Slide 1: Imugene to Present at Planet MicroCap Showcase 2019
ASX Announcement Imugene to Present at Planet MicroCap Showcase 2019 _________________________________________________________________________________ For personal use only SYDNEY, Australia, 1 May 2019: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced its partici
Slide 2: Our vision
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
Slide 3: An Emerging Leader in Cancer Immuno-Oncology
For personal use only AN EMERGING LEADER IN CANCER IMMUNO-ONCOLOGY Investor Presentation May 2019
Slide 4: Notice: Forward Looking Statements
N O T I C E : F O R W A R D L O O K I N G S TAT E M E N T S For personal use only 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 a
Slide 5: Key investment highlights
Key investment highlights • Promising Phase 1 clinical trial results across lead candidate B cell vaccines For personal use only Strong preliminary results from • Currently have two therapies (HER-Vaxx and B-Vaxx) in Phase 2 studies with a pipeline of other ongoing clinical trials therapies and comb
Slide 6: Experienced management team
Lead by an experienced management team which have significant clinical development commercialisation expertise in the sector Leslie Chong Paul Hopper Dr Axel Hoos Mr Charles Walker For personal use only SYDNEY, AU SYDNEY, AU PHILADELPHIA, USA BRISBANE, AU Managing Director & CEO Executive Chairman N
Slide 7: Scientific Advisory Board
Imugene‘s Scientific Advisory Board consists of world leading oncologist, researchers and developers For personal use only Prof. Josep Tabernero Prof Pravin Kaumaya Dr. Michael Galigiuri VALL D’HEBRON, BARCELONA, Prof Tanios BekaiI Saab OHIO STATE UNIVERSITY, USA CITY OF HOPE, USA SPAIN MAYO CLINIC,
Slide 8: Immuno-oncology: A high-value therapeutic approach
Immuno–oncology: A high-value therapeutic approach For personal use only Immuno-oncology - A rapidly B cell peptide vaccines provide A pioneer and leader in the B cell growing market potential benefits peptide cancer vaccine space • Immuno-oncology allows for a ü Potentially leading to a better • Im
Slide 9: B cell based antibodies have distinct advantages to existing treatments
B cell based antibodies have distinct advantages to existing treatments B cell Vaccines offer a unique For personal use only opportunity to intervene at multiple points in the immune system and create immune memory which N ATU R A L B C EL L DER I V ED MONOCLONAL enhances durability of response. ANT
Slide 10: What is Imugene's B cell vaccine (HER-Vaxx) trying to solve?
What is Imugene’s B cell vaccine (HER-Vaxx) trying to solve? For personal use only HER-2 is a • HER-2 (Human Epidermal clinically and Growth Factor Receptor) HER-2 commercially stimulates cancer cells to grow validated target for cancer treatment • 10 - 30% of gastric, breast, ovarian and pancreatic
Slide 11: How does HER-Vaxx work?
How does HER-Vaxx work? 3 Peptides “mimic” the epitope For personal use only (antibody binding site) HER-Vaxx stimulates the patients B cells to produce antibodies that target only those cancer cells with HER-2 on their surface B cells attack the cancer cell CANCER HER-VAXX B CELL IMMUNOTHERAPY AC T
Slide 12: A significant market opportunity across key Imugene vaccines
For personal use only A significant market opportunity across key Imugene vaccines GASTRIC CANCER LUNG CANCER (HER - VAXX) (KEY- VAXX) Newly diagnosed 1m cases per year, globally Incidence 1.8m cases per year, globally cases 19% relate to HER2+ cancers 5 year relative < 25% ~18% survival rate Progno
Slide 13: Imugene has a developing pipeline of cancer vaccines
Imugene has a developing pipeline of cancer vaccines Clinical Clinical development development For personal use only Pre-Clinical Phase 1 Phase 2 Key Data / Results Key IP patents • Successful completion of Phase 1b trials Intellectual property • Strong trial results with no safety or toxicity issue
Slide 14: Imugene discovery pipeline
Imugene discovery pipeline Imugene has the ability to advance these programs at any point For personal use only Program Pre-clinical ID of candidate Her-1 (EGFR) Her-3 IGF-1R VEGF Combination (numerous) PD-L1 12
Slide 15: HER-Vaxx: Successfully completed Phase 1B study
HER-Vaxx: Successfully completed Phase 1B study… For personal use only Phase 1b – Complete Trial Patients Study Endpoints Study Results • Phase 1b • Gastric Cancer HER-Vaxx in • Recommended Phase • 50 µg selected as the • Open label • Up to 18 patients combination 2 Dose of HER-Vaxx RP2D in 3 cohort
Slide 16: Positive results for HER-Vaxx Vaccine Phase 1b trial
Positive results for HER-Vaxx Vaccine Phase 1b trial For personal use only Key Findings Change from baseline (%) in tumour size 40 ü 11 out of 14 were evaluable for vaccine-specific immune 20 responses and tumour response assessment 0 * ü Those patients that were dosed with 50 micrograms showed Chan
Slide 17: Positive results for HER-Vaxx Phase 1b trial continued
Positive results for HER-Vaxx Vaccine Phase 1b trial continued For personal use only 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 anti
Slide 18: Phase 2 commenced
…and commenced Phase 2 For personal use only Phase 2 commenced - First patient dosed March 2019 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 sur
Slide 19: KEY-Vaxx: A new entrant in the checkpoint inhibitor market
KEY-Vaxx: A new entrant in the checkpoint inhibitor market For personal use only — KEY-Vaxx is a PD-1 B cell vaccine, How PD-1 targeted Limitations of current aimed to induce the body to treatments work treatments produce polyclonal antibodies while • Current checkpoint inhibiting existing commercia
Slide 20: How does KEY-Vaxx work?
