NEW YORK – Oryzon Genomics said Tuesday that it received a non-refundable public grant worth about €1.9 million ($2 million) to develop iadademstat as a treatment for acute myeloid leukemia.
Iadademstat is a small molecule inhibitor of lysine-specific histone demethylase 1 (LSD1). The US Food and Drug Administration has cleared the Madrid-based company to conduct a Phase Ib trial (FRIDA) of iadademstat with Astellas' Xospata (gilteritinib) in patients with relapsed or refractory acute myeloid leukemia harboring an FLT3 mutation.
The trial will evaluate safety and tolerability of the drug combination in about 45 patients, and establish a recommended dose for a Phase II trial. Additional endpoints for the trial include rates of complete remission, duration of response, and measurable residual disease.
The grant will fund development of a formulation and manufacturing process for iadademstat and part of the costs of the FRIDA clinical trial.
Oryzon also said that the European Commission awarded it the Seal of Excellence, a quality label that recognizes the value of an R&D project and helps other funding bodies take advantage of the EC's evaluation process.
"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," Oryzon CEO Carlos Buesa said in a statement. "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."
Oryzon is also investigating iadademstat as a first-line treatment in combination with immune checkpoint inhibitors for small-cell lung cancer and in neuroendocrine tumors.