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.
Oryzon Genomics, S.A., 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.