AUTL Autolus Therapeutics ADS

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO

LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago).

ASCO Oral Presentation, abstract #6504:

Title: Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX Phase Ib/II study

Session Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Session date and time: Friday, May 31, 2024, 14:45 – 17:45 EDT, 19:45 – 22:45 BST

Presenting Author: Dr Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX

A conference call and webcast to discuss the presented data will be held at 9:30 am EDT/2:30 pm BST on Saturday June 1, 2024. Conference call participants should pre-register using this to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the of Autolus’ website.

About Autolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit

About obe-cel (AUTO1)

Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. In clinical trials of obe-cel, this “fast off-rate” profile reduced toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in r/r Adult ALL patients. The results of the FELIX trial, a pivotal trial for adult ALL, have been submitted and accepted by the FDA with a PDUFA target action date of November 16, 2024, and a filing has also been accepted by the EMA. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

About obe-cel FELIX clinical trial

Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint was overall response rate, and the secondary endpoints included duration of response, MRD negative CR rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660].

Contact:

Olivia Manser

+44 (0) 7780 471568

Julia Wilson

+44 (0) 7818 430877

Susan A. Noonan

S.A. Noonan Communications



 



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24/04/2024

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Reports on Autolus Therapeutics ADS

 PRESS RELEASE

Abstract for longer-term follow-up and additional data analysis of Piv...

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was ...

 PRESS RELEASE

Autolus Therapeutics to Report First Quarter 2024 Financial Results an...

Autolus Therapeutics to Report First Quarter 2024 Financial Results and Host Conference Call on May 14, 2024 LONDON, April 23, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will release its first quarter 2024 financial results and operational highlights before open of US markets on Tuesday, May 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company’s financial results and provide a general bu...

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Autolus FIRST LOOK: European dossier acceptance for obe-cel

The EMA has accepted the marketing authorisation application for review of obe-cel for r/r B-ALL, following the earlier acceptance by the FDA in January 2024. Looking ahead, Autolus is set for an eventful year with the FDA decision on obe-cel (PDUFA 16 November), as well as multiple data readouts including initial data from the phase 1 SLE trial by YE24, which we think could position obe-cel to become a pipeline in a product. We reiterate our BUY rating and $11 TP.

 PRESS RELEASE

Autolus Therapeutics announces acceptance of Marketing Authorization A...

Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL) Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALLThe US marketing application is under review with a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024 LONDON, April 02, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceu...

 PRESS RELEASE

Autolus Therapeutics Announces Changes to its Board of Directors

Autolus Therapeutics Announces Changes to its Board of Directors LONDON, April 01, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director. John H. Johnson advised the Board of his decision to step down from his role as Chairman of the Board and Non-Executive Director. These changes are effective as of today, April 1, 2024. “On behalf of the Board and Managemen...

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