Oryzon wins US patent allowance for iadademstat-gilteritinib AML combo
Oryzon Genomics has received a Notice of Allowance from the United States Patent and Trademark Office for a patent application covering combinations of its LSD1 inhibitor iadademstat with gilteritinib, a FLT3 inhibitor marketed by Astellas, for the treatment of myeloid cancers including acute myeloid leukemia. The allowed claims also extend to certain other LSD1 inhibitors paired with gilteritinib. Once formally granted, the patent is expected to expire in 2042, before any potential term adjustment or extension.
Oryzon already holds granted US patents covering iadademstat in combination with venetoclax and azacitidine, and the Barcelona-headquartered company describes this new allowance as reinforcing what it terms its "iadademstat franchise." A corresponding patent has been granted in Taiwan, with applications pending in additional jurisdictions.
Clinical backdrop
The intellectual property move is backed by emerging clinical data. At the European Hematology Association annual congress in June 2026, Oryzon presented updated results from two Phase Ib studies. In the FRIDA trial, iadademstat combined with gilteritinib achieved a composite complete remission rate of 67% at the dose level selected for expansion in heavily pretreated patients with relapsed/refractory FLT3-mutated AML. Oryzon noted that contemporary real-world data for gilteritinib monotherapy in a broadly comparable population report a CR/CRi rate of 28% and median overall survival of 7.1 months, providing an informal benchmark for the combination's apparent activity.
The ALICE-2 study, an investigator-initiated trial led by Oregon Health and Science University, tested iadademstat with venetoclax and azacitidine in first-line AML and reported a 100% overall response rate, an 89% composite complete remission rate and a 78% strict complete remission rate. Historical data for the venetoclax-azacitidine doublet suggest roughly 36% of patients fail to achieve a clinical response, making the triplet results noteworthy. Oryzon has indicated it plans a potentially registrational study in first-line AML, contingent on positive final ALICE-2 data. More mature datasets from both trials are expected to be presented before the end of 2026.
Neus Virgili, Oryzon's Chief IP Officer, said the allowance "reinforces the long-term protection of our iadademstat franchise" alongside the broader patent portfolio covering other AML combination regimens.
Market and competitive context
AML is a crowded but commercially significant indication. The approval of gilteritinib monotherapy (Xospata) for FLT3-mutated R/R AML, together with the venetoclax-azacitidine combination (Venclexta plus azacitidine) in front-line unfit patients, has reshaped the treatment landscape over the past five years. Combination strategies layering a novel mechanism on top of established backbones are now a dominant clinical development paradigm, with several companies exploring IDH inhibitors, menin inhibitors and other epigenetic agents in analogous triplet or doublet designs.
LSD1 inhibition remains a relatively early epigenetic modality in haematology. Oryzon is among a small number of companies advancing LSD1-targeted programmes into later-stage combination studies, and securing robust IP coverage around specific combination regimens is a standard commercial precaution when a modality gains clinical traction. The 2042 expiry horizon, if the patent is granted without significant challenge, provides Oryzon with a long runway for commercial exploitation should iadademstat reach approval in AML. Investors will be watching the year-end data readouts from FRIDA and ALICE-2 as the critical near-term catalysts for any decision on a registrational programme.