PLX8394 Targets Patients With Non-V600 BRAF Mutations and Advanced V600 Patients
June 03, 2020 09:00 AM Eastern Daylight Time
BERKELEY, Calif. & JERUSALEM–(BUSINESS WIRE )–Novellus, a precision-oncology drug development company, announced today 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. PLX8394 is currently completing a Phase 1/2 trial in patients with advanced, unresectable solid tumors.
“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.
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.
Plexxikon, a member of the Daiichi Sankyo Group since February 2011, is a leader in structure-guided discovery and the development of novel small molecule pharmaceuticals to treat human disease. Plexxikon is developing a portfolio of preclinical and clinical stage compounds to address significant unmet medical needs in oncology and other therapeutic areas. Plexxikon’s
Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant advantage over other drug discovery approaches.
Novellus is a precision oncology drug development company focused on developing treatments to unique patient sub-populations. Using proprietary computational and functional-genomic tools, Novellus is able to identify well-defined patient sub-populations, thus optimizing the clinical development process and ensuring high patient responses.