Nerviano, 22 October 2021
Nerviano Medical Sciences (NMS Srl,) a member of NMS Group and a pharmaceutical company developing innovative new chemical entities (NCE) for the treatment of cancers, today announces that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate NMS-03602173, a second-generation oral inhibitor of IDH1 and IDH2, in advanced solid tumors.
“The go-ahead received from FDA to initiate a Phase 1 trial with NMS-03602173 accelerates our race against IDH1/2-mutated cancers,” said Gregory Wu, Ph.D., CEO of NMS Srl. “Inhibiting IDH1/2 mutant enzymes is a validated therapeutic approach and FDA-approved IDH inhibitors have shown a benefit for a subset of cancer patients. However, the therapeutic responses obtained so far are modest, particularly in solid tumors,” said Wu. “NMS-03602173 was fully discovered and developed by our team, and is a potential Best-In-Class, second-generation dual inhibitor of mutant IDH1/2 aiming to provide more durable clinical benefits to a broader patient population worldwide with IDH-mutant solid tumors.”
“NMS-03602173 has a distinctive mode of action and superior activity with a favorable safety profile in preclinical studies, compared to approved IDH inhibitors. We believe that these features will translate into improved clinical efficacy to overcome the resistance to first-generation IDH inhibitors and increase life expectancy of cancer patients with IDH1 and IDH2 mutations.” added Frank Gan, Pharma D., Head of Global Clinical Development at NMS Srl.
Under this IND, NMS-03602173 will be initially tested in a Phase 1, First-In-Human (FIH) study (IDHA-173-001) as a single agent for adult patients with IDH-mutated advanced/metastatic solid tumors, including cholangiocarcinoma, which have exhausted standard treatment options. The primary objectives of the trial are to determine the maximum tolerated dose and the recommended dose for further study as well as the general safety profile and tolerability. Exploratory objectives include pharmacodynamic and predictive biomarkers analysis.
NMS-03602173, fully discovered and developed by NMS Srl, is a potent, highly selective and orally available investigational new drug for the treatment of patients with IDH1 and IDH2 mutated solid tumors, including low grade gliomas, cholangiocarcinoma, and chondrosarcoma. Mutant isocitrate dehydrogenase enzyme (IDH) enzymes are driver oncogenes in different types of solid tumors and hematologic malignancies, due to their gain-of-function activity that results in accumulation of the oncometabolite d-2-hydroxyglutatrate (2-HG). NMS-03602173 showed the ability to decrease intracellular levels of 2-HG and to induce cell differentiation and tumor growth inhibition in models of IDH1and IDH2 mutated tumors in preclinical studies.