Arix Bioscience plc: Autolus Announces Update on AUTO4 and AUTO5 Programmes

Arix Bioscience plc (LSE: ARIX) ("Arix"), a global healthcare and life science company
supporting medical innovation notes its portfolio company, Autolus Therapeutics plc
(NASDAQ: AUTL) ("Autolus"), announced that the first patient has been dosed in its Phase
1/2 LibrA T1 clinical trial of AUTO4, a developmental therapy for the treatment of
relapsed or refractory TRBC1-positive peripheral T cell lymphoma (PTCL). In addition,
Autolus also announced that data on its preclinical sister programme, AUTO5 targeting
TRBC2-positive lymphoma, were presented at the 60th American Society of Hematology (ASH)
Annual Meeting, San Diego.

    The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and full text of the announcement from
Autolus is contained below.

<pre>        For more information on Arix, please contact:


    Arix Bioscience plc
    Charlotte Parry, Head of Investor Relations
    +44(0)20-7290-1072
    [email protected]


    Optimum Strategic Communications
    Mary Clark, Supriya Mathur
    +44(0)203-714-1787
    [email protected]


    Burns McClellan (US Media & IR Enquiries)
    Bill Slattery Jr., Nancie Steinberg
    +1-212-213-0006
    [email protected]

</pre>     
    About Arix Bioscience plc 

    Arix Bioscience plc is a global healthcare and life science company supporting medical
innovation. Headquartered in London and with an office in New York, Arix Bioscience
sources, finances and builds world class healthcare and life science businesses addressing
medical innovation at all stages of development. Operations are supported by privileged
access to breakthrough academic science and strategic relationships with leading research
accelerators and global pharmaceutical companies.

    Arix Bioscience plc is listed on the Main Market of the London Stock Exchange. For
further information, please visit www.arixbioscience.com [http://www.arixbioscience.com ]

    Autolus Therapeutics Announces Update on its Novel CAR T Cell Program  for Peripheral
                                T Cell Lymphoma (PTCL)  

     -First patient dosed in Phase 1/2 trial of AUTO4 in TRBC1-positive peripheral T cell
                                       lymphoma- 

       -Preclinical data for AUTO5 targeting TRBC2-positive peripheral T cell lymphoma
       presented at the 60th Annual American Society of Hematology (ASH) Meeting- 

    Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company
developing next-generation programmed T cell therapies for the treatment of cancer, today
announced that the first patient has been dosed in its Phase 1/2 LibrA T1 clinical trial
of AUTO4, a developmental therapy for the treatment of relapsed or refractory
TRBC1-positive peripheral T cell lymphoma (PTCL). In addition, the company also announced
that data on the preclinical sister program, AUTO5 targeting TRBC2-positive lymphoma, were
presented at the 60th American Society of Hematology (ASH) Annual Meeting, San Diego.
Autolus' T cell program comprises a companion diagnostic to determine whether the PTCL is
TRBC1- or TRBC2-positive and two novel CAR T cell product candidates AUTO4 and AUTO5. PTCL
is a rare and heterogeneous form of non-Hodgkin lymphoma, currently estimated to affect
approximately 2,900 patients in the United States, annually.1

    "There are limited treatment options for patients with relapsed and/or refractory
peripheral T cell lymphoma. We are particularly excited to participate in the LibrA T1
trial of AUTO4, a novel CAR T cell therapy for this aggressive cancer," said Dr. Kate
Cwynarski, Principal Investigator, Consultant Haematologist at University College London
Hospital and Honorary Senior Lecturer at University College London.

    "Effective systemic treatment for peripheral T cell lymphomas remains a challenge. CAR
T therapies selectively targeting TRBC1-positive and TRBC2-positive T cell lymphomas have
the potential to be major therapeutic advances," said Steven T. Rosen, M.D. provost and
chief scientific officer of City of Hope and director of the Beckerman Research Institute
of City of Hope."

    On December 2 at the 60th ASH Annual Meeting in San Diego, the company presented data
from preclinical studies of AUTO5 targeting TRBC2. TRBC1 and TRBC2 are virtually identical
in sequence, and antibody binders had to be designed to differentiate TRBC1 from TRBC2
extracellular domains by selectively recognizing a single inversion of two amino acids.
Employing a structural biology approach and molecular modelling techniques, a binder was
generated that could bind TRBC2 without binding to TRBC1, and when included in a CAR T
approach, selectively eliminated TRBC2-positive cells.

    Structure guided engineering of highly specific Chimeric Antigen Receptors for the
complete treatment of T cell lymphomas (Abstract number 1661, poster presentation from
6:15 PM PST- 8:15 PM PST, on Saturday, December 1, 2018.) 

