Allogene Therapeutics, Inc. · NASDAQ:ALLO
Allogene Therapeutics — AACR Annual Meeting 2023
14 slides from Allogene Therapeutics's conference presentation, April 2023
Slide 1: TRAVERSE: A phase 1 multicenter study evaluating the safety and efficacy of ALLO-316 in ccRCC
TRAVERSE: A phase 1 multicenter study evaluating the safety and efficacy of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) Samer A Srour, MD1; Ritesh Kotecha, MD2; Brendan Curti, MD3; Jad Chahoud, MD4; Alexandra Drakaki, MD, PhD5; Lily Tang, PhD 6; Lovely Go
Slide 2: TRAVERSE: First-in-Human Trial of Allogeneic Anti-CD70 CAR T Candidate for RCC
TRAVERSE: First-in-Human Trial of Allogeneic Anti-CD70 CAR T Candidate for RCC Relapsed and refractory RCC represents high unmet need • Large patient population with poor survival outcomes1-3 • Limited effective therapeutic options after failure of immune checkpoint inhibitors (ICIs) and tyrosine
Slide 3: TRAVERSE: Study Design and Objectives
TRAVERSE: Study Design and Objectives • Phase 1 multicenter, dose-escalation study, exploring two conditioning regimens and 4 cell dose levels (DLs) Conditioning Regimen FCA FC Dose Regimen DL1 DL2 DL3 DL4 Fludarabine (F) 30 mg / m2 daily x 3 Cell Dose 40 x 106 80 x 106 120 x 106 240 x 106 Cyclophos
Slide 4: TRAVERSE: Patient Demographics and Disposition
TRAVERSE: Patient Demographics and Disposition All patients had advanced or metastatic ccRCC Patients who received ALLO-316a and prior therapy ICI and TKI Demographic Data at Baseline (n=19) Age, median (range), yrs 62 (50, 70) Gender: Male / Female, % 84 / 16 Median time from enrollment to init
Slide 5: ALLO-316: Safety and Tolerability
ALLO-316: Safety and Tolerability Toxicity Patients who received ALLO-316 (n=19) • The safety profile is overall comparable to what is seen All Grades Grade 3+ with autologous CAR T TEAEs of Interestb n (%) n (%) • One DLT event (Gr 3 type 2 autoimmune hepatitisa) in Infusion-Related Reaction 1 (5
Slide 6: ALLO-316: Anti-Tumor Activity in CD70+ RCC
ALLO-316: Anti-Tumor Activity in CD70+ RCC Patients evaluable for efficacy (n=18): All Patients CD70+ Patients (n=18c) (n=10c) • ORR = 17%, DCR = 89% Response Ratesa ORRa, n (%) 3 (17) 3 (30) Patients with CD70+ RCC (n=10): DCR, n (%) 16 (89) 10 (100) • 3/10 (30%) achieved PR • DCR = 100% H-Scor
Slide 7: ALLO-316: Anti-Tumor Activity in CD70+ RCC
ALLO-316: Anti-Tumor Activity in CD70+ RCC 100 CD70 Negative or Unknown (N=8) CD70 Positive (N=10) 80 Change from Baseline, BOR (%) 60 40 20 0 5% Reduction * * -20 30% Reduction -40 -60 PD SD -80 PR -100 * Confirmed PRs DL1 DL1 DL1 DL2 DL2 DL1 DL1 DL1 DL2 DL1 DL3 DL1 DL2 DL2 DL2 DL3 DL2 DL1 FCA FC F
Slide 8: ALLO-316: Durable Disease Control in CD70+ RCC
ALLO-316: Durable Disease Control in CD70+ RCC * PR SD PD Death Due to Disease Progression Death Not Attributed to Disease Progression Follow-up ongoing Re-Treatment Start Anti-Cancer Therapy Confirmed PR *Deepening response from D28 (27% reduction from baseline) to D56 (35% reduction from baseline)
Slide 9: TRAVERSE Case Study 1: Deepening Response After Lowest Tested Cell Dose
TRAVERSE Case Study 1: Deepening Response After Lowest Tested Cell Dose 68-year-old man with Baseline Month 1 Month 6 metastatic RCC to the lungs, refractory to multiple ICIs (ipilimumab, nivolumab, and pembrolizumab) and axitinib Treated with FCA and ALLO- 316 40M CAR+ cells Responded with in
Slide 10: TRAVERSE Case Study 2: Primary Tumor Shrinkage in Patient With Stable Disease
TRAVERSE Case Study 2: Primary Tumor Shrinkage in Patient With Stable Disease 70-year-old male with RCC metastatic to adrenal and bone, refractory to axitinib and pembrolizumab Treated with FCA and 80M CAR+ cells Best Overall Response of Stable Disease with 45% decrease in size of primary left
Slide 11: Robust ALLO-316 CAR T Cell Expansion, Persistence and Tumor Trafficking
Robust ALLO-316 CAR T Cell Expansion, Persistence and Tumor Trafficking ALLO-316 Detected in 3 of 4 ALLO-316 Expansion After Single-Dose Available Tumor Aspirates High CAR T cell expansion was observed following both conditioning regimens and at relatively low cell doses; in peripheral blood, medi
Slide 12: ALLO-316 Eliminates CD70+ Host T Cells, Preventing Allorejection and Supporting Persistence
ALLO-316 Eliminates CD70+ Host T Cells, Preventing Allorejection and Supporting Persistence Day 4 Host T CAR T CD8 CD3 ALLO-316 CAR CD70 Day 10 Host T Following ALLO-316 infusion, alloreactive host T cells upregulate CD70 by Day 4 ALLO-316 expands by Day 10 and eliminates CD70+ host T cells whil
Slide 13: Summary: Preliminary Safety and Efficacy of ALLO-316 in Advanced RCC
Summary: Preliminary Safety and Efficacy of ALLO-316 in Advanced RCC Off-the-shelf CAR T with encouraging anti-tumor activity and no unexpected safety signals Treatment initiated with a median of 5 days from enrollment Safety profile consistent with autologous CAR T Anti-tumor activity in rela
Slide 14: Thank You!
Thank You! To our patients, their families and caregivers, & our clinical trial investigators and sites The CD70 ALLO CAR-T program, which utilizes Cellectis technology, is exclusively licensed from Cellectis by Allogene and Allogene holds global development and commercial rights.