On November 2, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the online publication of four abstracts submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 9 to 12, 2023 (Press release, Autolus, NOV 2, 2023, View Source [SID1234636820]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to presenting data from a number of our clinical trials at ASH (Free ASH Whitepaper) this year, with obe-cel continuing to show a potentially best-in-class profile across several indications," said Dr. Christian Itin, Chief Executive Officer of Autolus. "Importantly, ahead of our expected BLA filing later this year, we will be presenting safety, efficacy and longer follow up data of obe-cel in relapsed/refractory B-ALL from the FELIX phase Ib and the pivotal phase II study, a pooled analysis from the ALLCAR19 and FELIX Phase Ib studies and the ALLCAR19 extension study, as well as data demonstrating the robustness of obe-cel’s manufacturing process. Additionally, we will be presenting the first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma."

Oral Presentations:

Title: Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the Ongoing FELIX Phase Ib/II Study
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Expanding Disease Targets for CAR-T Cell Therapies
Session date and time: Saturday, December 9, 2023, 3:15 PM PT
Session room: San Diego Convention Center, Room 6B
Publication Number: 222
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary:
Obe-cel is an autologous chimeric antigen receptor (CAR) T cell product with a novel CD19 binding domain conferring a fast antigen off-rate designed for an improved benefit risk ratio.
In this session, pooled analysis of data from all patients treated to date in the FELIX study will be presented, with an extended follow up. Data continued to demonstrate high rates of CR/CRi and a favorable safety profile. Additionally, subgroup analysis data suggests better outcomes in patients with low leukemia burden at screening/lymphodepletion, with higher rates of deep MRD negative complete remission and no Gr ≥3 CRS and one Gr ≥3 ICANS.

Title: Development of a Phase I Study Evaluating the Activity of Modular CAR T for Multiple Myeloma (MCARTY) Targeting BCMA and CD19 for Improved Persistence
Session Title: 703. Cellular Immunotherapies: Basic and Translational: Cellular Immunotherapy: Preclinical and Translational Insights
Date and time: Saturday, December 9, 2023, 4:15 PM PT
Session room: San Diego Convention Center, Room 6A
Publication Number: 350
Presenting Author: Dr. Lydia Lee, Consultant Haematologist & Senior Clinical Research Fellow, University College London, Research Department of Haematology (UCLH)

Summary:
AUTO8 is a dual targeting autologous CAR T therapy targeting BCMA and CD19 using two independently expressed CARs for multiple myeloma. In the MCARTY study, we demonstrate dual CD19/BCMA targeting, alongside feasibility of clinical grade manufacture by double-transduction. Clinical responses were seen in 6 of 6 evaluable patients.
Poster Presentations:

Title: Long-Term Efficacy and Safety of Obecabtagene Autoleucel (obe-cel) in Adult Patients (pts) with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia ([R/R B-ALL]; Pooled Analysis from ALLCAR19 and FELIX Phase Ib Studies) or Other B-cell Malignancies (ALLCAR19 Extension Study)
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Session date and time: Saturday, December 9, 2023, 5:30 PM – 7:30 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 2114
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary:
The clinical activity of obe-cel has been explored in adults with R/R B-ALL in a Phase I study (ALLCAR19), and a Phase Ib/II study (FELIX). Additionally, obe-cel has been tested in patients with R/R B-cell chronic lymphocytic leukemia (B-CLL) and R/R B-cell non-Hodgkin lymphoma (B-NHL).
Data from the pooled analysis of r/r ALL patients treated with obe-cel in the ALLCAR19 and FELIX Ib studies demonstrate that after a median follow up of >3 years approximately 30% of patients remain in remission without subsequent transplant. In the CLL and NHL cohorts of the ALLCAR19 study and with >2 years follow up, the studies show durable responses and a low incidence of serious infections. In summary, obe-cel shows durable remissions in a range of B-cell malignancies with an excellent and consistent safety profile.

Title: Delivery of Obecabtagene Autoleucel (obe-cel, AUTO1) for the FELIX Pivotal Study Demonstrating Robust Cell Processing, Robust Release Testing, and Reliable Logistics, Together with Readiness for Sustainable Patient (pt) Care
Session Title: 711. Cell Collection and Processing: Poster III
Session date and time: Monday, December 11, 2023, 6:00 PM – 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 4892
Presenting Author: Michael Merges VP, Process Development, Autolus

Summary:
The FELIX study successfully demonstrated the robust operability of obe-cel manufacturing, QC and logistics processes, meeting target V2C (time from leukapheresis to quality release) and V2D (time from leukapheresis to delivery of product to the hospital). All apheresis starting material was successfully processed despite the multitude of constraints posed by the COVID-19 pandemic. Further optimization and improvements made during the study increased reliability, consistency and precision of the manufacturing process, and supported the development of a new obe-cel manufacturing facility with greater production capacity that aims to achieve a ≥95% manufacturing success rate with ≤15-day V2C times.
Abstracts can be viewed via the ASH (Free ASH Whitepaper) abstract portal