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IMUGENE LIMITED — Investor Presentation 2019
Apr 30, 2019
65124_rns_2019-04-30_9f9787d2-6381-484a-8115-4f340dd6ed10.pdf
Investor Presentation
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ASX Announcement
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Imugene to Present at Planet MicroCap Showcase 2019
SYDNEY, Australia, 1 May 2019 : Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced its participation in the Planet MicroCap Showcase Conference.
Leslie Chong, MD and CEO of Imugene, is scheduled to present a corporate overview and business update on 1 May 2019 in Las Vegas, United States.
The presentation is enclosed in this announcement and is available on the Imugene website.
For further information please contact:
Leslie Chong
Managing Director and Chief Executive Officer
T: +61 458 040 433
Follow us on Twitter @TeamImugene
Like us on Facebook @Imugene
Connect with us on LinkedIn @Imugene Limited
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Our unique platform technology seeks to harness the body’s immune system to generate antibodies against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody therapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.
IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected]
Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become a foundation treatment for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.
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IMUGENE LIMITED ACN 009 179 551
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AN EMERGING LEADER IN CANCER IMMUNO-ONCOLOGY Investor Presentation May 2019
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N OTI C E : FO RWAR D LO O KI N G STATE ME N T S
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 in which it would be a contravention of applicable law.
Key investment highlights
Strong preliminary results from ongoing clinical trials
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Promising Phase 1 clinical trial results across lead candidate B cell vaccines
-
Currently have two therapies (HER-Vaxx and B-Vaxx) in Phase 2 studies with a pipeline of other therapies and combinations undergoing earlier stage development
-
Robust pipeline of novel B cell vaccines targeting large therapeutic areas
Robust pipeline of B cell vaccines targeting high potential areas
-
Immuno-oncology treatments are at the forefront of cancer innovation with the leading drugs[1] generating over US$23bn in 2018
-
Vision to transform and improve the treatment of cancer patients
-
Company currently fully funded in supporting all clinical research programs
Fully funded to progress clinical program
-
Focus on continuing to build awareness for the product through acceptance of abstracts and presentations at key industry conferences such as AACR
-
A number of key clinical and preclinical catalysts are expected in 2019
Best in class leadership team with a track record in drug development
Active market with numerous commercialisation and M&A opportunities in the sector
-
Experienced board and management team with successful track record developing, licensing and commercialising early stage drugs
-
Currently targeting the gastric and lung cancer market with the potential to extend beyond these indications in the future
-
The immuno-oncology sector has attracted intense interest from big pharma as highlighted from recent M&A and licensing deals
Notes:
- The subset Herceptin, Perjeta, Opdivo and Keytruda
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Lead by an experienced management team which have significant clinical development commercialisation expertise in the sector
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Leslie Chong
SYDNEY, AU
Managing Director & CEO
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Paul Hopper SYDNEY, AU Executive Chairman
Dr Axel Hoos PHILADELPHIA, USA Non-Executive Director
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20+ years of oncology experience across Phase I – III clinical development programs
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Founder of Imugene
-
Senior Vice President and Head of Oncology at GSK
-
Extensive international & ASX biotech capital markets experience particularly in immuno-oncology & vaccines
-
Former Medical Lead for Yervoy, the first immunooncology treatment to improve first survival
-
Ex Senior Clinical Program Lead at Genentech, one of the world’s most successful biotech businesses which sold the best selling breast cancer drug Herceptin
-
Former Chairman of Viralytics, Founder & Director of Prescient
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Chairman of the BoD of the Sabin Vaccine Institute
-
Co-Chair of the Cancer Immunotherapy Consortium Think-Tank
-
Also worked at global majors GSK and Exelixis
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Mr Charles Walker BRISBANE, AU Non-Executive Director
-
Experienced listed biotech CEO and CFO (ASX:ACL and ASX:IMU)
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Extensive financial markets experience having executed 50+ cross border transactions
-
Clinical experience includes managing pipeline of drugs in all stages from discovery, through to Phase III to product launch
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Management team
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Dr Lesley Russell
SYDNEY, AU
Non-Executive Director
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25+ years of senior international operational and leadership experience having worked at Amgen, Eli Lilly, Teva, and Cephalon
-
Extensive knowledge and experience with new drug development
Dr Mark Marino CALIFORNIA, USA Chief Medical Officer
Dr Nick Ede MELBOURNE, AU Chief Technology Officer
-
28+ years of experience in drug development
-
25+ years peptide vaccine and drug development
-
Former CMO of Cytori, • Former CEO Adistem and Head of Clinical CEO of Mimotopes Pharmacology • VP Chemistry Chiron (now at Eisai and Roche, Head Novartis), Research Fellow
-
of R&D at Mannkind and CRC Vaccine Technology
-
VP Clinical Development at Daiichi
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Dr Anthony Good SYDNEY, AU Vice President of Clinical Research
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20+ years experience in global clinical development
-
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
Imugene has a team with oncology drug development experience
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Imugene‘s Scientific Advisory Board consists of world leading oncologist, researchers and developers
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Prof Pravin Kaumaya OHIO STATE UNIVERSITY, USA
-
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
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Dr. Michael Galigiuri CITY OF HOPE, USA
-
President of City of Hope National Medical Center and holds the Deana and Steve Campbell Physicianin-Chief.
