Syncona
Limited
Autolus commences
clinical trial programmes
18 September 2017
Syncona Ltd (“Syncona”), a leading healthcare company focused on
investing in and building global leaders in life science, today
notes that its portfolio company, Autolus, which is developing and
commercialising next-generation engineered T-cell therapies to
combat cancer, has announced the commencement of three clinical
trials in its two lead programmes, AUTO2 and AUTO3.
In its AUTO2 APRIL study in multiple myeloma, Autolus has
announced the initiation and completion of the first dose cohort of
its Phase I/II study of its dual-targeted Chimeric Antigen Receptor
(CAR) T cell therapy in patients with relapsed/refractory multiple
myeloma. AUTO2 is the first dual targeting CAR-T cell therapy in
clinical development for the treatment of multiple myeloma.
Autolus has also initiated its AUTO3 programme with two Phase
I/II studies, AMELIA in pediatric Acute Lymphoblastic Leukaemia and
ALEXANDER in adult Diffuse Large B Cell Lymphoma. AUTO3 is the
first dual targeting CAR T cell therapy to enter clinical studies
targeting CD19 and CD22 with independently-acting CARs.
[ENDS]
Enquiries
Syncona Ltd
Siobhan Weaver
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
investing in 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. Our current investment portfolio consists
of seven high quality companies in life science and a leading range
of fund investments. We seek to partner with the best,
brightest and most ambitious minds in science to build globally
competitive businesses. We are established leaders in gene therapy,
cell therapy and advanced diagnostics, and focus on delivering
dramatic efficacy for patients in areas of high unmet need.
Our market leading funds portfolio seeks to generate superior
returns by investing in long only and alternative investment funds.
This represents a productively deployed evergreen funding base
which enables us to take a long term approach to investing in life
sciences as we target the best new opportunities and support our
existing portfolio companies to grow and succeed.
Syncona is aligned with two of the premium charitable funders in
UK science, the Wellcome Trust, original founder of Syncona, and
Cancer Research UK, both of which are significant shareholders in
our business. We make a donation of 0.3% of Net Asset Value
to a range of charities each year.
About Autolus:
Autolus is a clinical-stage, biopharmaceutical company, focused
on the development and commercialisation of engineered T-cell
immunotherapy products to combat cancer. Building on its advanced
cell programming and manufacturing technologies, Autolus has
developed a pipeline of product candidates for the treatment of
both haematological malignancies and solid tumours. For further
information please visit the Company’s website at:
www.autolus.com
About AUTO2 and the APRIL study:
AUTO2 is a chimeric antigen receptor T cell (CAR-T cell) therapy
that targets both B cell maturation antigen (BCMA) and
transmembrane activator and calcium modulator and cyclophilin
ligand interactor (TACI). By targeting TACI in addition to BCMA on
the same cancer cell, more patients may be eligible for CAR-T
treatment and less patients may be at risk of cancer relapse due to
loss of BCMA expression on their cancer. In addition, AUTO2 also
carries an RQR8 safety switch which allows the T cells to be
removed with a single high dose of rituximab.
The APRIL Study is a single-arm, open-label, multi-centre, Phase
I/II Study evaluating the safety and clinical activity of AUTO2, a
CAR-T Cell Treatment Targeting BCMA and TACI, in patients with
relapsed or refractory multiple myeloma. In the dose-escalation
phase I/II study cohorts of patients will receive ascending doses
of AUTO2 to determine the maximum tolerated dose and establish a
recommended dose. The second part of the study is an expansion
phase where patients will receive AUTO2 to further evaluate the
safety, tolerability and clinical activity at this recommended
dose.
Multiple myeloma is a type of blood cancer that affects the
plasma cells and is the second most commonly diagnosed blood
cancer, after non-Hodgkin lymphoma. There are a number of approved
therapies to treat the disease but there is currently no cure.
About AUTO3 and the AMELIA and
ALEXANDER studies:
AUTO3 is an autologous T cell product, genetically modified to
express two separate chimeric antigen receptors (CARs) which
recognise CD19 and CD22, two antigens expressed by cancer cells in
B cell leukaemia and lymphoma. AUTO3 is designed to minimize the
risk of relapse due to antigen loss, a key mechanism of resistance
shown in single antigen targeting CAR-T therapies.
The AMELIA study is is a single?arm, open-label, multi-centre,
phase I/II study evaluating the safety and clinical activity of
AUTO3 in paediatric and young adult patients with relapsed or
refractory B Cell Acute Lymphoblastic Leukaemia (ALL). The
ALEXANDER Study is a Phase I/II, open-label, multi-centre study to
evaluate the safety and efficacy of AUTO3 administered by
intravenous infusion in adult Diffuse Large B Cell Lymphoma (DLBCL)
patients. The studies are dose-escalation phase I/II trials in
which cohorts of patients will receive ascending doses of AUTO3 to
determine the maximum tolerated dose and establish a recommended
dose. The second part of the study is an expansion phase where
patients will receive AUTO3 to further evaluate the safety,
tolerability and clinical activity at this recommended dose. In
addition to the effects of AUTO3 alone, combination with
short-duration use of a checkpoint inhibitor is also being
evaluated in the ALEXANDER Study.
ALL is a cancer of the bone marrow and blood, in which the body
makes abnormal white blood cells (lymphocytes). The disease
progresses quickly and is the most common childhood cancer in the
U.S and EU. DLBCL is an aggressive type of non-Hodgkin lymphoma
(NHL) that develops from the B cells in the lymphatic system. It is
a rapidly growing blood cancer, which can occur in lymph nodes or
outside of the lymphatic system, in the brain, bone, breast, skin,
thyroid, gastrointestinal tract, and testes.
About CAR-T therapy:
CAR-T therapy involves re-programming a patient’s immune system
to kill tumour cells. T-cells, a type of white blood cell, are
extracted from a patient’s blood, manipulated outside the body to
incorporate the CAR gene, and then returned to the patient by
infusion. The CAR gene introduces a targeting mechanism to the
T-cells, enabling them to recognise, engage and destroy tumour
cells in a highly specific manner. Clinical trials of CAR T-cells
in multiple myeloma and B-cell malignancies, including non-Hodgkin
lymphoma, suggest that this approach may transform treatment of
cancer patients, many of whom have no other therapeutic
options.