On November 19, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, reported thart they have entered into a strategic collaboration to co–develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) with the hope of providing an effective new therapy for patients with difficult-to-treat tumors (Press release, Bridge Biotherapeutics, NOV 19, 2021, View Source [SID1234595850]).
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The joint collaboration for BridgeBio’s GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs.
Under the terms of the non-exclusive agreement, BridgeBio and Helsinn will have the option to collaborate on preclinical oncology programs that are identified from time to time by either party. The agreement is designed to magnify the ability of both companies to identify small oncology interventions that may have greater potential to help patients in combination with larger investigational therapies. For each program that the parties agree to pursue, they will share global development responsibilities under an agreed cost split. Helsinn will have exclusive manufacturing and commercial rights to the programs under the agreement, with BridgeBio receiving a profit share on U.S. sales and tiered royalties on ex-U.S. sales.
The first program under the framework collaboration agreement that the parties will pursue is GPX4, a potentially first-in-class inhibitor that may be an effective new therapy for certain cancer patients. GPX4 is an enzyme that is often elevated in cancer tissue and associated with a worse prognosis for patients. GPX4 neutralizes toxic free radicals at the lipid membrane, protecting cells from death by ferroptosis. The GPX4 inhibitor is being developed to induce ferroptosis in cancer cells with the potential to impact approximately 500,000 patients in need of a therapeutic option. The safety and efficacy of GPX4 has not yet been established by any health authority world-wide.
"We are excited to expand our collaboration with Helsinn to develop and potentially commercialize our GPX4 program. Our hope is that together we can move even more swiftly to advance this potential precision oncology therapy for cancer patients living with severe unmet medical needs," said BridgeBio’s chairman of oncology, Frank McCormick, Ph.D., F.R.S., D.Sc. (Hon).
Riccardo Braglia, vice chairman and CEO at Helsinn Group, commented: "This non-exclusive pipeline agreement with BridgeBio has the potential to be transformational for Helsinn because BridgeBio’s world class drug discovery platform can augment our innovative oncology pipeline. It also affords Helsinn the opportunity to identify and offer potential programs on which the parties could collaborate. BridgeBio’s deep expertise in drug hunting and early preclinical development combined with Helsinn’s drug development and global commercial platform can facilitate an ongoing cadence of moving novel therapies into clinical development with the potential to meaningfully improve the lives of patients with cancer. We’re delighted to get started with our first program, GPX4, and look forward to updating the market on this and additional programs in due course."
The non-exclusive framework agreement builds on an earlier global collaboration and licensing agreement that BridgeBio and Helsinn Group’s affiliates, Helsinn Healthcare S.A. and Helsinn Therapeutics (U.S.), Inc., entered into in March 2021. Under that agreement, Helsinn Therapeutics is jointly responsible for further development and commercialization activities for infigratinib, a small molecule kinase inhibitor of FGFR, in oncology and all other indications except for skeletal dysplasias (including achondroplasia) in the United States and other regions (excluding China, Hong Kong, and Macau), sharing profits and losses on an equal basis. This includes exclusive commercialization rights for infigratinib in Canada, where Health Canada recently approved TRUSELTIQ (infigratinib) under the Notice of Compliance with Conditions (NOC/c) policy, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or other rearrangement. Helsinn will fund the majority of ongoing and future research and development related to infigratinib in oncology in the foregoing territory. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and potential payments totaling up to $2.45 billion USD in the aggregate. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau.