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RNS Number : 3367L
Syncona Limited
12 May 2022
Syncona Limited
Autolus to present clinical data updates at EHA Congress
12 May 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
European Hematology Association (EHA) Congress, held between 9-12
June, 2022. A copy of the announcement is set out below, with key
highlights as follows:
-- Positive early safety and efficacy data from AUTO4 in T cell
lymphoma (TCL), with AUTO 4 demonstrating a tolerable safety
profile. 5 out of the 9 patients achieved complete metabolic
responses (CMR) one month post treatment, including all 3 patients
treated at the highest dose level.
-- Promising early safety and efficacy data in the AUTO1/22
programme in paediatric acute lymphoblastic leukaemia (pALL), with
5 out of 8 evaluable patients remaining in minimal residual disease
(MRD) negative complete response (CR) at a median follow up of 4.8
months post treatment.
-- Early safety and efficacy data in AUTO1 (obe-cel) in
relapsed/refractory primary central nervous system lymphoma (PCNSL)
from 6 patients.
-- Early safety and efficacy findings in obe-cel in
relapsed/refractory B cell non-Hodgkin's lymphoma (B-NHL), and
chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma
(SLL), in 19 patients in total, with obe-cel showing a tolerable
safety profile despite high disease burden amongst patients, along
with excellent CR rates.
Autolus will present more detail on these programmes and next
steps in their development in a webcast following the EHA
presentations.
Martin Murphy, Chief Executive Officer of Syncona Investment
Management Limited, said: "We continue to be highly encouraged by
the progress across Autolus' broader clinical pipeline as it
progresses towards a meaningful read-out from its lead programme,
obe-cel, in adult ALL in the second half of this year. The early
clinical data which will be presented at EHA underlines the strong
safety and efficacy profile of Autolus' range of therapies, further
supporting the value of the company's technology. We look forward
to seeing further follow-up data from the company as it progresses
its pipeline of programmes, in order to provide treatments for
patients suffering from a range of B and T cell cancers."
[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
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / 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 Four Clinical Data Updates at
the European Hematology Association Congress
- AUTO4: oral presentation on initial clinical experience in peripheral T cell lymphoma
- AUTO1/22: oral presentation on initial experience in r/r
pediatric B-cell acute lymphoblastic leukemia
- obe-cel: poster presentation in r/r primary CNS lymphoma
- obe-cel: poster presentation in r/r B-non-Hodgkins lymphoma
and chronic lymphoblastic leukemia
- Conference call to be held on June 13, 2022 at 7:30 am EST/12:30 pm BST
-
LONDON , May 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 four abstracts submitted to the European
Hematology Association (EHA) Congress to be held June 9-12, 2022.
Autolus plans to present more detail on these programs and the next
steps in a conference call following the EHA presentations, on June
13, 2022, details below.
"We are delighted to be presenting encouraging early clinical
data from four of our pipeline programs, including important
additive safety and efficacy data from our lead asset obe-cel in
indications beyond adult r/r B-ALL. These data demonstrate the
inherent value in both our pipeline and our technology base from
which it originates, " said Dr. Christian Itin, Chief Executive
Officer of Autolus. "With oral presentations on the early safety,
tolerability, feasibility and preliminary efficacy of AUTO4 and
AUTO1/22, we're in a great place to evaluate the next strategic
steps for these candidates and further build on the data presented
here."
Abstracts to be presented:
1. Title: Safety and preliminary efficacy findings of AUTO4, a
TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive
selected T Cell Non-Hodgkin Lymphoma LINK
Session Title: Gene therapy and cellular immunotherapy -
Clinical 2
Session date and time: Saturday, June 11 - 16:30 - 17:45
CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S261
Presenting Author: Kate Cwynarski
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. As of 9
February 2022, 9 patients screened for r/r TRBC1+ peripheral T-cell
lymphoma have been treated with AUTO4. Two patients had prior stem
cell transplantation. After lymphodepletion with Flu/Cy, 3 patients
received 25 x 10(6) CAR T cells, 2 patients received 75 x 10(6) CAR
T cells, 1 patient received 225 x 10(6) CAR T cells and 3 patients
received 450 x 10(6) CAR T cells. AUTO4 demonstrated a tolerable
safety profile, with no patient experiencing any dose limiting
toxicities, and no neurotoxicity/immune effector cell-associated
neurotoxicity (ICANS). Three patients experienced cytokine release
syndrome (CRS) (1 patient with Grade 1, 1 patient with Grade 2 and
1 patient with Grade 3). Of the 9 patients treated, 5 patients had
achieved complete metabolic responses (CMR) by PET-CT at Month 1, 1
patient remains with a partial response (PR) 6 months post AUTO4
infusion, and 3 patients did not respond. All 3 patients at the
highest dose level achieved a CMR at Month 1.
