Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced new data highlighting progress on
AUTO3, the company’s CD19 and CD22 dual targeting CAR T product
candidate being investigated in the ALEXANDER study, a Phase 1/2
clinical study in relapsed/refractory diffuse large B cell lymphoma
(DLBCL), during the American Society of Hematology (ASH)
All-Virtual Annual Meeting, held between December 5-8, 2020.
As of the October 30, 2020 data cut-off date, 49
patients in the ALEXANDER study have been treated and were
evaluable for safety. AUTO3 was observed to be well tolerated, with
low rates of cytokine release syndrome (CRS) and neurotoxicity
(NT). Across all 49 patients, there was only one case of Grade 3
CRS with primary infusion, and only three cases of NT were
reported, with two being ≥ Grade 3. None of the patients achieving
a complete response (CR) experienced any NT and all cases of NT
were seen in a setting of disease progression and with confounding
factors. No prophylactic measures of any kind have been used to
manage patients in this study.
The majority of patients receiving AUTO3 in the
outpatient setting did not require hospital admission. Those
patients admitted were easily managed, with no patients requiring
ICU care. Combined with the overall favorable safety data across
the Phase 1 study, the profile of AUTO3 supports administration in
an outpatient setting.
Across all dose levels, 43 patients were
evaluable for efficacy, with an objective response rate (ORR) of
65% and a CR rate of 51%. Of the 29 evaluable patients receiving
the recommended Phase 2 dose (a dose of ≥ 150 x 106 cells) and
pre-conditioning with pembrolizumab at Day -1, the ORR was 66% and
the CR rate was 55%. A subsequent analysis of these data suggested
a superior response rate at higher dose levels, with 15 evaluable
patients treated at 450 x 106 cells achieving an ORR of 87% and a
CRR of 73%.
Across all cohorts in the study, 73% (16/22) of
patients achieving a CR were without disease progression at a
median follow up of 4 months (1 – 24 months). Of note, none of the
five patients who achieved a CR in the cohort receiving three doses
of pembrolizumab had disease progression.
“AUTO3 continues to have a tolerable and
favorable safety profile when compared with approved CD19 CAR T
therapies,” said Dr. Aravind Ramakrishnan, Medical Director,
Adult Blood and Marrow Transplant, Texas Transplant Institute
at the Sarah Cannon Blood Cancer Center at St.
David’s South Austin Medical Center. “The complete
response rate is high and the longest patient on the study is now
over 2 years post treatment and remains in remission.”
Dr. Christian Itin, chairman and chief
executive officer of Autolus, added, “AUTO3 continues to show a
high level of clinical activity across all dose levels and
conditions evaluated in this expanded Phase 1 study. The favorable
tolerability profile was confirmed in the outpatient cohort which
supports the use of AUTO3 in an outpatient setting. This
differentiated profile may widen the potential use of CAR T therapy
in DLBCL. Based on these data, we are assessing a strategy that
potentially optimizes the development path in r/r DLBCL and expect
to update on next steps for AUTO3 in Q1 2021.”
Investor call on Monday
December 7, 2020 Management will host a
conference call and webcast today at 4:00 pm ET/9:00 pm GMT to
discuss the ASH data. To listen to the webcast and view the
accompanying slide presentation, please go
to: https://www.autolus.com/investor-relations/news-and-events/events.
The call may also be accessed by dialing (866)
679-5407 for U.S. and Canada callers or (409) 217-8320 for
international callers. Please reference conference ID 9188389.
After the conference call, a replay will be available for one week.
To access the replay, please dial (855) 859-2056 for U.S. and
Canada callers or (404) 537-3406 for international callers. Please
reference conference ID 9188389.
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 AUTO3AUTO3 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 diffuse large B
cell lymphoma in the ALEXANDER clinical study, 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 the efficacy, safety
and therapeutic potential of AUTO3 and the future clinical
development of AUTO3 including progress, expectations as to the
reporting of data, conduct and timing. 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 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.
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.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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