Helsinn has notified BridgeBio Pharma affiliate QED Therapeutics that it is terminated its global collaboration and licensing agreement for infigratinib that had a potential value in excess of $2 billion in development and commercialization milestones.
BridgeBio reported the decision in a terse filing with the U.S. Securities and Exchange Commission in September saying only that Helsinn cited “commercial considerations.” Endpoints News first reported on the filing.
LianBio, which has a collaboration with BridgeBio for infigratinib in China in a separate filing with the U.S. Securities and Exchange Commission said that the company notified it that Helsinn would withdraw its application with the U.S. Food and Drug Administration to market infigratinib and would permanently discontinue distribution of the drug. LianBIo said BridgeBio informed it that it plans to close the ongoing global phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma.
As a result, LianBio is terminating activities related to the PROOF-301 clinical trial in China and no longer plans to pursue development and commercialization of infigratinib in cholangiocarcinoma in its licensed territories. LianBio expects to continue the ongoing phase 2a proof of concept clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification and other solid tumors with FGFR alterations.
BridgeBio said it continues to pursue development of infigratinib as a potential treatment of non-oncology indications, such as in achondroplasia worldwide, excluding China, Hong Kong and Macau.
Author: Rare Daily Staff
Stay Connected
Sign up for updates straight to your inbox.