2. Title: Dual antigen targeting with co-transduced CD19/22 CAR
T cells for relapsed/refractory ALL (AUTO1/22) LINK
Session Title: Gene therapy and cellular immunotherapy -
Clinical 1
Session date and time: Saturday, June 11 - 11:30 - 12:45
CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S259
Presenting Author: Sara Ghorashian
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 8 February 2022, 10
pediatric ALL patients have been treated with AUTO1/22 and 8 are
evaluable with >1 month follow-up. 5 of 8 patients had relapsed
post allogeneic stem cell transplant (SCT), 4 had received prior
Blincyto and 3 had relapsed after prior Kymriah. CRS occurred in
7/8 patients (grade 1 n=2, grade 2 n=5), but severe CRS was not
seen. 7 of 8 evaluable patients achieved MRD negative complete
response (CR) at 1 month post infusion. Overall, at a median follow
up of 4.8 months, 5/8 patients remain in MRD negative CR at last
follow up. The study results demonstrate that dual CD19/22
targeting CAR T cells generated by co-transduction show an
acceptable safety profile, with robust expansion/persistence and
early efficacy in a heavily pre-treated cohort. To date with
limited follow-up we have not observed antigen negative relapse but
longer follow up is needed.
3. Title: Safety and efficacy findings of AUTO1, a fast off-rate
CD19 CAR, in relapsed/refractory Primary CNS Lymphoma LINK
Session Title: Poster session
Session date and time: Friday, June 10 - 16:30 - 17:45 CEST
Final Abstract Code: P1460
Presenting Author: Claire Roddie
Summary: Relapsed/refractory primary central nervous system
lymphoma (PCNSL) has a median overall survival of 2-8 months and
few therapeutic options. obe-cel (AUTO1) has previously
demonstrated high remission rates, low incidence of CRS/ICANS and
long-term persistence, making it a viable treatment option for
PCNSL. As of 14 February 2022, the CAROUSEL study enrolled 6
patients with r/r PCNSL where the median prior lines of treatment
was 2. 5 patients were infused with IV AUTO1 and 1 patient with
intraventricular AUTO1. Following CAR T infusion, Grade 1 and 2 CRS
affected 1 and 3 patients respectively and any Grade ICANS was
observed in 2 patients with 2 Grade 3 events. AUTO1 engraftment and
response was evaluable in 4 patients at 1 month following iv
infusion. 2 of 4 patients had no measurable disease at 2 and 6
months of follow up respectively. AUTO1 showed encouraging
remission rates and excellent CAR T engraftment/expansion in the
blood and CSF. Intraventricular administration was well-tolerated
and showed that AUTO1 has activity via that route in a patient who
failed IV therapy. Additional patients updated biological data and
longer follow up will be presented.
4. Title: Safety and efficacy findings of AUTO1, a fast off-rate
CD19 CAR, in relapsed/refractory B-Cell Non-Hodgkin's Lymphoma
(B-NHL), and chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic
Lymphoma (SLL) LINK
Session Title: Poster session
Session date and time: Friday, June 10 - 16:30 - 17:45 CEST
Final Abstract Code: P1459
Presenting Author: Claire Roddie
Summary: obe-cel (AUTO1) has demonstrated an excellent safety
profile in previous trials, with low levels of CRS/ICANS and
long-term engraftment of CAR T cells, making it an ideal CAR T
candidate to evaluate in B-NHL, CLL/SLL. As of 8 February 2022, 19
patients had been infused with AUTO1; 10 with low grade NHL, 6 with
DLBCL and 3 with CLL. Patients treated had received a median of 3
prior lines of treatment. Grade 1 CRS was reported in 6/19 and
Grade 2 CRS in 3/19. No ICANS was observed in the B-NHL and CLL
cohorts. In the lg-NHL and DCBCL cohorts, 10/10 and 4/5 evaluable
patients respectively were in CMR post-treatment. Responses were
ongoing in 9/10 lg-NHL at 12 months and in 4/4 DLBCL at months
1,3,3 and 6. In the CLL cohort, 2/3 evaluable patients achieved MRD
negative remission in the bone marrow with residual small volume
lymph nodes by CT at 6 and 3 months of follow up respectively.
AUTO1 demonstrated a tolerable safety profile in patients with r/r
B-NHL and CLL despite high disease burden. Early data shows
excellent complete remission rates and CAR engraftment/expansion.
Additional patients, updated data and longer follow up will be
presented.
# # #
Conference Call
Management will host a conference call and webcast on June 13,
2022 at 7:30 am ET/12:30 pm BST to discuss the EHA 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: 6594553. 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:
6594553.
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 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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