Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies for the treatment of cancer, announced four oral and
two poster presentations related to its AUTO1, AUTO2 and AUTO3
programs at the 61st American Society of Hematology (ASH) Annual
Meeting and Exposition, to be held December 7-10, 2019 in Orlando,
FL.
“We are pleased that AUTO1 data will be
presented in three oral presentations at ASH. The data form the
basis for our decision to move AUTO1 into a pivotal clinical trial
in adult ALL, our highest priority program,” said Dr. Christian
Itin, chairman and chief executive officer of Autolus. “We are also
looking forward to presenting data on our other hematological
clinical programs at ASH. These presentations will further
illustrate the significant progress we have made across our
clinical portfolio this year.”
The abstracts have been published today and are
available on the ASH website at
https://www.hematology.org/Annual-Meeting/Abstracts/.
The oral presentation details are as
follows:
Title: AUTO1 – A novel
fast off CD19CAR delivers durable remissions and prolonged CAR T
cell persistence with low CRS or neurotoxicity in adult
ALLPresenter: Dr Claire RoddieSession Date and Time:
Saturday, December 7, 2:45 PM Eastern Time
Title: AUTO1 – Therapy of pediatric
B-ALL with a lower affinity CD19 CAR leads to enhanced expansion
and prolonged CAR T cell persistence in patients with low bone
marrow tumor burden, and is associated with a favorable toxicity
profilePresenter: Dr Sara GhorashianSession Date and
Time: Saturday, December 7, 2:30 PM Eastern Time
Title: AUTO1 – Clonal dynamics of early
responder and long-term persisting CAR-T cells in
humansPresenter: Dr Luca BiascoSession Date and
Time: Saturday, December 7, 8:15 AM Eastern Time
Title: AUTO3
– Ongoing Phase 1/2 ALEXANDER clinical
trial in patients with relapsed/refractory diffuse large B cell
lymphoma (DLBCL)Presenter: Dr Kirit ArdeshnaSession Date
and Time: Saturday, December 7, 3:15 PM Eastern Time
The poster presentation details are as
follows:
Title: AUTO2 – Phase 1
First-in-Human study of AUTO2, the first chimeric antigen receptor
(CAR) T cell targeting APRIL for patients with relapsed/refractory
Multiple Myeloma (RRMM)Presenter: Dr Rakesh PopatSession
Date and Time: Sunday, December 8, 6:00 PM – 8:00 PM Eastern
Time
Title: AUTO3 – Phase
1/2 AMELIA clinical trial of AUTO3 in patients with
relapsed/refractory pediatric acute lymphoblastic leukemia
(pALL)Presenter: Professor Persis AmroliaSession Date and
Time: Sunday, December 8, 6:00 PM – 8:00 PM Eastern Time
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.
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 AUTO2
AUTO2 is the first dual-targeting programmed T
cell product candidate binding to two targets on multiple myeloma
cells. AUTO2 uses a human ligand, known as APRIL, which binds to
two antigens, B cell Maturation Antigen, or BCMA, and the
transmembrane activator and CAML interactor, or TACI, both of which
are expressed on the surface of multiple myeloma cancer cells.
AUTO2 is designed to address a key escape route used by
hematological cancers in response to T cell therapies.
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
TaylorVice President, Corporate Affairs and Communications
Autolus+1-240-801-3850s.taylor@autolus.com
UK:Julia Wilson+44 (0) 7818 430877 j.wilson@autolus.com
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