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Novellus, Plexxikon Enter Worldwide License Agreement for BRAF Inhibitor PLX8394

NEW YORK – Precision oncology company Novellus said on Wednesday that it has entered into an exclusive worldwide license agreement with Plexxikon for its BRAF inhibitor PLX8394.

PLX8394 is an investigational drug that is currently being studied in Phase I/II trials in BRAF-mutated tumors. 

In pre-clinical studies, researchers found that PLX8394 selectively inhibits ERK signaling in tumors driven by BRAF alterations, including BRAF fusions, splice variants, and V600 mutations. However, the drug spares RAF function in normal cells. 

"We believe that the combination of PLX8394 with our Functional Annotation for Cancer Treatment technology will enable rapid and successful development of this novel BRAF inhibitor for patient subpopulations in dire need," Novellus CEO Michael Vidne said in a statement.

The next-generation sequencing-based FACT assay is designed to test the functional effects of variants of unknown significance in response to various cancer treatments and predict clinical results.

"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," Vidne continued.

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

Novellus partnered with Centre Léon-Bérard in 2018 to gauge the accuracy of its FACT assay in predicting treatment response in cancer patients. 

That same year, Novellus also announced that it raised $6 million in equity financing