ORYZON to Present Updated Positive Clinical Data for Iadademstat in Hematological Malignancies at ASH 2026

• Three iadademstat abstracts have been accepted for presentation 
• Updated data from the ongoing Phase Ib ALICE-2 trial combining iadademstat with azacitidine and venetoclax in newly diagnosed, unfit AML patients showed a 95% overall response rate, 84% composite complete remission (CRc) rate and 74% CR rate; updated ALICE-2 data following completion of enrollment to be presented at the meeting
• Topline results from the Phase Ib FRIDA trial of iadademstat in combination with gilteritinib in high-risk, heavily pre-treated and refractory FLT3 mutant AML patients showed a 67% CRc rate at the dose level selected as Recommended Phase 2 dose

MADRID and CAMBRIDGE, Mass., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced updated positive clinical data from early-stage clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia and in myeloproliferative neoplasms. The findings will be presented in poster sessions at the American Society of Hematology (ASH) 68^th Annual Meeting, taking place December 12-15, 2026 in New Orleans, Louisiana.

“We look forward to returning to ASH 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 Vice President 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 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, 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 2026 website.

About Oryzon
Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, which is being evaluated in several ongoing Phase I and II studies and has demonstrated strong preliminary clinical activity in acute myeloid leukemia, including a 95% overall response rate (ORR) in first-line AML; and vafidemstat, its lead CNS program, which is Phase III–ready in borderline personality disorder (BPD). In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which the Company has nominated ORY-4001 as a clinical candidate for potential development in Charcot–Marie–Tooth disease (CMT), amyotrophic lateral sclerosis (ALS), and other neurological disorders. The Company also operates a robust platform for biomarker identification and target validation across malignant and neurological diseases. For more information, visit www.oryzon.com

About Iadademstat
Iadademstat (ORY-1001) is an oral, highly selective inhibitor of the epigenetic enzyme LSD1, with potent differentiating effect in hematologic cancers. Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L acute myeloid leukemia (AML) patients (ALICE trial). Iadademstat is currently being evaluated in combination with azacitidine and venetoclax in 1L AML in the ALICE-2 trial, an investigator-initiated study (IIS) led by OHSU, and in combination with gilteritinib in the company-sponsored Phase Ib FRIDA trial in relapsed/refractory FLT3-mutant AML, with highly encouraging preliminary safety and efficacy data reported in both trials: 95% overall response rate (ORR) and 84% composite complete remission rate (CRc), with 74% strict CR in 1L AML, and 67% CRc in R/R Flt3-mut AML (as per ASH 2026 abstracts). Subject to positive final data in the ALICE-2 study, the company has announced plans to conduct a potentially registrational study in 1L AML. Additional studies in hematologic malignancies include an IIS in myelodysplastic syndrome (MDS) and National Cancer Institute (NCI)-sponsored trials in myeloproliferative neoplasms and 1L AML conducted under the Cooperative Research and Development Agreement (CRADA) between Oryzon and the NCI. Beyond hematological cancers, iadademstat is being evaluated in extensive stage small cell lung cancer (ED-SCLC) in a Phase I/II randomized trial in 1L in combination with immune checkpoint inhibition (ICI) sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center, and an IIS trial in combination with ICI and radiotherapy. Oryzon has also expanded iadademstat into non-oncological hematology indications, with ongoing trials in sickle cell disease and essential thrombocythemia. Iadademstat has orphan drug designation for AML in the US and EU and for SCLC in the US.

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