Ann Meulemans

Biography

OMO-1 is a highly selective small molecule MET kinase inhibitor that has demonstrable single agent cellular and in vivo activity only in MET driven preclinical models as expected from a highly selective agent. OMO-1 has recently been explored in a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events. Available dose and exposure correlations and optimal dosing regimes that were defined in this healthy volunteer trial will guide and expedite clinical evaluation in forthcoming patient trials. The clean safety profile observed in the healthy volunteer trial needs to be confirmed in an accelerated Phase 1 dose escalation study carried out in non selected cancer patients followed by demonstrating evidence of clinical activity in a MET biomarker selected expansion cohort. A Phase 2a study to confirm activity in MET biomarker selected population will generate proof of concept data to support a larger registration trial. Innovative study design and timelines that are envisaged will allow OMO-1 to leapfrog competitors and achieve best in class status. Based on the high combination potential inherent to OMO-1 and known MET pharmacology, additional opportunities for significantly increasing market size exist in a range of indications with a defined set of evidence driven, biomarker selected, combination partners.

Research Interest

OMO-1 is a highly selective small molecule MET kinase inhibitor that has demonstrable single agent cellular and in vivo activity only in MET driven preclinical models as expected from a highly selective agent. OMO-1 has recently been explored in a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events. Available dose and exposure correlations and optimal dosing regimes that were defined in this healthy volunteer trial will guide and expedite clinical evaluation in forthcoming patient trials. The clean safety profile observed in the healthy volunteer trial needs to be confirmed in an accelerated Phase 1 dose escalation study carried out in non selected cancer patients followed by demonstrating evidence of clinical activity in a MET biomarker selected expansion cohort. A Phase 2a study to confirm activity in MET biomarker selected population will generate proof of concept data to support a larger registration trial. Innovative study design and timelines that are envisaged will allow OMO-1 to leapfrog competitors and achieve best in class status. Based on the high combination potential inherent to OMO-1 and known MET pharmacology, additional opportunities for significantly increasing market size exist in a range of indications with a defined set of evidence driven, biomarker selected, combination partners.