Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — American Society of Clinical Oncology Analyst Call 2024
26 slides from Autolus Therapeutics's conference presentation, Jun 3, 2024
Slide 1: American Society of Clinical Oncology Analyst Call
American Society of Clinical Oncology Analyst Call 1 June 2024 Autolus.com
Slide 2: Disclaimer
Disclaimer These slides contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,”
Slide 3: Agenda
Agenda 3 Developing Next Generation Programmed T Cell Therapies • Welcome and Introduction: Olivia Manser, Director, Investor Relations • The obe-cel program to date: Dr. Christian Itin, CEO • ASCO Data: Dr. Claire Roddie • Q&A: Dr. Christian Itin and Dr. Claire Roddie
Slide 4: Autolus overview – scaling towards commercialization
Autolus overview – scaling towards commercialization Obe-cel potentially best in class CAR T for r/r adult ALL • FELIX pivotal trial showed high ORR, encouraging EFS and favorable tolerability with low levels of high-grade CRS and ICANS • PDUFA target action date November 16, 2024 • EMA filing submi
Slide 5: obe-cel program evolution
obe-cel program evolution OBE-CEL FOR ALL
Slide 6: The FELIX phase 1b/2 study
The FELIX phase 1b/2 study Developing Next Generation Programmed T Cell Therapies 6 1United States Department of Transportation, Bureau of Transportation Statistics 2021 [online]. Available at: https://www.bts.gov/data-spotlight/commercial-aviation-2020-downturn-airline-passengers-employment-profits
Slide 7: ASH2023: FELIX pooled analysis: EFS in all treated patients
ASH2023: FELIX Phase 1b/2 pooled analysis: EFS in all treated patients* • Median follow-up time was 16.6 months (range: 3.7−36.6 months) • 17/99 (17%) responders proceeded to SCT while in remission Developing Next Generation Programmed T Cell Therapies 7 The event-free survival estimate at 12 months
Slide 8: ASH2023: EFS by leukemic burden prior to lymphodepletion
ASH2023: EFS by leukemic burden prior to lymphodepletion* Developing Next Generation Programmed T Cell Therapies 8 Lower leukemic burden is associated with better outcomes *Censoring new non-protocol anti-cancer therapies including SCT with disease assessment by IRRC (data cut-off date: September 13
Slide 9: ASH2023 FELIX pooled analysis: CRS and ICANS
ASH2023 FELIX Phase 1b/2 pooled analysis: CRS and ICANS • No grade ≥3 CRS and/or ICANS were observed in patients with <5% BM blasts at lymphodepletion • Vasopressors were used to treat CRS in 2.4% of patients • The treatment was generally well tolerated • Two deaths were considered treatment-related
Slide 10: ASCO 2024
ASCO 2024
Slide 11: Obe-cel in adults with R/R B-ALL: OS, EFS and impact of CAR T persistency and SCT
PRESENTED BY: OBECABTAGENE AUTOLEUCEL (OBE-CEL, AUTO1) IN ADULTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: OVERALL SURVIVAL, EVENT-FREE SURVIVAL AND THE POTENTIAL IMPACT OF CHIMERIC ANTIGEN RECEPTOR T-CELL PERSISTENCY AND CONSOLIDATIVE STEM CELL TRANSPLANTATION IN THE OPEN-LABEL,
Slide 12: Takeaway messages
PRESENTED BY: 12 • 40% of responders in ongoing remission without subsequent SCT/other therapy, with a median follow-up of 21.5 months • Survival outcomes show potential of long-term plateau • SCT consolidation in remission following obe-cel did not improve EFS or OS • Ongoing CAR T persistence was
Slide 13: Background: Obe-cel
PRESENTED BY: 13 • A novel fast off-rate anti-CD19 autologous CAR T-cell therapy • Potential to improve persistence and reduce immune-mediated toxicity • FELIX (NCT04404660): an open-label, multi-center, single-arm Phase Ib/II study evaluating safety and efficacy of obe-cel in adult R/R B-ALL1–3 • P
Slide 14: Study design
