iOnctura, a clinical-stage precision oncology company focused on neglected and hard-to-treat cancers, has expanded its clinical trial programme for lead candidate roginolisib into the US.
Several US trial sites are now enrolling patients in the OCULE-01 phase II study in metastatic uveal melanoma, with an additional study, led by Jennifer Brown, under way in chronic lymphocytic leukaemia (CLL) at Dana-Farber Cancer Institute. Brown is director of the CLL Center of the Division of Hematologic Malignancies at the Dana-Farber Cancer Institute.
Catherine Pickering, CEO and co-founder of iOnctura said: “We are proud to begin the next phase of iOnctura’s global growth by making roginolisib available to US patients in our clinical studies. The enthusiastic response from US investigators, leading research centres, and patient communities highlights the significant opportunity to impact outcomes for individuals with limited treatment options.”
Roginolisib, an orally dosed small molecule allosteric modulator of PI3Kδ, is being investigated in multiple randomised phase II studies in solid and haematological malignancies. The global phase II randomised OCULE-01 study will assess whether roginolisib improves overall survival in patients with metastatic uveal melanoma who have progressed on prior therapy. Patients from both the US and Europe are now being treated in the study, which started in March 2025.
Roginolisib is also being investigated in patients with non-small cell lung cancer (NSCLC) and myelofibrosis. In these diseases, targeting the PI3Kδ pathway in combination with standard therapies has the potential to reverse resistance.
Seeing the promise of roginolisib as a combination therapy, the US Department of Defense (DoD) recently awarded a substantial grant to Brown to explore the potential of roginolisib in relapsed/refractory CLL in a phase I/II study.
Brown, the principal investigator on the study and grant, said: “We are enthusiastic about the potential of roginolisib in enhancing treatment outcomes for CLL patients who have relapsed after prior Bruton’s tyrosine kinase inhibitor therapy. We feel roginolisib offers a promising avenue to improve remission depth and duration in combination with venetoclax and rituximab, whilst minimizing treatment-related side effects.”
Recently published preclinical evidence by Sasi, Tarantelli et al. supports the synergistic potential of roginolisib and venetoclax in the treatment of CLL.
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