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Syncona Limited
03 December 2018
Syncona Limited
Autolus announces update on AUTO4 and AUTO5
03 December 2018
Syncona Ltd, a leading healthcare company focused on founding,
funding and building global leaders in life science, notes the
announcement that its portfolio company, Autolus Therapeutics Plc
(NASDAQ: AUTL) (Autolus), has dosed the first patient 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, CA.
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.
[S]
Enquiries
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Tel: +44 (0) 20 7611 2031
Tulchan Communications
Martin Robinson
Lisa Jarrett-Kerr
Tel: +44 (0) 207 353 4200
Copies of this press release and other corporate information can
be found on the company website at: www.synconaltd.com
About Syncona:
Syncona is a leading FTSE250 healthcare company focused on
founding, funding and building global leaders in life science. Our
vision is to deliver transformational treatments to patients in
truly innovative areas of healthcare while generating superior
returns for shareholders.
We seek to partner with the best, brightest and most ambitious
minds in science to build globally competitive businesses.
We take a long-term view, underpinned by a deep pool of capital,
and are established leaders in gene and cell therapy. We focus on
delivering dramatic efficacy for patients in areas of high unmet
need.
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 60(th) 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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