Surenes (France), and, Nerviano, 24th September, 2015 – Servier and Nerviano Medical Sciences together announced today the start of a first in Human clinical trial of the drug S 81694 (NMS-P153), an inhibitor of the mitotic checkpoint kinase MPS1 discovered by Nerviano Medical Sciences and thereafter acquired and further developed by Servier.
The study is an open-label, non-randomized, multicenter international trial in patients with advanced or metastatic solid tumors who have failed previous therapies. An initial dose-escalation stage will be followed by expansion in specific solid tumors. The study is designed to confirm the safety and pharmacokinetics of S 81694, administered as a single agent. Secondary objectives include initial assessment of efficacy and determination of the recommended dose for phase 2.
Servier is the sponsor of the study, which is being conducted in Belgium and The Netherlands by Nerviano’s clinical affiliate Clioss. S 81694 is supplied by Nerpharma, the CMO affiliate of Nerviano.
Jean-Pierre Abastado, Ph.D., Director of the Oncology Innovation Therapeutic Pole at Servier, said: “We are very enthusiastic about the initiation of this study as S 81694 (NMS-P153) is a novel potent inhibitor of MPS1. MPS1 represents an original target overexpressed during the M phase in many types of cancers. S 81694 is highly selective for MPS1 and a brief exposure to S 81694 is sufficient to commit cancer cells to death”.
Emmanuel Canet, M.D., PhD, President of Servier R&D stressed that “With the entry in clinical phase of this new antitumoral compound, Servier is reinforcing its commitment to provide innovative therapeutic solutions for unmet needs in patients with serious illnesses”.
Arturo Galvani, Ph.D., Director of Drug Discovery at Nerviano Medical Sciences commented: “we have been working together with Servier, a company engaged in cutting-edge research in oncology, in an outstanding collaboration to successfully advance S81694 to clinical development and hope that this first step will further translate into clinical benefit for patients with cancer”.
MPS1 (also known as TTK) is a conserved kinase which is highly expressed in a number of human tumors of different origin. MPS1 plays a critical role in the control of a stage of the cell division cycle known as mitosis. During mitosis, MPS1 is involved in regulation of the spindle assembly checkpoint, a mechanism required for chromosome alignment and segregation. The activity of this checkpoint has been shown to be up-regulated in aneuploid tumors, comprising approximately 90% of solid and 70% of hematological cancers. In accelerating mitosis, MPS1 inhibitors have a novel mode of action as compared to currently available drugs targeting this stage of cell division.