Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the ESMO Virtual Congress 2020
September 18 2020 - 3:05AM
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 CAR T cell therapy being investigated in the
ALEXANDER study, a Phase 1/2 clinical trial in relapsed/refractory
diffuse large B cell lymphoma (DLBCL), during the European Society
for Medical Oncology (ESMO) Virtual Congress 2020, beginning 18
September.
“Today we presented data from our recommended
Phase 2 dose cohort from the ALEXANDER trial of AUTO3, a CD19 and
CD22 dual targeting CAR T product candidate in DLBCL. The data
support a best in class profile with a high level of complete
remissions and a well tolerated safety profile,” said
Dr. Christian Itin, chairman and chief executive officer of
Autolus.
“AUTO3 has a tolerable and very favorable safety
profile when compared with approved CD19 CAR T therapies,” said Dr
Craig Moskowitz, Professor of Medicine at Miller School of
Medicine, University of Miami Health System. “It has a
promising complete response rate of 64%, as demonstrated in the
completed cohorts at the recommended Phase 2 dose range and, thus
far, these complete remissions also appear durable. Among all dose
cohorts with a median follow up of 6 months, 93% of the patients
who achieved a complete response did not relapse.”
As of the data cut-off date of August 3, 2020,
35 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 have
been treated and were evaluable for safety. AUTO3 was well
tolerated, with no Grade 3 or higher cytokine release syndrome
(CRS) with primary infusion and low rates of neurotoxicity
(NT). Across all 35 patients, only three cases of NT have
been reported, with two having ≥ Grade 3. Among the 20
patients treated at a dose of ≥ 150 x 106 cells with
pre-conditioning pembrolizumab on day minus 1 (D-1), which is the
declared recommended Phase 2 dose (RP2D), one patient experienced
≥Grade 3 NT (patient died due to disease progression and multiorgan
failure). None of the patients achieving a complete response
(CR) experienced any NT and all cases of NT reported have been
atypical in nature and seen in a setting with disease progression
and confounding factors.
In terms of efficacy data, of the 35 patients
dosed to date, 30 patients were evaluable within their completed
cohort. The cohort receiving a dose of ≥ 150 x 106 cells and
pre-conditioning pembrolizumab D-1 (the RP2D) had an objective
response rate (ORR) of 71% and CR rate of 64%. For all
patients on study across all dose levels that were evaluable, the
ORR was 68% and CR rate of 54%.
Investor call on Friday September 18,
2020 Management will host a conference call and webcast
today at 8:00 am EDT/1:00 pm BST to discuss the ESMO 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) 652-5200 for U.S.
and Canada callers or (412) 317-6060 for International callers.
Please ask to be joined into the Autolus Therapeutics call. After
the conference call, a replay will be available for one year on
Autolus’ website.
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 trial, with a 20-patient
cohort that was initiated in Q2 2020 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
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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