Autolus Therapeutics provides an update on its manufacturing facility in Stevenage, UK
September 16 2021 - 7:00AM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced that planning approval has been
granted to build the Company’s new manufacturing facility in
Stevenage, UK. The 70,000 square foot facility is being built by
Merit Holdings Limited as general contractor for the Reef Group,
who will lease the facility to Autolus. Global commercial launch
capacity for obecabtagene autoleucel (obe-cel) will initially be
provided by the existing clinical trial manufacturing facility at
The Cell and Gene Therapy Catapult (CGTC) facility, and will then
move to the new Autolus facility which will allow for GMP capacity
for approximately 2,000 batches a year initially, with scope to
expand.
“Stevenage is rapidly becoming one of Europe’s
largest clusters for biotechnology and the establishment of our own
manufacturing facility will secure global commercial launch
capacity for obe-cel,” said Dr. Christian Itin, chief executive
officer of Autolus. “We are excited by the progress we are making
with obe-cel for the treatment of adult patients with acute
lymphoblastic leukemia (ALL) and expect data from the pivotal FELIX
study in 2022.”
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 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 our academic partner, UCL,
Obe-cel is currently being evaluated in a Phase 1 clinical trial in
adult ALL and B-NHL. The company has also progressed Obe-cel to the
FELIX study, a potential pivotal study.
About Obe-cel
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 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 the future clinical
development, efficacy, safety and therapeutic potential of obe-cel,
including progress, expectations as to the reporting of data,
conduct and timing and potential future clinical activity and
milestones; 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:
Lucinda Crabtree, PhDVice President, Business
Strategy and Planning+44 (0) 7587 372
619l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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