy Consortium Think-Tank
v stages form discovery, through to Phase III to launched products
Paul Hopper (Sydney, Australia) Dr Nick Ede (Melbourne, Australia)
Executive Chairman Chief Technology Officer
• International & ASX biotech capital markets experience • Over 25 years peptide vaccine and drug development
particularly in immuno-oncology & vaccines
• Former CEO Adistem, CEO Mimotopes
• Chairman of Viralytics, Founder & Director of Prescient,
Founder of Imugene & Polynoma LLC, former Director • VP Chemistry Chiron (now Novartis), Research Fellow CRC
pSivida, Somnomed & Fibrocell Science Vaccine Technology
Dr Mark Marino (California, U.S.A.) Dr Anthony Good (Sydney, Australia)
Chief Medical Officer Vice President of Clinical Research
• Over 28 years of experience in drug development • Over 20 years global clinical development experience.
• Integral to the development of significant new medicines
• Former CMO of Cytori, Head of Clinical Pharmacology at including Viagra, Revatio, Lipitor, and Somavert.
Eisai and Roche, Head of Research and Early Development • Ex Pfizer Global Research and Development, Ex Covance
at Mannkind, VP Clinical Development at Daiichi-Sankyo Clinical Services. 4
IMUGENE SCIENTIFIC ADVISORY BOARD
Prof Peter Schmid Prof Ursula Wiedermann-Schmidt
Barts Cancer Institute, Queen Mary University of Medical University of Vienna, Austria
London Chief Scientific Officer
Consultant Medical Oncologist • 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
v
Dr Neil Segal Dr Yelina Janjigian
Memorial Sloan Kettering Cancer Center, U.S.A. Memorial Sloan Kettering Cancer Center, U.S.A.
Medical Oncologist Medical Oncologist
• Expertise in GI, Colon, Pancreatic cancers • Expertise in esophageal and stomach (gastric) cancer
• Active clinical immuno-oncology researcher • Active in GI clinical trials testing combinations of Her-2 and
• Clinical lead in several trials using PD-L1 inhibitors checkpoint inhibitor therapies
9
Imugene develops vaccines to boost and
direct the body’s immune system to specifically
target and
v
attack cancer
cells.
6
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
7
CURRENT PHASE 1B/2, IN GASTRIC CANCER
Phase 1b lead-in Phase 2
• Open label • Open label
• ~70 patients from sites in Asia
• ~Up to 18 patients in 3 cohorts of up to 6 pts per
cohort • Combination with chemo
• Combination with chemo/cisplatin • Randomized
• Primary Endpoints:
• Endpoints:
- TBD PFS and/or OS
- Recommended Phase 2 Dose of HER-Vaxx
- Safety: any HER-Vaxx toxicity
v - (cont. on Ph1b results)
• Secondary endpoint:
- Immunogenicity (anti-HER-2 antibody titres) - Immune response
2H, 2017 : Phase 1B 2H, 2018: Phase 1B 1H, 2019: Commence 1H, 2020: Interim Phase
Patients Enrolled Recruitment Completed Phase 2 2 Data Available
8
STRATEGIC ACQUISITION
WORLDWIDE, EXCLUSIVE
LICENSE
Ongoing
v Her- 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
9
PROFESSOR PRAVIN KAUMAYA & DR. TANIOS BEKAII SAAB
v
10IMUGENE PIPELINE
CLINIC OR CLINIC READY
CLINICAL DEVELOPMENT
PROGRAM PRE-CLINICAL
PHASE 1 PHASE 2
HER-Vaxx (HER2)
B-Vaxx (HER2)
KEY-Vaxx (PD-1)
Her-2 & PD-1 Combo
v
DISCOVERY PIPELINE
PROGRAM DISCOVERY/PRE-CLINICAL ID OF CANDIDATE
Combination:
Her-1; Her-2; Her-3; IGF-1R
Her-1 (EGFR)
Her-3
IGF-1R
VEGF
Combination (numerous)
PD-1/PDL-1
11ACQUIRED HER-2 VACCINE (B-VAXX): ENCOURAGING PHASE
1 TRIAL RESULTS
160%
dose level 1
140%
dose level 2
% maximal change in SPD from baseline
✭10 out of 24 patients 120%
dose level 3
had stable disease & 1 100% dose level 4
out of 24 patients had 80% ✭Best Response
partial response; 1 60% † PR
patient had PFS at 40+ * SD
40%
months * PD if not indicated
20% *
v* ** *
0%
-20%
No toxicity
observed -40% †
-60% *
-80%
Phase Ib Immunotherapy Trial with a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide
Vaccine emulsified in ISA 720 and nor-MDP Adjuvant in Patients with Advanced Solid Tumors, Immunological Response and Clinical
Outcome. Tanios Bekaii-Saab, Daniel H. Ahn, Christina Wu, Robert Wesolowski, Amir Mortazavi, Maryam Lustberg, Jeffrey Fowler,
Bhuvaneswari Ramaswamy, Lai Wei, Jay Overholser and Pravin T.P. Kaumaya.
