Sparks - Oryzon Genomics

Oryzon Genomics has announced Spanish regulatory authorisation for VIVALDI, a Phase Ib pilot study evaluating its lead oncology asset, iadademstat, in combination with azacitidine and venetoclax, the current standard of care for certain patients with newly diagnosed acute myeloid leukaemia (AML). The study, sponsored by Spanish cooperative research group CETLAM and involving 13 hospitals, will focus on difficult-to-treat patient subgroups, including those with TP53 or RAS pathway mutations, which are associated with poor responses to existing treatments. Oryzon will supply iadademstat, an LSD1 inhibitor (a drug targeting an enzyme involved in regulating gene expression), for the study. VIVALDI builds on encouraging preliminary results from the US-based Phase II ALICE-2 trial, where the same combination achieved a 100% overall response rate and an 89% composite complete remission rate in first-line AML (interim data across 18 evaluable patients), as reported at EHA 2026.

Beyond generating additional clinical evidence in high risk patient populations, VIVALDI should provide valuable operational experience to support the planned European expansion of Oryzon’s pivotal ALICE-3 programme, while potentially informing future regulatory discussions. ALICE-3 is being prepared as a potentially registrational Phase III trial in newly diagnosed AML, with initiation targeted for 2027, subject to regulatory clearance and appropriate financing. The next important catalyst for investors is the presentation of final ALICE-2 data at the American Society of Hematology (ASH) annual meeting in December 2026, which should provide further clarity on iadademstat’s efficacy and safety profile in this setting, ahead of pivotal development.