LianBio Announces Clinical Supply Agreement with AstraZeneca in China to Evaluate BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations
12 Julio 2023 - 7:00AM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced a clinical supply agreement
with AstraZeneca in China to evaluate the safety and efficacy of
BBP-398, an investigational SHP2 inhibitor, in combination with
AstraZeneca’s osimertinib, an epidermal growth factor receptor
(EGFR) inhibitor, in a Phase 1 clinical study for the treatment of
patients with non-small cell lung cancer (NSCLC) with EGFR
mutations.
"In China, a disproportionately high percentage of NSCLC
patients harbor EGFR mutations,” said Yizhe Wang, Ph.D., Chief
Executive Officer of LianBio. “While EGFR inhibitors are a critical
part of the standard of care, most patients eventually acquire
resistance to these therapies. We believe BBP-398 is a
differentiated SHP2 inhibitor with the potential to restore
sensitivity to EGFR inhibitors when used in a combination
setting.”
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.
The planned 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. LianBio expects to initiate this trial in the
second half of 2023.
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. 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 KRASG12C inhibitor, in patients
with advanced solid tumors with KRASG12C 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 “expect,” “believe,”
“continue,” “estimate,” “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, BBP-398’s potential to
restore sensitivity to EGFR inhibitors when used in a combination
setting, and LianBio’s plans to initiate a Phase 1 trial in the
second half of 2023 to evaluate BBP-398 in combination with
osimertinib in patients with locally advanced or metastatic NSCLC
with EGFR mutations. 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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