Nerviano Medical Sciences, forerunner in oncology drug discovery and development and a NMS group member, today announced the enrollment and dosing of the 1st patient in a phase I First in Human (FIH) study of NMS-293 as a single agent to treat patients with advanced solid tumors.
“We are pleased to see the first participant enrolled in our Phase 1 trial. This makes a significant milestone for us and recognition of our endeavors to provide new, safe and effective treatment for patients in need of options.” said Gregory Wu, Ph.D., CEO of Nerviano Medical Sciences. “With the unique preclinical features, NMS-293 can be further developed as a single agent and in drug combination therapy regimes. We look forward to sharing positive results in the coming years.”
NMS-293 is an orally available small molecule inhibitor of poly (ADP-ribose) polymerase-1 (PARP-1) with high efficacy in preclinical models deficient in homologous recombination repair (HRR), such as those mutated in BRCA1 and/or BRCA2 genes. These mutations are frequently found particularly in breast, ovarian, pancreatic and prostate cancers.
NMS-293 possesses unique features compared to other PARP inhibitors that are either approved or in development, such as its selectivity for PARP-1 vs PARP-2 isoenzyme and the lack of “trapping” effects, which might result in better tolerability in terms of undesired hematopoietic effects, especially when combined with chemotherapy. In addition, the high brain penetration of the compound provides a potential for the treatment of brain tumors and brain metastasis.
This clinical trial will be conducted in two parts and will enroll up to 100 patients in China, Europe and USA. The first part is to evaluate the safety and pharmacokinetic profile of NMS-293 and determine a recommended dose for part 2. The second part of the study is to assess the preliminary clinical activities and safety profile of NMS-293 at the recommended dose in patients with different types of cancers harboring a germline BRCA mutation.
Please refer to www.clinicaltrials.gov, using the NCT identifier (NCT 04182516) for more information.