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Syncona Limited
10 June 2022
Syncona Limited
Autolus presents clinical data updates at EHA Congress
10 June 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 the publication of clinical data
across multiple programmes at the European Hematology Association
(EHA) Congress, being held between 9-12 June, 2022.
Key highlights are as follows:
-- Positive early safety and efficacy data from AUTO4 in 10
patients with T cell lymphoma (TCL), with AUTO4 demonstrating a
tolerable safety profile. As of 26 April 2022, 9 patients were
evaluable for efficacy and all 3 evaluable patients treated at the
highest dose level achieved complete metabolic responses (CMR) one
month post treatment. 2 of these patients remain in ongoing CMR at
months 3 and 6 respectively, with the other patient relapsing after
3 months.
-- Encouraging early safety and efficacy data in AUTO1/22 in
paediatric acute lymphoblastic leukaemia (pALL), with 9 out of 11
patients achieving complete response. At a median follow up of 8.7
months, 6 of the 9 responding patients were in minimal residual
disease (MRD) negative complete remission.
-- 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 data in obe-cel in
relapsed/refractory B cell non-Hodgkin's lymphoma (B-NHL) and
chronic lymphocytic leukaemia (CLL). obe-cel continues to display a
favourable safety profile. Of the 20 patients evaluable for
efficacy, the overall response rate was 18 out of 20 patients.
The full text announcement from Autolus is contained below and
can be accessed at: https://www.autolus.com/investor-relations .
Management will host a conference call and webcast on 13 June 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.
[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 Presents Clinical Data Updates at the
European Hematology Association Congress
- AUTO4 shows high level of clinical activity with a novel
targeting approach for patients with T Cell Lymphoma
- AUTO1/22 demonstrates encouraging and durable responses in
children ineligible for commercial CAR T product
- Obe-cel shows high level of sustained clinical activity in
B-NHL patients and first activity in Primary CNS Lymphoma
Conference call to be held on Monday June 13, 2022 at 7:30 am
EST/12:30 pm BST
LONDON , June 10, 2022 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announces the
publication of clinical data across multiple programs at the
European Hematology Association (EHA) Congress, being held June
9-12, 2022.
Autolus will hold a conference call on Monday June 13 2022 at
7:30 am EST / 12:30 pm BST, which will include participation from;
Dr. Steven Horwitz, M.D., Department of Medicine, Lymphoma Service,
Memorial Sloan Kettering Cancer Center; Dr. Kate Cwynarski, Chair
UK T cell Lymphoma Group, Consultant Hematologist, University
College London Hospital; and Autolus' management team.
"We are excited to be presenting this first clinical data for
two new product candidates, AUTO4 with its unique targeting
approach for T cell lymphoma and AUTO1/22 a dual targeting CAR T
product for the treatment of children with ALL," said Dr. Christian
Itin, CEO of Autolus. "With obe-cel progressing towards pivotal
data in the FELIX trial in adult patients with ALL, we are pleased
to show obe-cel's broader utility in B-NHL patients, mirroring the
high level of activity and well manageable safety profile we have
seen in previous trials."
"This year's EHA is an important meeting for Autolus with four
presentations providing updates from ongoing clinical studies,"
said Dr. Martin Pule, Chief Scientific Officer of Autolus. "In an
oral presentation we will present AUTO4 clinical data for the first
time. These data suggest that AUTO4 has the potential to become an
important therapeutic option for patients with T cell lymphoma. In
a second presentation, we will present our finding from clinical
testing of AUTO1/22. These data show that AUTO1/22 can induce
remission in children with B-ALL, including in those whose disease
was not successfully treated with commercial CAR T product.
Further, data suggest that AUTO1/22 can prevent antigen escape. In
two additional presentations, we demonstrate incremental obe-cel
data in B-NHL and B-CLL, as well as some early data in PCNSL.
Obe-cel continues to have consistent safety and efficacy data
across these indications."
"As clinicians, we are always searching for new strategies to
address unmet needs in aggressive blood cancers," said Dr. Steven
Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial
Sloan Kettering Cancer Center, New York. "T Cell Lymphomas are
particularly challenging, and I've been following Dr. Pule's
strategy of CAR T targeting based on the mutually exclusive
expressions of TRBC1 or TRBC2 with great interest. Any advance in
bringing new effective therapies to patients with T cell lymphomas
is of great importance."