How does KEY-Vaxx work? HOW CANCER STAYS UNDETECTED BY KEY-VAXX STOPS THE CANCER CELL FROM AVOIDING For personal use only THE IMMUNE SYSTEM T-CELL RECOGNITION AND KILLING PD-L1 PROTEIN L C EL T- Gives T-cells the ability to RE PD- recognise the cancer cell and ANTI PD-1 CANCER CE 1 PT O mount an imm
Slide 21: PD-1/HER-2 Combination: Potential to increase response rates
PD-1/HER-2 Combination: Potential to increase response rates in HER-2+ cancers For personal use only % CANCER GROWTH INHIBITION IN COLORECTAL CANCER MODEL Immuno-oncology combinations driving value • Combining drugs for better immuno-oncology PD-1 vaccine plus Her-2 vaccine 90% outcome is driving va
Slide 22: KEY-Vaxx: Vaccine development path
KEY-Vaxx: Vaccine in Phase 1 development path Current status For personal use only PRE-CLINICAL MILSTONES 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
Slide 23: B-Vaxx: Phase 1 trial results leading into Phase 2
B- Vaxx: Phase 1 trial results leading into Phase 2 For personal use only Similar to HER-Vaxx, B-Vaxx is a B cell Broad tumour types treated in Phase 1; peptide cancer vaccine designed to now in Phase 21 treat tumours that over-express the HER-2 receptor by binding to the same regions as Herceptin®
Slide 24: Oncology continues to dominate the deal making landscape
Oncology continues to dominate the deal making landscape 32 of the 35 multi-billion dollar oncology licensing deals in the last five years have focused on immuno-oncology For personal use only Licensing, joint ventures & research only oncology deals Oncology dominates the deal making landscape by vo
Slide 25: The immuno-oncology market is experiencing robust growth
The immuno-oncology market is experiencing robust growth Strong deal activity involving big pharma with For personal use only a number of M&A and licensing transactions Strong sales for leading immuno-oncology Acquisition Upfront Stage of clinical treatments Date Research focus value component devel
Slide 26: Robust cash position with supportive institutional shareholder base
For personal use only Robust cash position with supportive institutional shareholder base Public Market Overview Share Price Performance (last 6 months) Share Price 1 A$0.018 Price (A$) IMU releases Volume (k) 0.030 appendix 4C results 90,000 Market Capitalisation 2 A$65.0M (Sept quarter) IMU advanc
Slide 27: Clinical development and milestones
Clinical development and milestones Phase 2 clinical trials for key indications underway – trials underpinned by For personal use only additional value-adding studies and an exciting pipeline With a proactive approach to business development and brand awareness through participation in key STUDIES 1
Slide 28: Appendix
For personal use only Appendix 26
Slide 29: The global immuno-oncology sector is rapidly growing
The global immuno-oncology sector rapidly growing For personal use only With strong interest in the sector, Imugene‘s Significant growth in global immuno-oncology products have the potential to outperform pipelines of 2017 and 2018 exsiting treatments T-cell targetted 2018 419 86 49 immunomodulator
Slide 30: Other corporate activity in the immuno-oncology sector
For personal use only Other corporate activity in the immuno-oncology sector Licensee Licensor Year Technology / Mechanism of action Phase of lead asset I-O Total ($ millions) Upfront ($ millions) Merck & Co. AstraZeneca 2017 PD1/PDL1 small molecule combinations Launched ü 8,500 1,600 BMS CytomX 201
Slide 31: Other corporate activity in the immuno-oncology sector
Other corporate activity in the immuno-oncology sector Licensee Licensor Year Technology / Mechanism of action Phase of lead asset I-O Total ($ millions) Upfront ($ millions) For personal use only Shire Symphogen 2016 Checkpoint inhibitors Discovery ü 1,775 175 (Baxalta) Shire Precision Allogeneic C
Slide 32: Other corporate activity in the immuno-oncology sector
For personal use only Other corporate activity in the immuno-oncology sector Licensee Licensor Year Technology / Mechanism of action Phase of lead asset I-O Total ($ millions) Upfront ($ millions) Roche NewLink Genetics 2014 TDO/IDO inhibitors Phase 1 ü 1,150 50 (Genetech) Servier Cellectis 2014 T c
Slide 33: Intellectual Property
Intellectual Property For personal use only Patent title Description Patent Number Expiry Date Territories ‘Vaccine against cancer diseases that are WO02068474 Granted in Australia, Europe, Protects specific HER-2 B-cell epitopes 27 Feb 2022 associated with the HER- Canada, the USA and Israel 2/neu
Slide 34: For personal use only
For personal use only Leslie Chong Managing Director & CEO leslie.chong@imugene.com +61 458 040 433