iOnctura announces first patient dosed in a phase I clinical study of its novel highly selective PI3Kδ inhibitor, IOA-244 for solid tumours

Geneva, Switzerland, 26 February 2020: iOnctura SA., a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, announces it has  dosed the first patient in a first-in-human dose escalation and expansion study evaluating the safety and preliminary efficacy of its lead programme IOA-244, which is being developed as a novel targeted therapy for solid tumours. 

The phase I study will enrol approximately 60 patients with solid tumours that overexpress PI3Kδ and are burdened by immune cells of the suppressor phenotype that are sensitive to PI3Kδ inhibition. The dose escalation part of the study will evaluate the safety, tolerability and pharmacokinetic profile of IOA-244 and is being led by principal investigators Professor Evans from the Beatson West of Scotland Cancer Centre and University of Glasgow, and Professor Maio from the University Hospital of Siena. Results from the phase I study are expected in early 2021.

Michael Lahn, Chief Medical Officer of iOnctura, commented: “Our mission is to achieve true precision medicine that optimally treats patients according to the root causes of their disease. The start of this trial represents an important milestone for iOnctura to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications.  This study will generate important insights into IOA-244, and its potential to provide meaningful and lasting clinical benefit for patients with cancer. We are very pleased to collaborate with Professor Evans and Professor Maio on this significant first-in-human dose escalation study. We look forward to continuing our evolution into a leading biopharmaceutical company with a diverse and sustainable pipeline in cancer and fibrosis.”

Professor Maio, Department of Medical Oncology, University Hospital of Siena, Italy said: “We are excited to participate in iOnctura’s first-in-human study. iOnctura’s innovative and differentiated approach has the potential to offer new, advanced treatment options to cancer patients and we are looking forward to evaluating this promising and unique target.”

Commenting on the study, recently appointed Clinical Advisory Board member, Dr. Jordi Rodón Ahnert, Clinical co-director, MD Anderson Cancer Center, added: “The design of the clinical trial is novel because it is going to investigate patients with expected high PI3Kδ expression and immune suppression both of which are underlying causes of treatment resistance in many solid tumours. iOnctura’s novel compound, IOA-244, could be critically important for the treatment of solid tumours that are burdened with an immune-suppressive tumour microenvironment.”