BridgeBio stepped in to take over the drug and also launch a subsidiary, QED Therapeutics, to drive the development of infigratinib.
Palo Alto, Calif.-based BridgeBio Pharma is launching a new spinout to develop a recently-abandoned Novartis cancer treatment now in its possession.
BridgeBio, which hit the streets in 2015, said it licensed infigratinib (BGJ398), a highly potent and selective inhibitor of the tyrosine kinase receptor FGFR, from Novartis. Novartis had been developing the drug in a mid-stage trial for the treatment of patients with chemotherapy-refractory bile duct cancer (cholangiocarcinoma) containing FGFR2 fusions. Novartis though opted to discontinue that program last year.
BridgeBio stepped in to take over the drug and also launch a subsidiary, QED Therapeutics, to drive the development of infigratinib. BridgeBio launched QED Therapeutics with an initial financial commitment of $65 million. BridgeBio did not disclose terms of the deal with Novartis. However, the company noted the $65 million being used to finance QED is inclusive of a substantial upfront payment to Novartis as well as equity in QED. Novartis will also receive additional payments upon the realization of development and sales milestones as well as royalties, the company said.
BridgeBio’s business model is to launch a subsidiary to develop each of its 15 pipeline assets. Last year the company launched Eidos Therapeutics, to develop a novel small-molecule treatment for transthyretin (TTR) amyloidosis.
Daniel Hoth, QED’s chief medical officer, said QED Therapeutics is committed to moving infigratinib into late-stage development and further prove the “strong efficacy in cancer that has already been demonstrated across multiple trials.” In its announcement this morning, BridgeBio said FGFR has been implicated as a driver mutation across multiple oncologies – including roughly one out of every five cases of cholangiocarcinoma and urothelial carcinoma. Additionally, FGFR has also been seen as a driver mutation in multiple forms of pediatric skeletal dysplasias, namely achondroplasia, which affects one out of every 20,000 live births, the company said.
Early clinical results of Infigratinib showed the drug demonstrated meaningful activity in patients with chemotherapy-refractory bile duct cancer (cholangiocarcinoma) containing FGFR2 fusions. Cholangiocarcinoma affects approximately 6,000 to 8,000 patients a year in the United States. Treatment options are limited, and survival rates vary depending on whether cholangiocarcinoma is found on the bile duct branches within the liver versus those outside of the liver.
“We have a late-stage, targeted oncology compound that has demonstrated clear efficacy in the clinic. With the same molecule, we have a potential best-in-class therapy to treat achondroplasia at its source,” Neil Kumar, chief executive officer of BridgeBio, said in a statement.
In addition to its clinical data in FGFR-driven cancer, infigratinib has demonstrated potential in skeletal dysplasias, including achondroplasia, a form of dwarfism. BridgeBio noted that published research demonstrated that low doses of infigratinib corrected pathological hallmarks of achondroplasia in mouse models.
In September 2017, BridgeBio snagged $135 million in a series C round.
