iOnctura commences randomized Phase II study in metastatic uveal melanoma

iOnctura Netherlands United States of America United Kingdom Switzerland

First patient dosed in Phase II OCULE-01 study with roginolisib, an allosteric modulator of PI3K?The European Medicines Agency (EMA) has granted Orphan Drug Designation for roginolisib for treatment of uveal melanoma - benefits include 10 years market exclusivity in the European Unionthe US Food and Drug Administration (FDA) granted ODD for roginolisib in UM.

Paul Nathan, Principal Investigator of the Phase II OCULE-01 study said: 'Roginolisib has so far shown impressive tolerability and an interesting median overall survival of 16 months in patients with uveal melanoma who had progressed on prior systemic therapy. With roginolisib's attractive safety profile and the encouraging survival data observed in the first-in-human dose study, we look forward to continuing to investigate the potential of roginolisib in patients with limited therapeutic options.'

Catherine Pickering, CEO and Co-Founder of iOnctura added: 'We have achieved our first significant milestone for 2025 by starting one of several planned randomized Phase II studies for roginolisib. We are excited by the potential of roginolisib across a number of indications including uveal melanoma, non-small cell lung cancer and myelofibrosis, and we look forward to early data readouts by the end of the year.'

About iOnctura

iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is an allosteric modulator of PI3K? with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3K?, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture.

About roginolisib

Roginolisib is an allosteric modulator of PI3K? with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3K?, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. The PI3K signaling pathway is one of the most commonly dysregulated pathways across multiple cancer types. The potential of roginolisib has been validated by positive clinical signals in Phase I in solid tumor and hematological malignancies, including a doubling of overall survival compared to historical controls in rare eye cancer, uveal melanoma. The company has carefully designed its clinical program to allow full development in uveal melanoma, while in parallel validating the program in larger market indications. The Phase II OCULE-01 study in uveal melanoma started in March 2025 and Phase II studies in other cancers, including non-small cell lung cancer and myelofibrosis, are being initiated.

[1] Emergen Research, Jan 2024

 

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