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iOmx doses first patient in pivotal phase 1 study

The study becomes the first-in-human clinical trial involving OMX-0407 in a specific patient group.

iOmx Therapeutics – a company developing targeted cancer immunotherapy treatments – has announced that the first individual has been dosed in its phase 1 clinical trial researching its OMX-0407 candidate. The therapy is a first-in-class oral salt-inducible kinase (SIK) inhibitor.

The trial is an open-label, single-arm, multi-location phase 1 clinical trial studying the tolerability and safety of the treatment as monotherapy among patients with previously treated unresectable solid tumours. At present, the study has been approved by regulators in Belgium and Spain.

It also becomes the first-in-human clinical trial involving OMX-0407 monotherapy in this specific patient group and is designed to gauge the pharmacodynamic activity of the therapy.

Meanwhile, as part of the process, ‘SIK family member’, SIK3, has been established through regulating the NF-?B gene landscape via phosphorylation of class 2a histone deacetylases and CREB-regulated transcriptional coactivators.

SIK3 was highlighted using iOmx’s systematic screening platform – iOTargTM – as a novel immune-protective kinase. Inhibition of SIK3 with OMX-0407 targets a novel immune evasion biology by sensitising tumours to immune-derived ligands of the TNF superfamily.

Dr Murray Yule, chief medical officer at iOmx, is optimistic about the candidates’ prospects: “With an exciting novel mode of action, OMX-0407 holds the potential to address multiple solid tumours that are not responsive to conventional immune checkpoint inhibitors. Our research has shown that inhibition of SIK with OMX-0407 potentiates tumour cell apoptosis by unleashing intra-tumoural death receptor signalling resulting in anti-tumour efficacy in pre-clinical models resistant to conventional immune checkpoint blockade.”

He added: “We would like to express our gratitude to the investigators, their teams and the patient community for their support and trust in our treatment approach with OMX-0407.”

Dr Apollon Papadimitriou, chief executive officer at iOmx, concluded: “We are proud to bring our first iOTarg platform-derived product candidate into the clinic. This is a significant milestone for iOmx as we pursue our goal to deliver better medical options for patients failing current cancer immunotherapy treatments.”