Autolus Therapeutics Presents Encouraging Additional Data Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline ...
30 January 2020 - 11:00PM
Autolus Therapeutics plc (Nasdaq: AUTL) today announced
additional data regarding its ongoing Phase 1/2 clinical trial of
its next-generation programmed T cell therapy, AUTO3, to treat
adults with relapsed/refractory diffuse large B cell lymphoma
(DLBCL). The data is to be presented in a keynote lecture titled
“Improved CAR T cell approaches for lymphoid malignancies,” by Dr.
Martin Pulé, clinical senior lecturer in the Dept. of Hematology at
UCL Cancer Institute and chief scientific officer of Autolus
Therapeutics, at the EHA-EBMT 2nd European CAR T Cell Meeting to be
held on January 30, 2020 at 17:15 P.M. CET in Stiges (Barcelona),
Spain.
“The incremental update in the AUTO3 trial
presented at the 2nd European CAR T Cell Meeting continue to
support the encouraging early indications of durability and high
level of activity previously reported. Together with the
encouraging signs of a manageable safety profile in adult patients
with DLBCL, these early data for AUTO3 show the potential for a
differentiated product profile,” said Dr. Christian Itin,
chairman and chief executive officer of Autolus.
“I’m pleased to be presenting today an
encouraging data update from our ALEXANDER trial of AUTO3, our
CD19/CD22 dual-targeting CAR-T product candidate in DLBCL,” said Dr
Martin Pulé, founder and chief scientific officer of Autolus.
“Together with the data we have generated to date for AUTO1 in
acute lymphoblastic leukemia (ALL) patients, we now have two
programs specifically designed for the development of the
respective hematological malignancies.”
As of the data cut-off date of January 21, 2020
(data availability as of January 28, 2020), 18 patients in the
ALEXANDER Phase 1/2 clinical trial of AUTO3 were evaluable for
safety and efficacy with minimum 28-day follow-up. In the cohorts
dosed at 450 x 106 AUTO3 cells plus pembrolizumab, five out of
seven patients (ORR=71%) achieved a response (complete response +
partial response) and four out of seven patients (CRR=57%) achieved
a complete response. Across all dose levels, seven out of eight
complete responders (87%) had ongoing complete responses at a
median follow up of six months (range of one month - 18 months).
All seven out of seven complete responders (100%) treated with
AUTO3 and pembrolizumab have ongoing complete responses as of
January 21, 2020 at a median follow up of three months (range of
one month - 18 months). AUTO3 was generally well tolerated, with no
patients experiencing dose limiting toxicity, and there were no
treatment-related deaths. One patient experienced Grade 4 lung
infection due to para-influenza virus that was possibly considered
to be related to treatment and the patient is recovering. Such
infections are a common event in late stage DLBCL patients. No
patients experiencing Grade 3 or higher Cytokine Release Syndrome
(CRS) were reported with primary treatment (one patient experienced
Grade 3 CRS on retreatment), and one of 18 patients experienced a
Grade 3 neurotoxicity that resolved swiftly with administration of
steroids. As of the data cut-off, no patient has experienced
neurotoxicity of any grade in cohorts treated with AUTO3 and
pembrolizumab.
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.
About AUTO3
AUTO3 is the first investigational CAR T cell
therapy containing two independent chimeric antigen receptors
targeting CD19 and CD22 that have each been independently designed
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 adult diffuse large B cell lymphoma in
the ALEXANDER clinical trial and in pediatric ALL in the AMELIA
clinical trial.
About AUTO1
AUTO1 is a novel investigational CD19-targeting
CAR T cell therapy designed to overcome the limitations in safety -
while maintaining similar levels of efficacy - compared to current
CD19 CAR T cell therapies. AUTO1 has a fast target binding off-rate
designed to minimize excessive activation and associated cytokine
release, which may reduce toxicity. In addition, the fast off-rate
may reduce T cell exhaustion, enhance persistence and improve the
programmed T cells' ability to engage in serial killing of target
cancer cells. AUTO1 is currently being evaluated in two Phase 1
studies, one in pediatric ALL and one in adult ALL.
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 anticipated development plans for Autolus’ product
candidates, including statements regarding the potential
indications and benefits of AUTO3 and AUTO1 and the potential of
AUTO3 to treat adult DLBCL. 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 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:
Lucinda Crabtree, PhDVice President, Investor
Relations and Corporate Communications+44 (0) 7587 372
619l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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