PRESENTED BY: 14 Prof. Elias Jabbour Screening Leukapheresis Split dose infusion Day 1 Day 10 Enrollment Bridging therapy Efficacy and safety follow-up Cy 500 mg/m2 Lymphodepletion Flu 30 mg/m2 Tumor burden-guided split dosing BM blasts ≤20% 100 × 106 CAR T-cells 310 × 106 CAR T-cells BM blasts >20%
Slide 15: Patient eligibility and endpoints
PRESENTED BY: 15 Prof. Elias Jabbour Selected endpoints§ • CR/CRi rate per IRRC • DoR • EFS • OS • MRD-negativity rate (<10–4) • Safety • CAR T expansion/persistence • Manufacture feasibilityCohort A ≥5% BM blasts n = 107 (84%) Cohort B MRD-positive n = 13 (10%) Cohort C Isolated EMD n = 7 (6%) Enro
Slide 16: Baseline characteristics
PRESENTED BY: 16 Prof. Elias Jabbour Baseline characteristics Heavily pre-treated patients Cohort IIA ≥5% BM blasts (N = 94) Total (N = 127) Age in years, median (range) 50 (20–81) 47 (20–81) Gender, male/female 47/47 66/61 Hispanic or Latino, n (%) 29 (30.9) 38 (29.9) Philadelphia chromosome-positi
Slide 17: Majority of responders show durable response
PRESENTED BY: 17 Prof. Elias Jabbour CR or CRi n = 99 (78%) Infused N = 127 Started new anti-cancer therapy n = 5 (5%) Subsequent SCT in remission (MRD-negative) n = 18 (18%) Ongoing remission without subsequent SCT or other therapy‡ n = 40 (40%) No response or not evaluable n = 28 Relapsed/ died n
Slide 18: Event-free survival
PRESENTED BY: 44.0 (35.2, 52.5) 127 12231017263647637991 Without censoring for SCT Without censoring for SCT 9.0 (6.57, 14.32) 18 Prof. Elias Jabbour Event-free survival Subset of patients benefit from standalone treatment with obe-cel • All (18/18) patients who had SCT in remission were MRD-negativ
Slide 19: Overall survival
PRESENTED BY: Overall survival Potential long-term plateau 19 Pr ob ab ili ty (% ) 90 80 70 60 50 40 30 20 10 100 0 Time (months)Patients at risk 237255186108127 Without censoring for SCT (main analysis) 0 413937353331292725232119171513119751 3 43 Prof. Elias Jabbour Obe-cel in adult R/R B-ALL: OS,
Slide 20: CAR T persistence and predicted relapse
PRESENTED BY: 20 Prof. Elias Jabbour HR 2.7 (95% CI: 1.4, 5.3) HR 1.7 (95% CI: 0.7, 3.8) CAR T persistence and predicted relapse Ongoing CAR T persistence correlates with long-term EFS Pr ed ic te d EF S Loss of CAR T persistence at Month 6 Loss of CAR T persistence at Month 12 Ongoing CAR T persist
Slide 21: Landmark analysis among patients in ongoing remission at 6 months
PRESENTED BY: 21 Prof. Elias Jabbour Landmark analysis among patients in ongoing remission at 6 months Ongoing CAR T persistence at 6 months is associated with improved EFS Obe-cel in adult R/R B-ALL: OS, EFS and impact of CAR T persistence and consolidative SCT in the FELIX study Ongoing persistenc
Slide 22: Conclusions
PRESENTED BY: 22 • 40% of responders in ongoing remission without subsequent SCT/other therapy, with a median follow-up of 21.5 months • 12-month EFS and OS rates 49.5% and 61.1%, respectively • Survival outcomes show potential of long-term plateau • SCT consolidation in remission following obe-cel
Slide 23: Acknowledgments
PRESENTED BY: 23 • The authors would like to acknowledge: Patients, families, friends and caregivers Study investigators and coordinators Healthcare staff at the study sites • Contact: Prof. Elias Jabbour ejabbour@mdanderson.org • Third-party medical writing assistance, under the direction of
Slide 24: Newsflow
Newsflow Dr. Christian Itin
Slide 25: Autolus planned news flow
Autolus planned news flow Developing Next Generation Programmed T Cell Therapies 25 Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel FELIX data update at ASCO, EHA & ASH 2024 June & December 2024 Obe-cel Marketing Authorization Application to MHRA Second half 2024 Obe-cel U.S. FDA
Slide 26: Thank you
Autelus Thank you — OX TAN Autolus.com
Autolus Therapeutics — American Society of Clinical Oncology Analyst Call 2024 on 6ix