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RNS Number : 4139J
Syncona Limited
12 December 2022
Syncona Limited
Autolus presents clinical data updates at ASH Congress
12 December 2022
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 presented new data highlighting progress across
its broader portfolio 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 presented from the ALLCAR19 trial of
obe-cel in relapsed refractory (r/r) adult acute lymphoblastic
leukemia (ALL), with 35% of patients remaining in complete
remission (CR) three years after treatment with obe-cel
-- Encouraging efficacy data in obe-cel in relapsed/refractory B
cell non-Hodgkin's lymphoma (B-NHL), and chronic lymphocytic
leukaemia (CLL), with a 92% ORR (overall response rate) amongst
patients evaluable for efficacy
-- Strong activity levels observed in the AUTO1/22 programme in
paediatric acute lymphoblastic leukaemia (pALL), alongside a
favourable tolerability profile in a heavily pre-treated
population
-- Clinically meaningful responses in AUTO4 in T cell Lymphoma
(TCL), with sustained complete metabolic response (CMR) in patients
at 9 and 12 months
Management will host a conference call and webcast on 12
December 2022 at 10.30am ET/3.30pm GMT to discuss the ASH data. To
listen to the webcast and view the accompanying slide presentation,
please go to the events section of Autolus' website.
Martin Murphy, Chief Executive Officer and Chair of Syncona
Investment Management Limited, said: "It is fantastic to see the
long-term follow up data in the ALLCAR19 academic study of obe-cel
in r/r adult ALL demonstrating its durability potential. This
follows on from the recent announcement that the company has met
its primary endpoint at interim analysis in the pivotal Phase II
FELIX trial of obe-cel. We are also pleased to see the release of
additional data from Autolus' broader pipeline, which reflects the
strength of the company's technology and platform at what is a very
exciting moment in the company's development. Autolus has a strong
balance sheet and positive data in its lead programme to power the
business forward over the next year."
[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 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 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 Clinical Data Updates at the
American Society of Hematology (ASH) Annual Meeting 2022
- Obe-cel: 35% of relapsed/refractory adult B-ALL patients in
the ALLCAR19 trial remain in complete remission at a median follow
up of three years without the need for additional anti-leukemia
therapy
- Obe-cel: continues to show high level of sustained clinical activity in B-NHL patients
- AUTO1/22: no antigen negative relapse seen in responding patients
- AUTO4: first sustained metabolic CRs at 9 and 12 months of
follow-up in T cell Lymphoma patients
LONDON , December 12, 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 posters with updates from three Phase 1
clinical trials to be presented at the American Society of
Hematology (ASH) Annual Meeting, December 10-13, 2022.
"With three years of median follow-up in our Phase 1 ALLCAR19
study we see 35% of adult relapsed/refractory B-ALL patients
treated with obe-cel in sustained complete remissions between 24
and 47 months without any need for additional anti-leukemia
therapy. Remarkably, these patients in long term remissions also
have long-term persisting CAR T cells, a unique feature of
obe-cel," said Dr. Christian Itin, Chief Executive Officer of
Autolus. "With the initial data from the pivotal Phase 2 FELIX
trial tracking the outcome of our previous ALLCAR19 trial, we are
excited about the potential prospects of obe-cel in adult ALL
patients and look forward to presenting the full data of the FELIX
study in mid-2023. The potentially best-in-class profile of obe-cel
is supported by the data we have observed in NHL, with continued
high levels of clinical activity paired with an encouraging
tolerability profile across DLBCL, MCL, FL and CLL."
"It's great to be presenting clinical updates for AUTO1/22 in
pediatric B-ALL and AUTO4 in peripheral T Cell Lymphoma. AUTO1/22
shows encouraging response rates in patients ineligible for
commercial CAR T therapy, with 83% of patients achieving MRD
negative complete responses. Importantly, we have not observed
antigen negative relapse," said Dr. Martin Pule, Chief Scientific
Officer at Autolus. "In the AUTO4 study, some patients have
experienced durable metabolic CRs, including one patient up to the
one-year mark. This is a notable finding given the poor prognosis
of relapsed/refractory T cell lymphomas."
Conference Call
Management will host a conference call and webcast at 10:30 am
ET/3:30 pm GMT to summarize the ASH data. The webcast can be
accessed at this link .
A simultaneous audio webcast and replay will be accessible on
the events section of Autolus website.
Posters 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 (B-ALL) and Other B-Cell Malignancies
LINK to poster
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: In the B-ALL cohort, 7 out of 20 (35%) patients were
observed to be in ongoing Complete Remission (CR) at median follow
up of 36 months (IQR 24-47) post-AUTO1 without the need for
additional anti-leukemia therapy. Ongoing long-term remissions
appear to be associated with CAR-T persistence, which was also
observed in these 7 patients at their last follow-up. One patient
with a subsequent stem cell transplant (SCT) also achieved long
term remission but lost CAR T persistence after SCT. In the B-cell
non-Hodgkin lymphoma/chronic lymphocytic leukemia (NHL/CLL)
cohorts, AUTO1 continues to display a favorable tolerability
profile with no immune effector cell-associated neurotoxicity
syndrome (ICANS) or Grade >= 3 cytokine release syndrome (CRS)
across different indications. Of 25 patients with NHL/CLL evaluable
for efficacy, the best overall response rate (ORR) was 23/25 (92%).
AUTO1 was observed to be well-tolerated and active in diffuse large
B-cell lymphoma (DLBCL), with 7 of 8 patients in ongoing CR at last
follow-up. In CLL, 4 of 5 treated patients achieved undetectable
minimal residual disease (uMRD) in the bone marrow (BM), ongoing at
last follow-up. While no relapses were seen in DLBCL patients, late
CD19+ relapses were seen in follicular lymphoma (FL), and ongoing
CAR-T persistence appears to be important.
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 poster
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: AUTO1/22 demonstrated a strong level of activity with
83% (10/12) MRD negative complete remissions and a favorable
tolerability profile in a very challenging patient population (4
patients failed previous Kymriah treatment with three having
CD19-negative disease, 3 had non-central nervous system (CNS)
extra-medullary disease, which is associated with poor outcomes
with CAR T therapy). AUTO1/22 showed excellent expansion, with a
median 7.5 months duration of persistence of CD22 CAR. No antigen
negative relapse was seen in responding patients. At a median
follow up of 8.7 months, five of 10 responding patients were in MRD
negative complete response (4-12 months) with two after further
therapy for early loss of CAR T persistence.
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 poster
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: Having shown proof of concept at EHA in June 2022,
AUTO4 treatment for peripheral T-cell Lymphoma continues to be
observed to be well tolerated with no dose-limiting toxicities.
Ongoing responses at 9- and 12-months post-dosing at the highest
dose tested (450x106) are encouraging, and suggests a potential
clinical benefit for patients. No CAR T cell expansion was observed
in peripheral blood, but CAR T cells were detected in an
on-treatment lymph node biopsy. Optimization of the AUTO4
manufacturing process has been performed, resulting in a product
candidate with a more naive and central memory phenotype. The study
is ongoing, with additional patients due to be treated to define
the recommended Phase 2 dose.
# # #
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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