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Elected President of the American Association for Cancer Research (AACR) in 2017
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Prof. Josep Tabernero VALL D’HEBRON, BARCELONA, SPAIN
-
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)
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Prof Tanios BekaiI Saab MAYO CLINIC, USA
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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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Prof. Ursula
Prof Peter Schmid
Wiedermann-Schmidt
BARTS CANCER INSTITUTE,
MEDICAL UNIVERSITY OF VIENNA,
QUEEN MARY UNIVERSITY OF LONDON
AUSTRIA
• Medical Oncologist • Co-inventor of HER-Vaxx
• Expertise in breast and • Professor of Vaccinology
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Dr Neil Segal
MEMORIAL SLOAN KETTERING
CANCER CENTER, USA
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Dr Yelina Janjigian MEMORIAL SLOAN KETTERING CANCER CENTER, USA
-
Medical Oncologist
- Medical Oncologist
-
Expertise in GI, Colon, Pancreatic cancers
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Professor of Vaccinology at Medical University of Vienna
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Expertise in esophageal and stomach (gastric) cancer
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Expertise in breast and lung cancer, cancer immunotherapy and early drug development
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immunotherapy and early • Active clinical immuno• Active in GI clinical trials drug development oncology researcher testing combinations of Her-
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• Leads the Centre of • Clinical lead in several 2 and checkpoint inhibitor Experimental Medicine at trials using PD-L1 therapies Barts Cancer Institute inhibitors
Imugene has a world renowned advisory board of scientists and oncologists
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Immuno–oncology: A high-value therapeutic approach
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Immuno-oncology - A rapidly growing market
B cell peptide vaccines provide potential benefits
-
ü Potentially leading to a better outlook for the long term survival of patients with advanced cancers
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Immuno-oncology allows for a more targeted treatment
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Harnesses the patients own immune system to recognise and destroy cancer cells
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ü Has the potential to inhibit tumour recurrence with potentially less toxic side effects
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Multiple first-line treatments approved
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A pioneer and leader in the B cell peptide cancer vaccine space
-
Imugene is the market pioneer and leader in B cell peptide cancer vaccines
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Currently has the most advanced B cell peptide cancer vaccines clinical program in the industry
I n v e s t o r P r e s e n t a t i o n
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B cell based antibodies have distinct advantages to existing treatments
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| B cell Vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which enhances durability of response. |
N A T U R A L B C E L L D E R I V E D A N T I B O D I E S M O N O C L O N A L A N T I B O D I E S |
|
|---|---|---|
| Safety Efficacy Durability Usability 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) Polyclonal Ab response reduces risk of resistance and potentially increases efficacy Monoclonal Ab - single shot Antibodies continuously produced a lasting immune response to inhibit tumour recurrence Half life up to 12 days sometimes less Potentially low numbers of vaccinations required per year Requires regular infusion Cost Expensive course of treatment >US$100K per year Low cost of production enables greater pricing flexibility facilitating combination |
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What is Imugene’s B cell vaccine (HER-Vaxx) trying to solve?
