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RNS Number : 4511V
Syncona Limited
13 December 2021
Syncona Limited
Autolus presents positive AUTO1 (obe-cel) data
13 December 2021
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"), presented new data on AUTO1 (obe-cel) and AUTO1/22
during the 63(rd) American Society of Hematology (ASH) Annual
Meeting & Exposition, being held between December 11-14, 2021.
A copy of the announcement is set out below:
-- In the ongoing Phase I ALLCAR19 study, obe-cel continues to
show sustained durability of response, with patients approaching 42
months of follow-up and an event free survival of 46% at 24
months.
-- Initial data in the Phase Ib portion of the pivotal FELIX
study of obe-cel in relapsed refractory (r/r) adult acute
lymphoblastic leukaemia (ALL) demonstrated response and safety data
consistent with the Phase I ALLCAR19 study. Autolus expects to
publish the full data from the FELIX study in 2022.
-- Updated obe-cel data in r/r B cell non-Hodgkin's lymphoma
(B-NHL) from the ALLCAR19 extension study show a metabolic complete
response in 100% of patients with follicular lymphoma, mantle cell
lymphoma and diffuse large B cell lymphoma, with long-term
persistence evident.
-- Initial data in AUTO1/22 in paediatric ALL is encouraging
with high level of activity and good engraftment; data from the
full cohort of patients expected in H1 2022.
Martin Murphy, Chief Executive Officer of Syncona Investment
Management Limited, said: "We continue to be highly encouraged by
the data coming out of the obe-cel programme. The comparable
response and safety data between the FELIX and ALLCAR19 studies is
very promising, whilst the durability of response in patients in
the ALLCAR19 study reinforces the potential for obe-cel to be a
long-lasting, transformational therapy. The differentiated profile
of obe-cel means it has potential across other blood cancers, as
highlighted by the positive data presented in B-NHL and B-CLL
patients in the ALLCAR19 extension and the early data from AUTO1/22
in the paediatric ALL setting. We believe the company is well
positioned as it looks to deliver pivotal data from the FELIX study
in 2022."
Autolus management will host a conference call and webcast today
at 8:00 am ET/1:00 pm 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.
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 31044873. 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
31044873.
[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 Clay / Fergus Witt
Tel: +44 (0) 20 3981 7940
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 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 presents positive obe-cel data at the 63rd
ASH Annual Meeting & Exposition
- Obe-cel shows sustained durability of response with
morphological EFS of 46% at 24 months in the ALLCAR19 study
- Obe-cel response and safety data from the Phase 1b portion of
the FELIX study consistent with the Phase 1 ALLCAR19 study
- Obe -cel achieves a metabolic CR in 100% patients with FL, MCL
and DLBCL, with long term persistence evident and without ICANS or
high grade CRS
- Dual targeting AUTO1/22 shows data consistent with high level
of activity and good engraftment
Conference Call and Webcast to be held Monday, Dec 13, 2021 at
8:00 am ET / 1:00 pm GMT
LONDON , December 13, 2021 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, presented further
progress on obecabtagene autoleucel (obe-ce l) in an oral
presentation [Abstract 477] entitled "Industrialization of an
Academic Miltenyi Prodigy-Based CAR T Process" at the 63rd American
Society of Hematology (ASH) Annual Meeting & Exposition, being
held between December 11-14, 2021. The Company also presented an
update of obe-cel in relapsed/refractory aggressive and indolent
B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic
Leukaemia (CLL) patients from the ALLCAR19 extension study, as well
as preclinical and initial engraftment data with AUTO1/22 in
Pediatric ALL in two separate poster presentations [Abstracts 3823
and 1710, respectively].
"We continue to observe sustained responses with obe-cel, with
an EFS of 46% at 24 months and patients approaching up to 42 months
of durability in the ALLCAR-19 study, supporting the curative
potential of obe-cel as a standalone therapy in r/r B-ALL patients.
Furthermore, we were encouraged to observe comparable safety and
high complete response data between patients treated in the
academic ALLCAR19 study and those in the Phase 1b portion of the
Autolus sponsored FELIX study", said Dr. Christian Itin, chief
executive officer of Autolus. "In addition, we are excited to
observe further positive data for obe-cel in r/r B-NHL and B-CLL
patients, as well as compelling initial data for AUTO1/22, pointing
to the potential for indication expansion and life cycle management
opportunities longer term."
Obe-cel in Adult Acute Lymphoblastic Leukemia patients (FELIX
study)
Oral Presentation Title: Industrialization of an Academic
Miltenyi Prodigy-Based CAR T process
Session Name : 711. Cell Collection and Processing: Advances in
Mobilization, Collection, Manipulation and Engineering of HSCs and
T Cells
Abstract : #477
Date: Sunday, December 12, 2021
Session Time: 12:00 PM - 1:30 PM ET; Presentation Time: 12:30 PM
ET
Location : Georgia World Congress Center, Hall A1
Presenter : Dr. Claire Roddie MD, PhD, FRCPath, Consultant
Haematologist and Honorary Senior Lecturer, Cancer Institute,
University College London (UCL)
Initial experience in the phase 1b portion of the FELIX 1b/2
study (NCT04404660) resulted comparable results as seen in the
Phase 1 ALLCAR19 study. As of the cut-off date of 13 September, 16
patients in the Phase 1b part of the FELIX study had received
obe-cel. Patient characteristics in the FELIX 1b portion were
broadly comparable to those observed in the ALLCAR19 study in r/r
adult B-ALL.
