Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (October 2021)
31 slides from Imugene's investor presentation, Oct 5, 2021
Slide 1: Imugene October 2021
For personal use only ASX: IMU IMUGENE October, 2021
Slide 2: Disclaimer
Disclaimer For personal use only 1. The information in this presentation does not constitute personal investment 4. Neither the Company nor any of its directors, officers, employees, advisers, advice. The presentation is not intended to be comprehensive or provide all associated persons or subsidiar
Slide 3: Introduction to Imugene
Introduction to Imugene For personal use only Imugene is a biotech company 2018 SEP 2021 headquartered in Australia and Licensed extensive B cell Entered the publicly traded on the Australian portfolio and platform from S&P/ASX 300 OSU and Mayo Clinic M AY 2 0 21 Index Securities Exchange (ASX:IMU)
Slide 4: Investment Highlights
Investment Highlights For personal use only • Three novel technology platforms: Oncolytic virotherapies, onCARlytics in cellular therapy and B-Cell activating immunotherapies • B-Cell Technologies: HER-Vaxx Phase 2 in gastric cancer and PD1-Vaxx in NSCLC • CF33 Oncolytic Virotherapies: 2 (CHECKvacc
Slide 5: Three Novel Technology Platforms
Three Novel Technology Platforms For personal use only onCARlytics CF33 Oncolytic Virus B Cell Immunotherapy CHECKvacc CF33-CD19 CAR T Combination Therapy VAXINIA HER-Vaxx PD1-Vaxx “Armed” PD-L1 Parental Virus Virus TIGIT-Vaxx, PDL1-Vaxx, LAG3-Vaxx, TIM3-Vaxx, VEGF-Vaxx, CTLA4-Vaxx etc 5
Slide 6: Imugene's Deep Pipeline
Imugene’s Deep Pipeline CMC & Intellectual For personal use only Technology Program Pre-Clinical IND Phase I Phase II Key Data / Results Property • Compelling pre-clinical activity in multiple cancers when combining onCARlytics (CF33-CD19) with CD19 CAR T onCARlytics CF33-CD19 • Combination of onCAR
Slide 7: International Leadership Team with Extensive Commercialisation Expertise in the Sector
International Leadership Team with Extensive Commercialisation Expertise in the Sector For personal use only Imugene has a team with oncology drug development experience Leslie Chong Paul Hopper Dr Jens Eckstein Dr Lesley Russell Dr Axel Hoos Charles Walker SYDNEY, AU SYDNEY, AU CAMBRIDGE, USA PHILA
Slide 8: B-Cell Immunotherapies
For personal use only B-Cell Immunotherapies 8
Slide 9: B Cell Based Antibodies Have Distinct Advantages To Existing Treatments
B Cell Based Antibodies Have Distinct Advantages To Existing Treatments For personal use only B cell Vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which N AT U R A L B C E L L DE R I V E D MONOCLONAL enhances durability of response.
Slide 10: HER-Vaxx Phase 2 Recruitment Complete
HER-Vaxx Phase 2 Recruitment Complete For personal use only Trial Patients Study Primary Endpoints • Phase 2 • HER-2+++ Randomised • Overall survival • Open label • HER-2++ FISH/CISH +ve HER-Vaxx in combination Secondary Endpoints • Asia • Advance or metastatic with standard of care chemotherapy • P
Slide 11: AACR 2021 Presentation Poster
AACR 2021 Presentation Poster Abstract No. CT107 A PHASE 1B/2 OPEN-LABEL STUDY WITH RANDOMIZATION IN PHASE 2 OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY For personal use only IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR G
Slide 12: AACR Presentation Highlights
AACR Presentation For personal use only Highlights Treatment with HER-Vaxx clearly Analysis of the antibody data reveals high demonstrates that all patients develop high levels are maintained during the treatment levels of HER2-specific antibodies early in the and maintenance phases, with only minim
Slide 13: HER-Vaxx Phase 2: Interim Analysis
HER-Vaxx Phase 2: Interim Analysis For personal use only ENDPOINT OVERALL SURVIVAL PROGRESSION FREE SURVIVAL Intent to Treat (Primary) Intent to Treat (Secondary) Her-Vaxx + Chemotherapy Her-Vaxx + Chemotherapy Treatment Chemotherapy Only Chemotherapy Only All Patients N=27 14 13 14 13 Events 4 8 6
Slide 14: HER-Vaxx Phase 2: Interim Analysis
HER-Vaxx Phase 2: Interim Analysis TR EATM EN T EM ERG EN T A DV ER S E EV EN T S For personal use only HER-VAXX + CHEMOTHERAPY C H E M O T H E R A P Y O N LY (N=14) (N=13) Patients with at least one 13 92.9% 12 92.3% TEAE n % n % Grade 1 / 2 7 50% 5 38.5 % Grade > 3 6 42.9% 7 53.8% Serious AE* 1 7.
