Nerviano 22 June 2023_Nerviano Medical Sciences Srl (NMS), a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, is delighted to announce the FDA Clearance of Investigational New Drug (IND) Application for NMS-03592088 (NMS-088), a novel, potent FLT3 inhibitor.
NMS-088 is poised to transform the landscape of FLT3 inhibitor by addressing a critical unmet medical need. It offers a breakthrough solution that has the potential to improve patient outcomes and significantly enhance quality of life. The IND approval enables NMS to advance to the next stage of clinical development, initiating critical trials to evaluate the safety, efficacy, and therapeutic potential of this next-generation FLT3 inhibitor.
“We are incredibly proud of this IND approval, which underscores our commitment to innovation and improving patient care,” said Lisa Mahnke, MD, PhD, CMO of NMS. “This milestone is a testament to the hard work, dedication, and scientific expertise of our talented team. We remain steadfast in our mission to bring forth groundbreaking solutions that make a real difference in the lives of patients.”
The forthcoming clinical trial will be conducted in partnership with renowned medical centers and institutions as part of NMS’s global program. This collaborative approach ensures the rigorous evaluation and comprehensive assessment of NMS-088’s safety, efficacy, and potential benefits across diverse patient populations.
As NMS moves forward with clinical trials, the company remains committed to adhering to the highest ethical and regulatory standards. Patient safety and well-being will remain paramount throughout the entire process, with careful monitoring and adherence to strict protocols.
About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a rapidly progressing hematologic malignancy that most frequently develops in older adults. FLT3 mutations occur in approximately 30% of AML patients and are associated with aggressive disease, higher relapse rates and worse survival. Despite the approval of FLT3 inhibitors midostaurin and gilteritinib the prognosis of patients with relapsed or refractory disease is poor.
NMS-03592088 is a novel, potent inhibitor of FLT3, KIT and CSF1R, all relevant targets in AML. NMS-03592088 showed superior preclinical activity compared with approved FLT3 inhibitors in different FLT3-driven models. In addition, NMS-03592088 is active on FLT3 gatekeeper mutation F691L causing resistance to first generation FLT3 inhibitors. NMS-03592088 is being developed in AML with two studies currently recruiting (MKIA-088-001 and MKIA-088-002)
Link: 20230622 FLT3 IND Clearance