Oryzon Achieves 100% ORR with Iadademstat Triplet in Newly Diagnosed AML at EHA 2026

With a registrational study in first-line AML now targeted for 2027, Oryzon Genomics' updated ALICE-2 and FRIDA trial data presented at the European Hematology Association (EHA) Annual Congress carry direct implications for CMC teams and contract manufacturing organizations beginning to model commercial-scale LSD1 inhibitor supply chains.

In the Phase Ib ALICE-2 trial (NCT06357182), iadademstat combined with azacitidine and venetoclax produced a 100% overall response rate (18/18), an 89% composite complete remission rate (16/18), and a 78% complete response rate (14/18) in newly diagnosed, unfit AML patients. Responses occurred predominantly within cycle 1. Notably, all patients carrying TP53 or RAS pathway mutations achieved complete response, a subgroup historically associated with poor outcomes on standard doublet therapy.

The FRIDA trial, evaluating iadademstat with gilteritinib in FLT3-mutated relapsed/refractory AML, reported a 67% composite complete remission rate alongside a favorable safety profile, consistent with earlier readouts. A meaningful proportion of ALICE-2 patients subsequently transitioned to allogeneic hematopoietic cell transplantation, a downstream variable that process development teams will need to account for when modeling real-world demand cycles and batch scheduling.

For drug substance manufacturers and CMOs engaged in early commercial readiness discussions, the LSD1 inhibitor class presents distinct synthetic complexity. Selective LSD1 inhibitors typically require tightly controlled stereochemical synthesis steps, and any registrational program filing under 21 CFR Part 211 or ICH Q10 quality system expectations will demand robust process validation packages well ahead of a 2027 IND-to-BLA transition timeline. Oryzon has not publicly disclosed its CMO partnerships or current manufacturing scale, leaving supply-chain architecture an open question as enrollment in ALICE-2 passes the 80% threshold.

Final ALICE-2 data are expected by year-end 2026, the checkpoint that will most directly shape the registrational study design and, with it, the process validation and comparability requirements CMC leads will need to address before pivotal batches are committed.

Source: Oryzon Genomics via company press release, June 10–11, 2026.