Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, updated its business outlook, strengthening its
focus on its potentially transformational CAR T cell therapy
candidate, AUTO1, which is being investigated in relapsed /
refractory adult B-Acute Lymphoblastic Leukemia (ALL).
“We are very excited about the unique
characteristics of AUTO1 that we reported at ASH in December 2020,
with some patients continuing in molecular complete remission at 24
months without a subsequent transplant, an event-free survival of
52% at 12 months and a well-tolerated safety profile. Taking into
consideration the high unmet need in adult ALL and the commercial
opportunity this represents, we are prioritizing this program with
potential pivotal data expected in 2022,” said Dr. Christian
Itin, chairman and chief executive officer of Autolus. “We also
plan to capitalize on the differentiated profile of AUTO1 by
exploring activity in additional B-cell malignancies, including
Primary CNS Lymphoma (PCNSL) where no adequate standard of care
currently exists. We expect to see first data from these additional
indications in 2021.”
Additional clinical data points in 2021 are
expected from AUTO1/22, a novel dual targeting CAR T cell based
therapy candidate based on AUTO1, with the first pediatric ALL
patient dosed in December 2020, and AUTO4 in Peripheral T Cell
Lymphoma (PTCL), which will continue in 2021 through a dose
escalation phase. Furthermore, the company continues to progress
its pipeline of next generation programs, including for solid tumor
indications, in collaboration with its academic partners.
With the prioritization of the AUTO1 program,
the company plans to seek a partner for the AUTO3 program, its CD19
and CD22 dual targeting CAR T product candidate being investigated
in relapsed/refractory diffuse large B cell lymphoma (DLBCL),
before progressing the program into the next phase of development.
In addition, through Q1 2021, the company will adjust its workforce
and infrastructure footprint, which will involve an overall
reduction in headcount of approximately 20%. The company expects to
realize cash savings, on an annualized basis, of approximately $15
million per annum once the operational changes are fully
implemented. Additionally, the company announced a reorganization
of its management team. David Brochu was promoted to Chief
Technical Officer (CTO) with expanded responsibilities from Senior
Vice President, Product Delivery. Senior Vice Presidents
Dr. Adam Hacker and Dr. Nushmia Khokhar will be leaving the
company in Q1 2021. A search for a new Chief Medical Officer is
ongoing.
“Building on its differentiated clinical
profile, we believe AUTO1 is well positioned to deliver fundamental
value for patients and shareholders. Our organizational focus will
position us well to realize the potential of AUTO1 and lay the
foundation for the next opportunities in our pipeline with several
clinical proof of concepts targeted during 2021 and 2022,” said
Dr. Christian Itin, chairman and chief executive officer of
Autolus.
About Autolus Therapeutics
plcAutolus 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.
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 ability of the programmed T
cells to engage in serial killing of target cancer cells. AUTO1 is
currently being evaluated in two Phase 1 trials, one in pediatric
ALL and one in adult ALL. The company has also now progressed the
program to a potential pivotal trial, AUTO1-AL1.
About AUTO1-AL1 pivotal
trialThe AUTO1-AL1 trial will enroll patients with
relapsed / refractory ALL. The trial will have a short Phase1b
component prior to proceeding to a single arm Phase 2 trial. The
primary endpoint is overall response rate and the key secondary
endpoints include duration of response, MRD negative CR rate and
safety. The trial will enroll approximately 100 patients across 30
of the leading academic and non-academic centers in the United
States, United Kingdom and Europe.
About AUTO3AUTO3 is a programmed T cell
investigational 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 diffuse large B cell lymphoma in the
ALEXANDER clinical trial, including a 20-patient cohort to assess
feasibility of treatment in an outpatient setting.
Forward-Looking StatementsThis
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’ refocus in
business strategy; the efficacy, safety and therapeutic potential
of AUTO1 and the future clinical development of AUTO1, including
progress, expectations as to the reporting of data, conduct and
timing and potential future activity in additional B-cell
malignancies; expectations regarding the initiation, design and
reporting of data from the AUTO1-AL1 trial and other clinical
trials; the development of Autolus’ pipeline of next generation
programs, including for solid tumor indications, in collaboration
with its academic partners, including expectations as to the
reporting of data, conduct and timing; the efficacy, safety and
therapeutic potential of AUTO3 and ability for Autolus to obtain a
partner for next stages of clinical development; needs for
additional funding and ability to raise additional capital;
Autolus’ ability to attract and retain qualified employees and key
personnel; the restructuring program and Autolus’ expected cash
savings as a result of the restructuring program and operational
changes. 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.
These risks and uncertainties include, but are not limited to, the
risks that Autolus’ preclinical or clinical programs do not advance
or result in approved products on a timely or cost effective basis
or at all; the results of early clinical trials are not always
being predictive of future results; the cost, timing and results of
clinical trials; that many product candidates do not become
approved drugs on a timely or cost effective basis or at all; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; and the impact of the ongoing COVID-19 pandemic
on Autolus’ business. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause Autolus’ 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 with the Securities
and Exchange Commission on March 3, 2020, as amended, as well as
discussions of potential risks, uncertainties, and other important
factors in Autolus' subsequent filings with the Securities and
Exchange Commission. 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
619 l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.comSusan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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