Biossil to acquire Galera’s dismutase mimetics portfolio for up to $105M

Galera Therapeutics (GRTX) entered into an asset purchase agreement with Toronto-based biotech Biossil for the acquisition of Galera’s dismutase mimetics portfolio, including avasopasem and rucosopasem. The agreement includesan upfront payment of $3.5M, and potential future regulatory and commercial milestones, and contingent value rights of up to $105M in aggregate. Biossil assumes all further obligations to Blackstone Life Sciences under Galera’s 2018 Amended and Restated Purchase and Sale Agreement for dismutase mimetics products, notably a 4% royalty should avasopasem or rucosopasem reach commercialization. Galera’s lead program remains its pan-inhibitor of Nitric Oxide Synthase, L-NMMA or tilarginine, licensed from The Methodist Hospital of Houston, Texas, which is in a multicenter Phase 2 trial in metaplastic breast cancer in combination with alpelisib and nab-paclitaxel. The trial involved a lead-in to optimize the dose of alpelisib with this combination, which was completed at Houston Methodist, and enrollment is being expanded to two additional sites, the University of Texas MD Anderson Cancer Center and the National Institute of Health Clinical Center. In a 407-patient randomized double-blind phase 3 trial, avasopasem produced a statistically significant, 16% relative reduction in the incidence of severe oral mucositis and a 56% relative reduction in SOM duration in patients receiving standard-of-care chemoradiotherapy for locally advanced, nonmetastatic head and neck cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Dismutase mimetics also have a well-developed mechanistic role in anti-cancer therapeutics in preclinical studies, and Galera completed a pilot trial of avasopasem combined with stereotactic body radiotherapy in patients with locally advanced pancreatic cancer.