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RNS Number : 1244W
Syncona Limited
09 December 2019
Syncona Limited
Autolus announces new data in AUTO3 at ASH
09 December 2019
Syncona Ltd, a leading healthcare company focused on founding,
building and funding global leaders in life science, notes the
announcement that its portfolio company, Autolus Therapeutics Plc
(NASDAQ: AUTL) (Autolus), announced new data highlighting progress
on its next-generation programmed T cell therapies to treat
patients with relapsed/refractory diffuse large B-cell lymphoma
(DLBCL) and pediatric acute lymphoblastic leukemia (ALL). The data
were presented at the 61st American Society of Hematology (ASH)
Annual Meeting and Exposition in Orlando, FL.
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. Autolus management
will host an investor conference call on Monday, December 9, at
8:30 a.m. EDT/ 1:30pm GMT, to review the data presented at ASH. To
listen to the webcast and view the accompanying slide presentation,
please go to:
https://www.autolus.com/investor-relations/news-and-events/events
[S]
Enquiries
Syncona Ltd
Siobhan Weaver / Annabel Clay
Tel: +44 (0) 20 3981 7940
FTI Consulting
Brett Pollard / Ben Atwell / Natalie Garland-Collins
Tel: +44 (0) 20 3727 1000
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 Announces New Data Showcasing
Clinical Progress of AUTO3 in B Cell Malignancies
Preliminary data on AUTO3 in DLBCL demonstrate safety and
feasibilty of CD19 and CD22 dual targeting CAR T
90% complete response and 100% overall survival at 12 months in
CAR T naive
pediatric ALL patients dosed with AUTO3
Investor call to be held December 9 at 8:30 am ET / 1:30 pm GMT
to review data
LONDON, UK, December 8, 2019 -- Autolus Therapeutics plc
(Nasdaq: AUTL) announced today new data highlighting progress on
AUTO3, the first-in-human bicistronic CD19 and CD22 CAR, in
patients with relapsed/refractory diffuse large B-cell lymphoma
(DLBCL) and pediatric acute lymphoblastic leukemia (ALL). The data
were presented at the 61(st) American Society of Hematology (ASH)
Annual Meeting and Exposition in Orlando, FL.
"DLBCL is an aggressive and rapidly progressing cancer, and
early response is critical to ensuring positive outcomes for these
patients. The data from the AMELIA trial of AUTO3 in pediatric ALL
has informed us on the encouraging role of dual antigen targeting
in reducing target-negative relapses and delivering high levels of
complete molecular remission with well-tolerated safety," said Dr.
Christian Itin, chairman and chief executive officer of Autolus.
"We look forward to advancing AUTO3 to a decision point in
relapsed/refractory DLBCL by the mid-point of next year."
Title: Phase 1/2 study of AUTO3, the first bicistronic chimeric
antigen receptor (CAR) targeting CD19 and CD22 followed by an
anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B
Cell Lymphoma (DLBCL): Results of cohort 1 and 2 of the ALEXANDER
study (Abstract # 246)
Dr. Kirit Ardeshna, consultant hematologist, Department of
Hematology, University College London Hospital NHS Foundation
Trust, gave an oral presentation with updated data from the
ALEXANDER Phase I/2 study of AUTO3, the first bicistronic CAR T
targeting CD19 and CD22 followed by an anti-PD1, in Diffuse Large B
Cell Lymphoma (DLBCL). The trial is divided into a phase 1 safety
cohort and a phase 2 efficacy cohort, and is designed to assess
safety (incidence of >= Grade 3 toxicity occurring within 75
days of AUTO3 infusion) and other primary and secondary endpoints
including overall response and other safety, efficacy and product
generation measures.
In the dose escalation phase, 16 patients were treated, with 4
patients dosed at 50 x 10(6) cells without pembrolizumab; 11
patients were dosed at escalating doses of AUTO3 with pembrolizumab
administered at day 14 as follows: 3 at 50 x 10(6) cells, 4 at 150
x 10(6) cells, and 4 at 450 x 10(6) of AUTO3; and 1 patient was
dosed with 450 x 10(6) cells with pembrolizumab administered 1 day
before AUTO3 infusion. Fourteen patients were evaluable at one
month.
