Autolus Therapeutics Announces Updated Manufacturing Facility Strategy Leveraging its UK Operations
March 29 2021 - 8:00AM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced its updated manufacturing
facilities strategy for commercial supply of AUTO1.
Autolus now plans to establish global commercial
launch capacity in the UK, enabling the company to leverage the
expertise and skill base of its U.K. employees. This will be
provided by a combination of the existing clinical trial
manufacturing facility at The Cell and Gene Therapy Catapult (CGTC)
facility and a new Autolus facility. This revised strategy aims to
deliver a less capital-intensive commercial manufacturing
infrastructure at a lower cost base.
In conjunction with this new facilities
strategy, Autolus’ lease for the manufacturing and office facility
at 9950 Medical Center Drive in Rockville, MD, has been mutually
terminated, triggering a cash payment to Autolus and ending all of
the company’s payment obligations under the lease.
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 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 study 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 Autolus’ refocused
business strategy, including specifically on the 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;
expectations regarding the initiation, design and reporting of data
from clinical trials; the development of Autolus’ pipeline of next
generation programs, including for solid tumor indications, in
collaboration with its academic partners, including expectations as
to the reporting of data, conduct and timing; the efficacy, safety
and therapeutic potential of AUTO3 and ability for Autolus to
obtain a partner for next stages of clinical development; needs for
additional funding and ability to raise additional capital;
Autolus’ ability to attract and retain qualified employees and key
personnel; the restructuring program and Autolus’ expected cash
savings as a result of the restructuring program and operational
changes; and Autolus’ expected cash runway. 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 3, 2020, as amended, 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, Investor
Relations and Corporate Communications+44 (0) 7587 372
619 l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.comSusan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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