Slide 15: PD1-Vaxx
For personal use only PD1-Vaxx 15
Slide 16: PD1-Vaxx Phase 1: Study Design
PD1-Vaxx Phase 1: Study Design For personal use only Part 1: Monotherapy Dose Escalation Part 2: Combination Escalation & Dose Expansion (Planned) PD1-Vaxx Monotherapy (MTD/OBD evaluation) Cohort 1 Cohort 2 Cohort 3 10 µg 50 µg 100 µg Combination OBD IMU-201 IMU-201 IMU-201 n = 3-6 n = 3-6 n = 3-6 I
Slide 17: PD1-Vaxx Phase 1: Recruiting
PD1-Vaxx Phase 1: Recruiting Current Status For personal use only MILESTONES 1st Patient Dosed 1st Patient Dosed Cohort 3 Cleared, Cohort 1 Cleared Cohort 2 Cleared 1st Patient Dosed Cohort 1 Cohort 2 RP2D & Expansion Jan 2021 April 2021 Cohort 3 30 Nov 2020 Feb 2021 Opened Ohio State University (op
Slide 18: ESMO 2021 Presentation Poster
ESMO 2021 Presentation Poster IMPRINTER: An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), For personal use only Poster ID: 1367 TiP a B-Cell Immunotherapy, in Adults with Non-Small Cell Lung Cancer John Jae Won Park1, Gary Richardson2 , Martin Gutierrez3,
Slide 19: Oncolytic Virus CF33
For personal use only Oncolytic Virus CF33 19
Slide 20: CF33 Mechanism of Action
CF33 Mechanism of Action For personal use only HOW A VIRUS KILLS A CELL Step 1: Step 2: Step 3: Virus enters cell Virus duplicates itself Cell explodes, releasing thousands of brand new virus particles • Direct infection, replication within and cancer cell killing • Viral infection increases local c
Slide 21: CHECKvacc Phase 1 TNBC Study
CHECKvacc Phase 1 TNBC Study CF33+hNIS+aPD-L1 (“Armed” Virus) For personal use only FDA IND Cleared COHORT | 3-6 PATIENTS Identify: COHORT | 3-6 PATIENTS Recommended Phase 2 Dose (RP2D) Metastatic Triple Negative COHORT | 3-6 PATIENTS RP2D Expansion Breast Cancer Based on: 12 Patients COHORT | 3-6 P
Slide 22: VAXINIA Phase 1 MAST Study
VAXINIA Phase 1 MAST Study (Metastatic Advanced Solid Tumours) For personal use only Dose Admin Part 1: VAXINIA Monotherapy Part 2: VAXINIA + SOC IO* Dose Escalation Combination Dose Escalation IT IT IV Identify IT IV Identify IT Administration Head & Neck, Monotherapy Combination Advanced COHORT CO
Slide 23: The CAR T Solid Tumour Challenge & Imugene's Solution
The CAR T Solid Tumour Challenge & Imugene’s Solution NEW CONCEPT For personal use only Chimeric Antigen Receptor (CAR) T cell therapy has had limited activity in solid tumours, largely due to a lack of selectively and highly expressed surface antigens, such as the blood B cell antigen Utilise OV’s
Slide 24: Introducing onCARlytics
Introducing onCARlytics “OnCARlytics makes For personal use only the treatment of solid tumours by CAR T drugs viable” Dr Saul Priceman Watch: Combination CAR T Oncolytic Virus Immunotherapy Kills Tumours OnCARlytics is a novel and effective combination immunotherapy utilizing its exclusively licens
Slide 25: Mechanism of Action: How does it work?
Mechanism of Action: How does it work? For personal use only onCARlytics makes solid tumours “seen” by CD19 directed CAR T 1 1. OnCARlytics infects tumour cells 4 2. Virus replication and production of CF33-CD19 on the cell surface 2 enabling CD19 CAR T cell targeting 3. Tumour cell lysis leads to v
Slide 26: onCARlytics delivers CAR Targets to solid tumours
% 37.8%<1% 6.8% 63.8% 11.5%; this version22.2% 98.0% 37.8% 63.8% 98.0% bioRxiv preprint doi: https://doi.org/10.1101/843052 posted November 16, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without pe
Slide 27: Published Front Cover of Science Translational Medicine Journal in 2020
Published Front Cover of Science Translational Medicine Journal in 2020 For personal use only Effective combination immunotherapy using oncolytic viruses to deliver CAR targets to solid tumours Park AK, Fong Y, Kim SI, Yang J, Murad JP, Lu J, Jeang B, Chang WC, Chen NG, Thomas SH, Forman SJ, Pricema
Slide 28: Four FDA Approved CD19 CAR T's
Four FDA Approved CD19 CAR T’s For personal use only Approved and in-development autologous or allogeneic CD19 CAR Ts can be partnered with Imugene’s onCARlylics for treating solid tumours: 28
Slide 29: Milestones
Milestones Technology Milestone For personal use only onCARlytics 1st Patient Dosed onCARlytics FDA IND Clearance PD1-Vaxx Combination RP2D Next 12-24 months onCARlytics GLP Toxicology Study VAXINIA 1st Patient Dosed onCARlytics FDA Pre-IND Meeting onCARlytics GMP manufacturing for pre-clinical toxi
Slide 30: Financial Summary
Financial Summary Public Market Overview Share Price Performance (last 6 months) For personal use only Share Price 1 A$0.415 52 week range 0.052 - 0.515 Market Capitalisation 2 A$2.43B Cash equivalents (30 Jun 21)3 A$29.5M Enterprise Value A$2.538B Top 5 Shareholders (as at September 2021) Citicorp
Slide 31: Imugene Limited
For personal use only ASX: IMU IMUGENE LIMITED www.imugene.com info@imugene.com