Bristol-Myers inks option deal to buy F-star Alpha and its FS102
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New York
October 31 , 2014
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US pharma major Bristol-Myers Squibb Company, and UK-based F-star Alpha
Ltd. announced that the companies, together with the F-star Alpha Ltd.
shareholders, have entered into an agreement that provides Bristol-Myers
Squibb the exclusive option to acquire F-star Alpha Ltd, and gain
worldwide rights to its lead asset FS102. FS102 is a novel phase 1 ready
Human Epidermal growth factor Receptor 2 (HER2)-targeted therapy in
development for the treatment of breast and gastric cancer among a
well-defined population of HER2-positive patients who do not respond or
become resistant to current therapies.
“This agreement is
consistent with our R&D strategy to develop promising treatments
that address areas of high unmet medical need, and provides the
opportunity to complement our oncology portfolio with a novel targeted
therapy,” said Francis Cuss, MB BChir, FRCP, executive vice president
and chief scientific officer, Bristol-Myers Squibb. “We look forward to
working with F-star and leveraging our broad clinical expertise in
oncology to uncover the full potential of FS102.”
“We are
thrilled that a company with the oncology experience and expertise of
Bristol-Myers Squibb will be advancing our first clinical asset with the
potential to provide a significant improvement over the current
standard of care for a defined group of patients with HER2-positive
cancer,” said John Haurum, chief executive officer at F-star
Biotechnology Ltd. “In addition to the important improvement of cancer
therapy FS102 may provide to patients, this programme also provides
validation of the Modular Antibody Technology platform as a powerful
engine to discover and rapidly develop novel targeted biologics.”
HER2
is a highly validated target in breast and gastric cancers, and plays a
significant role in the growth of tumors and subsequent poor clinical
outcome for patients with breast cancer and other solid tumours.
Therapies that target HER2 have shown success in improving patient
outcomes; however, a high proportion of HER2-positive patients do not
respond to currently available treatments, and those who do may
eventually develop resistance.
FS102 is a HER2 targeted Fcab that
has the potential to eliminate cancer cells through a novel mechanism
of action in a biomarker-defined patient population. FS102 works
differently than current HER2-targeted therapies, with the potential to
overcome resistance that has developed against other HER2-targeted
drugs. It binds to a unique site on HER2 and then induces programmed
cell death in HER2-positive tumour cells. In preclinical studies, FS102
has demonstrated encouraging efficacy against certain HER2-positive
cancers and major regression in tumours, including those that are
refractory to treatment with trastuzumab plus pertuzumab.
Under
the terms of the agreement, Bristol-Myers Squibb will make payments
aggregating to $50 million that consist of an option fee for the right
to acquire F-star Alpha Ltd., payment for certain rights and licenses
from F-star Alpha Ltd. and a clinical milestone payment upon initiation
of the Phase 1 trial. Bristol-Myers Squibb will be responsible for
conducting and funding development of FS102 during the option period.
Bristol-Myers Squibb can exercise the option to acquire F-star Alpha
Ltd. in its sole discretion upon its decision to commence a phase 2b
trial. Total aggregate consideration may reach $475 million, which
includes the payments aggregating to $50 million, the option exercise
fee, and milestone payments upon the commencement of a phase 3 clinical
trial and regulatory approvals in the US and Europe.
F-star GmbH
and its wholly-owned subsidiary F-star Biotechnology Ltd. (F-star) is a
biopharmaceutical company dedicated to developing novel bispecific
antibody products that provide a significant improvement over the
current standard of care. In 2013, F-star established an asset-centric
vehicle structure through the formation of F-star Alpha Ltd., which
included out-licencing of FS102 from F-star to F-star Alpha Ltd.
Given
its strong patent position, F-star is the only biopharmaceutical
company with the ability to create and develop Fcabs and bispecific
antibodies by modifying the constant region of an antibody. In
particular, F-star’s Modular Antibody Technology enables rapid discovery
and development of bispecific antibodies by engineering additional
binding sites into the constant region of an antibody. This technology
offers unprecedented speed and ease in the development and manufacturing
of genuine bispecific antibody products. Using the Modular Antibody
Technology, F-star generates bispecific antibodies (mAb2) that possess
the favourable characteristics of traditional monoclonal antibodies,
without the production challenges often associated with other antibody
formats. F-star is now applying its proprietary technology to the
development of a pipeline of product candidates.
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