Arix Bioscience
plc
Autolus announces
update on AUTO4 and AUTO5 programmes
LONDON, 3 December 2018: 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.
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
Mary Clark, Supriya Mathur
+44 (0)203 714 1787
optimum.arix@optimumcomms.com
Burns McClellan (US Media & IR
Enquiries)
Bill Slattery Jr., Nancie Steinberg
+1 212-213-0006
arix@burnsmc.com
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
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-
LONDON, December 1, 2018 -- 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.
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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