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IMUGENE LIMITED — AGM Information 2018
Nov 12, 2018
65124_rns_2018-11-12_9392ad5a-9a31-4f05-a656-0cae35842d52.pdf
AGM Information
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HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPY
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Leslie Chong Managing Director & Chief Executive Officer AGM November. 2018
Developing Cancer Immunotherapies
EXECUTIVE SUMMARY
Experienced Imugene B-cell Synergistic Technology Management & Board Vaccine Pipeline Licensed from Ohio State University and The Mayo Meeting milestones Broadened and strengthened clinical Clinic Successful M&A activity programs globally, including U.S. and Appointment of Dr. Mark European centres ( 2 trials in patients) Full spectrum of indications and v Marino to C.M.O. HER-Vaxx milestones of Phase 1b targets to choose from, including Strengthening S.A.B. members completed; Phase 2 activity checkpoint inhibitors and combination commenced therapies B-Vaxx Phase 2 ongoing
- KEY-Vaxx pre-clinical work started
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A TEAM WITH A TRACK RECORD IN DRUG DEVELOPMENT
Leslie Chong (Sydney, Australia)
Managing Director & Chief Executive Officer
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Over 20 years of oncology experience in Phase I – III of clinical program development
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Leadership role involvement in two marketed oncology products
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Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco
Paul Hopper (Sydney, Australia) Executive Chairman
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International & ASX biotech capital markets experience particularly in immuno-oncology & vaccines
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Former Chairman of Viralytics, Founder & Director of Prescient, Founder of Imugene & Polynoma LLC, former Director pSivida, Somnomed & Fibrocell Science
Dr Mark Marino (California, U.S.A.) Chief Medical Officer
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Over 28 years of experience in drug development
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Former CMO of Cytori, Head of Clinical Pharmacology at Eisai and Roche, Head of Research and Early Development at Mannkind, VP Clinical Development at Daiichi
Dr Nick Ede (Melbourne, Australia)
Chief Technology Officer
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Over 25 years peptide vaccine and drug development
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Former CEO Adistem, CEO Mimotopes
Dr Axel Hoos (Philadelphia, U.S.A.)
Non-Executive Director
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VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology
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Senior Vice President and Head of Oncology at GSK
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Former Medical Lead for Yervoy, the first survival improving medicine in Immuno-Oncology
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Chairman of the BoD of the Sabin Vaccine Institute
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Co-Chair of the Cancer Immunotherapy Consortium Think-Tank
Mr. Charles Walker (Brisbane, Australia)
Dr Anthony Good (Sydney, Australia) Vice President of Clinical Research
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Over 20 years global clinical development experience.
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Integral to the development of significant new medicines including Viagra, Revatio, Lipitor, and Somavert.
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Ex Pfizer Global Research and Development, Ex Covance Clinical Services.
Non-Executive Director
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Experienced listed biotech CEO and CFO (ASX;ACL and ASX:IMU)
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Experienced in financial markets including executing 55 international tech corporate transactions
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Clinical experience includes managing pipeline of drugs in all stages form discovery, through to Phase III to launched products
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IMUGENE SCIENTIFIC ADVISORY BOARD
Prof Pravin Kaumaya Ohio State University, U.S.A.
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Prof of Medicine Department of Obstetric Gynecology at Ohio State University
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Research focus in tumour immunology, mechanisms of tumour cell-immune cell interactions, and immune mechanisms
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Research focus on fields of vaccine with emphasis on peptide vaccines for cancer
Prof. Ursula Wiedermann-Schmidt Medical University of Vienna, Austria
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Co-inventor of HER-Vaxx
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Professor of Vaccinology at Medical University of Vienna
Prof Peter Schmid
Barts Cancer Institute, Queen Mary University of London
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Medical Oncologist
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Expertise in breast and lung cancer, cancer immunotherapy and early drug development
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Leads the Centre of Experimental Medicine at Barts Cancer Institute
Prof. Josep Tabernero
Vall d’Hebron, Barcelona, Spain
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President of European Society for Medical Oncology (ESMO)
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President of the Medical Oncology Department at the Vall d’Hebron
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• Director of the Vall d”Hebron Institute of Oncology (VHIO)
Dr Neil Segal
Memorial Sloan Kettering Cancer Center, U.S.A.
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Medical Oncologist
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Expertise in GI, Colon, Pancreatic cancers
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Active clinical immuno-oncology researcher
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Clinical lead in several trials using PD-L1 inhibitors
Prof Tanios BekaiI Saab
Mayo Clinic, U.S.A.
Dr Yelina Janjigian
Memorial Sloan Kettering Cancer Center, U.S.A.
