QED Therapeutics and Helsinn Group Team Up to Co-Develop Cancer Drug

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QED Therapeutics, an affiliate of BridgeBio Pharma, announced today their global collaboration and licensing agreement with Helsinn Group. The collaboration is to co-develop and commercialize Infigratinib, an oral FGFR1-3 selective inhibitor, for patients dealing with cholangiocarcinoma (bile duct cancer).

Infigratinib will be commercialized for oncology and all other indications other than skeletal dysplasia. The said agreement would still have to go through a regulatory review and customary closing conditions, which are expected to take place in Q2 of this year.

Under the agreement, BridgeBio will be receiving more than $2 billion as an upfront, regulatory and commercial payment, all while still retaining the full rights for Infigratinib use in skeletal dysplasias and achondroplasia.

Infigratinib is an orally administered ATP-competitive tyrosine kinase inhibitor that functions to inhibit fibroblast growth factor receptor (FGFR). As of December 2020, Infigratinib is still being investigated for various cancers such as cholangiocarcinoma, upper tract urothelial carcinoma (UTUC), urothelial carcinoma of the bladder (UCB) and other FGFR-driven cancers.

In a 2019 study by QED, the company reported that patients with UTUC have different genetic profiles than those with (UCB), especially regarding the FGFR3 alterations. The data showed a 50% response rate by patients treated with Infigratinib and adverse effects were present and generally consistent among their patients.

In July of 2020, Infigratinib testing on patients with recurrent glioblastoma started. The study aimed to confirm Infigratinib's ability to cross the blood-brain barrier and hit molecular targets in high-grade glioma patients with FGFR genetic alterations.

Recently, in December 2020, Infigratinib was accepted by the U.S. Food and Drug Administration (FDA) to be studied as a treatment option for cholangiocarcinoma, a rare and often fatal disease with only a 9% survival rate. A new drug application (NDA) was granted Priority Review under the Real-Time Oncology Review (RTOR) pilot program. This program was initiated by the FDA to speed up the delivery of effective cancer treatments to patients in dire need.

This partnership of QED and Helsinn is closely tied to BridgeBio's vision "to unlock the full potential of infigratinib for patients with FGFR-driven cancers,” said BridgeBio CEO and founder Neil Kumar, Ph.D.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO mentioned that "the combination of BridgeBio and its lead oncology product candidate, infigratinib, fall into the strategic sweet spot of a quality company and product with which we look to work."

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