Bristol-Myers Squibb Company (NYSE:BMY) and Five Prime
Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have
entered into an exclusive clinical collaboration agreement to
evaluate the safety, tolerability and preliminary efficacy of
combining Opdivo (nivolumab), Bristol-Myers Squibb’s
investigational PD-1 (programmed death-1) immune checkpoint
inhibitor, with FPA008, Five Prime’s monoclonal antibody that
inhibits colony stimulating factor-1 receptor (CSF1R). The Phase
1a/1b study will evaluate the combination of Opdivo and FPA008 as a
potential treatment option for patients with non-small cell lung
cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer,
colorectal cancer and malignant glioma. Bristol-Myers Squibb has
proposed the name Opdivo, which, if approved by health authorities,
will serve as the trademark for nivolumab.
Opdivo and FPA008 are part of a new class of cancer treatments
known as immunotherapies that are designed to harness the body’s
own immune system to fight cancer. Opdivo is approved in Japan for
the treatment of patients with unresectable melanoma, and is being
developed in multiple tumor types in more than 50 clinical trials.
FPA008, in development as a potential treatment for rheumatoid
arthritis (RA) and solid tumors, has initiated dosing for a Phase 1
clinical trial in RA. Preclinical data suggest that combining
antibodies targeting PD-1 and CSF1R may lead to an enhanced
anti-tumor immune response compared to either approach alone in
treating cancer.
“This collaboration supports our strategy to expand the clinical
development of Opdivo, including novel combination regimens and
across numerous tumor types,” said Michael Giordano, senior vice
president, Head of Development, Oncology, Bristol-Myers Squibb. “We
are excited to build upon our existing relationship with Five Prime
Therapeutics in immuno-oncology, and explore the full potential of
Opdivo and FPA008 in multiple tumor types.”
“We are pleased to establish a second collaboration with
Bristol-Myers Squibb in the area of immuno-oncology,” said Lewis T.
“Rusty” Williams, M.D., Ph.D., president and chief executive
officer of Five Prime. “Their vision aligns with our commitment to
advancing promising immune-modulating targets, alone or in
combination, to create next-generation immunotherapies for cancer
patients. We look forward to initiating this study and expanding
the development of FPA008 as a potential immunotherapy for these
six types of cancer.”
Under the terms of this agreement, Bristol-Myers Squibb will
make a one-time payment of $30 million to Five Prime and will be
responsible for study costs. Five Prime will conduct the clinical
trial, which is expected to begin in 2015. The agreement provides
for exclusivity with respect to the development, with a
collaborative partner, of combination regimens of anti-PD-1/PDL1
antagonists together with an anti-CSF1R antagonist. Bristol-Myers
Squibb will have a time-limited right of first refusal subject to
certain conditions if Five Prime wishes to seek a partner for
FPA008.
About Opdivo (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as
checkpoint pathways, to hide from the immune system and shield the
tumor from immune attack. Opdivo is an investigational, fully-human
PD-1 immune checkpoint inhibitor that binds to the checkpoint
receptor PD-1 expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to
study Opdivo in multiple tumor types consisting of more than 50
trials – as monotherapy or in combination with other therapies – in
which more than 7,000 patients have been enrolled worldwide. Among
these are several potentially registrational trials in NSCLC,
melanoma, renal cell carcinoma (RCC), head and neck cancer,
glioblastoma and non-Hodgkin lymphoma (NHL).
In 2012, the FDA granted Fast Track designation for Opdivo in
NSCLC, melanoma and RCC. In April 2014, the company initiated a
rolling submission with the FDA for Opdivo in third-line
pre-treated squamous cell NSCLC and expects to complete the
submission by year-end. The FDA granted Opdivo Breakthrough Therapy
Designation in May 2014 for the treatment of patients with Hodgkin
lymphoma after failure of autologous stem cell transplant and
brentuximab. On July 4, Ono Pharmaceutical Co. announced that
Opdivo received manufacturing and marketing approval in Japan for
the treatment of patients with unresectable melanoma, making Opdivo
the first PD-1 immune checkpoint inhibitor to receive regulatory
approval anywhere in the world. On September 26, Bristol-Myers
Squibb announced that the FDA accepted for priority review the
Biologics License Application for previously treated advanced
melanoma, and the Prescription Drug User Fee Act goal date for a
decision is March 30, 2015. The FDA also granted Opdivo
Breakthrough Therapy status for this indication. In the European
Union, the European Medicines Agency (EMA) has validated for review
the Marketing Authorization Application (MAA) for Opdivo in
advanced melanoma. The application has also been granted
accelerated assessment by the EMA’s Committee for Medicinal
Products for Human Use. The EMA also validated for review the MAA
for Opdivo in NSCLC.
About FPA008
FPA008, an antibody that inhibits colony stimulating factor-1
receptor (CSF1R), blocks the activation and survival of
monocytes and macrophages. Inhibition of CSF1R in
inflamed RA joints blocks the production of inflammatory
cytokines by macrophages and inhibits osteoclasts,
monocyte-lineage cells that can cause bone erosions and joint
destruction. Inhibition of CSF1R in many cancers reduces
the number of immunosuppressive tumor-associated
macrophages (TAMs), thereby facilitating an immune
response against tumors.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About Five Prime Therapeutics
Five Prime Therapeutics, Inc. discovers and develops innovative
therapeutics to improve the lives of patients with serious
diseases. Five Prime's comprehensive discovery platform, which
encompasses virtually every medically relevant extracellular
protein, positions it to explore pathways in cancer, inflammation
and their intersection in cancer immunotherapy, an area of oncology
with significant therapeutic potential and a growing focus of the
company's R&D activities. Five Prime has entered into strategic
collaborations with leading global pharmaceutical companies and has
promising product candidates in clinical and late preclinical
development. For more information, please visit
www.fiveprime.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that nivolumab will receive regulatory approval in the U.S. either
as a single agent or in a combination regimen, or, if approved,
that it will become a commercially successful product.
Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect
Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2013 in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Five Prime Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Five Prime's
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include statements regarding the planned
clinical development of a combination of FPA008 and nivolumab.
Factors that may cause actual results to differ from those
expressed or implied in the forward-looking statements in this
press release are discussed in Five Prime's filings with the U.S.
Securities and Exchange Commission, including the "Risk Factors"
contained therein. Except as required by law, Five Prime assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.comorFive Prime Therapeutics:Amy
Kendall, 415-365-5776amy.kendall@fiveprime.com
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