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Oryzon Genomics S.A.
- BME:ORY
- OTC PINK:ORYZF
Oryzon says three iadademstat abstracts accepted for ASH 2025
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- Company
- Oryzon Genomics S.A.
- Listings
- BME:ORY, OTC PINK:ORYZF
- Announcement type
- Operational update
- Published
- Source announcement
- oryzon.com
| Measure | Figure | Period |
|---|---|---|
| Patients had been enrolled | 34 patients | At the time of abstract submission |
| Response rate | 67% response rate (8/12 patients) | in the 12 evaluable patients |
| Overall response rate (ORR) | 100% (n=8) | from the first 8 patients enrolled |
| Complete remission (CR) | 88% | from the first 8 patients enrolled |
| Estimated 6‑month overall survival (OS) | 88% | After a median follow-up of 9 months |
Figures are quoted from this announcement and selected automatically.
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Announcement Summary
Oryzon Genomics, S.A. (ORY) announced that three abstracts on iadademstat were accepted for presentation at ASH 2025.
- The 67th ASH Annual Meeting is scheduled for December 6-9, 2025, in Orlando, Florida, covering AML and MPN studies.
- FRIDA Phase Ib had enrolled 34 patients across 4 dose-level cohorts, including 14 patients at the selected expansion dose.
- Among 12 evaluable FRIDA patients, the response rate was 67% (8/12) and complete response rate was 58% (7/12).
- Three FRIDA patients underwent HSCT. The OHSU-sponsored trial combines iadademstat, azacitidine and venetoclax in newly diagnosed AML.
- Among the first 8 OHSU trial patients, ORR was 100% (n=8), CR was 88%, and MLFS was 12.5%.
- The NCI-sponsored Phase II MPN trial recently started enrolling; dose escalation will preced randomized 1:1 treatment, with 25 patients on each arm.
Poster presentations are scheduled for December 6, 7 and 8, 2025; updated FRIDA data will be presented. The primary MPN endpoint is ALR-C or better within 4 cycles, with interim futility analysis after 25 patients are enrolled and followed for ALR-C.
Investor FAQs
Oryzon Genomics announced that three abstracts featuring iadademstat had been accepted for presentation at the 67th American Society of Hematology Annual Meeting. The abstracts cover two ongoing AML studies and a Trial-in-progress abstract for a new randomised study in advanced myeloproliferative neoplasms.
The abstracts will be presented at the ASH Annual Meeting in Orlando, Florida, USA, from December 6-9, 2025. The source gives individual presentation dates and times for each abstract, including December 6, December 7 and December 8, 2025.
Oryzon Genomics describes itself as a clinical-stage biopharmaceutical company and a global leader in epigenetics. Iadademstat is its selective LSD1 inhibitor for onco-hematology, and the announcement covers its use in combination studies for blood cancers.
The announcement identifies Oryzon Genomics, S.A. with ISIN Code: ES0167733015 and the ticker symbol ORY. It does not state a listing venue.
The Phase Ib FRIDA study, NCT05546580, is evaluating the safety, tolerability and recommended Phase 2 dose of iadademstat plus gilteritinib in FLT3-mutated relapsed or refractory AML. At the time of abstract submission, 34 patients had been enrolled and 4 dose level cohorts had been evaluated in the escalation phase.
At the selected dose for expansion, the combination showed a 67% response rate, representing 8/12 patients, and a 58% complete response rate, defined as CR+CRh+CRi and representing 7/12 patients, among 12 evaluable patients. Three patients had undergone HSCT, and Oryzon Genomics said updated data would be presented at the congress.
Oryzon Genomics said the combination was tolerable at the tested doses and that the study was in the expansion phase at one selected pharmacologically active dose. The announcement does not provide a separate numerical safety result for the combination.
The Phase Ib trial, NCT06357182, is evaluating iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed AML. Preliminary data from the first 8 patients enrolled were scheduled for presentation at ASH.
The first 8 patients produced an overall response rate of 100% (n=8), with 88% achieving complete remission and 12.5% achieving a morphologic leukemia-free state. After a median follow-up of 9 months, the estimated 6-month overall survival was 88%, and no dose-limiting toxicities were observed.
The Phase II study, NCT06661915, is investigating ASTX727, an oral decitabine and cedazuridine treatment, with or without iadademstat in accelerated/blast-phase myeloproliferative neoplasms. It will compare iadademstat plus ASTX727 with ASTX727 monotherapy during a randomised phase after dose escalation.
The dose-escalation phase will use a 3+3 design to identify the recommended Phase 2 dose of iadademstat plus ASTX727. The randomised phase will use a 1:1 allocation, with 25 patients treated on each arm, and the primary endpoint will be the rate of acute leukaemia response-complete or better within 4 cycles of therapy.
The study is sponsored and conducted by the National Cancer Institute and had recently started enrolling patients when the announcement was made. An interim futility analysis will be performed after 25 patients are enrolled and followed for acute leukaemia response-complete.
Dr Ana Limón said the emerging AML data indicated that adding iadademstat to venetoclax plus azacitidine or to gilteritinib enhanced efficacy without increasing toxicity, and described the finding as particularly noteworthy in the FLT3-positive relapsed/refractory population. Chief Executive Officer Dr Carlos Buesa said the results to be presented were very promising and showed potential for iadademstat to work with existing standard-of-care regimens, while also referring to good tolerability.
The third abstract is a Trial-in-progress abstract, which provides the design, objectives and status of the ongoing trial without reporting results. The source states that the study had recently started enrolling patients, so the abstract does not provide clinical outcome data for the randomised MPN study.
Source announcement
- Company
- Oryzon Genomics S.A.
- Title
- ORYZON announces positive clinical data of iadademstat at ASH-2025
- Published
- Source site
- oryzon.com
Read the source announcement on oryzon.com
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