REG-Syncona Limited: Autolus commences clinical trial programmes <Origin Href="QuoteRef">SYNCS.L</Origin>

SynconaAnnouncement

18/09/2017 07:00

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. 



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