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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.
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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 1 https://www.autolus.com/investor-relations/news-and-events/press-releases 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
2 charlotte@arixbioscience.com
Optimum Strategic Communications
Supriya Mathur, Shabnam Bashir, Manel Mateus
+44 (0)20 3922 1906
3 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: 4 www.arixbioscience.com
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
5 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 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
6 l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
7 j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
8 susan@sanoonan.com
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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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2. mailto:charlotte@arixbioscience.com
3. mailto:optimum.arix@optimumcomms.com
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