AUTO3 was well-tolerated, with no patients experiencing >=
Grade 3 cytokine release syndrome (CRS) with primary infusion and 1
of 14 experiencing Grade 3 neurotoxicity that resolved swiftly with
steroids. There were no pembrolizumab immune-related toxicities and
the majority of grade 3 or higher adverse events were
hematological. Low levels of serum cytokines are consistent with
the observed low levels of CRS and neurotoxicity.
Across all tested doses 5 patients achieved a complete response,
with 4 of 5 complete responses ongoing, the longest at 18 months.
All CRs were achieved without need for steroid or tocilizumab-based
management of the patients or ICU level care.
"The phase 1 preliminary data on AUTO3, the novel and first in
human bicistronic CD19 and CD22 CAR in relapsed/refractory DLBCL,
show that the dual targeting approach appears safe, with 0% severe
CRS (>= grade 3). The duration of complete response is
impressive as well and provides hope that AUTO3 may reduce the high
rates of relapse seen with CD19 CAR Ts," said Dr. Anas Younes,
Chief, Lymphoma Service at Memorial Sloan Kettering Cancer
Center.
AUTO3 - (Poster) - Phase 1/2 AMELIA clinical trial of AUTO3 in
patients with relapsed/refractory pediatric acute lymphoblastic
leukemia (pALL) (Abstract # 2620)
Professor Persis Amrolia, lead investigator and Consultant in
Bone Marrow Transplant at Great Ormond Street Hospital (GOSH) and
NIHR Research Professor of Transplantation Immunology at UCL Great
Ormond Street Institute of Child Health (ICH), presented data from
the AMELIA trial, a Phase 1/2, open-label, multi--center study to
characterize the safety and clinical activity of AUTO3 in pediatric
and young adult patients with relapsed/refractory ALL. The study
recruited a total of 18 patients to the active dose (>= 3 x
10(6) /kg) cohorts, and product was manufactured successfully for
14 of the 15 patients (93%) who underwent leukapheresis. Eleven
patients were treated with AUTO3, manufactured using a
semi-automated closed manufacturing process. Ten of 11 patients
were CAR T cell-naive, while 1 had previously received CAR T cell
therapy.
AUTO3 was well-tolerated overall, with no patients experiencing
>= Grade 3 CRS and no patients experiencing >= Grade 2
neurotoxicity, in doses >=3x10(6) /kg CAR-T cells. No
AUTO3-related deaths were reported.
Among the 10 CAR T-naïve patients, at a median follow-up time of
9.7 months (range 1.8- 18), 9 of 10 patients (90%) achieved a
complete response, and 8 of 10 (80%) achieved complete molecular
remission by PCR. Estimated overall survival at 12 months was 100%.
There are 2 ongoing patients in complete molecular remission at 12
and 15 months post-AUTO3 infusion, respectively. The most common
cause of relapse was due to loss of CAR T-cell persistence. The
median persistence of CAR-T cells in blood was 170 days.
Investor call to discuss data on Monday, December 9
Autolus management will host an investor conference call on
Monday, December 9, at 8:30 a.m. EDT/ 1:30pm GMT, to review the
data presented at ASH.
To listen to the webcast and view the accompanying slide
presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
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 9796038. 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
9796038.
About AUTO3
AUTO3 is a programmed T cell therapy containing two independent
chimeric antigen receptors targeting CD19 and CD22 that have each
been independently optimized 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 pediatric ALL in
the AMELIA clinical trial and in diffuse large B cell lymphoma in
the ALEXANDER clinical trial.
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.
Forward-Looking Statement
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' financial condition and results of operations, as well as
statements regarding the anticipated development of Autolus'
product candidates, including its intentions regarding the timing
for providing further updates on the development of its product
candidates, and the sufficiency of its cash resources. 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 the company 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.
# # #
Investor and media contact:
Silvia Taylor
Vice President, Corporate Affairs and Communications
Autolus
+1-240-801-3850
s.taylor@autolus.com
UK:
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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