ORYZON announces first patient dosed in an Investigator-initiated Phase Ib study of iadademstat in first-line acute myeloid leukemia

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the first patient has been dosed in an investigator-initiated Phase Ib dose-finding trial of iadademstat, Oryzon’s potent and selective LSD1 inhibitor, in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML), sponsored by the Oregon Health & Science University (OHSU) Knight Cancer Institute.

Under the direction of Dr. Curtis Lachowiez at OHSU Knight Cancer Institute, the study (NCT06357182) aims to test the safety, tolerability, and best dose of iadademstat when administered together with the standard-of-care venetoclax and azacitidine in treating patients with newly diagnosed AML. The trial also aims to assess the preliminary efficacy of the triple combination.

Dr. Curtis Lachowiez, Principal Investigator of the study, stated: “Given the activity observed with LSD1 inhibition in combination with azacitidine in AML, testing a triplet combination including iadademstat with the highly active backbone of azacitidine+venetoclax is the logical next step to hopefully improve outcomes of patients living with AML if proven to be safe and active”.

Dr. Carlos Buesa, Oryzon’s CEO, added: “This trial builds on the positive results obtained in our ALICE trial in first-line AML, where the combination of iadademstat with azacitidine showed strong antileukemic activity with deep and durable responses and a manageable safety profile, including in patients with high-risk prognostic factors that respond poorly to venetoclax+azaciditine.”

In AML, iadademstat is also being evaluated in a company-sponsored Phase Ib trial in combination with gilteritinib in patients with relapsed/refractory AML harboring a FMS-like tyrosine kinase mutation (FLT3mut+). This FRIDA trial is being conducted in the U.S. Preliminary results from FRIDA, corresponding to the first two cohorts, were recently presented at the European Hematology Association (EHA) 2024 congress in June. Our results demonstrated that combination of iadademstat plus gilteritinib was safe and well tolerated, and showed encouraging antileukemic activity.