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HER-2 (Human Epidermal Growth Factor Receptor) stimulates cancer cells to grow
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10 - 30% of gastric, breast, ovarian and pancreatic cancer patients have tested HER-2 positive
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The incidence of increased HER2 (known as over expression) in the body is associated with a higher chance of cancer spreading and an increased probability of cancer recurrence
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HER-2 is a
clinically and
commercially
HER-2
validated target
for cancer
treatment
N O R M A L
H E A L T H Y C E L L
C A N C E R C E L L
O V E R E X P R E S S I N G
H E R - 2
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Imugene‘s products have the potential to improve upon commercialised HER-2 treatments such as Herceptain and Perjeta
I n v e s t o r P r e s e n t a t i o n
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How does HER-Vaxx work?
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3 Peptides “mimic” the epitope
(antibody binding site)
H E R - V a x x s t i m u l a t e s t h e
p a t i e n t s B c e l l s t o p r o d u c e
a n t i b o d i e s t h a t t a r g e t o n l y
t h o s e c a n c e r c e l l s w i t h
H E R - 2 o n t h e i r s u r f a c e
B c e l l s a t t a c k
t h e c a n c e r c e l l
CANCER
H E R - V A X X B C E L L
CELL
I M M U N O T H E R A P Y A C T I V AT I O N
B CELLS A N T I B O D Y
H E R - 2
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A significant market opportunity across key Imugene vaccines
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| G A S T R I C C A N C E R | L U N G C A N C E R | ||
|---|---|---|---|
| ( H E R - VA X X ) | ( K E Y- VA X X ) | ||
| Incidence | Newly diagnosed cases |
1m cases per year, globally 19% relate to HER2+ cancers |
1.8m cases per year, globally |
| 5 year relative survival rate |
< 25% | ~18% | |
| Prognosis | Survival | Median survival is 7-10 months | 17% chance of surviving at least 5 years |
| Existing | US$140,000 per year | n.a | |
| treatment | n.a | US$150,000 per year | |
| costs | n.a | US$157,000 per year |
Sources: Scientific journals, press releases and internal company findings
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Imugene has a developing pipeline of cancer vaccines
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| Clinical | Clinical | |||||
|---|---|---|---|---|---|---|
| development | development | |||||
| Pre-Clinical | Phase 1 | Phase 2 | Key Data / Results | Key IP patents | ||
| • | Successful completionof Phase 1b trials | |||||
| HER-Vaxx (HER- 2) |
• • • |
Strong trial results withno safety or toxicity issues All patients hadincreased antibody response 11/14evaluable patients with encouraging clinical |
Intellectual property patents expiring April 2027, August 2030 & April 2036 |
|||
| responses | ||||||
| • | KEY-Vaxx has shown encouraging response in | |||||
| preclinical studies | ||||||
| • | Strong inhibition of tumour growthin mouse models of | Intellectual property | ||||
| KEY-Vaxx (PD-1) | colorectal cancer (outperformed industry standard | patents expiring March | ||||
| mouse PD-1 mAb) | 2037 & February 2038 | |||||
| • | Signs of increased tumour growth inhibition when co- | |||||
| administered with B-Vaxx | ||||||
| • | Positive Phase 1 resultsand now currently in phase 2 | |||||
| • | B-Vaxx isfully fundedby OSU grant | Intellectual property | ||||
| B-Vaxx (HER-2) | • | 14/24evaluable late stage patients with encouraging | patents expiring April | |||
| clinical response | 2027 & August 2030 | |||||
| • | Pre-clinical studies showed90% cancer growth | |||||
| HER-2 & PD-1 | inhibitionin colorectal cancer model with the | |||||
| Vaccine Combination |
• | combination Potentially solves the industry problemof additive toxicity of combined checkpoint inhibitors if safety of |
||||
| vaccines maintained in combination |
I n v e s t o r P r e s e n t a t i o n
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Imugene discovery pipeline
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Imugene has the ability to advance these programs at any point
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Program Pre-clinical ID of candidate Her-1 (EGFR) Her-3 IGF-1R VEGF Combination (numerous) PD-L1
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HER-Vaxx: Successfully completed Phase 1B study…
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Phase 1b – Complete
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Trial Patients Study
Endpoints
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• •
-
Phase 1b Gastric Cancer HER-Vaxx in Recommended Phase
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• • Open label Up to 18 patients combination 2 Dose of HER-Vaxx in 3 cohorts (10, with chemo: • Safety and Toxicity
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30 and 50 µg) Cisplatin and • Immunogenicity (anti-
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5FU or HER-2
