PALO ALTO, Calif., July 27, 2021 /PRNewswire/ -- BridgeBio
Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage
biopharmaceutical company founded to discover, create, test and
deliver meaningful medicines for patients with genetic diseases and
cancers with clear genetic drivers, today announced a
non-exclusive, co-funded clinical collaboration with Bristol Myers
Squibb to evaluate the combination of BBP-398, a potentially
best-in-class SHP2 inhibitor, with
OPDIVO® (nivolumab) in patients with advanced solid
tumors with KRAS mutations with the hope of providing an effective
new treatment option for patients with difficult-to-treat
cancers.
The collaboration will also include the initiation of a Phase
1/2 study to evaluate the safety and preliminary efficacy of
BBP-398 in combination with both OPDIVO as doublet therapy, and
OPDIVO plus a KRASG12C
inhibitor as triplet therapy in non-small cell lung cancer (NSCLC)
with KRAS mutations, as first- and second-line treatment options.
Under the terms of the non-exclusive collaboration, BridgeBio will
sponsor the study and Bristol Myers Squibb will provide nivolumab.
Both BridgeBio and Bristol Myers Squibb will share the cost of
clinical development activities for the combination trial.
SHP2 is a protein-tyrosine
phosphatase that links growth factor, cytokine and integrin
signaling with the downstream RAS/ERK MAPK pathway to regulate
cellular proliferation and survival. Overactivity of the
SHP2 pathway, often driven by
distinct genetic mutations, is a critical contributor to many forms
of cancer, and is a mechanism of resistance to several targeted
therapies.
"Cancers that are driven by hyperactive MAPK signaling,
including certain RAS mutations such as
KRASG12C, may be sensitive to
SHP2 inhibition," said Frank McCormick, Ph.D., chairman of oncology at
BridgeBio. "With this collaboration, we hope to better
elucidate our SHP2 inhibitor's
ability to enhance immuno-oncology and other targeted therapies to
potentially provide options for patients with difficult-to-treat
cancers as quickly and safely as possible."
KRAS mutations occur in approximately 27% of NSCLC cases
and approximately 17% of malignant solid tumors. Combination of
anti-PD-1 treatment with BBP-398, and other targeted therapies,
could be promising for patients with KRAS mutations.
"A priority of ours is to develop innovative medicines that
target tumor intrinsic mechanisms including the MAPK pathway," said
Emma Lees, senior vice president,
oncology research at Bristol Myers Squibb. "We look forward to
beginning the clinical exploration of the mechanistic rationale and
therapeutic benefit from combining robust MAPK pathway inhibition
and PD-1 blockade in KRAS mutant NSCLC."
"We are pleased to collaborate with Bristol Myers Squibb and
advance BridgeBio's larger strategy to fully interrogate BBP-398, a
potentially best-in-class SHP2
inhibitor, as an ideal combination agent for certain cancer
patients given its profile and potential for once daily dosing,"
said Eli Wallace, Ph.D., chief
scientific officer of oncology at BridgeBio. "By partnering
with one of the strongest oncology players in the industry, we hope
to provide a new therapeutic approach to cancer patients in
need."
BridgeBio is currently advancing its Phase 1 clinical trial in
patients with solid tumors driven by mutations in the MAPK
signaling pathway, including RAS and receptor tyrosine kinase
genes.
OPDIVO® is a trademark of Bristol-Myers Squibb
Company.
About BBP-398
BBP-398 was developed through a collaboration with The
University of Texas MD Anderson Cancer
Center's Therapeutics Discovery division. BridgeBio previously
entered into a strategic collaboration with LianBio for clinical
development and commercialization of BBP-398 in combination with
various agents in solid tumors such as NSCLC, colorectal and
pancreatic cancer, in mainland China and other major Asian markets.
About BridgeBio Pharma, Inc.
BridgeBio Pharma (BridgeBio) is a biopharmaceutical company
founded to discover, create, test and deliver transformative
medicines to treat patients who suffer from genetic diseases and
cancers with clear genetic drivers. BridgeBio's pipeline of over 30
development programs ranges from early science to advanced clinical
trials and its commercial organization is focused on delivering the
company's two approved therapies. BridgeBio was founded in 2015 and
its team of experienced drug discoverers, developers and innovators
are committed to applying advances in genetic medicine to help
patients as quickly as possible. For more information
visit bridgebio.com.
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements
we make in this press release may include statements that are not
historical facts and are considered forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the "Securities Act"), and Section 21E of the Securities Exchange
Act of 1934, as amended (the "Exchange Act"), which are usually
identified by the use of words such as "anticipates," "believes,"
"estimates," "expects," "intends," "may," "plans," "projects,"
"seeks," "should," "will," and variations of such words or similar
expressions. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act and are making this statement for
purposes of complying with those safe harbor provisions.
These forward-looking statements, including statements relating to
expectations, plans, and prospects regarding the success of our
non-exclusive, co-funded clinical collaboration with Bristol Myers
Squibb, the timing and success of a Phase 1/2 study to evaluate the
safety and preliminary efficacy of BBP-398 in combination with both
OPDIVO as doublet therapy, and OPDIVO plus a KRASG12C
inhibitor as triplet therapy in non-small cell lung cancer with
KRAS mutations, as first- and second-line treatment options, the
ability of our SHP2 inhibitor's
ability to enhance immuno-oncology and other targeted therapies to
potentially provide options for patients with difficult-to-treat
cancers as quickly and safely as possible, the incidence of KRAS
mutations and the promise of targeted therapies for patients with
such mutations, the success of current and future relationships
with third-party collaborators and academic partners, and the
potential ability of our product candidates to treat genetically
driven diseases and cancers with clear genetic drivers, reflect our
current views about our plans, intentions, expectations, strategies
and prospects, and are based on the information currently available
to us and on assumptions we have made and are not forecasts,
promises nor guarantees. Although we believe that our plans,
intentions, expectations, strategies and prospects as reflected in
or suggested by these forward-looking statements are reasonable, we
can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual
results may differ materially from those described in the
forward-looking statements and will be affected by a number of
risks, uncertainties and assumptions, including, but not limited
to, the success of our product candidates to treat genetically
driven diseases and cancers with clear genetic drivers, the success
of our collaboration with Bristol Myers Squibb, as well as those
risks set forth in the Risk Factors section of BridgeBio's most
recent Annual Report on Form 10-K and BridgeBio's other SEC
filings. Moreover, we operate in a very competitive and rapidly
changing environment in which new risks emerge from time to time.
Except as required by applicable law, we assume no obligation to
update publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
BridgeBio Contact:
Grace Rauh
BridgeBio Pharma, Inc.
Grace.rauh@bridgebio.com
(917) 232-5478
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