Swiss biopharma iOnctura has raised €80m ($85.8m) in Series B financing to fund the Phase II clinical trials for its two lead cancer therapies, roginolisib and cambritaxestat. The company plans to start in various cancer indications including non-small cell lung cancer (NSCLC) and primary myelofibrosis, later this year.
The gold standard of business intelligence. Roginolisib is an allosteric modulator of a phosphoinositide 3-kinase delta (PI3Kδ), which induces an immune response by signalling the growth and division proliferation of white blood cells. PI3Kδ is also overexpressed in multiple haematological cancers where its hyperactivity is associated with tumour progression and invasive potential.
In January, roginolisib received an orphan drug designation from the US Food and Drug Administration (FDA). The PI3K class of drugs have faced a setback in recent years after the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously recommended that “future approvals of PI3K inhibitors for hematologic malignancy indications be supported by randomised trial data”, in 2022. The decision was based on (AEs) and high rates of toxicity associated with the drug class.
Roginolisib is being evaluated in a (NCT04328844) as a monotherapy and in combination with chemotherapy in patients with advanced or metastatic cancers, including metastatic uveal melanoma, a rare eye cancer. Of the 23 metastatic uveal melanoma patients treated with 80mg roginolisib, less than 5% showed Grade .