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capecitabine antibody titres)
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Study Results
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50 µg selected as the RP2D
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No safety or toxicity issues
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All patients had increased antibody response
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Best Response Rates
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1 Complete Response
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5 Partial Response
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4 Stable Disease
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I n v e s t o r P r e s e n t a t i o n
Positive results for HER-Vaxx Vaccine Phase 1b trial
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Key Findings
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ü 11 out of 14 were evaluable for vaccine-specific immune responses and tumour response assessment
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ü Those patients that were dosed with 50 micrograms showed marked increases of HER-2 specific antibody levels
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ü 2 of the 3 patients dosed with 50 micrograms demonstrated greater than 40% reduction in tumour size from baseline to day 56
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ü The vaccines were well tolerated and safe with antibody responses at the highest dose of 50 micrograms with no significant local or systemic side effects
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ü Trial showed clear dose-dependence of HER-2 specific antibody production
Change from baseline (%) in tumour size
40 20 ~~*~~ 0 -20 -40 Complete response -60 Partial response Progressive disease -80 Stable disease ~~-100~~ RECIST definitions; Complete response (CR) Disappearance[1] of all target lesions Partial response (PR) At least 30% decrease in size of target lesions At least 20% increase in size of target lesions or the appearance Progressive disease (PD) of one or more new lesions: * Target lesions decrease by 30%; per RECIST PD due to 2 new lesions Neither sufficient shrinkage to qualify for PR nor sufficient Stable disease (SD) increase to qualify for PD
- Defined as less than 10mm for the sum of all the target lesions
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I n v e s t o r P r e s e n t a t i o n
Positive results for HER-Vaxx Vaccine Phase 1b trial continued
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Key Findings
HER2-specific IgG ANTIBODIEs in Cohort 1, 2, and 3 measured in sera obtained at treatment visits
- ü The 50 µg dose of IMU-131 produced the most consistent p467 specific antibodies and HER-2 specific antibodies
compared to the 10 and 30 µg doses
-
ü All 14 patients reported adverse events with majority of the events assessed as Grade 1 to 3 severity and not related to IMU-131 , but were consistent with those known to occur with the concomitant chemotherapy
-
ü IMU-131 was well-tolerated with no significant local or systemic reactions and there was no need for pre-treatment or for modification to the dose or treatment schedule due to
safety
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…and commenced Phase 2
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Phase 2 commenced - First patient dosed March 2019
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Trial Patients Study Primary Endpoints • • • Phase 2 Gastric Cancer Randomized Overall survival • • Open label Up to 70 patients HER-Vaxx in combination • Progression-free • Asia with standard of care survival • Eastern Europe chemotherapy • India Or Secondary Endpoints Standard of care chemo: • Safety and Tolerability Cisplatin and 5FU or • Immune response capecitabine or oxaliplatin
Phase 2 designed to provide definitive data
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I n v e s t o r P r e s e n t a t i o n
KEY-Vaxx: A new entrant in the checkpoint inhibitor market
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—
How PD-1 targeted treatments work
PD-1 targeted treatments block PD-L1 expressing tumour cells from binding PD-1 on T- cells (resulting in increased activation of the T cell immune response in the tumour microenvironment)
Limitations of current treatments
-
Current checkpoint inhibiting monoclonal antibody therapies only effective in 1030% of patients
-
Require intravenous infusions every 2-3 weeks and has a high toxicity profile when used in combination
KEY-Vaxx is a PD-1 B cell vaccine , aimed to induce the body to produce polyclonal antibodies while existing commercialised immunotherapies Keytruda[®] (Merck) and Opdivo[®] (BMS) are monoclonal antibodies
Current phase: Phase 1 (commence in Q4 2019)
- Very expensive
KEY-Vaxx potentially addresses these problems
Next key milestones GLP tox results Drug manufacture FDA IND
I n v e s t o r P r e s e n t a t i o n
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How does KEY-Vaxx work?
