On June 3, 2020 Novellus, a precision-oncology drug development company, reported that it has entered into an exclusive worldwide license agreement with Plexxikon, a member of the Daiichi Sankyo Group, for PLX8394, its clinical-stage oncology drug candidate which targets the BRAF protein (Press release, Novellusdx, JUN 3, 2020, View Source [SID1234560782]). PLX8394 is currently completing a Phase 1/2 trial in patients with advanced, unresectable solid tumors.

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"We are excited about executing this agreement with Novellus for PLX8394, as it enables our unique BRAF inhibitor to potentially offer clinical benefit for non-V600 patients as well as V600 patients that lack other treatment options," said Gideon Bollag, PhD, Plexxikon CEO.

"We are very pleased to sign this agreement with Plexxikon, an established drug development company with an impressive track record, including two marketed oncology drugs. We believe that the combination of PLX8394 with our Functional Annotation for Cancer Treatment (FACT) technology will enable rapid and successful development of this novel BRAF inhibitor for patient subpopulations in dire need," said Michael Vidne, PhD, Novellus CEO. "This agreement is the first step in Novellus’ strategy to develop compounds by functionally testing them on hundreds of mutations to identify hyper-specific biomarkers and match them with the right patients."

Under the terms of the agreement, Plexxikon grants Novellus rights to research, develop, manufacture and exclusively commercialize PLX8394 worldwide. Plexxikon will receive an undisclosed upfront payment, additional developmental milestones, and royalty payments.

About PLX8394

PLX8394 is an investigational, oral, small molecule inhibitor of the oncogenic BRAF serine/threonine-protein kinase, which accelerates BRAF mutant cancers by activating the RAS/MAPK pathway. PLX8394 is a next-generation BRAF inhibitor that blocks signaling from both monomeric BRAFV600 and dimeric BRAFnon-V600 mutant proteins, and unlike previous BRAF inhibitors, does not induce paradoxical activation of the MAPK pathway in cells with stimulated RAS signaling. The drug has demonstrated favorable preliminary clinical data in a biomarker-driven Phase 1/2 study in patients with advanced, unresectable solid tumors. The study will now enroll more patients.