Fresh from raising nearly $86m in financing last month, iOnctura will now start evaluating lead asset roginolisib in non-small cell lung cancer (NSCLC).

The expansion to roginolisib’s clinical programme is via clinical collaboration agreements with the ETOP IBCSG Partners Foundation and GSK, iOnctura said in a 9 July press release.

The Swiss biopharma iOnctura outlined plans for a Phase II study that will investigate roginolisib in combination with GSK’s PD-1 inhibitor Jemperli (dostarlimab). The combo therapy will be evaluated in NSCLC patients resistant to first-line checkpoint inhibitor therapy, with or without docetaxel.

Roginolisib is an allosteric modulator of phosphoinositide 3-kinase-δ (PI3Kδ), which iOnctura says is “widely recognised as a ‘master switch’ of cancer.” Inhibition of the protein elicits an anti-tumour effect, which induces immune system activity against cancer cells.  In January this year, roginolisib received an orphan drug designation from the US Food and Drug Administration (FDA).

iOnctura is basing the combination with GSK’s programmed death receptor (PD-1) on “emerging clinical and translational biomarker data,” adding that it may prevent or reverse drug resistance in NSCLC. This enhanced anti-tumour immune activity would also be without significant addition of toxicity, according to the biopharma.

Roginolisib is being evaluated in a Phase I clinical trial (NCT04328844) as a monotherapy and in combination with chemotherapy in patients with advanced or metastatic cancers, including metastatic uveal melanoma. The biopharma reported positive efficacy results at the 80mg dose, with grade 1 and 2 adverse events observed in the continuous daily dosing portion of the trial for patients with solid tumors.

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iOnctura’s CEO Catherine Pickering said: “The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development program with potentially synergistic combinations in NSCLC.”

P13K inhibitors faced a setback in recent years after the FDA’s Oncologic Drugs Advisory Committee (ODAC) lost confidence in the safety profile of the drugs. The agency recommended that future approvals of PI3K inhibitors for haematologic malignancy indications should require randomised trial data, as per a vote in 2022. The decision was based on high levels of fatal adverse events (AEs) and toxicity observed in patients taking the drug class.

Roche made a recent advancement in the space, securing FDA priority review in breast cancer for the PI3K inhibitor inavolisib as a combination therapy with fulvestrant and Pfizer’s Ibrance (palbociclib).

iOnctura raised €80m ($85.8m) in Series B financing earlier this year, helping to fund Phase II activity for roginolisib and its other candidate cambritaxestat, autotaxin inhibitor.