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HOW CANCER STAYS UNDETECTED BY THE IMMUNE SYSTEM
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b i n d i n g
CANCER
CELL
P D - L 1
P R O T E I N
P
D -
R EC E 1
P
TO R
L L
- C E
T
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The PD-L1 protein binds to the PD-1 receptor and stops the T-Cell from recognising the cancer cell, allowing the cancer cell to survive and spread
KEY-VAXX STOPS THE CANCER CELL FROM AVOIDING T-CELL RECOGNITION AND KILLING
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P D - L 1
P R O T E I N
Gives T-cells the ability to
recognise the cancer cell and A N T I P D - 1 CANCER
p A b B I N D S CELL
mount an immune response T - C E L L
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- K E Y V A X X I M M U N O T H E R A P Y Induces the body to produce polyclonal A N T I P D - 1 antibodies (pAb) p A b
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ANTI PD-1 antibody RESPONSE
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PD-1/HER-2 Combination: Potential to increase response rates in HER-2+ cancers
Immuno-oncology combinations driving value
-
Combining drugs for better immuno-oncology outcome is driving value creation
-
Big Pharma are looking for novel combinations that
-
ü Combine without increasing toxicity
-
ü Combine with minimal cost increase
ü Combine for better response rates and efficacy
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% C A N C E R G R O W T H I N H I B I T I O N I N C O L O R E C T A L C A N C E R M O D E L
PD-1 vaccine plus Her-2 vaccine 90%
PD-1 vaccine 65%
PD-1 mAb 39%
Control (PBS) 0%
0% 20% 40% 60% 80% 100%
Inhibition of cancer growth 16 days after infusion of cancer cells
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Opdivo / Yervoy Case Study
Imugene’s novel therapies have the potential to tick all three boxes
In 2018, the FDA approved the Opdivo and Yervoy combination for a subset of patients with metastatic colorectal cancer
Provides a novel therapeutic option with a higher response rate than that from monotherapy immunotherapy
BUT more significant toxicity is noted with the combination, and immune-mediated side effects need to be monitored
Although early in development, Imugene’s PD-1 and Her-2 cancer vaccines potentially provide efficacy and response rate with minimal toxicity
I n v e s t o r P r e s e n t a t i o n
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KEY-Vaxx: Vaccine in Phase 1 development path
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Current status
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PD-1 Successful Finalise
Q4, 2019:
candidate CMC pre-clinical regulatory IND FDA/IND
Commence
vaccine manufacturing FDA de-briefing submissions Granted by Q4, 2019
Phase 1
identified meeting in Q1, 2019 Q3, 2019
Phase 1 – Dose Seeking /Signal Finding Phase 2 – Expansions Assumption
COHORT 3 | 3-6 PATIENTS Indication Expansion
IDENTIFY OUTCOMES
(12-20 patients)
Optimal Biological ü Safety Proof of
COHORT 2 | 3-6 PATIENTS Dose (OBD) ü Immunogenicity Expansions
ü tumour PD Concept
Indication Expansion
COHORT 1 | 3-6 PATIENTS (12-20 patients)
M I L S T O N E S
P R E - C L I N I C A L
P R O P O S E D
I N P A T I E N T P H A S E S
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I n v e s t o r P r e s e n t a t i o n
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B- Vaxx: Phase 1 trial results leading into Phase 2
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Similar to HER-Vaxx, B-Vaxx is a B cell peptide cancer vaccine designed to treat tumours that over-express the HER-2 receptor by binding to the same regions as Herceptin® and Perjeta®
Funded by OSU
It has been shown in pre-clinical studies and in a completed Phase I study to stimulate a potent polyclonal antibody response to HER-2
B r o a d t u m o u r t y p e s t r e a t e d i n P h a s e 1 ; n o w i n P h a s e 2[1]
ü 2 out of 24 patients had partial response ü 1 patient had Progression free survival at 40+ months
14 24
ü Accepted for publication in peer reviewed journal
patients had stable disease
NO TOXICITY OBSERVED
Note:
- 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 tumours, 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. Clinical Cancer Research manuscript accepted for publication March 2019.
