On September 21, 2022 Nerviano Medical Sciences S.r.l. (NMS), a member of the NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported the signing of a collaboration agreement with licensing option with Merck Healthcare KGaA (Merck), for the next-generation highly selective and brain penetrant PARP1 inhibitor NMS-293 (Press release, Nerviano Medical Sciences, SEP 21, 2022, View Source [SID1234623258]).

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PARP (poly (ADP-ribose) polymerase) is key in the repair of DNA damage and PARP inhibitors have been shown to be highly efficacious in the treatment of tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers which are BRCA mutated.

NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors. NMS-293 is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to US$65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

"NMS-293 is the first next-generation PARP1 inhibitor to enter clinical trials. 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 ADCs, 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," stated Hugues Dolgos, Pharm.D., chief executive officer of NMS and NMS Group. "NMS has built a unique and proprietary platform of first-in-class and best-in-class assets and expanded to new target classes like PARP with NMS-293 as our flagship. We believe that Merck, a global leader in DNA repair with a well-established commercialization footprint, is the ideal partner to maximize the value of our program."

"Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile," said Victoria Zazulina, M.D., Head of Development Unit Oncology for the Healthcare business of Merck. "The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients."

During the option period, NMS and Merck will collaborate on the clinical development of NMS-293 as monotherapy and in combination, with NMS designing, sponsoring, conducting, and funding global clinical trials.

About NMS-293

NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

20220921-NMS Srl announces Collaboration and Option to License Agreement with Merck-Final