Petra Pharma announces licensing agreement with Takeda Pharmaceutical Company

Petra Pharma Corporation announced that it has secured a global license from Takeda Pharmaceutical Company Limited to develop, manufacture and commercialize serabelisib and two additional PI3Kα-specific inhibitors. The agreement grants Petra 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 pioneering 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 CEO, Brian O’Callaghan.

Petra’s leading-edge research builds on the recent work of Scientific Co-Founder, Lewis Cantley, Ph.D. (Weill Cornell Medical Center) and his collaborators, whose paper in the August 2018 issue of Nature* identified strategies to disrupt the glucose/insulin feedback loop with the potential to dramatically improve the anti-tumor response.

“Current treatment modalities have been challenging due to an on-target effect of PI3Kα inhibitors causing hyperglycemia and consequent elevation of serum insulin, which can re-activate PI3K in tumors, allowing them to survive,” said Dr. Cantley. “The approach Petra is taking disrupts the glucose/insulin feedback loop, which in preclinical models significantly increases anti-tumor efficacy.”

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

* Hopkins BD, Pauli C, Du X, et al. Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature. 2018;560(7719):499-503.