LianBio Announces Clearance to Initiate in China the Phase 2a Trial of Infigratinib in Patients with Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma with FGFR2 Gene Amplification

SHANGHAI & PRINCETON, N.J.--(BUSINESS WIRE)--LianBio, a biotechnology company focused on bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Company’s Clinical Trial Application (CTA) to conduct the Phase 2a trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification.

LianBio has in-licensed the oncology rights for infigratinib from QED Therapeutics, an affiliate of BridgeBio Pharma, Inc., and is responsible for the clinical development, registration application and future commercial operations of the product candidate in Mainland China, Hong Kong and Macau.

Infigratinib is an investigational oral, selective inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that has shown activity in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations ^[1][2]. The Phase 2a trial is a multicenter, single-arm study designed to explore and evaluate the pharmacokinetic profile, efficacy and safety of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification. Infigratinib is also currently under Phase 3 global development by LianBio and BridgeBio for patients with FGFR2 fusion positive cholangiocarcinoma.

“With strong support from our partner, BridgeBio, the exploratory study highlights LianBio’s continued commitment to expand its global footprint and develop potential breakthrough therapeutics in China,” said Dr. Bing Li, Chief Executive Officer of LianBio. “Gastric cancer is the third most common cancer in China, causing approximately 300,000 deaths every year. This clearance by the China NMPA to conduct the Phase 2a trial of infigratinib in gastric cancer will enable LianBio to work towards addressing the significant unmet medical need for this growing patient population.”

References

1. Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO 2018 Annual Meeting. Poster #LBA28.
2. Pal K. et al. Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 alterations; Cancer Discovery 2018.

About LianBio

LianBio’s mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and major Asian markets through partnerships that provide access to science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics. For more information, please visit lianbio.com.

About the LianBio and BridgeBio Pharma, Inc. Strategic Alliance

In August 2020, LianBio entered into a strategic alliance with BridgeBio, a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, to develop and commercialize its programs in China and other major Asian markets. This strategic relationship initially focuses on two of BridgeBio’s targeted oncology drug candidates: FGFR inhibitor infigratinib, currently in Phase 3 global development for FGFR-driven tumors, and Phase 1-ready SHP2 inhibitor BBP-398, for tumors driven by RAS and receptor tyrosine kinase mutations. The agreement also provides LianBio with preferential future access in China and certain other major Asian markets to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio’s programs in China and other major Asian markets, allowing BridgeBio and LianBio to quickly bring innovation to large numbers of patients with high unmet need.