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Merck KGaA, Nerviano Enter License Agreement for PARP1 Inhibitor NMS-293

NEW YORK – Merck KGaA and Nerviano Medical Sciences on Wednesday entered into a collaboration and licensing agreement for Nerviano's NMS-293, a PARP1 inhibitor being studied in certain biomarker-defined solid tumors.

Under the agreement, Merck KGaA will pay Nerviano $65 million upfront and in option exercise fees for the rights to NMS-293. Nerviano will also be eligible for future payments if it meets certain development, regulatory, and commercial milestones, along with tiered royalties on net sales of NMS-293.

During the option period, Merck KGaA and Nerviano will collaborate on the development of NMS-293, with Nerviano designing, sponsoring, conducting, and funding the clinical trials. Once Merck KGaA exercises the licensing option, the Darmstadt, Germany-based drugmaker will gain exclusive rights to research, develop, manufacture, and commercialize NMS-293.

NMS-293 is currently being studied in a Phase I/II trial in combination with chemotherapy in patients with diffuse gliomas and recurrent IDH-wild-type glioblastoma. Nerviano is also studying the drug as a single agent in a Phase I study in advanced solid tumors harboring BRCA1/2 mutations. That trial is enrolling patients with breast, epithelial ovarian, castration-resistant prostate, or pancreatic cancer.

"NMS-293 is the first next-generation PARP1 inhibitor to enter clinical trials," Nerviano CEO Hugues Dolgos said in a statement. "Based on its unique features, NMS-293 has strong potential in combination with a wide variety of DNA-damage accumulating agents, such as chemotherapy, DNA repair inhibitors, or [antibody-drug conjugates], in tumor settings that are precluded to current PARP inhibitors, such as brain tumors, and where there is an urgent global need to find treatments."