Oryzon Gains Spanish Authorization for VIVALDI Phase Ib AML Study

Spanish regulatory authorization of the VIVALDI study positions Oryzon Genomics to generate European clinical data on iadademstat ahead of the planned ALICE-3 Phase III registrational program, with direct implications for CMC planning and future EU regulatory submissions. The Phase Ib pilot, sponsored by CETLAM and authorized in Spain on 3 November 2026, will enroll newly diagnosed AML patients in subpopulations with poor responses to standard-of-care, specifically those carrying TP53 or RAS pathway mutations.

CETLAM, a cooperative clinical research group with over three decades of experience in acute leukemia and myelodysplastic syndromes, is sponsoring the study across 13 Spanish hospitals. Oryzon is supplying iadademstat and collaborating operationally. The trial evaluates iadademstat in combination with azacitidine and venetoclax, a triplet regimen layered onto the current standard-of-care backbone for ND-AML.

For regulatory affairs leads tracking the iadademstat dossier, the dual-track structure is notable. VIVALDI runs as an investigator-sponsored pilot in parallel with Oryzon's U.S.-based ALICE-3 preparations, a configuration that allows the company to accumulate European site-level operational data, patient recruitment patterns, protocol adherence across cooperative group hospitals, before committing to a formal European arm of the registrational trial. CEO Carlos Buesa confirmed that VIVALDI findings in TP53-mutated and adverse-risk populations may inform future regulatory discussions, without specifying a submission timeline.

The scientific rationale draws on two prior studies. In ALICE-1, led by Vall d'Hebron University Hospital, iadademstat combined with azacitidine showed activity in TP53-positive patients, a population where durable remissions remain rare. ALICE-2 data, which Oryzon has indicated will be presented at the upcoming ASH annual meeting, underpins the ALICE-3 design. VIVALDI's correlative substudies are intended to deepen mechanistic understanding of LSD1 inhibition in these high-risk leukemia subtypes, data that could support labeling discussions if the molecule advances to approval.

QA and CMC teams supporting cross-jurisdictional programs should note that the investigator-sponsored model places GMP supply obligations on Oryzon while CETLAM holds the sponsor role for regulatory purposes in Spain, an arrangement that requires clear technical agreements and batch release coordination aligned with 21 CFR Part 211 equivalents under EU GMP Annex 13 for investigational medicinal products.

The pace at which VIVALDI site activation proceeds across all 13 hospitals will serve as an early operational benchmark for Oryzon's capacity to execute a multi-country European trial footprint under ALICE-3.

Source: Oryzon Genomics via company press release, 3 November 2026.