TIDMSYNC
RNS Number : 4646B
Syncona Limited
30 January 2020
Syncona Limited
Autolus announces additional data in AUTO3 at EHA
30 January 2020
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes its portfolio company, Autolus Therapeutics Plc (NASDAQ:
AUTL) (Autolus) has announced additional data regarding its ongoing
Phase 1/2 clinical trial of its next-generation programmed T cell
therapy, AUTO3, to treat adults with relapsed/refractory diffuse
large B cell lymphoma (DLBCL).
The data is to be presented in a keynote lecture titled
"Improved CAR T cell approaches for lymphoid malignancies," by Dr.
Martin Pulé, clinical senior lecturer in the Dept. of Hematology at
UCL Cancer Institute and chief scientific officer of Autolus
Therapeutics, at the EHA-EBMT 2nd European CAR T Cell Meeting to be
held on January 30, 2020 at 17:15 P.M. CET in Stiges (Barcelona),
Spain.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and full text of the
announcement from Autolus is contained below. The slide
presentation from Dr. Martin Pulé's lecture at the EHA-EBMT 2nd
European CAR T Cell Meeting will be available at:
https://www.autolus.com/investor-relations/news-and-events/events.
[S]
Enquiries
Syncona Ltd
Siobhan Weaver / Annabel Clay
Tel: +44 (0) 20 3981 7924
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
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.
About Syncona
Syncona is a leading FTSE250 healthcare company focused on
founding, building and funding a portfolio of global leaders in
life science. Our vision is to build a sustainable, diverse
portfolio of 15 - 20 companies focused on delivering
transformational treatments to patients in truly innovative areas
of healthcare, through which we are seeking to deliver strong
risk-adjusted returns for shareholders.
We seek to partner with the best, brightest and most ambitious
minds in science to build globally competitive businesses. We take
a long-term view, underpinned by a strategic capital base which
provides us with control and flexibility over the management of our
portfolio. We focus on delivering dramatic efficacy for patients in
areas of high unmet need.
Autolus Therapeutics Presents Encouraging Additional Data
Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline
in Blood Cancers
- Initial data show encouraging clinical activity with
manageable safety profile
- No neurotoxicity observed to date in patients treated with
AUTO3 +
pembrolizumab
Data presented at EHA-EBMT 2nd European CAR T Cell Meeting
points to potential differentiated profile for AUTO3
LONDON, January 30, 2020 - Autolus Therapeutics plc (Nasdaq:
AUTL) today announced additional data regarding its ongoing Phase
1/2 clinical trial of its next-generation programmed T cell
therapy, AUTO3, to treat adults with relapsed/refractory diffuse
large B cell lymphoma (DLBCL). The data is to be presented in a
keynote lecture titled "Improved CAR T cell approaches for lymphoid
malignancies," by Dr. Martin Pulé, clinical senior lecturer in the
Dept. of Hematology at UCL Cancer Institute and chief scientific
officer of Autolus Therapeutics, at the EHA-EBMT 2nd European CAR T
Cell Meeting to be held on January 30, 2020 at 17:15 P.M. CET in
Stiges (Barcelona), Spain.
"The incremental update in the AUTO3 trial presented at the
2(nd) European CAR T Cell Meeting continue to support the
encouraging early indications of durability and high level of
activity previously reported. Together with the encouraging signs
of a manageable safety profile in adult patients with DLBCL, these
early data for AUTO3 show the potential for a differentiated
product profile," said Dr. Christian Itin, chairman and chief
executive officer of Autolus.
"I'm pleased to be presenting today an encouraging data update
from our ALEXANDER trial of AUTO3, our CD19/CD22 dual-targeting
CAR-T product candidate in DLBCL," said Dr Martin Pulé, founder and
chief scientific officer of Autolus. "Together with the data we
have generated to date for AUTO1 in acute lymphoblastic leukemia
(ALL) patients, we now have two programs specifically designed for
the development of the respective hematological malignancies."
As of the data cut-off date of January 21, 2020 (data
availability as of January 28, 2020), 18 patients in the ALEXANDER
Phase 1/2 clinical trial of AUTO3 were evaluable for safety and
efficacy with minimum 28-day follow-up. In the cohorts dosed at 450
x 10(6) AUTO3 cells plus pembrolizumab, five out of seven patients
(ORR=71%) achieved a response (complete response + partial
response) and four out of seven patients (CRR=57%) achieved a
complete response. Across all dose levels, seven out of eight
complete responders (87%) had ongoing complete responses at a
median follow up of six months (range of one month - 18 months).
All seven out of seven complete responders (100%) treated with
AUTO3 and pembrolizumab have ongoing complete responses as of
January 21, 2020 at a median follow up of three months (range of
one month - 18 months). AUTO3 was generally well tolerated, with no
patients experiencing dose limiting toxicity, and there were no
treatment-related deaths. One patient experienced Grade 4 lung
infection due to para-influenza virus that was possibly considered
to be related to treatment and the patient is recovering. Such
infections are a common event in late stage DLBCL patients. No
patients experiencing Grade 3 or higher Cytokine Release Syndrome
(CRS) were reported with primary treatment (one patient experienced
Grade 3 CRS on retreatment), and one of 18 patients experienced a
Grade 3 neurotoxicity that resolved swiftly with administration of
steroids. As of the data cut-off, no patient has experienced
neurotoxicity of any grade in cohorts treated with AUTO3 and
pembrolizumab.
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.
About AUTO3
AUTO3 is the first investigational CAR T cell therapy containing
two independent chimeric antigen receptors targeting CD19 and CD22
that have each been independently designed for single target
activity. By simultaneously targeting two B cell antigens, AUTO3 is
designed to minimize relapse due to single antigen loss in patients
with B cell malignancies. AUTO3 is currently being tested in adult
diffuse large B cell lymphoma in the ALEXANDER clinical trial and
in pediatric ALL in the AMELIA clinical trial.
About AUTO1
AUTO1 is a novel investigational CD19-targeting CAR T cell
therapy designed to overcome the limitations in safety - while
maintaining similar levels of efficacy - compared to current CD19
CAR T cell therapies. AUTO1 has a fast target binding off-rate
designed to minimize excessive activation and associated cytokine
release, which may reduce toxicity. In addition, the fast off-rate
may reduce T cell exhaustion, enhance persistence and improve the
programmed T cells' ability 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.
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 anticipated development plans for Autolus' product candidates,
including statements regarding the potential indications and
benefits of AUTO3 and AUTO1 and the potential of AUTO3 to treat
adult DLBCL. 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. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our 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 on November 23, 2018 as well as
discussions of potential risks, uncertainties, and other important
factors in Autolus' future filings with the Securities and Exchange
Commission from time to time. 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:
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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END
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