NEW YORK – Clinical-stage biopharmaceutical company iOnctura SA said on Wednesday that it has dosed the first patient in its Phase I study of its lead investigational agent IOA-244, a highly selective PI3K delta inhibitor.
The Phase I trial will enroll around 60 patients with solid tumors that overexpress the protein PI3K delta or have a high burden of suppressor immune cells. The dose escalation segment of the study will evaluate the safety, tolerability, and pharmacokinetic profile of IOA-244. The trial will take place in The Beatson West of Scotland Cancer Centre in the United Kingdom and the University Hospital of Siena in Italy. iOnctura, which is a Geneva, Switzerland-based spinout of Merck KGaA's venture arm, expects to announce results from the Phase I study in early 2021.
iOnctura CMO Michael Lahn said in a statement, "The start of this trial represents an important milestone for iOnctura to clinically demonstrate that highly selective PI3K inhibition not only drives an immune-mediated response but also a direct anti-tumoral effect in a stratified patient population across multiple solid tumor indications."
In preclinical animal studies, IOA-244 improved anti-tumor immunity and inhibited tumor growth when administered as a monotherapy or in combination with either anti-PD-1 or anti-PD-L1 therapy. Additionally, IOA-244 produced an effect in a mouse xenograft model of patient-derived melanoma cells with high PIK3CD expression.
Novartis in 2019 garnered FDA approval for the first PI3K inhibitor alpelisib (Piqray) to treat advanced or metastatic breast cancers harboring PIK3CA mutations.
Jordi Rodón Ahnert, clinical co-director of MD Anderson Cancer Center and a member of iOnctura's clinical advisory board, said, "The design of the clinical trial is novel because it is going to investigate patients with expected high PI3K expression and immune suppression, both of which are underlying causes of treatment resistance in many solid tumors. iOnctura's novel compound, IOA-244, could be critically important for the treatment of solid tumors that are burdened with an immune-suppressive tumor microenvironment."