- As of the data cut off date of 15 October 2021, ALLCAR19 data
shows morphological EFS for obe-cel is 46% at 24 months with a
median follow-up of 29.3 months and patients approaching up to 42
months of durability
- Baseline characteristics between FELIX Phase 1b and ALLCAR19
studies are similar. 75% patients in the FELIX Phase 1b had >20%
blasts at pre-conditioning, compared with 60% patients in ALLCAR19.
56.3% patients received prior blinatumomab in the FELIX Phase 1b
study compared with 25% in ALLCAR19(1) .
- High level of CR/CRi response rate at 1 month observed across
both studies, with 12/16 patients in the FELIX Phase 1b study,
consistent with 17/20 (1) patients in the ALLCAR19 study.
- Safety consistent between the ALLCAR19 study and FELIX Phase
1b study, with no patient having high grade ( >=Grade 3)
cytokine release syndrome (CRS). 1 of 16 patients experienced a
Grade 3 immune effector cell-associated neurotoxicity syndrome
(ICANS) in the FELIX Phase 1b study, as compared with 3 of 20
patients in ALLCAR-19 study(1) .
The company expects to present data from the Phase 2 portion of
the FELIX study in 2022.
1 Roddie et al. "Durable responses and low toxicity after fast
off-rate CD19 CAR-T therapy in adults with relapsed/ refractory
B-ALL." DOI: 10.1200/JCO.21.00917 Journal of Clinical Oncology -
published online before print August 31, 2021
Obe-cel (AUTO1) in Adult Acute Lymphoblastic Leukemia patients
(ALLCAR study)
Poster Presentation Title: Safety and Efficacy of AUTO1, a
Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Non-Hodgkin's
Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL)
Session Title: 704. Cellular Immunotherapies: Clinical: Poster
III
Abstract : #3823
Date : Monday, December 13, 2021
Presentation Time: 6:00 PM - 8:00 PM ET
Location: Georgia World Congress Center, Hall B5
Presenter : Dr. Claire Roddie, MD, PhD, FRCPath, Consultant
Haematologist and Honorary Senior Lecturer, Cancer Institute,
University College London (UCL)
As of the data cut-off date of October 15, 2021, 15 r/r B-NHL
and 1 B-CLL patient had received obe-cel with 14 patients evaluable
for response.
- 14 of 14 patients responded to obe-cel of which 13 of 14
patients achieved complete metabolic response per Lugano 2014, with
1 B-CLL patient in PR.
- 15 of 16 patients were without disease progression at last
follow-up, with 1 of 16 patients having died in CR from COVID-19.
Furthermore, long term persistence was demonstrated by qPCR.
- Median follow up time for Follicular Lymphoma (FL) and DLBCL
patients was 11.8 months (range 2-14.2m).
- Median follow up time for Chronic Lymphocytic Leukemia (CLL)
and Mantle Cell Lymphoma patients was 7.4 months (range
1.1-14.8m).
- Across all patients, obe-cel demonstrated a favorable safety
profile with no ICANS or severe Grade >= 3 CRS events.
The company expects to present further data from more B-NHL and
CLL patients in H1 2022.
AUTO1/22 in Pediatric Acute Lymphoblastic Leukemia patients
(CARPALL)
Poster Presentation Title: A high sensitivity aCD22 CAR combined
with aCD19 CAR to generate dual targeting CAR T cells for the
treatment of r/r B-ALL
Session Title: 703. Cellular Immunotherapies: Basic and
Translational: Poster I
Abstract : #1710
Date : Saturday, December 11, 2021
Presentation Time : 5:30 PM - 7:30 PM ET
Location : Georgia World Congress Center, Hall B5
Presenter: Dr. Sara Ghorashian, MD, PhD, Hon clinical senior
lecturer, UCL Great Ormond Street Institute of Child Health
Obe-cel had previously been tested in r/r pediatric B-ALL(2) in
the CARPALL Study. Whilst obe-cel was safe and effective, similar
to other studies in pediatric B-ALL, antigen escape was a common
cause of treatment failure. AUTO1/22 has been designed to address
antigen escape by the co- expression of a CD22 CAR with the CD19
CAR in obe-cel. Pre-clinical data demonstrated a high level of in
vitro and in vivo activity of AUTO1/22 against leukemia cells.
AUTO1/22 was shown to control leukemia in a mouse model of CD19
negative escape. AUTO1/22 is currently being tested in a study of
r/ r pediatric B-ALL. As of the cut-off date of October 21, 2021, 6
patients had received AUTO1/22. All pati ents showed engraftment of
single and double CAR positive populations, pointing to early CAR T
cell persistence. We expect to present clinical data from the full
cohort of patients in H1 2022.
2. Ghorasian et al. "Enhanced CAR T cell expansion and prolonged
persistence in pediatric patients with ALL treated with a
low-affinity CD19 CAR." Nature Medicine volume 25,
pages1408-1414(2019) (Sept 25, 2019)
Investor call details
Management will host a conference call and webcast on Monday,
December 13, 2021 at 8:00 am ET/1:00 pm 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.
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 9036269. 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
9036269.
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 obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling adult
patients with relapsed / refractory B-precursor ALL. The trial had
a Phase 1b component prior to proceeding to the single arm, Phase 2
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 is designed to enroll approximately
100 patients across 30 of the leading academic and non-academic
centers in the United States, United Kingdom and Europe.
[NCT04404660]
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 for patients with r/r
pediatric ALL. [ NCT02443831 ]
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; and expectations regarding the initiation,
design and reporting of data from clinical trials. 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 4, 2021, 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:
Lucinda Crabtree, PhD
Vice President, Business Strategy and Planning
+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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