Nerviano Medical Sciences announces FDA clearance of two INDs for its PARP1-selective, non-trapping inhibitor NMS-293 to start clinical studies in small cell lung cancer and BRCA wild-type ovarian carcinoma
NERVIANO, Italy and BOSTON, Mass.,13 January 2025 – Nerviano Medical Sciences S.r.l. (NMS), a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc., a wholly owned subsidiary of NMS, a global leader in oncological innovation, are pleased to announce that the U.S. Food and Drug Administration (FDA) has granted approval to proceed with two clinical studies in the relapse setting for small cell lung cancer and BRCA wild-type ovarian cancer. These important milestones bring the company closer to advancing its PARP1-selective, non-trapping, brain penetrant inhibitor NMS- 293 and potentially transforming the treatment landscape for patients.
The Phase I small cell lung cancer study PARPA-293-004 combines NMS-293 with temozolomide, similar to the ongoing study PARPA-293-002 in glioblastoma and high-grade glioma. The Phase 1 BRCA wild type ovarian study PARPA-293-003 combines NMS-293 with topotecan. Both studies evaluate safety and preliminary anti-tumor activity with the goal of advancing treatment options in these tumors. A major need in the PARP inhibitor field is to establish treatments outside of BRCA mutations by combining with chemotherapies. The non-trapping feature of NMS-293, together with PARP1 specificity, is designed to enhance tolerability with chemotherapy as presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023 (Geurts M. et al., Initial Results from 2 PhaseI Studies of NMS-03305293, a Selective PARP-1 Inhibitor).
“We are very pleased to have FDA allowance to proceed with these NMS-293 clinical studies, marking a strong step forward in our commitment to unmet medical need in cancer patients” stated Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. “These new INDs reflect NMS’ commitment to new cancer treatments for patients and to innovation of PARP1 targeting as reflected by the highly unique non-trapping, brain-penetrant design of NMS-293” stated Hugues Dolgos, PharmD, CEO of NMS.
