Autolus Therapeutics Announces Innovation Licensing and Access Pathway (ILAP) designation for obe-cel for the treatment of re...
June 15 2021 - 07:00AM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced that it has received innovative
licensing and access pathway (ILAP) designation from the UK
Medicines and Healthcare products Regulatory Agency (MHRA) for
AUTO1 (obecabtagene autoleucel, obe-cel), the company’s CAR T cell
therapy being investigated in the ongoing FELIX Phase 1b/2 study in
relapsed / refractory (r/r) adult B-cell Acute Lymphocytic Leukemia
(ALL) in patients 18 years and older.
“The ILAP designation for obe-cel, alongside the
recent PRIority MEdicines (PRIME) designation from the European
Medicines Agency (EMA), is another step forward in accelerating the
review process of this promising therapy,” said Dr. Christian
Itin, chief executive officer of Autolus. “Obe-cel continues to
show the potential to be differentiated on efficacy, durability and
safety from other CAR T cell products and could change standard of
care by offering a potentially curative therapy for r/r ALL.”
About ILAPILAP was announced in
December 2020 and launched at the start of 2021 in order to
accelerate the development and access to promising medicines and is
geared toward medicines that are in the early stages of
development. The pathway, part of the UK’s plan to attract life
sciences development in the post-Brexit era, features enhanced
input and interactions with MHRA and other stakeholders including
the National Institute for Health and Care Excellence (NICE) and
the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds
light on pathway to accelerate R&D, Regulatory
Focus 24 December 2020).The innovation passport designation is
the first step in the ILAP process and triggers the MHRA and its
partner agencies to chart a roadmap for regulatory and development
milestones with the goal of early patient access in the UK.
Other benefits of ILAP include access to range of
development tools, such as the potential for a 150-day accelerated
Marketing Authorization Application (MAA) assessment, rolling
review and a continuous benefit risk assessment.
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, 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 into the FELIX study, a
potential pivotal study.
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 and the 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; and the potential for an
accelerated regulatory approval pathway for obe-cel. 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 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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