ORYZON to Present Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia at EHA 2026
In first line, iadademstat with azacitidine and venetoclax continues to show favorable safety and 100% ORR, with a composite complete remission rate (CRc) of 93% (with 79% CR), and an estimated 12-month OS of 74%.
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that updated positive clinical data from two Phase Ib clinical trials evaluating its selective LSD1 inhibitor iadademstat in acute myeloid leukemia (AML) will be presented in two poster sessions at the European Hematology Association (EHA) Annual Congress, taking place June 11-14, 2026 in Stockholm, Sweden.
“We are encouraged by the updated findings from both the ALICE-2 and FRIDA trials, which continue to support the clinical activity and favorable safety profile of iadademstat-based combinations in AML,” said Carlos Buesa, Chief Executive Officer of Oryzon. “We look forward to presenting updated data at EHA 2026 from a larger patient cohort in the ALICE-2 study, likely representing approximately 75–80% of the planned enrollment, which we believe will provide a more mature assessment of both safety and efficacy of the triplet combination. Based on the strength of the emerging data, the Company is envisaging an accelerated clinical development plan for iadademstat in the first-line AML setting.”
Presentations details:
Title: Updated Safety and Efficacy Results of a Phase Ib Investigation of the LSD1 Inhibitor Iadademstat (ORY-1001) in Combination with Azacitidine and Venetoclax in Newly Diagnosed AML
Abstract ID: EHA-4924
Presenter: Curtis Lachowiez, MD, Oregon Health & Science University, Portland, United States of America Presentation
Date and Time: Saturday, June 13, 2026, 6:45-7:45 pm CEST.
As of the February 2026 data cutoff, the triplet combination of iadademstat, azacitidine and venetoclax evaluated in the ALICE-2 trial (NCT06357182) continues to demonstrate favorable safety and high response rates. Among evaluable patients (n=14/15) the overall response rate (ORR) was 100% with a complete response (CR) rate of 79% (n=11/14) and a composite complete remission (CRc: CR+CRh+CRi) rate of 93% (n=13/14). After a median follow-up of 6 months, the estimated 12-month OS rate was 74%. Updated data with additional patients and more mature responses will be presented at the meeting.
Title: Safety and Efficacy of Iadademstat Plus Gilteritinib in the FRIDA Expansion Cohort of FLT3‑Mutated Relapsed/Refractory Acute Myeloid Leukemia
Abstract ID: EHA-5879
Presenter: Amir Fathi, MD, Massachusetts General Hospital, Boston, United States of America
Presentation Date and Time: Friday, June 12, 2026, 6:45-7:45 pm CEST
Updated data from a heavily pre-treated relapsed or refractory FLT3mut AML population in the FRIDA trial (NCT05546580) evaluating iadademstat plus standard of care treatment gilteritinib demonstrated a favorable safety profile and a CRc rate of 67% (n=12/18). Additional data will be presented at the conference.
The abstracts are available on the EHA 2026 website here.