Autolus Therapeutics announces Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL selected for an oral presentation at EHA
12 5월 2023 - 8:00PM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announces that the abstract for the pivotal
Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in
relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia
(ALL) has been selected for an oral presentation at the European
Hematology Association (EHA) 2023 Congress, being held June 8 - 11,
2023, in Frankfurt.
EHA Oral Presentation: |
|
Title: |
Safety and efficacy of Obecabtagene autoleucel (obe-cel,
AUTO1), a fast-off rate CD19CAR in relapsed/refractory adult B-Cell
acute lymphoblastic leukemia (r/r B-ALL): Topline results of the
pivotal FELIX study |
|
|
Session Title: Gene therapy and
cellular immunotherapy - ClinicalPresentation
ID: S262Session date and
time: Saturday, June 10, 2023, 11:00 – 11:15 EDT, 16:00 –
16:15 BSTSession room: Harmonie
1Presenting Author: Dr. Claire Roddie, MD, PhD,
FRCPath, Consultant Haematologist and Honorary Senior
Lecturer, Cancer Institute, University College London
(UCL)
About Autolus Therapeutics
plcAutolus is a clinical-stage biopharmaceutical company
developing next-generation, programmed T cell therapies for the
treatment of cancer. Using a broad suite of proprietary and modular
T cell programming technologies, the Company is engineering
precisely targeted, controlled and highly active T cell therapies
that are designed to better recognize cancer 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 and solid tumors. For more information,
please visit www.autolus.com.
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. Designed to have a fast target binding off-rate to
minimize excessive activation of the programmed T cells, obe-cel
may reduce toxicity and be less prone to T cell exhaustion, which
could enhance persistence and improve the ability of the programmed
T cells to engage in serial killing of target cancer cells. In
collaboration with Autolus’ academic partner, UCL, obe-cel is
currently being evaluated in a Phase 1 clinical trials for B-NHL.
Autolus has progressed obe-cel to the FELIX trial, a pivotal trial
for adult ALL.
About obe-cel
FELIX clinical trialAutolus’ Phase 1b/2 clinical
trial of obe-cel has completed enrolment of adult patients with
relapsed / refractory B-precursor ALL in the morphological cohort.
The trial had a Phase 1b component prior to proceeding to the
single arm, Phase 2 clinical trial. The primary endpoint is overall
response rate, and the secondary endpoints include duration of
response, MRD negative CR rate and safety. The trial is designed to
enroll approximately 100 patients across 30 of the leading academic
and non-academic centers in the United States, United
Kingdom and Europe. [NCT04404660]
Forward-Looking StatementsThis
press release contains 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," "will," "could," "expects,"
"plans," "anticipates," and "believes." These statements include,
but are not limited to, statements regarding the continued
development of Autolus’ obe-cel program; the status of clinical
trials (including, without limitation, expectations regarding the
data that is being presented, the expected timing of data releases
and development, as well as completion of clinical trials) and
development timelines for the Company’s product candidates. Any
forward-looking statements are based on management's current views
and assumptions and involve risks and uncertainties that could
cause actual results, performance, or events to differ materially
from those expressed or implied in such statements. These risks and
uncertainties include, but are not limited to, the risks that
Autolus’ preclinical or clinical programs do not advance or result
in approved products on a timely or cost effective basis or at all;
the results of early clinical trials are not always being
predictive of future results; the cost, timing, and results of
clinical trials; that many product candidates do not become
approved drugs on a timely or cost effective basis or at all; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; and the impact of the ongoing COVID-19 pandemic
on Autolus’ business. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause Autolus’ actual results to differ from those contained in the
forward-looking statements, see the section titled "Risk Factors"
in Autolus' Annual Report on Form 20-F filed with the Securities
and Exchange Commission on March 7, 2023, as well as discussions of
potential risks, uncertainties, and other important factors in
Autolus' subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Autolus undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by
law.
Contact:
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-917-513-5303susan@sanoonan.com
Alexandra
Deschner+32-490-58-35-23a.deschner@autolus.com
Autolus Therapeutics (NASDAQ:AUTL)
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