TIDMSYNC
RNS Number : 7526U
Syncona Limited
01 April 2019
Syncona Limited
Autolus presents initial AUTO1 adult ALL data at AACR
01 April 2019
Syncona Ltd, a leading healthcare company focused on founding,
building and funding global leaders in life science, notes the
announcement from its portfolio company, Autolus Therapeutics Plc
(NASDAQ: AUTL) (Autolus), that Claire Roddie MB, PhD, FRCPath,
honorary senior lecturer, Cancer Institute, University College
London (UCL), today presented initial data from the ongoing Phase
1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell
leukemia (ALL) as a late-breaking poster presentation at the
American Association of Cancer Research (AACR) Annual Meeting 2019
in Atlanta, Georgia.
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.
[S]
Enquiries
Syncona Ltd
Siobhan Weaver / Annabel Clay
Tel: +44 (0)20 3981 7940
Copies of this press release and other corporate information can
be found on the company website at: www.synconaltd.com
About Syncona:
Syncona is a leading FTSE250 healthcare company focused on
founding, funding and building global leaders in life science. Our
vision is to deliver transformational treatments to patients in
truly innovative areas of healthcare while generating superior
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 deep pool of capital,
and are established leaders in gene and cell therapy. We focus on
delivering dramatic efficacy for patients in areas of high unmet
need.
Initial Results from Autolus Therapeutics' ALLCAR19 Phase 1/2
Trial in Adult Acute Lymphoblastic Leukemia Presented at the AACR
Annual Meeting
Initial results from the trial show 88% molecular complete
response at one month with
well-tolerated safety profile
Management to Hold Conference Call on April 2, 2019 at 8:00am ET
/ 1:00pm BST
LONDON, UK, April 1, 2019 -- Autolus Therapeutics plc (Nasdaq:
AUTL), a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies for the treatment of
cancer, announced that Claire Roddie MB, PhD, FRCPath, honorary
senior lecturer, Cancer Institute, University College London (UCL),
presented today initial data from the ongoing Phase 1/2 ALLCAR19
trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL)
as a late-breaking poster presentation at the American Association
for Cancer Research (AACR) Annual Meeting 2019 in Atlanta,
Georgia.
Relapsed / refractory B-cell acute lymphoblastic leukemia (r/r
B-ALL) in adults is an area of significant unmet clinical need.
Notably, no CD19 CAR T cell therapeutic has been approved for
adults with r/r B-ALL. The key challenges identified in clinical
studies testing standard CD19 CAR T-cells therapies in this setting
are considerable toxicity associated with severe cytokine release
syndrome (CRS) and high-grade neurological toxicity.
AUTO1 uses a novel CD19 binder that allows the CAR T cells to
disengage rapidly after target cell encounter and kill. Data from
the ongoing Phase 1/2 CARPALL trial of AUTO1 in pediatric ALL
presented at the EHA CAR T Meeting in February 2019 has shown that
AUTO1 has a well-tolerated safety profile without inducing high
grade CRS in pediatric patients.
As of the data cutoff date of March 18, 2019 in the ongoing
Phase 1/2 ALLCAR19 trial of AUTO1 in adult ALL patients, 13
patients were leukapheresed, and products for 12 patients were
manufactured, including 7 with Autolus' semi-automated, fully
enclosed manufacturing process. Two patients are pending infusion.
Among the 10 infused patients to date, the median age is 41 and 70%
were male, with median lines of treatment of 4 (the range is 2-7).
Five of the ten treated patients had >= 50% BM blasts and were
considered to be high-risk for severe CRS. Patients received a
split dose based on disease burden for a total dose of up to 410
million cells.
Safety results
Using the Lee criteria, there were no patients with severe CRS
(>= Grade 3), and 2 of 10 patients (20%) with Grade 2 CRS.
Tocilizumab was used in 2 of 10 patients (20%). None of the
patients were admitted to intensive care due to CRS. One patient
developed delayed G3 neurotoxicity following high levels of CAR T
expansion, which was quickly reversed with steroids. Four patients
died on study, two due to progression of leukemia and two due to
sepsis, a common complication of advanced ALL.
