LONDON, February 19, 2019 /PRNewswire/ --
Arix Bioscience plc (LSE: ARIX)
("Arix"), a global healthcare and life science company supporting
medical innovation, notes that its portfolio company, Autolus
Therapeutics plc (NASDAQ: AUTL), has presented updated data from
the ongoing Phase 1 CARPALL trial of AUTO1 in a poster presentation
at the European Hematology Association 1st European CAR T Cell
Meeting held in Paris, France,
February 14-16, 2019.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and the full text of the
announcement from Autolus is contained below.
About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science company
supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances
and builds world class healthcare and life science businesses
addressing medical innovation at all stages of development.
Operations are supported by privileged access to breakthrough
academic science and strategic relationships with leading research
accelerators and global pharmaceutical companies.
Arix Bioscience plc is listed on the Main Market of the London
Stock Exchange. For further information, please visit
http://www.arixbioscience.com
Autolus Therapeutics Announces
Updated Results From Ongoing
CARPALL Trial of Pediatric Acute
Lymphoblastic Leukemia Presented at the EHA
1st European CAR T Cell Meeting in
Paris
Updated results confirm
AUTO1 data from ASH 2017
No severe cytokine release
syndrome (Grade 3-5)
86% molecular
complete response rate after a single dose of
AUTO1
LONDON, UK, February 19,
2019 -- Autolus Therapeutics plc (NASDAQ: AUTL), a
clinical-stage biopharmaceutical company developing next-generation
programmed T cell therapies for the treatment of cancer, today
announced that Professor Persis Amrolia, Consultant in Bone Marrow
Transplant at Great Ormond Street Hospital (GOSH) and NIHR Research
Professor of Transplantation Immunology at University College
London (UCL) Great Ormond Street Institute of Child Health,
presented updated data from the ongoing Phase 1 CARPALL trial of
AUTO1 in a poster presentation at the European Hematology
Association 1st European CAR T Cell Meeting held in
Paris, France, February 14-16, 2019.
Enrolled patients had a median age of 9 years with a median of 4
lines of prior treatment. Seventeen patients were enrolled, and 14
patients received an infusion of CAR T cells. Ten of 14 patients
had relapsed post allogeneic stem cell transplant. Eight patients
were treated in second relapse, 5 in >second relapse and 3 had
relapsed after prior blinatumomab or inotuzumab therapy. Two
patients had ongoing CNS disease at enrollment.
Updated safety results
This data set confirms that AUTO 1 induces no severe cytokine
release syndrome (CRS) (Grade 3-5). Nine patients experienced Grade
1 CRS, and 4 patients experienced Grade 2 CRS. No patients
required tociluzumab or steroids. As previously reported, one
patient experienced Grade 4 neurotoxicity; there were no other
reports of severe neurotoxicity (Grade 3-5). The mean cumulative
exposure to AUTO1 CAR T cells in the first 28 days as assessed by
AUC was 1,721,355 copies/µg DNA. Eleven patients experienced
cytopenia that was not resolved by day 28 or recurring after day
28: 3 patients Grades 1-3 and 8 patients Grade 4. Two patients
developed significant infections, and 1 patient died from sepsis
while in molecular complete response (CR).
Updated efficacy results
With a single dose of CAR T cells at 1 million cells/kg dose,
12/14 (86%) achieved molecular CR.
Five patients relapsed with CD19 negative disease. Event free
survival (EFS) based on morphological relapse was 67% (CI 34-86%)
and 46% (CI 16-72%) and overall survival (OS) was 84% (CI 50-96%)
and 63% (CI 27-85%) at 6 and 12 months, respectively.
CAR T cell expansion was observed in all responding patients
(N=12), with CAR T cells comprising up to 84% of circulating T
cells at the point of maximal expansion. The median persistence of
CAR T was 215 days.
The median duration of remission in responding patients was 7.3
months with a median follow-up of 14 months. Five of 14 patients
(37%) remain in CR with ongoing persistence of CAR T cells and
associated B cell aplasia.
"AUTO1 combines a high molecular CR rate with excellent
persistence and a good safety profile in pediatric acute B cell
leukemia patients," said Professor Amrolia.
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, 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
studies, one in pediatric ALL and one in adult ALL.
For information about the CARPALL trial, visit
https://clinicaltrials.gov/ct2/show/NCT02443831
About Pediatric Acute Lymphoblastic Leukemia
(ALL)
According to the American Cancer Society, ALL is the most common
cancer diagnosed in children, with approximately 3,400 new cases
diagnosed in the United States
each year. Pediatric ALL occurs when the bone marrow makes too many
immature lymphocytes, which are a type of white blood cell. The
current standard of care for pediatric ALL patients is combination
chemotherapy. Although pediatric patients typically respond well to
first-line treatment, 10 to 20% of total patients relapse with
chemotherapy-resistant disease, leading to a significant unmet need
in pediatric patients with high-risk relapsed or refractory
ALL.
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 http://www.autolus.com.
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. 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.
SOURCE Arix Bioscience plc