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RNS Number : 7278H
Syncona Limited
07 December 2020
Syncona Limited
Autolus presents additional data on AUTO1
05 December 2020
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes that its portfolio company, Autolus Therapeutics Plc (NASDAQ:
AUTL) (Autolus), announced new data highlighting progress on its
AUTO1 program, the company's CAR T cell therapy being investigated
in the ongoing ALLCAR Phase 1 study in relapsed / refractory adult
B-Acute Lymphocytic Leukemia (ALL), during the American Society of
Hematology (ASH) All-Virtual Annual Meeting, held between December
5-8, 2020. A copy of the announcement is set out below.
Autolus noted that data from the ALLCAR study suggests AUTO1's
potential for transformational activity in adult patients with
relapsed / refractory ALL. The company also noted that the Phase
1b/2 pivotal study for the AUTO1 programme is under way and
enrolment projections have had to be adjusted in light of the
COVID-19 pandemic. The company now expects to enroll patients
throughout 2021 with a full data set in 2022.
Autolus management will host a conference call and webcast at
4:00 pm ET/9:00 pm GMT on Monday, 7(th) December, to discuss the
ASH data. To listen to the webcast and view the accompanying slide
presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
.
[S]
Enquiries
Syncona Ltd
Annabel Clay
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona (LON: SYNC) is a healthcare company focused on founding,
building and funding a portfolio of global leaders in life science.
Our purpose is to invest to extend and enhance human life. We do
this by founding and building companies to deliver transformational
treatments to patients in areas of high unmet need.
Our strategy is to found, build and fund companies around
exceptional science to create a dynamic portfolio of 15-20 globally
leading healthcare businesses 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 strategic 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 few treatment options, build
sustainable life science companies and deliver strong risk-adjusted
returns to shareholders.
Autolus Therapeutics presents compelling AUTO1 data from ALLCAR
Phase 1 study in Adult Acute Lymphoblastic Leukemia (ALL) during
the 62nd ASH Annual Meeting
Updated data from the ALLCAR study suggests AUTO1's potential
for transformational activity in adult patients with r/r ALL
Conference call and webcast to be held Monday, December 7,
2020
at 4:00 pm ET / 9:00 pm GMT
LONDON , December 5, 2020 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announced new
data highlighting progress on its AUTO1 program, the company's CAR
T cell therapy being investigated in the ongoing ALLCAR Phase 1
study in relapsed / refractory adult B-Acute Lymphocytic Leukemia
(ALL), during the American Society of Hematology (ASH) All-Virtual
Annual Meeting, held between December 5-8, 2020.
As of the November 12, 2020 data cut-off date, 20 patients with
r/r ALL had received AUTO1. AUTO1 was well tolerated, with no
patients experiencing >= Grade 3 cytokine release syndrome
(CRS). Three patients (15%), all of whom had high leukemia burden
(>50% blasts), experienced Grade 3 neurotoxicity (NT) that
resolved swiftly with steroids.
Of the 19 patients evaluable for efficacy, 16 (84%) patients
achieved minimum residual disease (MRD)-negative complete response
(CR) at one month. Most notably, the durability of remissions is
highly encouraging. Across all treated patients, event free
survival (EFS) at six and 12 months is 69% and 52% respectively.
Median EFS and overall survival (OS) has not been reached at a
median follow up of 16.9 months (range up to 30.5 months).
"The high level of sustained CRs observed with AUTO1 in adult
ALL, achieved without subsequent stem cell transplant, point to a
potentially transformational treatment for adult ALL," said Dr.
Claire Roddie, Consultant Hematologist, UCL Cancer Institute and
University College London Hospital. "Despite high disease burden
and despite this being a heavily pre-treated patient population on
study, AUTO1 remains well tolerated. It's encouraging to also
observe promising early activity and safety in indolent NHL."
"Adult ALL is a disease with high unmet need, whereby
approximately 60% of patients relapse or are refractory to first
line therapy," said Dr. Elias Jabbour, Professor of Leukemia at The
University of Texas MD Anderson Cancer Center. "AUTO1 is a novel
CD19 CAR T candidate with an impressive clinical profile. This
profile has the potential to change standard of care as a curative
therapy for r/r ALL."
Dr. Christian Itin, chairman and chief executive officer of
Autolus, added "We are excited about the long-term remissions
observed without a need for an additional stem cell transplant.
Remarkably, this outstanding result was achieved with a
well-tolerated safety profile in this fragile adult ALL population.
We believe the unique characteristics of AUTO1, seen in the ALLCAR
study, point to the potential for AUTO1 as a standalone and
transformational therapy in r/r ALL. Our Phase 1b/2 pivotal study
is under way, however, with the escalating COVID-19 pandemic,
enrolment projections have had to be adjusted. We now expect to
enroll patients throughout 2021 with a full data set in 2022."
In addition to adult ALL, the ALLCAR study was extended to
patients with indolent B cell Non-Hodgkin Lymphoma (NHL) (Cohort
1), high grade B-NHL (Cohort 2) and chronic lymphocytic leukemia
(CLL) (Cohort 3). As of the data cut-off date of November 12, 2020,
four patients in Cohort 1 had been infused with AUTO1. AUTO1 was
well tolerated, with no patients experiencing >= Grade 2 CRS and
no patients experiencing NT of any grade. All four patients
achieved a Complete Metabolic Response (CMR).
Investor call on Monday December 7, 2020
Management will host a conference call and webcast on Monday
December 7, 2020 at 4:00 pm ET/9:00 pm GMT to discuss the ASH data.
To listen to the webcast and view the accompanying slide
presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
.
The call may also be accessed by dialing (866) 679-5407 for U.S.
and Canada callers or (409) 217-8320 for international callers.
Please reference conference ID 9188389. After the conference call,
a replay will be available for one week. To access the replay,
please dial (855) 859-2056 for U.S. and Canada callers or (404)
537-3406 for international callers. Please reference conference ID
9188389.
About Autolus Therapeutics plc
Autolus 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 safety - while maintaining similar
levels of efficacy - 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. AUTO1 is
currently being evaluated in two Phase 1 studies, one in pediatric
ALL and one in adult ALL. The company has also now progressed the
program to a potential pivotal study, AUTO1-AL1.
About AUTO1-AL1 pivotal study
The AUTO1-AL1 study will enroll patients with relapsed /
refractory ALL. The study will have a short Phase1b component prior
to proceeding to a single arm Phase 2 study. The primary end point
is overall response rate and the key secondary end points include
duration of response, MRD negative CR rate and safety. The study
will enroll approximately 100 patients across 30 of the leading
academic and non-academic centers in the US, UK and Europe.
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 efficacy, safety and therapeutic potential of AUTO3 and the
future clinical development of AUTO3 including progress,
expectations as to the reporting of data, conduct and timing. 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 the company 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, PhD
Vice President, Investor Relations and Corporate
Communications
+44 (0) 7587 372 619
l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
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