ORYZON to present trial in progress Phase Ib FRIDA study at the upcoming 2023 ASCO annual meeting

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today announced the presentation of the trial in progress (TIP) FRIDA poster entitled Iadademstat in combination with gilteritinib for patients with mutated FLT3 relapsed/refractory acute myeloid leukemia at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, to be held in-person from June 2-6, 2023 at the McCormick Place in Chicago, Illinois.

Dr. Amir Fathi, Director of the Leukemia Program at Massachusetts General Hospital, is the Principal Investigator of the study and first author of the poster. He will be recording a brief video summarizing the poster information and study status.

Dr. Douglas V. Faller, Oryzon's Global Chief Medical Officer, will attend the poster presentation, which will take place during the Poster Discussion Session on Monday June 5 from 8:00 AM-11:00 AM within the Hematologic Malignancies-Leukemia, Myelodysplastic Syndromes, and Allotransplant Session.

FRIDA (NCT05546580) is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3·mutations. The trial's primary objectives are to evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3mut+ R/R AML and to establish the Recommended Phase 2 Dose (RP2D) for this combination. Secondary objectives include evaluation of the treatment efficacy, measured as the rate of complete remission and complete remission with partial hematological recovery (CR/CRh), the duration of responses (DoR) and the assessment of measurable residual disease (MRD). FRIDA will be conducted in 10-15 sites in the US. The study will enroll up to approximately 45 patients and if successful, the Company and FDA have agreed to hold a meeting to discuss the best plan to further develop this combination in this much in need AML population.

Presentation materials will be available both on the ASCO website and on our website under the Events section following the session.