ORYZON Announces Notice of Allowance for U.S. Patent Application Covering Iadademstat Combination With Gilteritinib

• Iadademstat is under clinical development in acute myeloid leukemia (AML), including in combination with gilteritinib in the Phase Ib FRIDA trial in patients with FLT3-mutated relapsed/refractory (R/R) AML 
• FRIDA data presented at EHA-2026 showed a high composite complete remission (CRc) rate of 67% in heavily pretreated FLT3-mutated R/R AML patients, together with a favorable safety profile

MADRID and CAMBRIDGE, Mass., Aug. 31, 2026 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application No. US 18/554,241, entitled “Combinations of LSD1 inhibitors for treating myeloid cancers”. The allowed claims cover combinations of iadademstat, or certain other LSD1 inhibitors, with gilteritinib and their use for the treatment of myeloid cancers, including acute myeloid leukemia (AML).

Once granted, the U.S. patent is expected to expire in 2042, excluding any potential patent term adjustment or patent term extension. A corresponding patent has recently also been granted in Taiwan, with additional patent applications pending in other jurisdictions.

“This U.S. Notice of Allowance further strengthens the intellectual property protection around iadademstat and its use in combination with gilteritinib in AML,” said Neus Virgili, Oryzon’s Chief IP Officer. “Together with our broader portfolio of patents covering iadademstat combinations with other AML therapies, this allowance reinforces the long-term protection of our iadademstat franchise.”

Iadademstat is currently being evaluated in seven ongoing oncology clinical trials, including the Phase Ib FRIDA study in combination with gilteritinib in FLT3-mutated relapsed/refractory AML and the Phase Ib ALICE-2 study in combination with venetoclax and azacitidine in first-line AML. Updated positive clinical data from both studies were presented at the European Hematology Association (EHA) 2026 Annual Congress in June.

In FRIDA, iadademstat in combination with gilteritinib achieved a composite complete remission (CRc) rate of 67% at the dose level selected for expansion in a heavily pretreated population with relapsed/refractory FLT3-mutated AML, together with a favorable safety profile. These results are particularly encouraging when compared with contemporary real-world data for gilteritinib monotherapy in a broadly comparable population, which reported a CR/CRi rate of 28% and a median overall survival of 7.1 months.

In ALICE-2, iadademstat in combination with venetoclax and azacitidine achieved a 100% overall response rate, an 89% CRc rate and a 78% complete remission rate. These findings compare favorably with historical outcomes for venetoclax plus azacitidine, where approximately 36% of patients failed to achieve a clinical response. Additional, more mature data from both studies are expected to be presented by year-end.

In addition to this patent family covering combinations with gilteritinib, Oryzon has patent protection covering combinations of iadademstat with venetoclax, azacitidine and other AML therapies, including granted patents in the United States and other major markets.

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, with several ongoing Phase I and II studies and which has demonstrated strong preliminary clinical activity in acute myeloid leukemia, including a 100% 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 in both trials reported at EHA-2026: 100% overall response rate (ORR) and 89% composite complete remission rate (CRc), with 78% strict CR in 1L AML, and 67% CRc in R/R Flt3-mut AML. 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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Oryzon Genomics, S.A.