SHANGHAI, China and PRINCETON, N.J., July 12, 2023 (GLOBE NEWSWIRE) — 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.
BBP-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.
LianBio 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 Statements
Statements 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.
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