Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in the use of
T- cell receptor (TCR) engineered T-cell therapy to treat cancer,
and GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) today announced that
the companies have expanded the terms of their strategic
collaboration agreement to accelerate Adaptimmune’s lead clinical
cancer program, an affinity enhanced T-cell immunotherapy
(GSK3377794) targeting NY-ESO-1, toward pivotal trials in synovial
sarcoma.
Adaptimmune and GSK announced a strategic collaboration and
licensing agreement in June 2014 for up to five programs, including
the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1
program through clinical proof of concept and, on exercise, will
assume full responsibility for the program.
“We are delighted to broaden our collaboration with GSK, which
is also fully committed to the development of this revolutionary
T-cell therapy,” commented James Noble, Adaptimmune’s Chief
Executive Officer. “We believe that our affinity enhanced T-cell
programs have the potential to deliver important clinical benefit
to cancer patients, and it is therefore essential that we
accelerate our efforts to meet their needs. We are working closely
with GSK to expedite development of our affinity enhanced T-cell
therapy targeting NY-ESO, and if we succeed in generating pivotal
data consistent with that of our ongoing studies, we believe it has
the potential to be the first engineered T-cell therapy to reach
the market.”
Dr. Axel Hoos, SVP Oncology R&D GSK said, “At GSK we’re
progressing a pipeline of immuno-oncology therapies to stimulate
anti-tumor immunity in patients. As we highlighted to investors at
our R&D event last year, this Adaptimmune collaboration is a
key element of that pipeline and is part of a comprehensive program
for cell and gene therapy. With this expanded collaboration, we
have the opportunity to accelerate the lead program in synovial
sarcoma toward pivotal trials and also to investigate several other
tumor types and combine the T-cell therapy with immune-modulating
therapies such as checkpoint inhibitors.”
Under the terms of the expanded agreement, the companies will
accelerate the development of Adaptimmune’s NY-ESO therapy into
pivotal studies in synovial sarcoma and will explore development in
myxoid round cell liposarcoma. Additionally, the companies may
initiate up to eight proof-of-principle studies exploring
combinations with other therapies, including checkpoint
inhibitors.
According to the expanded development plan, the studies will be
conducted by Adaptimmune with GSK effectively funding the pivotal
studies and sharing the costs of the combination studies via a
success based milestone structure.
Previous guidance relating to the collaboration disclosed
potential cash payments to Adaptimmune of approximately $350m over
the first 7 years from 2014 in relation to NY-ESO and two further
programs. Given the changes announced today, and the advances made
across the collaboration, Adaptimmune is updating and expanding
this disclosure. Under the terms of the expanded agreement, the
potential development milestones Adaptimmune is eligible to receive
solely in relation to the NY-ESO program could amount to
approximately $500 million, excluding previously received payments,
if GSK exercises its option and successfully develops NY-ESO in
more than one indication and more than one Human Leukocyte Antigen
(HLA) type. In addition, Adaptimmune would receive tiered
sales milestones and, as previously disclosed, mid-single to low
double digit royalties on worldwide net sales. GSK has the right to
nominate up to four additional targets in due course and
Adaptimmune is eligible to receive further significant undisclosed
milestone payments in relation to these earlier stage target
programs.
Adaptimmune has also reiterated its prior cash burn guidance,
which remains unchanged as the majority of the expansion and
acceleration costs will be funded by GSK. For the full year 2016,
the company expects its cash burn to be between $80 and $100
million, excluding cash burn associated with business development
activities, and expects its cash position at December 31, 2016,
including cash, cash equivalents, and short term deposits, to be at
least $150 million.
About affinity enhanced T-cell
candidates
Adaptimmune’s affinity enhanced T-cell candidates are novel
cancer immunotherapies that have been engineered to target and
destroy cancer cells by strengthening a patient’s natural T-cell
response. Using its proprietary technology, Adaptimmune has created
a pipeline of affinity enhanced T-cell therapies targeting certain
antigens, including cancer testis antigens such as NY-ESO.
NY-ESO-1 is one of the best-characterized and most immunogenic
cancer testis antigens, and is frequently expressed by tumors of
different origins and in advanced tumors. The company’s trials in
the NY-ESO-1 program in multiple myeloma, melanoma, sarcoma and
ovarian cancer continue to generate encouraging results.
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company
focused on novel cancer immunotherapy products based on its T-cell
receptor (TCR) platform. Established in 2008, the company aims to
utilize the body’s own machinery - the T-cell - to target and
destroy cancer cells by using engineered, increased affinity TCRs
as a means of strengthening natural patient T-cell responses.
Adaptimmune’s lead program is an affinity enhanced T-cell therapy
targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity
enhanced T-cell therapy has demonstrated signs of efficacy and
tolerability in Phase 1/2 trials in solid tumors and in hematologic
cancer types, including synovial sarcoma and multiple myeloma. In
addition, Adaptimmune has a number of proprietary programs. The
company has identified over 30 intracellular target peptides
preferentially expressed in cancer cells and is currently
progressing 12 through unpartnered research programs. Adaptimmune
has over 200 employees and is located in Oxfordshire, U.K. and
Philadelphia, USA. For more information:
http://www.adaptimmune.com
GSK – one of the world’s leading research-based
pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors' in the company's Annual Report on Form 20-F for
2014.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995
(PSLRA). These forward-looking statements involve certain
risks and uncertainties. Such risks and uncertainties could cause
our actual results to differ materially from those indicated by
such forward-looking statements, and include, without limitation:
the success, cost and timing of our product development activities
and clinical trials and our ability to successfully advance our TCR
therapeutic candidates through the regulatory and commercialization
processes. For a further description of the risks and uncertainties
that could cause our actual results to differ materially from those
expressed in these forward-looking statements, as well as risks
relating to our business in general, we refer you to our Annual
Report on Form 20-F filed with the Securities and Exchange
Commission on October 13, 2015. The forward-looking
statements contained in this press release speak only as of the
date the statements were made and we do not undertake any
obligation to update such forward-looking statements to reflect
subsequent events or circumstances.
Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 825-9306
E: will.roberts@adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mob: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
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