Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — EHA 2021
26 slides from Autolus Therapeutics's conference presentation, June 2021
Slide 1: Obe-cel Data Update - EHA 2021
Nasdaq: AUTL Obe-cel Data Update - EHA 2021 June 2021 Click to edit Master title style
Slide 2: Disclaimer
Disclaimer These slides and the accompanying oral presentation contain forward-looking statements within the meaning of the “safe harbor” provisions of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the Company’s anticipated cash runway; the saf
Slide 3: Agenda
Agenda o Welcome and Introduction: Dr. Christian Itin, CEO o Obe-cel (AUTO1) NHL data review: Dr. Martin Pule, CSO o Update on ALL : Dr. Christian Itin, CEO o Summary: Dr. Christian Itin, CEO o Q&A: Dr. Christian Itin, Dr. Martin Pule, Andrew Oakley (CFO) 3
Slide 4: Welcome & Introduction
Welcome & Introduction Dr. Christian Itin, CEO 4
Slide 5: Capitalizing on the unique profile of obe-cel in adult ALL
Capitalizing on the unique profile of obe-cel in adult ALL Evaluation of obe-cel activity in additional B-Cell malignancies PRODUCT INDICATION TARGET PHASE 1 PHASE 1B/2 Obe-cel Adult ALL CD19 ALLCAR-19 FELIX Obe-cel NHL & CLL CD19 ALLCAR-19 Primary CNS Obe-cel CD19 CAROUSEL Lymphoma AUTO1/22 Pediatr
Slide 6: Obe-cel has potential for transformational outcomes in Adult ALL
Obe-cel has potential for transformational outcomes in Adult ALL Data cut-off date May 17, 2021 o High level of sustained CR achieved without subsequent stem cell transplant o Durability of remissions highly encouraging – Across all treated patients, event free survival (EFS) at twelve and twenty-fo
Slide 7: Data Review - iNHL
Data Review - iNHL Dr. Martin Pule, CSO 7 * EHA June 2021
Slide 8: ALLCAR-19 study cohorts
ALLCAR-19 study cohorts Study expanded to evaluate activity of obe-cel in NHL and CLL Day 0 – Dose 1 Day 9 – Dose 2 Cohort Indication Pre-Conditioning (x106 CAR T-cells) (x106 CAR T-cells) A1 B-ALL ≤20% BM blasts CY / Flu 100 310 A2 B-ALL >20% BM blasts CY / Flu 10 400 B DLBCL CY / Flu / pembro 200
Slide 9: ALLCAR-19 cohort D - iNHL patient characteristics, persistence and safety
ALLCAR-19 cohort D - iNHL patient characteristics, persistence and safety Obe-cel shows excellent T cell expansion and engraftment with a manageable safety profile Baseline Characteristics N=9 CAR T Cell Expansion in Cohort D (B-NHL) Median age, years (range) 56 (39 - 68) Gender ALL is a 7M/ 2F Dise
Slide 10: ALLCAR-19 cohort D – iNHL clinical responses
ALLCAR-19 cohort D – iNHL clinical responses All patients treated achieved a metabolic Complete Response (CR) Median follow-up 6.1 months (range 4.0 - 8.1) ALL-36 ALL-34 Complete Response ALL-33 Death (Covid-19) ALL-32 ALL-31 CD19 +ve Relapse ALL-30 ALL-28 ALL-27 ALL-26 0 1 2 33 4 5 6 7 8 99 Duratio
Slide 11: A cross study comparison of obe-cel vs Tecartus and Kymriah in iNHL patients
A cross study comparison of obe-cel vs Tecartus® and Kymriah® in iNHL patients Obe-cel shows high level of complete responses with a manageable safety profile Obe-cel1 Tecartus2 Kymriah3 ALLCAR-19 ZUMA-5 ELARA Indication r/r FL & MCL r/r FL r/r FL n 9 81 97 ORR 100% 91% 86% CRR 100% 60% 66% CRS any
Slide 12: Summary and next steps for obe-cel outside of adult ALL
Summary and next steps for obe-cel outside of adult ALL o Initial obe-cel efficacy data in the iNHL cohort is encouraging o Obe-cel continues to show a consistent and favorable safety profile across all indications evaluated o Additional cohorts being explored, and further data planned for Q4 2021 o
Slide 13: Data Update ALL
Data Update ALL Dr. Christian Itin, CEO 13
Slide 14: No approved CAR T therapy for adult ALL patients
