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.
Copyright Business Wire 2015