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Oncology continues to dominate the deal making landscape
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32 of the 35 multi-billion dollar oncology licensing deals in the last five years have focused on immuno-oncology
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Licensing, joint ventures & research only oncology deals
by volume & value (2013 to 2017)
400 40000
350 35000
300 30000
250 25000
200 20000
150 15000
100 10000
50 5000
0 0
2013 2014 2015 2016 2017
Licensing volume Total value (US$m)
Number of deals
Total projected deal value (US$m)
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Oncology dominates the deal making landscape
35
30
25
20
15
10
5
0
Oncology Neurology Infection Diversified Gastrointestinal Immune Other
Merck BMSTakedaRocheAstra ZenecaJ&J Daiichi SankyoOno CelgeneAbbVieBoehringer IngelheimPfizerBayer Eli LillyNovartisAstellasGileadSanofi
Number of transactions (Last 5 years)
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Source: Clarivate Analytics Cortellis
22
The immuno-oncology market is experiencing robust growth
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Strong deal activity involving big pharma with a number of M&A and licensing transactions
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Stage of
Acquisition Upfront
Date Research focus clinical
value component
development
Oncolytic
A$500m Jun 2018 A$500m Phase I and II
Acquired immunotherapy
Clinical
US$2bn Jan 2019 US$300m Phase II
Immunotherapy
License
Cancer
US$1.8bn Oct 2017 ~US$100m Phase I
Vaccine
Acquired
Cancer
US$300m Feb 2019 Undisclosed Phase II
Acquired Vaccine
Cancer
US$125m May 2018 Undisclosed Phase I
Vaccine
Investment
Oncolytic
US$6.9bn Mar 2019 US$1.35b Phase II
immunotherapy
Investment
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Strong sales for leading immuno-oncology treatments
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US$7.2bn in 2018 sales
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US$6.7bn in 2018 sales
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US$7.1bn in 2018 sales US$2.8bn in 2018 sales
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In 2015 the immuno-oncology market was estimated at US$45bn and is expected to reach US$117bn by 2022
I n v e s t o r P r e s e n t a t i o n
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Robust cash position with supportive institutional shareholder base
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| Public Market Overview | |
|---|---|
| Share Price1 | A$0.018 |
| Market Capitalisation2 Cash equivalents (Mar-19) |
A$65.0M A$21.0M |
| Enterprise Value | A$44.0M |
| Top 5 Shareholders(as at April 2019) | |
| Private Portfolio Management | 6.2% |
| Platinum Asset Management | 3.6% |
| Dr. Nicholas Smith | 3.2% |
| Paul Hopper | 2.1% |
| Sarah Cameron | 1.7% |
Note:
Share Price Performance (last 6 months)
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Price (A$) IMU releases Volume (k)
0.030 appendix 4C results 90,000
IMU advances to
(Sept quarter)
phase II in gastric
80,000
trial
0.025
70,000
0.020 60,000
50,000
0.015
40,000
IMU releases
1H19 results
0.010 30,000
20,000
0.005
10,000
- -
Oct-18 Nov-18 Jan-19 Feb-19 Apr-19
Close price Volume traded
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-
As of 23 April 2019
-
Market capitalization calculations based on ordinary shares (3.61n) only and excludes the dilutive impact of options outstanding (625m)
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Clinical development and milestones
Phase 2 clinical trials for key indications underway – trials underpinned by additional value-adding studies and an exciting pipeline
| KEY-Vaxx PD-1 |
KEY-Vaxx Phase 1 Preclinical tox and manufacturing nearing completion with FDA IND in Q3 Key- Vaxx Commence Phase 1 |
|---|---|
| B-Vaxx HER-2 B-Vaxx Phase 1 clinical data published with further updates expected |
|
| Combo HER-2/PD-1 Combo pre-clinical Preclinical studies ongoing demonstrating benefits of combining IMU B cell vaccines in validated animal models of cancer |
|
