Imugene Ltd · ASX:IMU
Imugene — Bell Potter Emerging Leaders Conference 2024
28 slides from Imugene's conference presentation, May 2024
Slide 1: Developing Cancer Immunotherapies
ASX: IMU DEVELOPING CANCER IMMUNOTHERAPIES Bell Potter Emerging Leaders Conference May, 2024 Release authorised by the managing director and Chief Executive Officer, Imugene Limited
Slide 2: Disclaimer
DISCLAIMER 1. The information in this presentation does not constitute personal 4. Neither the Company nor any of its directors, officers, employees, investment advice. The presentation is not intended to be advisers, associated persons or subsidiaries are liable for any direct, comprehensive or pro
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION AS OF CASH AS OF A$114.1M A$520M 27 MAY 2024 31 MARCH 2024 4 DISEASE AREAS PLATFORM Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES Lung (NSCLC) Gastric Gastroesophageal Colorectal (CRC) Melanoma Head and Neck Hepatocellular Pancreatic Azer-Cel Research C
Slide 4: Imugene Clinical Executive Team
IMUGENE CLINICAL EXECUTIVE TEAM Over 150 years of combined experience in Clinical Development 13 FDA Approved Drugs to market Leslie Chong Dr. Paul Woodard , MD Dr Bradley Glover Ursula McCurry Dr. John Byon, MD, PhD Dr Monil Shah Chief Executive Chief Medical Officer Chief Operating Snr VP of Clini
Slide 5: Azer-cel CD19 Allogeneic CAR T Cell Therapy
AZER-CEL CD19 ALLOGENEIC CAR T CELL THERAPY 5
Slide 6: The Future of Cell Therapy Is Off the Shelf (Allogeneic) CAR T
THE FUTURE OF CELL THERAPY IS OFF THE SHELF (ALLOGENEIC) CAR T Patients shouldn't have to wait for treatment AUTOLOGOUS (AUTO) ALLOGENEIC (ALLO) • Auto CAR Ts are made from the patient’s own T-cells • Allo CAR Ts are made from a universal donor. Broad cells. Limited patient access (highly personaliz
Slide 7: Azer-cel Has Meaningful Clinical Activity in B Cell Malignancies
AZER-CEL HAS MEANINGFUL CLINICAL ACTIVITY IN B CELL MALIGNANCIES 84 patients treated with azer-cel 61 Non-Hodgkin lymphoma (NHL) 23 B-Cell lymphoblastic Patients leukaemia (B-ALL) Patients 58% ORR 41% CR 61% ORR 61% CR/CRi 1 2 All Doses / All LD* Regimens 1. ORR – Overall Response Rate 2. CR – Compl
Slide 8: Azer-cel Has the Potential to Be a New Standard of Care
Azer-cel AZER-CEL HAS THE POTENTIAL TO BE A NEW STANDARD OF CARE High response rates and durability 84 blood cancer patients treated with azer-cel : 61 patients with Non-Hodgkin lymphoma (NHL); 23 patients with B-Cell acute lymphoblastic leukaemia (B-ALL) Across All 61 Subjects NHL Patients 83% Over
Slide 9: Diffuse Large B-Cell Lymphoma Is an Aggressive Type of Non-Hodgkin Lymphoma
DIFFUSE LARGE B-CELL LYMPHOMA IS AN AGGRESSIVE TYPE OF NON-HODGKIN LYMPHOMA • B-cells become cancerous and grow uncontrollably • Most common type of non-Hodgkin lymphoma (80,500 cases/year) • Most common in people over 50 • Fast growing and needs rapid treatment • Relapsed/refractory DLBCL has a hig
Slide 10: How Is DLBCL Treated Today?
HOW IS DLBCL TREATED TODAY? ~30,000 New Cases in the U.S. Annually (2020 – SEER) 1st line 2nd line 3rd line R-CHOP (Combination High dose chemo w/ stem No standard of care – for Chemotherapy1) cell transplant or standard auto CAR T relapse chemo. Auto CD19 CAR T patients2 cell therapies: Yescarta (G
Slide 11: Azer-cel Case Study
AZER-CEL CASE STUDY Day 0 Day 28 63-year-old Male Dx: DLBCL Tumor Burden: 2029 mm2 8 Previous lines of therapy: 1. R-CHOP --> R-EPOCH (CR x 6 months) 2. Ritixumab + Cytarabine + Oxaliplatin + Dex 3. Yescarta (CR x 8 months) 4. CA-4948 (IRAK4/FLT3 inhibitor) (refractory) 5. Vemurafinib (BRAF inhib) (
Slide 12: Azer-cel Phase 1b Study Design
AZER-CEL PHASE 1B STUDY DESIGN Potentially leading to Phase 2 Pivotal Study in 2025 DOSE ESCALATION EXPANSION Patient Population DLBCL Dose Conditioning Relapsed Level Regimen (s) after CD19 Auto CAR T By 2025 Global CAR T relapse patient pool is expected to grow ~4x as autologous CAR T drugs become
Slide 13: Phase 2 Trial Assumptions (Potential Registrational/To Market)
PHASE 2 TRIAL ASSUMPTIONS (POTENTIAL REGISTRATIONAL/TO MARKET) Potential registrational trial (FDA approval) to start upon completion of the Phase 1B trial. Dependent on acceptable CR rate and durability of CR Population: Relapse after auto-CART in DLBCL patients Positive FDA guidance on the potenti
Slide 14: Imugene and Kincell Bio Partnership
