On November 4, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported updated positive clinical data from early-stage clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia and inmyeloproliferative neoplasms. The findings will be presented in poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 68th Annual Meeting, taking place December 12-15, 2026 in New Orleans, Louisiana.
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"We look forward to returning to ASH (Free ASH Whitepaper) and sharing exciting new clinical data on iadademstat with the hematologic oncology community," said Carlos Buesa, Chief Executive Officer of Oryzon. "We now have a growing amount of clinical evidence supporting the very promising efficacy of iadademstat in combination with standard-of-care treatment in AML, including in populations that respond poorly to current treatments, together with a manageable safety profile. In particular, the ALICE-2 data strongly support the tolerability of the combination, provide a clear rationale for dose selection for further development, and show highly encouraging efficacy. Together, these findings form a robust evidence package to support advancement into the planned ALICE-3 Phase III trial in newly diagnosed AML."
"The AML findings and early data in myeloproliferative neoplasms (MPN) represent complementary steps in understanding iadademstat’s therapeutic potential," said Ana Limon, Oryzon’s Senior Vicepresident for Clinical Development in Oncology. "ALICE-2 is helping guide our next stage of development in AML, while the preliminary MPN findings open a new avenue for investigation. Although these MPN data are early, they provide a foundation for further clinical evaluation."
Presentations details:
Title: A Phase Ib study of the triplet combination of iadademstat in combination with azacitidine and venetoclax for newly-diagnosed acute myeloid leukemia
Publication ID: 1634
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I
Presentation date and time: December 12, 2026, 5:30-7:30 pm local time
Room: MCCNO – Hall F
As of the July 2026 data cut of the ALICE-2 study (NCT06357182), the iadademstat/azacitidine/venetoclax triplet combination continued to demonstrate a manageable safety profile with encouraging efficacy in newly diagnosed acute myeloid leukemia (ND-AML), with high remission rates, rapid responses, acceptable hematologic recovery, and encouraging early survival. Among 19 efficacy-evaluable patients, ORR was 95%, including 84% composite complete remission (CRc) rate and 74% pure complete remission (CR) rate. After median follow-up of 8 months, 12-month overall survival (OS) was 76%, with median OS not yet reached. In patients with ELN2022 intermediate- or adverse-risk disease, 12-month OS rates were 100% and 74%, respectively, with median OS not reached. 82% of enrolled patients had ELN2022 adverse risk. Updated data with additional patients and more mature responses will be presented at the meeting.
Title: Iadademstat combination with gilteritinib is a safe and effective treatment in FLT3‑mutated relapsed/refractory acute myeloid leukemia: Topline results of the FRIDA trial
Publication ID: 1628
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I
Presentation date and time: December 12, 2026, 5:30-7:30 pm local time
Room: MCCNO – Hall F
The iadademstat/gilteritinib combination evaluated in the FRIDA Phase Ib trial (NCT05546580) demonstrated a manageable safety profile, similar to SoC treatment. In a high-risk, heavily pre-treated and refractory FLT3-mutant AML population, the combination achieved a high 67% composite complete remission rate and a 31% 12-month survival rate at the recommended Phase 2 dose (RP2D). Additional data will be presented at the meeting.
Title: Interim results of a phase II study of ASTX727 with or without iadademstat in patients with accelerated/blast-phase myeloproliferative neoplasms
Publication ID: 5532
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Presentation date and time: December 14, 2026, 6:00-8:00 pm local time
Room: MCCNO – Hall F
Interim results from the study (NCT06661915), based on data available as of the ASH (Free ASH Whitepaper) 2026 abstract submission cut-off date, showed that the combination of iadademstat and ASTX727 was well tolerated, with no dose-limiting toxicities (DLTs) observed. 50% of patients treated with the combination achieved acute leukemia response-partial (ALR-P) as best response. The trial continues in the dose escalation phase, 3 and higher iadademstat dose level cohorts will be explored to inform the selection of a recommended Phase 2 dose of iadademstat for the randomized portion of the study.
The abstracts are available online at the ASH (Free ASH Whitepaper) 2026 website.
(Press release, Oryzon, NOV 4, 2026, View Source;utm_medium=email&utm_campaign=NdP.27+2026-11-04+ASH+abstracts+ENG856 [SID1234674209])