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With a proactive approach to business development and brand awareness through participation in key conferences and acceptance in peer reviewed journals
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The global immuno-oncology sector rapidly growing
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With strong interest in the sector, Imugene‘s products have the potential to outperform exsiting treatments
Significant growth in global immuno-oncology pipelines of 2017 and 2018
Traditionally, cancer treatment options included: surgery, radiation, chemotherapy, and targeted therapy
Immunotherapy is rapidly evolving and now widely regarded as a 5[th] pillar of treatment
Sector growing rapidly - more than 600 licensing agreements signed in the oncology space (1/3 of these focused on immuno-oncology)
Potential benefits of B cell peptide vaccines include:
-
Cheaper to produce
-
Targeted and lasting immune response
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Safer and more convenient
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2018 419 86 49
T-cell targetted
immunomodulator 2017 223 60 36
Other 2018 581 63 85
immunomodulator 2017 262 66 64
2018 397 145 228
Cancer vaccine
2017 261 130 178
2018 448 176 227
Cell therapy
2017 179 112 109
Oncolytic virus 2018 137 2724
2017 95 3428
CD3 targeted 2018 125 28
bispecific mab
2017 4729
0 200 400 600 800
Preclinical Phase I Phase II Phase III Approved
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Source: www.cancerresearch.org
I n v e s t o r P r e s e n t a t i o n
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Other corporate activity in the immuno-oncology sector
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| Licensee | Licensor | Year | Technology / Mechanism of action | Phase of lead asset | I-O | Total ($ millions) | Upfront ($ millions) |
|---|---|---|---|---|---|---|---|
| Merck & Co. | AstraZeneca | 2017 | PD1/PDL1 small molecule combinations | Launched | ü | 8,500 | 1,600 |
| BMS | CytomX | 2014 | Immunotherapies using Probody Platform | Discovery | ü | 5,028 | 50 |
| Merck & Co. | Ablynx | 2014 | Multispecific antibodies against checkpoint proteins | Discovery | ü | 4,563 | 27 |
| Incyte | Merus | 2016 | Bispecific antibody platform | Discovery | ü | 3,700 | 120 |
| Celgene | OncoMed | 2013 | Anti stem cell products, incl. bispecific antibody | Phase 2 | ü | 3,332 | 155 |
| Pfizer | Cellectis | 2014 | CART cell therapies | Discovery | ü | 2,855 | 80 |
| Pfizer | Merck KGaA | 2014 | PD1/PDL1 development, and co-promotion of Xalkori | Phase 2 | ü | 2,850 | 850 |
| Celgene | Jounce | 2016 | I-O therapies | Discovery | ü | 2,824 | 225 |
| Sanofi | Regeneron | 2015 | Antibodies against LAG3, GITR and PDL1 | Phase 1 | ü | 2,665 | 640 |
| Novartis | Xencor | 2016 | Bispecific antibodies | Discovery | ü | 2,560 | 150 |
| J&J | Aduro BioTech | 2014 | Cancer vaccines using LADD immunotherapy platform | Discovery | ü | 1,999 | 12 |
| Servier | Pleris Pharmaceuticals |
2017 | Bispecific therapeutics using anticalin platform technology | Discovery | ü | 1,831 | 31 |
| Eli Lilly | CureVac | 2017 | Cancer vaccines using RNActive technology | Discovery | ü | 1,803 | 50 |
Source: Clarivate Analytics Cortellis
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Other corporate activity in the immuno-oncology sector
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| Licensee | Licensor | Year | Technology / Mechanism of action | Phase of lead asset | I-O | Total ($ millions) | Upfront ($ millions) |
|---|---|---|---|---|---|---|---|
| Shire (Baxalta) |
Symphogen | 2016 | Checkpoint inhibitors | Discovery | ü | 1,775 | 175 |
| Shire (Baxalta) |
Precision BioSciences |
2016 | Allogeneic CART cell therapies using ARCUS genome-editing technology |
Discovery | ü | 1,705 | 105 |
| Celgene | Acetylon | 2013 | HDAC inhibitors (incl. option to acquire Acetylon) | Phase 2 | 1,700 | 600 | |
| Sanofi | BionTech | 2015 | mRNA based immunotherapies | Discovery | ü | 1,560 | Undisclosed |
| Bayer | LoxoOncology | 2017 | Next-generation selective yrosine kinase inhibitors | Phase 2 | 1,550 | 400 | |
| Amgen Eli Lilly Celgene |
CytomX Innovent Biologics Bei Gene |