IMUGENE AND KINCELL BIO PARTNERSHIP Kincell Bio acquired Imugene’s North Carolina manufacturing facility • Imugene retains rights to azer-cel • Imugene will receive up to $6M USD in upfront and milestone-driven payments over 3 years • Imugene will recognize $32M USD in staff cost reductions, manufac
Slide 15: CF33 Oncolytic Virus
CF33 ONCOLYTIC VIRUS 15 15
Slide 16: CF33 Can Infect and Selectively Kill Tumor Cells
CF33 CAN INFECT AND SELECTIVELY KILL TUMOR CELLS 1 2 3 Virus enters Virus Cell explodes, tumour cell duplicates itself releasing thousands of brand new virus particles Engineering enhancements Multiple ways to kill cancer cells Precedent for approval • Infect and kill only cancer cells • Direct kill
Slide 17: Our Phase 1 MAST Study Has Enrolled Well
OUR PHASE 1 MAST STUDY HAS ENROLLED WELL Dose Administration (Parallel Groups) VAXINIA VAXINIA + Pembrolizumab Monotherapy Dose Escalation Combination Dose Escalation Cohort Expansion n=52-100 patients IT IV IT IV IT COHORT COHORT Intratumoural (IT) 3-6 PATIENTS 3-6 PATIENTS COHORT COHORT Administra
Slide 18: Phase 1 MAST Trial - Encouraging Early Signals
PHASE 1 MAST (METASTATIC ADVANCED SOLID TUMOURS) TRIAL - ENCOURAGING EARLY SIGNALS • 47 heavily pre-treated patients have been dosed to date (24 April 2024*), of which 40 patients have been evaluated, meaning they received at least their first scan at day 42 • Nearly half of the evaluable patients (
Slide 19: Turning Cold Tumours Hot
TURNING COLD TUMOURS HOT Complete Remission after Pseudoprogression (immune activity) in a Monotherapy patient with a cold tumour (bile tract cancer) Baseline scan Second scan Third scan Fourth scan Start of the Trial Pseudoprogression Decreased size Complete Remission (Tumour looks to have grown du
Slide 20: onCARlytics for Solid Tumors
ONCARLYTICS FOR SOLID TUMORS 20 20
Slide 21: Variety of Approved CD19 Drugs Only for Blood Cancers
VARIETY OF APPROVED CD19 DRUGS ONLY FOR BLOOD CANCERS • Many blood cancers such as leukemia and lymphoma have a • Solid cancers like breast, lung, gastric, colon, etc. don’t have a common protein, called CD19, on the surface of their cells common target such as CD19, on their cell surface • When you
Slide 22: Mechanism of Action: How Does It Work?
MECHANISM OF ACTION: HOW DOES IT WORK? onCARlytics makes solid tumors “seen” by CD19 targeting therapies 1. OnCARlytics infects tumour cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting 3. Tumour cell lysis leads to viral particle release and the
Slide 23: Phase 1 OASIS Trial
PHASE 1 OASIS TRIAL • Phase 1 trial designed to treat with onCARlytics (CF33-CD19) alone, or in combination with Blinatumomab (bispecific antibody targeting CD19) and either dosed IV or IT in metastatic advanced patients across multiple solid Combination treatment for solid tumours tumours • First I
Slide 24: Variety of Approved Therapies Available for Combination with onCARlytics
VARIETY OF APPROVED THERAPIES AVAILABLE FOR COMBINATION WITH ONCARLYTICS onCARlytics can become the preferred partner for CD19 therapies in solid tumours (~90% of cancer market) FIRST FDA APPROVED COMPANY TARGET APPROVAL CANCERS B-ALL, 2017 CD19 Auto CAR T DLBCL Combination Opportunities 2017 CD19 A
Slide 25: Azer-cel Offers onCARlytics an In-House Combination Approach for Solid Tumours
AZER-CEL OFFERS ONCARLYTICS AN IN-HOUSE COMBINATION APPROACH FOR SOLID TUMOURS •Azer-cel in combination with onCARlytics demonstrated sustained, robust activity against multiple tumour types Combination treatment for solid •100% killing of Triple Negative Breast Cancer (468P) and Gastric (SNU16) tum
Slide 26: Recently Achieved and Upcoming Key Catalysts
RECENTLY ACHIEVED AND UPCOMING KEY CATALYSTS RECENTLY ACHIEVED • AZER-CEL: Kincell Bio acquired manufacturing H2 2024 • VAXINIA: • VAXINIA: IT Expansion Open other indication • AZER-CEL: Prelim early DLBCL Phase 1b data update MAST trial positive early signals H1 2024 MAST FPI in higher dose cohorts
Slide 27: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION AS OF CASH AS OF A$114.1M A$520M 27 MAY 2024 31 MARCH 2024 4 DISEASE AREAS PLATFORM Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES Lung (NSCLC) Gastric Gastroesophageal Colorectal (CRC) Melanoma Head and Neck Hepatocellular Pancreatic Azer-Cel Research C
Slide 28: shareholderenquiries@imugene.com imugene.com
ASX:IMU shareholderenquiries@imugene.com imugene.com 28
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