Autolus Therapeutics Receives PRIME designation for AUTO1 for the treatment of adult ALL
April 01 2021 - 8:45AM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced that it has received PRIority
MEdicines (PRIME) designation from the European Medicines Agency
(EMA) for AUTO1, the company’s CAR T cell therapy being
investigated in the ongoing FELIX Phase 1b/2 study in relapsed /
refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
“We are pleased to have received PRIME
designation for AUTO1 as it will accelerate the review of a
promising therapy targeting unmet medical need,” said
Dr. Christian Itin, chairman and chief executive officer of
Autolus. “The designation comes soon after we presented compelling
activity and safety data from the ALLCAR Phase 1 clinical trial at
the 62nd American Society of Hematology (ASH) Annual Meeting. We
believe AUTO1 could change standard of care by offering a
potentially curative therapy for r/r ALL.”
About PRIMEThe PRIME program
aims to optimize development plans and speed up evaluation of
medicines that may offer a major therapeutic advantage over
existing treatments or benefit patients without treatment options.
The PRIME designation is awarded by the EMA to promising medicines
that target an unmet medical need. To be eligible and accepted for
PRIME, a medicine has to show its potential to benefit patients
with unmet medical needs based on early clinical data coupled with
non-clinical data. Through the PRIME program, the EMA offers
enhanced support to medicine developers including early interaction
and dialogue, and a pathway for accelerated evaluation by the
agency. The program is intended to optimize development plans and
expedite the review and approval process so that these medicines
may reach patients as early as possible.
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:
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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