ORYZON awarded EU Seal of Excellence and public financing of 2 M USD to develop iadademstat in Acute Myeloid Leukemia
- Non-refundable funds from the Next Generation-EU program
MADRID, SPAIN and CAMBRIDGE, MA, UNITED STATES, June 7th, 2022 - 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 it has been awarded the Seal of Excellence, a quality label awarded by the European Commission, and a non-refundable public grant of 1.87 M €.
The funding is for Oryzon’s project entitled “Development of new treatments against Acute Myeloid Leukemia (AML) using iadademstat,an epigenetic drug” with a duration of 30 months (January 2022 - June 2024). The overall goal of this project is to supplement the execution costs of iadademstat’s ongoing FRIDA clinical study, and to develop the formulation and manufacturing processes for industrial production and worldwide supply of iadademstat. The U.S. Food and Drug Administration (FDA) has recently approved an Investigational New Drug (IND) application for FRIDA, a clinical trial to evaluate efficacy and optimal dose of iadademstat plus gilteritinib in patients with relapsed/refractory AML with FLT3 mutations.
Dr. Carlos Buesa, Oryzon’s Chief Executive Officer, said: “We are grateful to the EU for honoring Oryzon with the Seal of Excellence award, and to the Spanish Ministry of Science and Innovation and CDTI for this financing from European funds. Europe needs to create technological and industrial acceleration instruments to compete globally with the USA and China. Our project is a clinical stage drug with an innovative mechanism of action and with potential for accelerated development. It will make a significant difference to patients, and is an ideal fit for this European strategy.”
The Spanish Ministry of Science and Innovation, through its subsidiary body CDTI, manages the procedure for the direct granting of funding for R&D projects and industrial feasibility studies of SMEs that have previously obtained a Seal of Excellence in the call of the European Innovation Council Accelerator instrument (EIC Accelerator) of the Horizon Europe Program. The Seal of Excellence certificate recognises the value of the proposal and helps other funding bodies take advantage of the high quality Commission evaluation process.
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European leader in epigenetics. Oryzon has one of the strongest portfolios in the field, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II clinical trials, and other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com
Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). In an ongoing Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2021 poster). The company has recently obtained approval from the U.S. FDA for its IND for FRIDA, a Phase Ib trial of iadademstat plus gilteritinib in patients with relapsed/refractory AML with FLT3 mutations. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). New trials in combination in SCLC and NET are under preparation. In total iadademstat has been dosed so far to more than 100 cancer patients in four clinical trials.
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