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FDA Clears Jazz Pharmaceuticals' IND for MAPK Inhibitor JZP815

NEW YORK – Jazz Pharmaceuticals said Wednesday that the US Food and Drug Administration has approved its investigational new drug application to study the pan-RAF inhibitor JZP815 in patients with solid tumors and hematologic malignancies characterized by MAPK pathway mutations.

Jazz will now begin a Phase I clinical trial of the drug in this setting, triggering a $5 million milestone payment to Redx under a 2019 agreement between the companies. Redx has previously received $6.5 million in milestone payments under the collaboration and is eligible for additional development, regulatory, and commercial milestone payments as well as tiered royalties on future net sales.

JZP815 inhibits RAF signaling and prevents paradoxical pathway activation resulting from BRAF selective inhibition. It has shown activity against tumors harboring three classes of BRAF mutations, plus BRAF fusions and CRAF mutations.

In 2021, Stand Up to Cancer and Jazz Pharmaceuticals signed a three-year, $4 million collaboration agreement to develop therapies for children with solid cancers and advance pan-RAF inhibitors for RAF- and RAS-mutated solid cancers including JZP815.

The Dublin-based firm is also testing Zepzelca (lurbinectedin) in a Phase II trial for advanced solid tumors including homologous recombination deficient (HRD) cancers.