LianBio Announces First Patient Treated in Phase 1 Trial of SHP2 Inhibitor BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations
August 03 2023 - 4:05PM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced the first patient has been
dosed in its Phase 1 clinical trial of BBP-398, an investigational
SHP2 inhibitor, in combination with AstraZeneca’s osimertinib, an
epidermal growth factor receptor (EGFR) inhibitor, for the
treatment of patients with non-small cell lung cancer (NSCLC) with
EGFR mutations.
SHP2 is a protein-tyrosine phosphatase that links growth factor,
cytokine and integrin signaling with the downstream RAS/MAPK
pathway to regulate cellular proliferation and survival.
Overactivity of SHP2 is a critical contributor to many forms of
cancer, is a mechanism of resistance to several targeted therapies,
and can suppress antitumor immunity.
EGFR mutations occur in approximately 40-50% of NSCLC cases in
Asia, more than twice the rate observed in the United States. By
combining SHP2 inhibition and EGFR inhibition, there is potential
to prevent oncogenesis and overactive cellular proliferation.
"BBP-398 is a potential best-in-class SHP2 inhibitor that was
designed to maximize combination potential,” said Yizhe Wang,
Ph.D., Chief Executive Officer of LianBio. “EGFR-mutant non-small
cell lung cancer patients who develop resistance to osimertinib
currently have limited treatment options, and we look forward to
evaluating BBP-398’s ability to restore sensitivity to osimertinib
when used as a combination agent.”
The multi-center, open-label Phase 1 trial is designed to
evaluate the safety, tolerability, pharmacokinetics, and anti-tumor
activity of BBP-398 in combination with osimertinib in patients
with locally advanced or metastatic NSCLC with EGFR mutations. The
trial includes a dose escalation phase, followed by expansion
cohorts. In July 2023, LianBio announced a clinical supply
agreement with AstraZeneca in China to procure osimertinib for this
trial.
About BBP-398BBP-398 is a SHP2 inhibitor that
is being developed for difficult-to-treat cancers and was founded
through a collaboration between BridgeBio and The University of
Texas MD Anderson Cancer Center’s Therapeutics Discovery division.
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. LianBio
and BridgeBio have a strategic collaboration for clinical
development and commercialization of BBP-398 in combination with
various agents in solid tumors such as non-small cell lung cancer,
colorectal and pancreatic cancer, in mainland China and other Asian
markets. In May 2022, BridgeBio entered an exclusive license with
Bristol Myers Squibb to develop and commercialize BBP-398 in all
indications worldwide, except for Mainland China, Macau, Hong Kong,
and Taiwan, Thailand, Singapore, and South Korea. BBP-398 is also
being studied by BridgeBio and its clinical collaborators,
including Bristol Myers Squibb for combination with OPDIVO®
(nivolumab) in patients with advanced solid tumors with KRAS
mutations; and with Amgen for combination with LUMAKRAS®
(sotorasib), Amgen’s KRAS G12C inhibitor, in patients with advanced
solid tumors with KRAS G12C mutations.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease.
LianBio is establishing an international infrastructure to position
the company as a partner of choice with a platform to provide
access to China and other Asian markets. For more information,
please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “believe,” “potential,”
“will” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the LianBio’s beliefs regarding the
differentiation of BBP-398 and BBP-398’s potential to restore
sensitivity to EGFR inhibitors when used in a combination setting.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: LianBio’s ability to successfully initiate and
conduct its planned clinical trials and complete such clinical
trials and obtain results on its expected timelines, or at all;
LianBio’s plans to leverage data generated in its partners’ global
registrational trials and clinical development programs to obtain
regulatory approval and maximize patient reach for its product
candidates; LianBio’s ability to identify new product candidates
and successfully acquire such product candidates from third
parties; competition from other biotechnology and pharmaceutical
companies; general market conditions; the impact of changing laws
and regulations and those risks and uncertainties described in
LianBio’s filings with the U.S. Securities and Exchange Commission
(SEC), including LianBio’s Annual Report on Form 10-K for the year
ended December 31, 2022 and subsequent filings with the SEC.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and LianBio specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Readers should not rely upon this information as current or
accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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