LianBio and BridgeBio Announce First Patient Dosed in China for Infigratinib Phase 2a Trial

LianBio, a biopharmaceutical company dedicated to bringing transformative medicines to patients in China and key Asian markets, andBridgeBio PharmaCo., Ltd. (Nasdaq Ticker Symbol:BBIO) announced,infigratinib In a2ain Phase clinical trialsCompletedFirst PatientAdministration。The trialTarget AudienceIncluding withFibroblast Growth Factor Receptor-2（FGFR2) locally advanced or metastatic gastric or gastroesophageal junction cancer with gene amplificationJunctionAdenocarcinoma patients, and those due toFGFROther patients with advanced solid tumors caused by genetic mutations.

“Infigratinib is a highly potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple tumor types driven by FGFR genetic alterations,” said Dr. Yi Zhe Wang, CEO of LianBio. “Given the high incidence of gastric cancer in China, LianBio is pursuing a development strategy in China to address this significant unmet medical need. This study marks the initiation of LianBio’s first clinical trial, underscoring our continued steady progress in delivering potentially transformative therapies to patients in Asia.”

TRUSELTIQ™ (infigratinib) is an oral selective inhibitor of FGFR1-3. It has been approved in the United States for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in patients whose tumors harbor FGFR2 fusions or rearrangements, as confirmed by an FDA-approved test. Infigratinib is currently undergoing clinical trials in patients with advanced urothelial carcinoma harboring FGFR3 genetic alterations to evaluate its efficacy in this population. LianBio has obtained authorization from BridgeBio Pharma to develop and commercialize infigratinib in mainland China, Hong Kong, and Macau.

This Phase 2a trial is a multicenter, open-label, single-arm clinical study conducted in China, designed to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma harboring FGFR2 gene amplifications, as well as in patients with other advanced solid tumors driven by FGFR genetic alterations. The primary endpoint is objective response rate (ORR); secondary endpoints include duration of response, safety, disease control rate, progression-free survival, and overall survival.

Preclinical data suggest that infigratinib may have potential efficacy in patients with gastric cancer. Results published in Cancer Discovery demonstrated tumor regression in multiple FGFR2-amplified in vivo gastric cancer models.

“We believe that infigratinib can make a meaningful impact on patients with gastric cancer and many other cancers harboring FGFR genetic alterations. We are pleased that LianBio has initiated this clinical trial in China, providing more treatment options for Chinese patients to match the growing diagnosis rate,” said Dr. Neil Kumar, Founder and Chief Executive Officer of BridgeBio. “With the recent accelerated approval of TRUSELTIQ™ (infigratinib) in the United States, we are hopeful that this trial will achieve pivotal results in another subgroup of cancer patients. We will continue to expand our oncology indication portfolio, committed to benefiting more patients in need.”

TRUSELTIQ™ (infigratinib) is an oral, ATP-competitive fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor that has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in patients whose tumors harbor FGFR2 fusions or other FGFR2 rearrangements, as detected by an FDA-approved test. TRUSELTIQ™ targets FGFR proteins and blocks downstream signaling. In clinical studies, TRUSELTIQ™ demonstrated clinically meaningful tumor shrinkage rates (overall response rate) and duration of response. TRUSELTIQ™ is not currently approved by the FDA for any other indications in the United States, nor has it been approved by any other health authorities, including those in China or other Asian markets. Clinical trials of TRUSELTIQ™ are currently ongoing for first-line cholangiocarcinoma, urothelial carcinoma (bladder cancer), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, testing, and delivering transformative therapies for patients with genetic diseases and cancers driven by well-defined genetic alterations. BridgeBio’s pipeline comprises more than 30 programs spanning from preclinical to late-stage clinical development. The company’s commercialization team is currently focused on expanding the reach of its first approved therapy. Founded in 2015, BridgeBio boasts a professional team with extensive expertise in drug discovery, research and development, and innovation, committed to leveraging genetic medicine to help patients as rapidly as possible.

LianBio’s mission is to deliver innovative therapies with robust scientific foundations and compelling clinical data to patients in China and other key Asian markets through efficient product development, enabled by strategic collaborations with leading global biopharmaceutical companies. By partnering with world-class collaborators across diverse therapeutic areas and geographies, LianBio has built a broad and clinically validated product pipeline poised to address unmet patient needs.

In August 2020, LianBio entered into a strategic alliance with BridgeBio. BridgeBio is a clinical-stage biopharmaceutical company focused on genetic diseases and cancers caused by well-defined genetic drivers. This strategic alliance is dedicated to the development and commercialization of BridgeBio’s portfolio in China and other major Asian markets. The collaboration initially focuses on two targeted oncology candidates from BridgeBio: infigratinib, an FGFR inhibitor for the treatment of FGFR-driven tumors, and BBP-398, an SHP2 inhibitor for the treatment of tumors driven by MAPK pathway gene mutations. The agreement also grants LianBio priority rights to access more than 20 pipeline products from BridgeBio in China and other major Asian markets. This partnership aims to advance and accelerate the clinical development and commercialization of BridgeBio’s product pipeline in the region, enabling BridgeBio and LianBio to jointly deliver innovative therapies to a large patient population with significant unmet medical needs.

References

1. Guagnano, V., Kauffman, A., Wörle, S., et al. “FGFR Genetic Alterations Predict for Sensitivity to NVP-BGJ398, a Selective Pan-FGFR Inhibitor.” Cancer Discovery 2 (2012): 1118-1133.