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RNS Number : 4684A
Syncona Limited
22 January 2024
Syncona Limited
Autolus announces acceptance of BLA for obe-cel
22 January 2024
Syncona Ltd, a leading healthcare company focused on creating,
building and scaling global leaders in life science, notes that its
portfolio company, Autolus Therapeutics plc (Nasdaq: AUTL)
("Autolus") has announced that the US Food and Drug Administration
(FDA) has accepted its Biologics License Application (BLA) for
obe-cel for patients with relapsed/refractory (r/r) adult B-cell
acute lymphoblastic leukaemia (ALL).
Highlights include:
-- Under the Prescription Drug User Fee Act (PDUFA), the FDA has
set a target action date of November 16, 2024 for reviewing the
application, under a standard review timeline consistent with
recently approved CAR T therapies. The FDA is not currently
planning to hold an advisory committee meeting to discuss this
application
-- The BLA submission is based on data from the pivotal FELIX
study of obe-cel in adult r/r B-ALL, most recently presented at the
Annual Meeting of the American Society for Hematology (ASH) in
December 2023
-- Autolus is on track to submit a marketing authorisation
application to the European Medicines Agency (EMA) in H1 CY2024
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations/news/ and the full text
of the announcement from Autolus is contained below.
[S]
Enquiries
Syncona Ltd
Annabel Clark
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life.
We do this by creating and building companies to deliver
transformational treatments to patients in areas of high unmet
need.
Our strategy is to create, build and scale companies around
exceptional science to create a diversified portfolio of 20-25
globally leading healthcare businesses, across development stage
and therapeutic areas, for the benefit of all our stakeholders. We
focus on developing treatments for patients by working in close
partnership with world-class academic founders and management
teams. Our balance sheet underpins our strategy enabling us to take
a long-term view as we look to improve the lives of patients with
no or poor treatment options, build sustainable life science
companies and deliver strong risk-adjusted returns to
shareholders.
Copies of this press release and other corporate information can
be found on the company website at: www.synconaltd.com
Forward-looking statements - this announcement contains certain
forward-looking statements with respect to the portfolio of
investments of Syncona Limited. These statements and forecasts
involve risk and uncertainty because they relate to events and
depend upon circumstances that may or may not occur in the future.
There are a number of factors that could cause actual results or
developments to differ materially from those expressed or implied
by these forward-looking statements. In particular, many companies
in the Syncona Limited portfolio are conducting scientific research
and clinical trials where the outcome is inherently uncertain and
there is significant risk of negative results or adverse events
arising. In addition, many companies in the Syncona Limited
portfolio have yet to commercialise a product and their ability to
do so may be affected by operational, commercial and other
risks.
Syncona Limited seeks to achieve returns over the long term.
Investors should seek to ensure they understand the risks and
opportunities of an investment in Syncona Limited, including the
information in our published documentation, before investing.
Autolus Therapeutics announces acceptance of Biologics License
Application for obecabtagene autoleucel (obe-cel) as a potential
treatment for relapsed/refractory Adult B-cell Acute Lymphoblastic
Leukemia (ALL)
- PDUFA Goal date is November 16, 2024
- Company on track to submit a marketing authorization
application to the European Medicines Agency (EMA) in the first
half of 2024
LONDON, January 22, 2024 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announces that
the U.S. Food and Drug Administration (FDA) has accepted its
Biologics License Application (BLA) for obecabtagene autoleucel
(obe-cel) for patients with relapsed/refractory (r/r) Adult B-Cell
Acute Lymphoblastic Leukemia (ALL). Under the Prescription Drug
User Fee Act (PDUFA), the FDA has set a target action date of
November 16, 2024, a standard review timeline consistent with
recently approved CAR T therapies. The FDA is not currently
planning to hold an advisory committee meeting to discuss this
application.
The BLA submission is based on data from the Pivotal Phase 2
FELIX study of obe-cel in adult r/r B-ALL. The data were presented
at the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting in June 2023, with updated data presented at the Annual
Meeting of the American Society for Hematology Meeting (ASH) in
December 2023.
"Acceptance of the BLA filing is an important milestone for
Autolus and we look forward to continuing our collaboration with
the FDA during the review cycle," commented Dr. Christian Itin,
Chief Executive Officer of Autolus. "With the PDUFA date set for
November, we remain focused on preparing for the potential launch
of obe-cel."
Autolus plans to submit a Marketing Authorization Application
for obe-cel in relapsed/refractory ALL to the European Medicines
Agency (EMA) in the first half of 2024.
Obe-cel has been granted Orphan Drug Designation by the FDA,
Orphan Medical Product Designation by the EMA, Regenerative
Medicine Advanced Therapy (RMAT) designation by the FDA and
PRIority MEdicines (PRIME) designation by the EMA for adult r/r
B-ALL.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing
next-generation, programmed T cell therapies for the treatment of
cancer and autoimmune disease. 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 target 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, solid tumors and
autoimmune diseases. For more information, please visit
www.autolus.com .
About obe-cel (AUTO1)
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. Obe-cel is designed with a
fast target binding off-rate to minimize excessive activation of
the programmed T cells. Clinical trials of obe-cel have
demonstrated that this "fast off-rate" profile reduces toxicity and
T cell exhaustion, resulting in improved persistence and leading to
high levels of durable remissions in r/r Adult ALL patients. The
results of the FELIX trial, a pivotal trial for adult ALL, are
being prepared for regulatory submissions with the FDA and EMA.
Autolus is conducting a Phase 1b study in paediatric patients with
ALL and aggressive B-NHL and iIn collaboration with UCL, obe-cel is
currently being evaluated in a Phase 1 clinical trials for
B-NHL.
About obe-cel FELIX clinical trial
Autolus' Phase Ib/II clinical trial of obe-cel enrolled adult
patients with relapsed / refractory B-precursor ALL. The trial had
a Phase Ib component prior to proceeding to the single arm, Phase
II clinical trial. The primary endpoint is overall response rate,
and the secondary endpoints include duration of response, MRD
negative CR rate and safety. The trial enrolled over 100 patients
across 30 of the leading academic and non-academic centers in the
United States, United Kingdom and Europe. [NCT04404660]
Forward-Looking Statements
This 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 Company's anticipated transition plans and timing from a
clinical to commercial stage company. 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; and possible safety
and efficacy concerns. 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 7, 2023, 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:
Olivia Manser
+44 (0) 7780 471568
o.manser@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
Lauren Williams
Investase
+44 23 9438 7760
lauren@investase.com
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