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REG-Arix Bioscience PLC Autolus provides business outlook for 2021 and 2022

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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

 

                                          # # #

 

 

═════════════════════════════════════════════════════════════════════════════════════════

   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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References

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   6. mailto:l.crabtree@autolus.com
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