iOnctura approached Niche for support after viewing our online guide to writing clinical study reports. They were approaching the end of a clinical study with their IOA-244 compound (roginolisib), a non–ATP-competitive, highly selective, tolerable PI3K delta inhibitor that targets solid tumours and breaks immune tolerance. iOnctura were looking at ways of facilitating the prompt delivery of the project’s clinical study report and its associated patient narratives. The Niche medical writing team quickly integrated with iOnctura’s clinical team, guiding them on issues like narrative format and document templates.

As the programme progressed Niche advised that iOnctura should submit an application of an Innovative Licencing and Access Pathway (ILAP) application to the MHRA. Niche exploited their regulatory experience in ILAP applications, which was promptly awarded. The Niche team continued to support iOnctura’s regulatory efforts with the production of a novel means of analysing their combined safety data and including these findings in their subsequent amendment to the CSR report, as well as an EU submission for Orphan Drug Designation and a US pre-Investigational New Drug request. The safety findings, indicating that continuous oral 80 mg QD dosing of roginolisib provides a favourable toxicity profile with longer than expected median OS, were reported in a Niche-written poster submitted to the 2024 ESMO congress. The Niche team continues to support progression of Roginolisib, most recently in providing support for the development of a non-clinical manuscript.

A letter of recommendation from iOnctura available on request.