On March 14, 2023 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, reported the enrollment of the first patient in its Phase Ib trial of iadademstat in combination with gilteritinib in patients with relapsed/refractory acute myeloid leukemia (AML) harboring a FMS-like tyrosine kinase mutation (FLT3mut+), at the Massachusetts General Hospital in Boston, US (Press release, Oryzon, MAR 14, 2023, View Source;utm_medium=email&utm_campaign=NdP.07+15-03-2023+FPI+FRIDA+ENG562 [SID1234628705]).
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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). The trial’s principal investigator is Amir Fathi, M.D., Associate Professor at Harvard Medical School and Director of the Leukemia Program at Massachusetts General Hospital. 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.
Dr. Carlos Buesa, President and CEO of Oryzon, said: "FRIDA’s initiation is a significant corporate milestone for Oryzon, marking a further expansion of our clinical pipeline as we seek to improve the treatment options for patients. Iadademstat has already shown strong efficacy data in AML. We hope this combination will open up new ways to treat these patients and make an important difference to their outlooks."
Oryzon’s Global Chief Medical Officer, Dr. Douglas Faller, said: "We are pleased to announce the first patient entering into the FRIDA trial. It is our hope that the combination of iadademstat and gilteritinib will safely provide deep and durable responses for patients whose leukemias are driven by FLT3 mutations."
FRIDA’s scientific rationale is based on iadademstat’s ability to inhibit the lysine specific demethylase 1 (LSD1), thereby triggering a powerful differentiating effect in hematologic cancers, as well as producing an anti-leukemic effect by targeting leukemic stem cells. Furthermore, the combination of iadademstat with
gilteritinib demonstrated a very strong synergy in FLT3·mut+ AML preclinical models. This together with the fact that iadademstat has been administered to more than 100 cancer patients (including AML patients) demonstrating a good safety profile, activity and excellent pharmacologic properties supports exploring its combination with FLT3 inhibitors in FLT3·mut+ AML, targeting between 30-40% of AML patients. In a recently finalized, Phase IIa study (ALICE trial) in elder/unfit AML patients, iadademstat demonstrated robust efficacy in combination with azacitidine, with 81% ORR in the evaluable patients, of which 64% were CR/CRi. Final data from the ALICE trial were presented as an oral communication at the recent 64th ASH (Free ASH Whitepaper) annual conference (see here for more details).