No approved CAR T therapy for adult ALL patients Successful therapy requires high level of activity and sustained persistence paired with good tolerability HIGH UNMET MEDICAL NEED ALL is a o Combination chemotherapy enables 90% of adult ALL patients to experience CR, but only 30% to 40% will achieve
Slide 15: Obe-cel shows sustained stand-alone activity in adult ALL patients
Obe-cel shows sustained stand-alone activity in adult ALL patients ALLCAR-19 Phase 1 EHA data cut - May 17 2021 xxx ALL-29 ALL-24 Complete Remission ALL-22 ALL-20 Not Evaluable ALL-19 ALL-18 MRD negative CR (PCR/Flow) ALL-17 Ongoing Disease ALL-16 ALL-15 CD19 -ve Relapse ALL-14 CD19 +ve Relapse ALL-
Slide 16: Obe-cel morphological event-free survival of 50.2%
Obe-cel morphological event-free survival of 50.2% at 24 Months MRD and morphological EFS curves are superimposable with a plateau seen from 12 months Obe-cel ALLCAR19 N 20 ORR 85% MRD Neg CR 85% Probability of relapse-free and alive DOR Median Not reached 12 months 64% Morph. EFS Median Not reached
Slide 17: Cross-study comparison between obe-cel and Tecartus
Cross-study comparison between obe-cel and Tecartus Baseline characteristics ALLCAR-19 ZUMA-3 Ph2# N=20 N=55 Age, median (range) 41.5 (18-62) 40 (19-84) Male, n (%) 13 (65%) 33 (60%) ECOG, n (%) 0 4 (20%) - 1 9 (45%) 39 (71%) 2 7 (35%) - Missing 0 - Philadelphia chromosome-positive, n (%) 6 (30%) 15
Slide 18: Cross-study comparison between obe-cel and Tecartus
Cross-study comparison between obe-cel and Tecartus Complete response rates, durability of effect and event free survival ALLCAR-19 ZUMA-3# Phase 1 Phase 2 Median follow-up 25.4 months 16.4 months Range (6.7, 38.7) (10.3, 22.1) N 20 55 ORR (CR/CRi) 85% 71% MRD-negative CR/CRi 85% 69% CR/CRi in ITT 1
Slide 19: Cross-study comparison between obe-cel and Tecartus
Cross-study comparison between obe-cel and Tecartus Morphological EFS ALLCAR-19 o Morpohlogical RFS / EFS graphs % of relapse-free and alive adjusted for identical time axis to allow for direct comparison of curves o Obe-cel dataset shows a plateau of responses from 12 months onwards ZUMA-3# RFS 24
Slide 20: Cross-study comparison between obe-cel and Tecartus
Cross-study comparison between obe-cel and Tecartus CAR T cell levels (median) in peripheral blood Median CAR T cell levels by flow cytometry (cells/uL) ALLCAR 19 ZUMA 3* Time from CAR T infusion (Months) 20 *Zuma-3 data - Shah et al. Lancet 2021
Slide 21: Cross-study comparison between obe-cel and Tecartus
Cross-study comparison between obe-cel and Tecartus Safety profile ALLCAR-19 ZUMA-3 Phase 1 Phase 2 N 20 55 CRS Any Grade 55% 89% CRS Grade ≥ 3 0 24% NE / ICANS Any Grade 20% 60% NE / ICANS Grade ≥ 3 15% 25% Treatment for CRS and/or ICANS Tocilizumab 35% 80% Steroids 20% 75% Vasopressor 0 40% 21
Slide 22: Obe-cel potentially differentiated on efficacy, durability and safety
Obe-cel potentially differentiated on efficacy, durability and safety Unique CAR T design drives differentiated product profile o Obe-cel has a high level of MRD-negative CR (85%) o Morphological EFS for obe-cel at 24 months was 50.2% o Long term CAR T persistence drives durability of effect o Obe-c
Slide 23: Summary & Next Steps
Summary & Next Steps Dr. Christian Itin, CEO 23
Slide 24: Building a market leading franchise based on obe-cel
Building a market leading franchise based on obe-cel Anchored in adult and pediatric ALL with options to move into additional B cell malignancies PRODUCT INDICATION STUDY STATUS Obe-cel Adult ALL FELIX Study enrolling - pivotal data in 2022 Obe-cel franchise Obe-cel B-NHL & CLL ALLCAR-19 Study enrol
Slide 25: Q&A
Q&A 25
Slide 26: Thank You
Thank You 26