Petra Pharma Corporation has secured a global license from Takeda Pharmaceutical Co. to develop, manufacture and commercialize serabelisib and two additional PI3Kα-specific inhibitors. Petra has a license for all human therapeutic uses, except for a subset of undisclosed rare-disease indications, which Takeda had previously out-licensed.  

Petra plans to initiate a Phase 1b/2 study with serabelisib in late 2019 to advance research and insights in PI signaling pathways with a focus on PIK3CA-mutated solid tumors. The PI3K signaling pathway is a frequently mutated pathway in human cancer.

“Today marks a transformational moment for Petra and a new era in the therapeutic use of PI3K inhibitors. We are pioneering new approaches that have the potential to increase tumor responses with PI3K inhibitors and minimize side effects, with profound clinical implications for patients diagnosed with a PIK3CA-mutated tumor,” said president and chief executive officer, Brian O’Callaghan.

This is the first licensing agreement between Petra and Takeda. Financial terms were not disclosed.