Rigel & Bristol-Myers Squibb Announce Research & Development Collaboration for TGF Beta Receptor Kinase Inhibitors for Use in...
February 23 2015 - 8:00AM
Business Wire
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) and Bristol-Myers
Squibb Company (NYSE:BMY) today announced that they have entered
into a collaboration agreement for the discovery, development and
commercialization of cancer immunotherapies based on Rigel’s
extensive portfolio of small molecule TGF beta receptor kinase
inhibitors. TGF beta can promote tumor growth, broadly suppress the
immune system and increase the ability of tumors to spread in the
body. The collaboration will focus on developing a new class of
therapeutics aimed at increasing the immune system’s activity
against various cancers either as monotherapy or in combination
with immune checkpoint inhibitors, including Bristol-Myers Squibb’s
Opdivo (nivolumab) and Yervoy (ipilimumab).
Under the terms of the agreement, Bristol-Myers Squibb will
obtain exclusive, worldwide rights to develop and commercialize
small molecule therapeutics derived from Rigel’s TGF beta library,
including, but not limited to, those approved to treat cancer.
Bristol-Myers Squibb will pay $30 million upfront and Rigel will be
eligible to receive development and regulatory milestones that
could total more than $309 million for a successful compound
approved in multiple indications. Rigel will also be eligible to
receive tiered royalties on the net sales of any products from the
collaboration.
“As a company dedicated to leading scientific advances in
immuno-oncology, we are committed to exploring the utility of TGF
beta inhibition as a potential therapeutic to fight certain
cancers,” said Carl Decicco, Ph.D., Head of Discovery, R&D,
Bristol-Myers Squibb. “Working with Rigel and having access to
their TGF beta receptor kinase inhibitors extends our existing
portfolio of immunotherapeutic approaches to include this key
mediator of immunosuppression in the tumor microenvironment.”
“This collaboration places our TGF beta receptor kinase
inhibitor program into the hands of Bristol-Myers Squibb, a premier
immuno-oncology company. Together, we believe TGF beta inhibition
may offer novel therapeutic opportunities in oncology treatments,”
said Raul Rodriguez, president and chief executive officer of
Rigel. “Rigel has focused on immunology, and oncology via numerous
partnerships. This collaboration is Rigel’s first in
immuno-oncology and is one of the Company’s several programs in
this area.”
TGF beta Inhibition
Within the immune system, TGF beta often plays an
immunosuppressive role by potently suppressing effector cell
proliferation and function while simultaneously promoting
differentiation of certain suppressive T-cells. This master
regulator is often present within tumor microenvironments and can
significantly dampen anti-tumor host immune responses. Current
evidence suggests that TGF beta can arise from many sources,
including the cancer itself, surrounding cells and infiltrating
macrophages.
Developing a drug that inhibits TGF beta signaling in cancer
patients has the potential to counteract an important mechanism
used by cancers to escape immuno-surveillance, thereby making this
signaling pathway an appealing therapeutic target for
immuno-oncology related applications.
Rigel has identified a large number of orally bioavailable,
potent and selective small molecule inhibitors of TGF beta receptor
kinases that have demonstrated in vivo efficacy, in preclinical
animal models of cancer, consistent with an immune-mediated
mechanism of action.
About Rigel
(www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage drug
development company that discovers and develops novel,
small-molecule drugs for the treatment of inflammatory and
autoimmune diseases, immuno-oncology related diseases, and muscle
disorders. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. Rigel currently
has the following product candidates in development: fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3
clinical trials for immune thrombocytopenic purpura (ITP) and
initiating a Phase 2 clinical trial for IgA nephropathy (IgAN);
R348, a topical JAK/SYK inhibitor, in a Phase 2 clinical trial for
dry eye in ocular graft-versus-host disease (GvHD); two oncology
product candidates in Phase 1 development with
partners BerGenBio AG and Daiichi Sankyo; and two
preclinical programs with AstraZeneca for R256 in asthma and
Bristol-Myers Squibb for TGF beta inhibitors in
immuno-oncology.
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.
Rigel Forward-Looking Statements
This release contains forward-looking statements relating to,
among other things, the discovery, development and
commercialization of cancer immunotherapies and the collaboration
with Bristol-Myers Squibb, potential payments and royalties to
Rigel, Rigel’s product development programs, and the timing of
expected results in its clinical programs. Any statements contained
in this press release that are not statements of historical fact
may be deemed to be forward-looking statements. Words such as
"planned," "will," "may," "expect," and similar expressions are
intended to identify these forward-looking statements. These
forward-looking statements are based on Rigel's current
expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward looking
statements as a result of these risks and uncertainties, which
include, without limitation, the availability of resources to
develop Rigel's product candidates, Rigel's need for additional
capital in the future to sufficiently fund Rigel's operations and
research, the uncertain timing of completion of and the success of
clinical trials, market competition, risks associated with and
Rigel's dependence on Rigel's corporate partnerships, as well as
other risks detailed from time to time in Rigel's reports filed
with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2014. Rigel does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
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 discovery, development and commercialization of
cancer immunotherapies. 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 we will be able to successfully develop a TGF Beta Receptor
Kinase Inhibitor. 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,
2014 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.
Bristol-Myers
SquibbMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorKen Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRigelMedia:Susan C. Rogers,
650-430-3777Rivily, Inc.,susan@rivily.comorInvestors:Raul
Rodriguez, 650-624-1302invrel@rigel.com
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