Efficacy results
Nine patients were evaluable for response at 1 month and 8 (88%)
had a molecular complete response. One patient died of sepsis
before the one-month evaluation point. At a median follow up of 5
months (range 0.62-10.6 months), 6/10 patients are alive and
continue to be in molecular remission. There continues to be
evidence of ongoing B cell aplasia and CAR T persistence.
"AUTO1 delivered promising early remission rates, CAR T cell
expansion and persistence in this adult ALL trial cohort," said Dr.
Roddie. "Despite enrolling patients with high tumor burden, the
safety profile in the trial appears to compare very favorably to
other CD19 CARs and is consistent with the safety profile of AUTO1
observed in pediatric patients in the CARPALL trial."
"These data from the ALLCAR19 study of AUTO1 in relapsed
refractory ALL, while early, are extremely encouraging, with a high
response rate we now associate with CAR T cell therapies, but with
a potentially improved safety profile. If AUTO1 continues to be
associated with a lower incidence of adverse events with additional
patients treated, this could represent an important advance for
more vulnerable adult patients, as side effects of these therapies,
including serious cytokine release syndrome and neurotoxicity,
limit our ability to treat these individuals." said Krishna
Komanduri, M.D., Kalish Family Chair in Stem Cell Transplantation
and Director, Adult Stem Cell Transplant Program at the Sylvester
Comprehensive Cancer Center at the University of Miami Miller
School of Medicine.
"The strong persistence of the CAR T cells over time, coupled
with the low frequency of severe CRS events seen in these patients,
represent encouraging initial data for AUTO1 in relapsed/refractory
adult ALL," said Dr. Christian Itin, chairman and chief executive
officer of Autolus Therapeutics. "We expect AUTO1 in adult ALL to
move into a registration trial towards the end of this year."
For information about the ALLCAR19 trial, visit
https://clinicaltrials.gov/ct2/show/NCT02935257?term=ALLCAR19&rank=1
Conference Call Information
Autolus management will host a conference call featuring Dr.
Roddie on Tuesday, April 2, 2019 at 8:00 am ET/ 1:00 pm BST to
discuss the ALLCAR19 data presented at AACR. To listen to the
webcast and view the accompanying slide presentation, please go to
https://www.autolus.com/investor-relations/news-events/events.
The call may also be accessed by dialing 866-679-5407 (U.S.) or
409-217-8320 (international) and referencing conference ID 7679666.
After the conference call, a replay will be available for one week.
To access the replay, please dial 855-859-2056 (U.S.) or
404-537-3406 (international) and enter conference ID 7679666.
About AUTO1
AUTO1 is a CD19 CAR T cell investigational therapy designed to
overcome the limitations in safety - while maintaining similar
levels of efficacy - 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, Autolus believes
AUTO1 may reduce toxicity and be less prone to T cell exhaustion,
which could enhance persistence and improve the T cells' abilities
to engage in serial killing of target cancer cells. In 2018,
Autolus signed a license agreement under which Autolus acquired
global rights from UCL Business plc (UCLB), the technology-transfer
company of UCL, to develop and commercialize AUTO1 for the
treatment of B cell malignancies. AUTO1 is currently being
evaluated in two Phase 1/2 trials, one in pediatric ALL and one in
adult ALL.
About Adult Acute Lymphoblastic Leukemia
According to the American Cancer Society, acute lymphoblastic
leukemia (ALL) is predicted to affect approximately 5,960 adults in
the United States in 2018. Combination chemotherapy enables 90% of
adult patients to experience CR (complete response). Despite this,
the prognosis of adult ALL is still poor and has not changed
significantly during the last two to three decades, with long-term
remission rates limited to 30-40%. Approximately 50% of all adult
ALL patients will relapse.
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.
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 company's product candidates and research programs including
the company's ongoing and planned clinical developments of AUTO1
including its timeline to move into a registration trial. 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 the company's Annual Report on Form 20-F
filed on November 23, 2018 as well as discussions of potential
risks, uncertainties, and other important factors in the company's
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.
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
FURUAABRKRASRAR
(END) Dow Jones Newswires
April 01, 2019 13:14 ET (17:14 GMT)
Syncona (LSE:SYNC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Syncona (LSE:SYNC)
Historical Stock Chart
From Apr 2023 to Apr 2024
