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Helsinn Establishes New R&D Hub in the U.S.

To support clinical work across its Global Fully Integrated Targeted Therapy (FITT) Strategy.

By: Kristin Brooks

Managing Editor, Contract Pharma

Helsinn Group, a global biopharma company with a pipeline of innovative oncology assets, has established a new dedicated R&D hub at its U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc. (HTU), that augments Helsinn Group’s global R&D organization.

As a result of the updated licensing agreement with BridgeBio Pharma Inc. announced in March 2022, Helsinn is creating a new R&D hub to support a significant expected increase in clinical activities for developing the FGFR tyrosine kinase inhibitor for oncology.
 
This new hub is the next step in the company’s strategy of creating a differentiated pipeline of highly innovative oncology assets and transforming Helsinn to a Fully Integrated Targeted Therapy company. Over the next five years, Helsinn plans to continue investing approximately 35 percent of the revenues from its commercial engine of supportive care and cancer therapeutic products into targeted therapeutics R&D.
 
Dr. Sergio Cantoreggi, Helsinn Group Chief Scientific Officer and Group Head of R&D, said: “By establishing this new R&D hub and enlarging our scientific expertise in the US, Helsinn is now perfectly positioned to develop products for patients with unmet needs in the largest global oncology market. This has been a highly exciting period for the Helsinn Group, and we are looking forward to welcoming many new colleagues to the Helsinn family in the weeks and months ahead.”
 

Key pillars of the full FITT strategy include:

Developing a FGFR tyrosine kinase inhibitor commercially available in the U.S. and approved in Canada and Australia for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or rearrangement. Phase III studies in first-line cholangiocarcinoma and adjuvant urothelial cancer are currently ongoing.
 
As part of the non-exclusive framework agreement with BridgeBio, initiating a preclinical program to co-develop and co-commercialize a glutathione peroxidase 4 (GPX4) inhibitor.
 
Studying a rearranged during transfection (RET) tyrosine kinase. Currently in a Phase I/II trial, the product candidate originates from a global co-development and co-commercialization agreement signed with Taiho Pharmaceutical Co., Ltd. in 2017. 
 
The parties will continue to jointly pursue preclinical, clinical and chemistry, manufacturing and controls (CMC) development for this product. The agreement is designed to reach as many patients as possible around the world through Helsinn’s own commercial infrastructures or valued partners.
 
Actively seeking new opportunities to be in-licensed or acquired.

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