DJ Autolus presents additional data on AUTO3 at ASH
Arix Bioscience PLC (ARIX)
Autolus presents additional data on AUTO3 at ASH
07-Dec-2020 / 17:47 GMT/BST
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The issuer is solely responsible for the content of this announcement.
Arix Bioscience plc
Autolus presents additional data on AUTO3 at ASH
LONDON, 07 December 2020: Arix Bioscience plc ("Arix", LSE: ARIX), a global
venture capital company focused on investing in and building breakthrough
biotech companies, notes that its portfolio company, Autolus Therapeutics
plc ("Autolus", Nasdaq: AUTL), today announced new data 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 trial 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.
Autolus noted that AUTO3 continues to show a differentiated product profile,
supporting potential for out-patient administration. Based on these data,
the company expects to provide an update on next steps for AUTO3 in Q1 2021.
The announcement can be accessed on the Autolus website at
https://www.autolus.com/investor-relations/news-and-events/press-releases
[1] and full text of the announcement from Autolus is contained below.
[ENDS]
Enquiries
For more information on Arix, please contact:
Arix Bioscience plc
Charlotte Parry, Head of Investor Relations
+44 (0)20 7290 1072
charlotte@arixbioscience.com
Optimum Strategic Communications
Supriya Mathur, Shabnam Bashir, Manel Mateus
+44 (0)20 3922 1906
optimum.arix@optimumcomms.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused on investing
in and building breakthrough biotech companies around cutting-edge advances
in life sciences.
We collaborate with exceptional entrepreneurs and provide the capital,
expertise and global networks to help accelerate their ideas into important
new treatments for patients. As a listed company, we are able to bring this
exciting growth phase of our industry to a broader range of investors.
www.arixbioscience.com [2]
Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the
62nd ASH Annual Meeting
AUTO3 continues to show a differentiated product profile supporting
outpatient administration
Conference call and webcast to be held Monday, December 7, 2020
at 4:00 pm ET / 9:00 pm GMT
LONDON, December 7, 2020 -- 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 [3].
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 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 [4].
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
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 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 efficacy, safety
and therapeutic potential of AUTO3 and the future clinical development of
AUTO3 including progress, expectations as to the reporting of data, conduct
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