2017 2015 2017 |
T cell engaging bispecific antibodies Bispecific antibodies (incl. anti cMet and anti-CD20) Anti-PD1 antibody, and marketing of Celgene’s products in China |
Discovery Phase 2 Phase 1 |
ü ü ü |
1,465 1,456 1,393 |
40 56 263 |
| GSK | Adaptimmune | 2014 | T cell therapy targeting the NY ESO antigen | Phase 2 | ü | 1,253 | 42 |
| Arrys Therapeutics |
AskAt | 2017 | Prostaglandin EP4 receptor antagonists | Phase 2 | ü | 1,200 | Undisclosed |
| Celgene | Sutro Biopharma | 2014 | Antibody drug conjugates | Discovery | ü | 1,185 | Undisclosed |
| Novartis | Cerulean Pharma | 2016 | Nanoparticle-drug conjugates using Dynamic tumour Targeting technology |
Discovery | 1,173 | 5 | |
| Roche | Molecular Partners | 2013 | DARPin-drug conjugates | Discovery | ü | 1,160 | 60 |
Source: Clarivate Analytics Cortellis
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Other corporate activity in the immuno-oncology sector
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| Licensee | Licensor | Year | Technology / Mechanism of action | Phase of lead asset | I-O | Total ($ millions) | Upfront ($ millions) |
|---|---|---|---|---|---|---|---|
| Roche (Genetech) |
NewLink Genetics | 2014 | TDO/IDO inhibitors | Phase 1 | ü | 1,150 | 50 |
| Servier | Cellectis | 2014 | T cell therapeutics, incl. UCART-19 | Discovery | ü | 1,120 | 10 |
| Amgen | Kite Pharma | 2014 | CART cell therapies using autologous cell therapy (eACT) platform |
Phase 2 | ü | 1,110 | 60 |
| Gilead | MacroGenics | 2013 | Dual-Affinity Re-Targeting (DART) products | Discovery | ü | 1,085 | 30 |
| Merck KGaA | F-Star Alpha | 2017 | Bispecific antibodies, incl. anti-PDL1 antibody | Discovery | ü | 1,067 | 66 |
| Amgen | Immatics Biotechnologies |
2017 | T cell-engaging bispecific immunotherapies | Discovery | ü | 1,030 | 30 |
| Roche | Blueprint Medicines | 2016 | Small molecules against immunokinases | Discovery | ü | 1,010 | 45 |
| Servier | Sorrento | 2016 | Anti-PD1 antibody | Discovery | ü | 1,000 | 28 |
| Pfizer | BioAlta | 2015 | Conditionally Active Biologic (CAB) antibody-drug conjugates | Discovery | ü | 1,000 | Undisclosed |
Source: Clarivate Analytics Cortellis
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Intellectual Property
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| Patent title | Description | Patent Number | Expiry Date | Territories | |
|---|---|---|---|---|---|
| ‘Vaccine against cancer | |||||
| diseases that are associated with the HER- |
Protects specific HER-2 B-cell epitopes | WO02068474 | 27 Feb 2022 | Granted in Australia, Europe, Canada, the USA and Israel |
|
| 2/neu Oncogene’ | |||||
| HER -Vaxx | ‘HER-2/neu Multi-peptide Vaccine’ ‘Multi-epitope Vaccine for HER-2/neu-associated Cancers’ |
Protects specific HER2 B-cell epitopes Protects fusion peptides comprising three noncontiguous B cell epitopes from the extracellular domain of HER-2/neu linked to one another and coupled with a |
WO2007118660 WO2011020604 |
11 April 2027 18 August 2030 |
Granted in Australia, Europe, Israel and Canada Granted in the USA and in Europe. |
| virosome or carrier protein | |||||
| ‘A vaccine composition and uses thereof’ |
Protects and claims composition of matter on P467-CRM197/Montanide HER-Vaxx drug product used in Phase |
WO2016164980 | 15 April 2036 | Granted in AU, SG and pending in US, EU, CN, TW, SK, IN, BR, NZ, JP |
|
| Ib/II trial ongoing. | |||||
| KEY - Vaxx | ‘A vaccine composition and uses thereof’ ‘Human PD1 peptide vaccines and uses thereof’ |
Protects multiple PD-1 peptide sequences to include in PD-1 vaccines. Protects methods of treatment. Protects specific PD-1 B-cell epitopes developed at OSU by Prof Kaumaya |
PCT/AU2019/050089 PCT/US2018/024831 WO2018183488 |
7 Feb 2038 28 March 2037 |
PCT filed. National Phase countries to include AU,US, EU, CN, TW, SK, IN, BR, NZ, JP PCT filed. National Phase countries to include AU,US, EU, CN, TW, SK, IN, BR, NZ, JP |
Intellectual Property covering B-Vaxx and other tumour targets developed at OSU are also licensed and owned by Imugene
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Leslie Chong Managing Director & CEO [email protected] +61 458 040 433