OMO-1 has potential to treat cancer as a monotherapy and in combination with EGFR TKIs for patients becoming resistant to or progressing on treatment
Beerse, Belgium, 25 September 2019 – OCTIMET Oncology NV, the Belgian life science company with a focus on accelerated development of highly selective differentiated MET kinase inhibitors is pleased to announce the recruitment of the first patient into the second module of its phase I/II clinical study in patients with advanced solid malignancies.
The Study (NCT03138083) is currently evaluating OMO-1 in a monotherapy setting as well as in combination with small molecule EGFR tyrosine kinase inhibitors (TKIs). OMO-1 is an oral, highly selective small molecule MET kinase inhibitor that has demonstrated potent single agent and combination activity in a range of preclinical models. OCTIMET obtained a worldwide exclusive license to OMO-1 from Janssen Pharmaceuticals which had previously carried out a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events.
The primary objective of Module 2 of this Phase I/II study is to demonstrate that OMO-1, in combination with EGFR TKIs, has an acceptable safety and tolerability profile in patients with advanced MET amplified cancer types, whose tumours are progressing during treatment with an EGFR-TKI; secondary objectives include determination of pharmacokinetic (PK) characteristics, and indication of clinical efficacy at doses and schedules at or below the monotherapy recommended phase 2 dose (RP2D). Preliminary top-line results of the combination of OMO-1 with EGFR TKIs are expected in 2020.
This adaptive study, with an innovative modular design, is being conducted in different countries across Europe and the USA.
Glen Clack, CMO of OCTIMET: “MET amplification is known to be a key driver of resistance to EGFR TKIs. This study module will explore the combination of OMO-1, a differentiated selective MET kinase inhibitor, with EGFR TKIs, and provide clear clinical proof of concept data for this combination.”
Shelley Margetson, CEO, of OCTIMET added: “This adaptive clinical trial with patient cohorts enriched for validated and highly relevant biomarkers is the hallmark of OCTIMET’s accelerated development approach and illustrates how we are striving to get effective drugs to the right patients as fast as possible.”
Shelley Margetson, CEO, OCTIMET Oncology NV
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