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Medical Oncologist
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Expertise in esophageal and stomach (gastric) cancer
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Active in GI clinical trials testing combinations of Her-2 and checkpoint inhibitor therapies
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Professor of College of Medicine and Science
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Program Co-Leader, GI Cancer, Mayo Clinic Cancer Center
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Medical Director, Cancer Clinical Research Office (CCRO)
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Senior Associate Consultant, Mayo Clinic AZ
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A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER?
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In a facility: Using B-cells in your body
VS
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B-cells are cells in the
human body that
naturally produce
millions of antibodies
Teaching B-cells to make antibodies using peptide
For example, Merck’s PD-1 inhibitor Keytruda
antigens
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CURRENT PHASE 1B/2, IN GASTRIC CANCER
Phase 1b Lead-in
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Open label
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~Up to 18 patients in 3 cohorts of up to 6 pts per cohort
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Combination with chemo/cisplatin
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Endpoints:
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Recommended Phase 2 Dose of HER-Vaxx
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Safety: any HER-Vaxx toxicity
Phase 2
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Open label
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~70 patients from sites in Asia
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Combination with chemo
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Randomized
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Primary Endpoints: v
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TBD PFS and/or OS
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(cont. on Ph1b results)
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•
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Immunogenicity (anti-HER-2 antibody titres) Secondary endpoint:
- Immune response
2H, 2018: Phase 1B 2H, 2017 : Phase 1B Completed 1H, 2019: Commence Phase Patients Enrolled 2
1H, 2020: Interim Phase 2 Data Available 5
STRATEGIC AQUISITION
WORLDWIDE EXCLUSIVE LICENSE
Six additional Three year Six patent IND ready PD-1 Ongoing Her-2 clinical candidates R&D contract with families, clinical trial clinical trial Her-1, Her-2, Her-3, access to Ohio 22 patents (Phase 1) (Phase 2) VEGF, IGF-1R CD28 translational labs Access to experience and expertise with Prof. Pravin Kaumaya and team
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PROF PRAVIN KAUMAYA & DR TANIOS BEKAII SAAB
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IMUGENE PIPELINE
CLINIC OR CLINIC READY
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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
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DISCOVERY PIPELINE
PROGRAM DISCOVERY/PRE-CLINICAL ID OF CANDIDATE
Her-1 (EGFR)
Her-3
IGF-1R
VEGF
Combination (numerous)
PD-1/PD-L1
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PD-1 “KEY-VAXX” VACCINE PHASE 1 DEVELOPMENT PATH 2018-2019
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Finalise regulatory
PD-1 2019: Commence
Formal IND submissions
CMC
candidate vaccine Phase 1
pre-clinical
manufacturing
Identified May, 2018
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Proposed Adaptive Phase 1/2
Expansions Assumption
PD-1 Vaccine Design
Cohort 3 3 - 6 OBD Indication Expansion
(12-20 patients)
Dose Finding
Proof of
Signal Seeking
Cohort 2 3 - 6 Expansion Concept
Safety
Immunogenecity
Tumor PD Indication Expansion
(12-20 patients)
Cohort 1 3 - 6
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FINANCIAL SUMMARY
ASX:IMU Options on issue
| Market Cap (Nov 18): | $75.8M AUD, $54.5M USD |
| Ordinary Shares: | 3.610 billion |
| 12 month price range: | 1.3 cents – 4 cents AUD |
| Avg daily volume: | 9M shares (August - November 2018) |
| Investment to Date: | ~$42.5M (public) ~$ 5.5M (VC) |
| Cash & Equivalents: | $23.83M (as at 30 Sep 2018) |
| No. of options | No. of options | Exercise Price | Exercise Price | Expiry | |||
|---|---|---|---|---|---|---|---|
| Listed: (IMUOA) |
242.5M | $0.026 | 30/11/2020 | ||||
| Listed: (IMUOB) |
248.3M | $0.04 | 30/11/2021 | ||||
| Unlisted: | 59.5M | $0.0247* | 09/03/2020* | ||||
| Total: | 550.3M | $0.03* | 02/01/2021* | ||||
| No. of Shares | % Capital | ||||||
| Private Portfolio Management | 224,551,412 | 6.22% | |||||
| Platinum Asset Management | 119,490,971 | 3.31% | |||||
| Dr. Nicholas Smith | 86,000,000 | 2.38% | |||||
| Paul Hopper Executive Chairman |
75,678,722 | 2.10% | |||||
| Sarah Cameron | 60,000,000 | 1.66% |
Leslie Chong Chief Executive Officer & v Managing Director [email protected]
+61 458 040 433