DJ Autolus provides business outlook for 2021 and 2022
Arix Bioscience PLC (ARIX)
Autolus provides business outlook for 2021 and 2022
06-Jan-2021 / 10:00 GMT/BST
Dissemination of a Regulatory Announcement, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
Arix Bioscience plc
Autolus provides business outlook for 2021 and 2022
LONDON, 06 January 2021: 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
("Autolus", Nasdaq: AUTL), today announced a business outlook for 2021 and
2022.
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.
For more information please visit: www.arixbioscience.com [2]
Autolus Therapeutics provides business outlook for 2021 & 2022
? Company prioritizes AUTO1, a potentially transformational treatment for
Adult Acute Lymphoblastic Leukemia (ALL), with full data from the
AUTO1-AL1 study expected in 2022
? Company intends to partner AUTO3, ahead of progressing into the next
phase of development
? Company adjusting its workforce and infrastructure footprint to align
with AUTO1 prioritization
? Company continues to develop its pipeline of next generation programs,
specifically tailored for oncology indications with high unmet need
LONDON, January 6, 2021 -- 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 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 [3].
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 trial
The 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 AUTO3
AUTO3 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 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 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, PhD
Vice President, Investor Relations and Corporate Communications
+44 (0) 7587 372 619
l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
# # #
ISIN: GB00BD045071
Category Code: MSCU
TIDM: ARIX
LEI Code: 213800OVT3AHQCXNIX43
OAM Categories: 3.1. Additional regulated information required to be
disclosed under the laws of a Member State
Sequence No.: 90947
EQS News ID: 1158754
End of Announcement EQS News Service
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(END) Dow Jones Newswires
January 06, 2021 05:00 ET (10:00 GMT)
