BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical
company focused on developing and commercializing innovative
molecularly targeted and immuno-oncology drugs for the treatment of
cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage
targeted oncology company, today announced an exclusive license
agreement for the development, manufacturing and commercialization
of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and
New Zealand. Mirati will retain exclusive rights for the
development, manufacturing and commercialization of sitravatinib
for the rest of world.
Sitravatinib is an investigational tyrosine kinase inhibitor
that has demonstrated potent inhibition of receptor tyrosine
kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER),
split family receptors (VEGFR2, KIT) and RET. It is being evaluated
by Mirati as a single agent in a Phase 1b expansion trial in
patients whose tumors harbor specific genetic alterations in
non-small cell lung cancer (NSCLC) and other tumors types.
Sitravatinib has shown encouraging interim results in an ongoing
Phase 2 trial in combination with nivolumab in NSCLC patients who
have progressed after prior treatment with a checkpoint
inhibitor.
“We are delighted to enter into this exclusive clinical
development and commercialization agreement for sitravantinib and
look forward to working with the experienced team at Mirati.
Sitravatinib is an exciting compound that has demonstrated a unique
tyrosine kinase inhibition profile and promising clinical activity
both as a single agent and in combination with a checkpoint
inhibitor in non-small cell lung cancer. This collaboration
complements our portfolio and will allow us to investigate
sitravatinib in combination with tislelizumab, our investigational
anti-PD-1 antibody, in China and the rest of the licensed
territory,” commented John V. Oyler, Founder, Chief Executive
Officer, and Chairman of BeiGene.
“We are excited to begin a partnership with BeiGene, which has
built a world-class global development organization with a strong
presence in Asia-Pacific, as well as an established commercial
organization in China. They have demonstrated an ability to enroll
patients quickly in a variety of indications which will augment our
development capabilities and expand the evaluation of sitravatinib
to additional tumor types for patients who are checkpoint inhibitor
naïve or who have been previously treated with a checkpoint
inhibitor,” said Charles M. Baum, M.D., Ph.D., President and Chief
Executive Officer of Mirati Therapeutics.
Under the agreement Mirati will receive an upfront cash payment
of $10 million from BeiGene. Additionally, Mirati is eligible to
receive up to $123 million of additional payments based upon the
achievement of certain development, regulatory and sales milestones
as well as significant royalties on future sales of sitravatinib in
the licensed territory.
About Sitravatinib
Sitravatinib (MGCD-0516) is a spectrum-selective kinase
inhibitor which potently inhibits receptor tyrosine kinases (RTKs)
including RET, TAM family receptors (TYRO3, Axl, MER), and split
family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as
a single agent in a Phase 1b expansion trial enrolling patients
that harbor RET, CHR4Q12, and CBL genetic alterations in NSCLC and
other tumors.
As an immuno-oncology agent, sitravatinib is being tested in
combination with anti PD-1 checkpoint inhibitor nivolumab in NSCLC
patients who have progressed after prior treatment with a
checkpoint inhibitor. Sitravatinib's potent inhibition of TAM and
split family receptors may help overcome resistance to checkpoint
inhibitor therapy through enhancement of dendric cell-dependent
antigen presentation, targeted depletion of immunosuppressive T
regulatory cells and myeloid-derived suppressor cells, and
conversion of tumor associated macrophages to an immune-enhancing
Type I composition, in the tumor microenvironment.
About Tislelizumab (BGB-A317)
Tislelizumab is an investigational humanized monoclonal antibody
that belongs to a class of immuno-oncology agents known as immune
checkpoint inhibitors. It is designed to bind to PD-1, a cell
surface receptor that plays an important role in downregulating the
immune system by preventing the activation of T-cells. Tislelizumab
has demonstrated high affinity and specificity for PD-1. It is
differentiated from the currently approved PD-1 antibodies in an
engineered Fc region, which is believed to minimize potentially
negative interactions with other immune cells. Tislelizumab is
being developed as a monotherapy and in combination with other
therapies for the treatment of a broad array of both solid tumor
and hematologic cancers. BeiGene and Celgene Corporation have a
global strategic collaboration for tislelizumab for solid tumors
outside of Asia (except Japan).
About Mirati Therapeutics
Mirati Therapeutics is a clinical-stage biotechnology company
focused on developing a pipeline of targeted oncology products
intended to treat specific genetic and epigenetic drivers of
cancer. This approach is transforming the treatment of patients by
targeting the genetic changes in tumor cells that result in
uncontrolled tumor growth and migration. Mirati's precision
oncology programs seek to treat the patients most likely to benefit
from targeted oncology treatments and are driven by drugs that
target very specific genetic mutations, directed by genomic tests
that identify patients who carry those driver mutations. Mirati's
immuno-oncology programs are novel small molecule drugs designed to
enhance and expand the efficacy of checkpoint inhibitors when given
in combination. In addition to its clinical programs, Mirati has
active discovery research efforts focused on novel oncology
targets. The promise of these approaches includes potentially
better patient outcomes, more efficient cancer treatment and faster
drug development.
About BeiGene
BeiGene is a global, commercial-stage, research-based
biotechnology company focused on molecularly targeted and
immuno-oncology cancer therapeutics. With a team of over 850
employees in China, the United States, and Australia, BeiGene is
advancing a pipeline consisting of novel oral small molecules and
monoclonal antibodies for cancer. BeiGene is also working to create
combination solutions aimed to have both a meaningful and lasting
impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle
albumin-bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA®
(azacitidine) in China under a license from Celgene
Corporation.i
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
BeiGene’s and Mirati’s advancement of, and anticipated clinical
development and regulatory milestones and plans related to
tislelizumab and sitravatinib and the potential benefits and
markets for BeiGene’s and Mirati’s product candidates.
Forward-looking statements are based on management’s current plans,
estimates, assumptions and projections, and speak only as of the
date they are made. BeiGene and Mirati undertake no
obligation to update any forward-looking statement in light of new
information or future events, except as otherwise required by law.
Forward-looking statements involve inherent risks and
uncertainties, most of which are difficult to predict and are
generally beyond our control. Actual results or outcomes may differ
materially from those implied by the forward-looking statements as
a result of the impact of a number of factors, many of which are
discussed in more detail in BeiGene’s most recent quarterly
report on Form 10-Q and other reports filed with
the Securities and Exchange Commission, with respect to
BeiGene’s forward-looking statements, and Mirati’s most recent
filings on Form 10-K and Form 10-Q and other reports filed with
the Securities and Exchange Commission, with respect to
Mirati’s forward-looking statements.
BeiGene Investor Contact
Lucy Li, Ph.D.+1 781-801-1800ir@beigene.com
BeiGene Media Contact
Liza Heapes+ 1 857-302-5663media@beigene.com
Mirati Therapeutics ContactTemre Johnson(858)
332-3562ir@mirati.com
i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of
Celgene Corporation.
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