Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced a poster presentation related to
AUTO1 (obecabtagene autoleucel, obe-cel) in relapsed / refractory
(r/r) indolent B cell lymphomas (IBCL) and included an update of
duration of response in r/r adult Acute Lymphoblastic Leukemia
(ALL) patients at the European Hematology Association (EHA) Virtual
Congress 2021.
“The stabilization of event-free survival at 50%
between 12 months and 24 months of follow-up supports the curative
potential of obe-cel as a standalone therapy for some adult ALL
patients,” said Dr. Christian Itin, chief executive officer of
Autolus. “The early data we presented in indolent B cell
non-Hodgkin lymphoma indicate a high level of clinical activity
combined with a manageable safety profile and could represent a
significant opportunity to expand the benefits of obe-cel treatment
to a broader population of patients with B cell malignancies.”
Title: Early safety and efficacy
findings of AUTO1 (CAT19), a fast-off rate CD19 CAR, in
Relapsed/Refractory Indolent B Cell Lymphomas
Presenter: Clare Roddie, MD,
PhD, FRCPath, Consultant Haematologist and Honorary Senior
Lecturer, Cancer Institute, University College London
(UCL)
Session Date and
Time: Friday, June 11, 2021 at 9.00 a.m.
CEST
Relapsed / refractory (r/r) indolent B
cell lymphomasAs of the data cut-off date of May 17,
2021, 13 patients in Cohort D with r/r IBCL had been enrolled in
the study and product was successfully manufactured for 12
patients, with one patient’s cells ongoing in manufacture. As of
the data cut-off date, 9 r/r IBCL patients had received AUTO1
infusion. Three patients were pending infusion (including the
patient noted above) and one patient died prior to lymphodepletion
due to a Covid-19 infection. Obe-cel was well tolerated and
demonstrated a favorable safety profile in adult patients with r/r
low grade B-cell lymphoma, despite high disease burden. All treated
patients achieved a complete metabolic remission and had robust CAR
T engraftment, expansion, and persistence.
Grade 1 cytokine release syndrome (CRS) was
reported in 4 patients and Grade 2 CRS in 1 patient. No immune
effector cell-associated neurotoxicity syndrome (ICANS) of any
grade was observed in the study. At a median follow-up of 6 months
(range 4.0-8.1m), eight of nine patients were disease free at last
follow-up with one patient who relapsed at month 6 but was rescued
with radiotherapy. One patient died of a COVID-19 infection at
month 5.6 whilst in complete metabolic remission.
Relapse / refractory adult Acute
Lymphoblastic LeukemiaAs of the data cut-off date of May
17, 2021, 20 patients in Cohort A with r/r ALL had received
obe-cel. The therapy was well tolerated, with no patients
experiencing Grade 3 or higher CRS. Three patients (15%), all of
whom had high leukemia burden (>50% blasts), experienced Grade 3
ICANS that resolved swiftly with steroids.
Of the 20 patients evaluable for efficacy, 17
(85%) of patients achieved minimum residual disease (MRD)-negative
complete remission (CR) at one month. Most notably, the durability
of remissions is highly encouraging. Across all treated patients,
event free survival (EFS) at twelve months and twenty-four months
is 50.2% with median EFS not being reached.
Conference CallManagement will
host a conference call and webcast today at 8:30 am ET/1:30 pm
BST to discuss the data presented at EHA. To listen to the webcast
and view the accompanying slide presentation, please go to the
events section of Autolus’ website.
The call may also be accessed by dialing (866)
679-5407 for U.S. and Canada callers or (409) 217-8320 for
international callers. Please reference conference ID 3697562.
After the conference call, a replay will be available for one week.
To access the replay, please dial (855) 859-2056 for U.S. and
Canada callers or (404) 537-3406 for international callers. Please
reference conference ID 3697562.
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 AUTO1 (obecabtagene
autoleucel)AUTO1 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, AUTO1 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 our academic partner, UCL, AUTO1 is currently
being evaluated in a Phase 1 clinical trial in adult ALL and B-NHL.
The company has also progressed AUTO1 to the FELIX study, a
potential pivotal study.
About AUTO1 FELIX studyThe
FELIX Phase 1b/2 clinical trial is enrolling adult patients with
relapsed / refractory ALL. The trial has a short Phase 1b component
prior to proceeding to a single arm Phase 2 clinical trial. The
primary endpoint is overall response rate, and the key secondary
endpoints include duration of response, MRD negative CR rate and
safety. The trial will enroll approximately 100 patients across
approximately 30 of the leading academic and non-academic centers
in the United States, United Kingdom and Europe.
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 Autolus’ development
of the AUTO1 program; the future clinical development, efficacy,
safety and therapeutic potential of its product candidates,
including progress, expectations as to the reporting of data,
conduct and timing and potential future clinical activity and
milestones; and expectations regarding the initiation, design and
reporting of data from clinical trials. 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 4, 2021, 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+1-212-966-3650susan@sanoonan.com
Autolus Therapeutics (NASDAQ:AUTL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Autolus Therapeutics (NASDAQ:AUTL)
Historical Stock Chart
From Apr 2023 to Apr 2024