Data presentations:
1. Title: Safety and preliminary efficacy findings of AUTO4, a
TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive
selected T Cell Non-Hodgkin Lymphoma
Session Title: Gene therapy and cellular immunotherapy -
Clinical 2
Session date and time: Saturday, June 11 2022 16:30 - 17:45
CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S261
Presenting Author: Kate Cwynarski
Conclusions: As of April 26 2022, 10 patients with
TRBC1-positive r/r T-cell lymphoma (Peripheral T-cell lymphoma Not
Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma
(AITL), Anaplastic Large cell lymphoma (ALCL)) have been treated
with AUTO4 in a Phase I dose escalation trial. Three patients had
prior stem cell transplantation. After lymphodepletion with Flu/Cy,
patients received either 25, 75, 225 or 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)
and no Grade 3 or higher infections. CRS was only seen at the
highest dose level of 450 x 10(6) CAR T cells (Grade 3 in 1
patient; Grade 1-2 in 3 patients). As of 26 April 2022, 9 patients
were evaluable for efficacy. At the highest dose level 3 of the 3
patients dosed achieved a complete metabolic remission (CMR) at 1
month. 2 of these patients remain in ongoing CMR by PET-CT at Month
3 and 6 respectively, whilst the 3(rd) relapsed at 3 months.
2. Title: Dual antigen targeting with co-transduced CD19/22 CAR
T cells for relapsed/refractory ALL (AUTO1/22)
Session Title: Gene therapy and cellular immunotherapy -
Clinical 1
Session date and time: Saturday, June 11 2022 11:30 - 12:45
CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S259
Presenting Author: Sara Ghorashian
Conclusions: As of May 27 2022, in 11 treated patients, we have
reproducibly generated a product that is balanced in CD19 and CD22
CAR expression, with predominance of dual CAR T cells and having a
mostly central memory phenotype. To date and in Kymriah-ineligible
patients, AUTO1/22 has demonstrated a favorable safety profile.
There have been no incidences of severe CRS, and one Grade 4 ICANS
which was indistinguishable from chemotherapy-related
leukoencephalopathy. We have seen excellent CAR T expansion, with
only 4 patients losing CAR T persistence at the last follow up.
Overall, 9 out of 11 patients achieved complete response, and there
were 2 non-responders. Notably, 2 out of 3 patients with CD19-ve
disease achieved complete response demonstrating the efficacy of
the CD22 CAR. Two patients relapsed with CD19+CD22+ disease, a
further patient had emergence of molecular MRD and all these events
were associated with lack of CAR T Cell persistence. No antigen
negative relapses were seen in responding patients. At a median
follow up of 8.7 months, 6 of 9 responding patients were in
MRD-negative complete remission (1-12 months) and the median
duration of b-cell aplasia has not been reached.
3. Title: Safety and efficacy findings of AUTO1, a fast off-rate
CD19 CAR, in relapsed/refractory Primary CNS Lymphoma
Session Title: Poster session
Session date and time: Friday, June 10 2022 - 16:30 - 17:45
CEST
Final Abstract Code: P1460
Presenting Author: Claire Roddie
Conclusions: Excellent AUTO1 expansion was observed in the
peripheral blood by qPCR, with persistence in all treated patients
at last follow-up. No grade >/=3 CRS was observed using IV or
I-VEN AUTO1 administration. Two cases of grade 3 ICANS were
reported following IV infusion. In the first case the patient had
several neurological deficits that evolved despite ICANS treatment
and were compatible with progressive PCNSL, as confirmed with the
month 1 MRI scan. The second case was a patient whose neurological
deficits improved with steroids/anakinra. Encouraging response
rates were observed: of 6 patients evaluable for efficacy following
IV AUTO1, the ORR was 4/6 (67%), with 2 CRs and 2 PRs. These four
responding patients are without disease progression at last follow
up. Two patients died from progressive PCNSL on study. Longer
follow-up is needed and enrolment of additional patients is
ongoing.
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)
Session Title: Poster session
Session date and time: Friday, June 10 2022 - 16:30 - 17:45
CEST
Final Abstract Code: P1459
Presenting Author: Claire Roddie
Conclusions: AUTO1 continues to display a favorable safety
profile with no ICANS or Grade >= 3 CRS. Long term persistence
of AUTO1 in the peripheral blood was demonstrated by qPCR. Of the
20 patients evaluable for efficacy, the overall response rate was
18/20 (90%). In the B-NHL cohorts the CRR was 16/17 (94%) (FL: 7/7,
MCL: 3/3, DBCL: 6/7). In the CLL cohort a best response of a PR was
achieved in 2/3 patients, notably both achieved MRD-negativity in
their marrow and both remain in PR at 10 and 6 months respectively.
Of the responding MCL, DLBCL, FL and CLL patients, 17/18 (94%) are
without disease progression at last follow-up. One MCL patient
relapsed six months following treatment and 1 FL patient died in CR
from COVID-19. Longer follow-up and enrolment of additional MCL,
FL, DLBCL and CLL patients is ongoing.
# # #
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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END
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