TIDMSYNC
RNS Number : 2627F
Syncona Limited
03 November 2022
Syncona Limited
Autolus to present clinical data updates at ASH Congress
3 November 2022
Syncona Ltd, a leading healthcare company focused on founding,
building and funding global leaders in life science, notes that its
portfolio company, Autolus Therapeutics Plc (Nasdaq: AUTL)
("Autolus"), has today announced that new data highlighting
progress across its broader portfolio will be presented at the
American Society of Hematology (ASH) Congress, held between 10-13
December, 2022. A copy of the announcement is set out below, with
key highlights as follows:
-- Positive durability data to be presented from the ALLCAR19
trial of AUTO1 (obe-cel) in relapsed refractory (r/r) adult acute
lymphoblastic leukemia (ALL)
-- Further encouraging efficacy data to be presented in obe-cel
in relapsed/refractory B cell non-Hodgkin's lymphoma (B-NHL), and
chronic lymphocytic leukaemia (CLL)
-- No antigen-negative relapse, which is a common cause of
treatment failure, observed in the AUTO1/22 programme in paediatric
acute lymphoblastic leukaemia (pALL)
Autolus will present more data on these programmes including
longer follow up data in AUTO1/22 and AUTO4 within the ASH
presentations.
Martin Murphy, Chief Executive Officer and Chair of Syncona
Investment Management Limited, said: "We continue to be highly
encouraged by the progress of Autolus' clinical pipeline, including
its lead programme of obe-cel in adult ALL. The data to be
presented from the ALLCAR19 Phase I trial underlines the strong
efficacy and durability profile of obe-cel, with the potential of
the therapy also supported by the data from the ongoing trials of
its use in B-NHL and CLL. The company is publishing initial results
in Q4 with data from its Phase II trial of obe-cel expected in H1
2023. This is a significant milestone for the business and we are
excited about its continued progress towards delivering a product
that will reach patients in real need."
[S]
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 risk
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Julia Bradshaw / 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 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 diversified 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 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.
Autolus Therapeutics to Present Three Clinical Data Updates at
the American Society of Hematology (ASH) Annual Meeting 2022
- obe-cel: poster presentation in B-ALL and B-NHL patients
- AUTO1/22: poster presentation in pediatric ALL patients
- AUTO4: poster presentation in T-Cell Lymphoma patients
LONDON , November 3, 2022 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announces the
online publication of three abstracts submitted to the American
Society of Hematology (ASH) Annual Meeting, to be held December
10-13, 2022.
"We're looking forward to presenting follow up data from three
of our clinical trials at ASH this year. Obe-cel continues to show
a potentially best-in-class profile across a number of indications,
and we will be presenting the encouraging safety, efficacy and
long-term follow up of obe-cel in relapsed/refractory B-ALL as well
as in the B-NHL cohorts from the ALLCAR19 study," said Dr.
Christian Itin, Chief Executive Officer of Autolus. "For both
AUTO1/22 in pediatric ALL patients and for AUTO4 in peripheral T
Cell Lymphoma we will present longer follow up data."
Abstracts to be presented:
1. Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a
Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute
Lymphoblastic Leukaemia and Other B-Cell Malignancies
LINK to abstract
Session Title: 704. Cellular Immunotherapies: Early Phase and
Investigational Therapies: Poster II
Session date and time: Sunday, December 11, 2022, 6:00 PM - 8:00
PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 3318
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath,
Consultant Haematologist and Honorary Senior Lecturer, Cancer
Institute, University College London (UCL)
Summary: obe-cel (AUTO1) has demonstrated an excellent safety
profile across 3 reported trials, with low levels of CRS/ICANS.
Overall, obe-cel has a tolerable safety profile in patients with
r/r B-cell cancers despite high disease burden. In the B-ALL cohort
of the ALLCAR19 study, long-term follow-up indicates that a subset
of patients continue in remission post- obe-cel without need for
further anti-leukemia therapy. In both indolent and aggressive NHL
and in CLL, obe-cel shows excellent ORR and CAR
engraftment/persistence. Additional patients, updated data and
longer follow up will be presented.
2. Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR
T Cells May Prevent Antigen-Negative Relapse after CAR T Cell
Therapy for Relapsed/Refractory ALL (AUTO1/22)
LINK to abstract
Session Title: 704. Cellular Immunotherapies: Early Phase and
Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM - 8:00
PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4650
Presenting Author: Dr. Sara Ghorashian, MD, PhD, Hon clinical
senior lecturer, UCL Great Ormond Street Institute of Child
Health
Summary: CD19 negative escape is a major cause of relapse after
CD19 CAR T cell therapy for relapsed/refractory (r/r) pediatric
ALL. To overcome this challenge, AUTO1/22 builds on the favorable
safety profile and excellent persistence of obe-cel by combining it
with an additional CD22 targeting CAR. As of 21 July 2022, 12
pediatric ALL patients have been treated with AUTO1/22. Overall, at
a median follow-up of 8.7 months (range 1-15 months), 6/10
responding patients remain in MRD negative CR at last follow-up.
Importantly, antigen-negative relapse has not been observed.
3. Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR
T-Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral
T-Cell Lymphoma
LINK to abstract
Session Title: 704. Cellular Immunotherapies: Early Phase and
Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM - 8:00
PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4634
Presenting Author: Dr Kate Cwynarski, Consultant Haematologist
University College London Hospitals (UCLH)
Summary: Peripheral T cell lymphomas (PTCL) are typically
aggressive, treatment resistant, and associated with poor
prognosis. Finding the right target is challenging because there is
a lack of tumor-specific antigens, and pan-T cell depletion leads
to immunosuppression. T cell lymphoma is clonal, and tumor cells
express either TRBC1 or TRBC2. AUTO4 targets TRBC1+ cells, which
allows part of the T cell compartment to be retained. This study is
ongoing, with additional patients due to be treated to define the
recommended phase 2 dose using the new manufacturing process.
# # #
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 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. 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 Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase 1
clinical trials for B-NHL. Autolus has progressed obe-cel to the
FELIX trial, a potential pivotal trial for adult ALL.
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell-based therapy
candidate based on obe-cel. It is designed to combine the enhanced
safety, robust expansion & persistence seen with the fast off
rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to
reduce antigen negative relapses. This product candidate is
currently in a Phase 1 clinical trial called CARPALL for patients
with r/r pediatric ALL. [ NCT02443831 ]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO4 is
specifically designed to target TRBC1 derived cancers, which
account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in
pre-clinical development. AUTO4 has been tested in a Phase 1
clinical trial, LibRA1 for patients with peripheral T cell
Lymphoma.
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
Autolus' development of the obe-cel 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; expectations
regarding regulatory approval process for any product candidates;
the collaboration between Autolus and Blackstone; the discovery,
development and potential commercialization of potential product
candidates including obe-cel using Autolus' technology and under
the collaboration agreement; the therapeutic potential for Autolus
in next generation product developments of obe-cel in B-cell
malignancies; the potential and timing to receive milestone
payments and pay royalties under the strategic collaboration; and
the Company's anticipated 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 10, 2022, 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
# # #
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END
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