Imugene Ltd · ASX:IMU
Imugene — Technical Presentation (February 2026)
15 slides from Imugene's technical presentation, February 2026
Slide 1: Safety and Efficacy of Azer-cel, an Allogeneic CD19 CAR T, Plus Low-Dose IL-2
Safety and Efficacy of Azer-cel, an Allogeneic CD19 CAR T, Plus Low-Dose Interleukin-2 (IL-2) in Patients With Relapse/Refractory (r/r) Large B-Cell Lymphoma (LBCL) Who Relapsed After Autologous CAR T Supriya Gupta, MD 1, Edmund K. Waller, MD, PhD 2, Ran Reshef, MD, MSc3, Vinay Vangaru, MD4, Adam Ol
Slide 2: Background
Background • Azercabtagene-zapraleucel (azer-cel, PBCAR0191) is an allogeneic anti- CD19 CAR T manufactured from healthy, adult donors • During dose escalation, an optimized LD regimen has been identified (Aug/Cy – Flu 30mg/m2 x 3 days, Cy 750mg/m2 x 3 days) as well as the RP2D (500 million cells) •
Slide 3: ARCUS Enables Precise Insertion of a CD19 CAR Into the TRAC Locus
ARCUS Enables Precise Insertion of a CD19 CAR Into the TRAC Locus I-Crel: Nature’s editing system, ARCUS: I-CreI engineered to evolved for highly precise, target desired genetic sites versatile gene editing Novel, proprietary KEY ADVANTAGES co-stimulation domain Non-integrating AAV vector, minimal o
Slide 4: Azer-cel Phase 1/1b Study Design
Azer-cel Phase 1/1b Study Design Dose escalation completed; now in Phase 1b expansion Dose Escalation Dose Escalation Cohort Expansion Key Inclusion Criteria (Parallel Groups) (Completed) Currently Enrolling (LBCL after CD19 CAR T) n=84 patients CONDITIONING Patient Population • CD19+ r/r DLBCL, NOS
Slide 5: Demographic & Disease Characteristics
Demographic & Disease Characteristics Demographics & Characteristics N=18 Median age (range), years 62.9 (28-86) >65 years, n(%) 10 (55.5) Male, (%) 13 (72.2) Ethnicity, n (%) Hispanic or Latino 1 (5.6) Not Hispanic or Latino 17 (94.4) Race, n (%) Asian 1 (5.6) White 17 (94.4) Median Time since Firs
Slide 6: Prior Treatment History
Prior Treatment History Prior Therapy N=18 Median lines of prior therapy, n (range) 4 (2-7) ≥ 4 Lines 11 (61.1) Prior anti-CD19 CAR T-cell therapy, n (%) 18 (100) Primary Refractory, n (%) 10 (55.5) Prior autologous stem cell transplant, n (%) 3 (16.7) Prior Bi-specific T-cell engager, n (%) 8 (44.4
Slide 7: Summary of Adverse Events
Summary of Adverse Events No Evidence of GvHD N=18 Adverse Events, n (%) Any Grade Grade ≥3 Any 18 (100) 14 (77.8) Serious 6 (33.3) 4 (22.2) Cardiac disorders 4 (22.2) 0 Infections* 9 (50.0) 6 (33) Heme Toxicity** Neutropenia 18 (100) 18 (100) Thrombocytopenia 18 (100) 9 (50) Anemia 18 (100) 7 (38.8
Slide 8: CRS and ICANS
CRS and ICANS N=18 No Grade ≥3 CRS events AEs, n(%) CRS ICANS occurred Any grade, n(%) 13 (72.2) 3 (16.7) ICANS Grade 3 events (N=2): Grade 1/2* 13 (72.2) 1 (5.6) • 1 event resolved in 1 day • 1 event resolved in 10 days Grade 3 0 2 (11.1) Grade 4 0 0 Grade 5 0 0 Median time to onset (range), days 3
Slide 9: Prolonged Cytopenias
Prolonged Cytopenias Event N=18 Participants with Prolonged Grade ≥3 Cytopenia present beyond D28, N (%) 9 (50) Prolonged Anemia Grade ≥3, N (%) 2 (11.1) Median time to recovery to Grade ≤ 2, median # of days (range) 33 (33, 33) Prolonged Neutropenia Grade ≥3, N (%) 5 (27.8) Median time to recovery
Slide 10: High Response Rates and Durable Responses Observed
High Response Rates and Durable Responses Observed 100 Duration of CR (DoCR) ORR: 81% CENSORED CR 1.0 Best Response, % PR Survival Probability 0.8 43.8% 50 N=16 0.6 0.4 37.5% 0.2 0.0 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Investigator assessed per Time (Months) Lugano 2014 classification M
Slide 11: Robust CAR T-cell Expansion is Observed
Robust CAR T-cell Expansion is Observed 4x105 Mean TRAC Copies/ug Genomic DNA (SEM) 3x105 2x105 1x105 0 Scn 0 1 3 7 10 14 21 28 42 60 90 120 150 180 270 Days Post Infusion Mean (± SEM) N=16 Peak CAR T-cell, copies/ug of gDNA 4.2x10 5 (±1.3x10 5) AUCD0-28 CAR T-cell, copies/ug of gDNA 3.2x10 6 (±1.0x
Slide 12: Prolonged CAR T-cell Persistence Is Observed in Responders
Prolonged CAR T-cell Persistence Is Observed in Responders CAR T-cell Kinetics Area Under the Curve (AUCD0-28) 5x105 1.5x107 (TRAC Copies/ug Genomic DNA) Mean AUCD0-28 With SEM Mean TRAC Copies/ug 4x105 Responders, n=13 Genomic DNA (SEM) Non-responders, n=3 1.0x107 3x105 2x105 5.0x106 1x105 * * 0 0
Slide 13: Sustained MRD Negativity in Complete Responders
Sustained MRD Negativity in Complete Responders Day 21/28 Day 60 Day 90 Day 120 Day 150/180 Day 270 Day 360 Patient 1 PR CR CR CR CR CR CR Patient 2 CR CR CR CR CR CR Patient 3 PR PR CR CR Patient 4 CR CR CR Patient 5 PR CR CR MRD negative MRD positive Positive below LOD Not done/data unavailable LO
Slide 14: Conclusions
Conclusions • Azer-cel, followed by low-dose IL-2, demonstrates encouraging clinical activity in patients with LBCL relapsed after prior autologous CD19 CAR T therapy • The safety profile was manageable with low-grade CRS and infrequent ICANS • The median duration of CR has not yet been reached, und
Slide 15: Acknowledgements
Acknowledgements • We thank the patients, families, friends, and caregivers associated with this study. • We acknowledge the dedicated study coordinators and healthcare teams at all participating sites, as well as the contributions of the following additional investigators: Houston Holmes, MD, MBA;