Cancer Discovery 2018 manuscript in preparation 12WHY 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.
13PD-1/HER-2 VACCINE COMBINATION ACTIVE IN MODEL
OF COLORECTAL CANCER WITH NO SIGNS OF TOXICITY
➤ All mice vaccinated over a period of 9 weeks % Cancer growth inhibition in Colorectal cancer model
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 vaccinated with
combination peptides (HER-2 and PD-1)
PD-1 vaccine 65%
were collected from mice and submitted for v
analysis
➤ No significant lesions were noted in any of PD-1 mAb 39%
the organs submitted for histologic
evaluation.
Control (PBS) 0%
➤ There were also no overt biochemical
abnormalities noted. 0% 20% 40% 60% 80% 100%
Inhibition of cancer growth 16 days after infusion of cancer cells
14PD-1 “KEY-VAXX” VACCINE PHASE 1 DEVELOPMENT PATH 2018-2019
Finalise
Formal regulatory IND 2019:
PD-1 CMC
pre-clinical submissions Commence
candidate vaccine manufacturing 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
10FINANCIAL 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
(April-July 2018) Top 5 shareholders (as at July 2018)
No. of Shares % Capital
~$42.5M (public)
Investment to Date: Private Portfolio Management 240,906,746 6.69%
~$ 5.5M (VC)
Platinum Asset Management 165,986,536 4.61%
$25.8M
Cash & Equivalents: Dr. Nicholas Smith 86,000,000 2.39%
(as at 31 July 2018)
J P Morgan Nominees
79,957,741 2.22%
Australia Limited
Paul Hopper
75,678,722 2.10%
Executive Chairman
16EXECUTIVE SUMMARY
Imugene B-cell
Vaccine Pipeline Synergistic Technology
Broadened and Acquisition from
strengthened clinical Experienced
Ohio State University
programs globally, brings Management &
the Imugene platform and and The Mayo Clinic
technology into US Board
Full spectrum
v of indications and
and European focused
targets to choose from, including Meeting milestones and
clinical trials
check point inhibitors and successful M&A activity
combination therapies.
Accelerates and advances
Imugene PD-1 vaccine program by
24 months
17EXECUTIVE SUMMARY
• Experienced management & board: Meeting milestones and successful
M&A activity
• Imugene B-cell vaccine pipeline: Broadened and strengthened clinical
programs globally, include U.S. and European centres
• HER-Vaxx milestones of Phase v1b recruitment completed; Phase 2
activity commences
• KEY-Vaxx pre-clinical work started
• Synergistic technology licensed from Ohio State University and The Mayo
Clinic: Full spectrum of indications and targets to choose from, including
check point inhibitors and combination therapies
18Leslie Chong
Chief Executive Officer &
Managing Director
v
leslie.chong@imugene.com
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