    About LibrA T1 P1/2 Clinical Trial 

    The LibrA T1 trial is a single-arm, open label, multi-center, Phase 1/2 trial
evaluating the safety and efficacy of AUTO4, a single dose intravenous CAR T cell
treatment targeting TRBC1 in patients with relapsed or refractory TRBC1-positive selected
PTCL. The trial will consist of a Phase 1 portion, or dose escalation phase, and a Phase 2
portion, or expansion phase. The Phase 1 portion of the trial, which is expected to enroll
up to 25 patients, is designed to evaluate up to three dose levels, beginning with a low
dose of 25 million AUTO4 cells in cohorts of three to six patients. If no dose limiting
toxicities are observed, the dose escalation phase of the trial will continue to higher
doses of 75 million AUTO4 cells and 225 million AUTO4 cells. Once a recommended dose has
been identified in the Phase 1 portion of the trial, up to 30 patients will be enrolled
and treated in the Phase 2 portion.

    About AUTO4 and AUTO5 

    AUTO4 is a programmed T cell therapy product candidate being developed to leverage a
new targeting approach based on the mutually exclusive expression of two subtypes of the T
cell receptor beta chain: AUTO4 targets TRBC1, while another of the company's product
candidates in development, AUTO5, targets TRBC2. Normal T cells contain both TRBC1 and
TRBC2 compartments, whereas T cell lymphoma cells are derived from mature cells and
express only TRBC1 or TRBC2. A companion diagnostic is used to identify if the T cell
lymphoma is TRBC1 or TRBC2 positive. Unlike non-selective approaches targeting the entire
T cell population that can lead to severe immunosuppression, this approach has the
potential to eradicate a portion of T cells containing the malignancy, while preserving a
healthy T cell sub-population to preserve cellular immunity.

    For more information about this trial and the inclusion criteria, visit
www.clinicaltrials.gov [http://www.clinicaltrials.gov ].

    About Peripheral T Cell Lymphoma (PTCL) 

    Lymphoma is the most commonly occurring blood cancer. The two main forms of lymphoma
are Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Lymphoma occurs when cells of
the immune system called lymphocytes, a type of white blood cell, grow and multiply
uncontrollably. Lymphomas can originate from two types of lymphocytes, B cells and T
cells. T cell lymphoma is a rare and heterogeneous form of NHL, representing approximately
10 to 20% of NHL cases and 3 to 4% of all hematological malignancies

    While T cell lymphoma is a smaller percentage of all lymphomas compared to B cell
lymphomas, T cell lymphoma is an aggressive disease. Most T cell lymphomas are PTCL, and
generally involve high-grade tumors, with a relatively high proportion of patients rapidly
developing significant morbidity. The five-year survival rate ranges from 18% to 24%. The
first-line treatment for PTCL consists of the combination chemotherapy CHOP, consisting of
cyclophosphamide, vincristine, doxorubicin and prednisolone. However, treatment with
chemotherapy introduces toxicity concerns, including low blood cell counts, nausea,
vomiting, diarrhea, hair loss, mouth sores, and increased risk of infections. Additionally,
 with CHOP chemotherapy, complete response rates are lower than in DLBCL and relapse is
more common. In many treatment centers, CHOP chemotherapy is consolidated with high-dose
chemotherapy and autologous or allogenic stem cell transplantation. According to National
Comprehensive Cancer Network (NCCN) guidelines, participation in a clinical trial is the
preferred option for all patients with T cell lymphoma with any stage disease.2

    REFERENCES

    1. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z,
Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review,
1975-2015, National Cancer Institute. Bethesda, MD,
https://seer.cancer.gov/csr/1975_2015 , based on November 2017 SEER data submission,
posted to the SEER web site, April 2018.

    2. Horwitz SM, Ansell SM, Ai WZ, Barnes J, Barta SK, Choi M, Clemens MW, Dogan A,
Greer JP, Halwani A, Haverkos BM, Hoppe RT, Jacobsen E, Jagadeesh D, Kim YH, Lunning MA,
Mehta A, Mehta-Shah N, Oki Y, Olsen EA, Pro B, Rajguru SA, Shanbhag S, Shustov A, Sokol L,
Torka P, Wilcox R, William B, Zain J, Dwyer MA, Sundar H. NCCN Guidelines Insights: T-Cell
Lymphomas, Version 2.2018. J Natl Compr Canc Netw. 2018 Feb;16(2):123-135. doi:
10.6004/jnccn.2018.0007. PubMed PMID: 29439173. 

    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.

    Forward-Looking Statement 

    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 progress, timing and results of the company's clinical trials and
the anticipated clinical development of the company's product candidates. 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. For a discussion of
other risks and uncertainties, and other important factors, any of which could cause our
actual results to differ from those contained in the forward-looking statements, see the
section titled "Risk Factors" in the company's Annual Report on Form 20-F filed on
November 23, 2018 as well as discussions of potential risks, uncertainties, and other
important factors in the company's future filings with the Securities and Exchange
Commission from time to time. 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.



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