iOnctura announces FDA clearance of IND application for roginolisib, a first-in-class allosteric modulator of PI3KD

iOnctura Netherlands United States of America United Kingdom Switzerland

Roginolisib is in development for solid and hematologic malignancies including uveal melanomais a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways such as cellular proliferation; escape from immune detection; and drug resistance. iOnctura's pioneering approach to drug development is expected to offer significant clinical benefits over the traditional approach of targeting a single pathway alone. iOnctura has progressed two therapeutic candidates into mid-stage clinical development: Roginolisib (IOA-244), an allosteric modulator of PI3K?; and IOA-289, a highly selective, non-competitive autotaxin (ATX) inhibitor. IOA-359, a TGF–? pathway inhibitor is also undergoing an extensive pre-clinical program in preparation for first-in-human studies. iOnctura is backed by specialist institutional investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland.

About roginolisib

Roginolisib (IOA-244) is a first-in-class small molecule allosteric modulator of PI3K?. Its unique structural and selectivity features drive a unique way of inhibiting PI3K? which translates into a highly beneficial tolerability and clinical benefit profile. PI3K? over-expression stimulates multiple cancer mechanisms and has an oncogenic role in many tumor types.  Roginolisib has a multi-modal effect on cancer; directly preventing cancer cell proliferation, harnessing an anti-tumor immune response via an effect on regulatory T-cells and cytotoxic T cells and potentiating the effect of immunotherapy. Roginolisib is currently in the extension phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating the drug in advanced cancers and as a combination partner for conventional and immune-therapies (NCT04328844).

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