ORYZON enters cooperative research and development agreement (CRADA) with U.S. National Cancer Institute to develop iadademstat in different cancers
Wednesday, July 20, 2022
Oryzon Genomics, S.A., a biopharmaceutical company focused on leveraging epigenetics to develop therapies for diseases with significant unmet medical needs, announced today the establishment of a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), a division of the National Institutes of Health. The collaboration between Oryzon and the NCI aims to explore the potential for further clinical development of Oryzon's clinical-stage LSD1 inhibitor, iadademstat, in various types of solid tumors and hematological cancers.
Dr. Carlos Buesa, President and CEO of Oryzon, expressed his enthusiasm for the agreement, stating, "This research and development agreement with the NCI serves as strong validation of iadademstat, which is currently one of the most potent and selective LSD1 inhibitors under clinical development. It will also enable us to significantly expand our clinical development program for this compound."
Dr. Douglas V. Faller, Oryzon's Global Chief Medical Officer, emphasized the collaborative nature of the partnership, stating, "This collaboration with the NCI on the development of iadademstat will allow us to work alongside some of the world's leading oncology researchers to further explore its therapeutic potential. It also greatly enhances our ability to conduct clinical trials across a wide range of indications, including in combination with other novel or established therapies such as immuno-oncology and molecularly-targeted agents."
Iadademstat is an orally active, highly potent, and selective inhibitor of the epigenetic enzyme LSD1, known for its differentiating effects in hematologic cancers. Over 100 cancer patients have already received treatment with iadademstat in several trials. Encouraging safety and efficacy data have been observed in an ongoing Phase IIa trial (ALICE trial) involving elderly 1L acute myeloid leukemia (AML) patients who received iadademstat in combination with azacitidine. Oryzon is now commencing a Phase Ib trial of iadademstat in combination with gilteritinib for FLT3 mutant relapsed/refractory AML patients, which recently received IND approval from the FDA. In addition to hematological cancers, the inhibition of LSD1 has shown potential as a therapeutic approach for certain solid tumors, including small cell lung cancer (SCLC), neuroendocrine tumors, and medulloblastoma, among others. Preliminary efficacy results have been reported from a Phase IIa trial combining iadademstat with platinum/etoposide in second-line ED-SCLC patients (CLEPSIDRA trial, now concluded). Iadademstat has recently obtained orphan drug designation from the FDA for SCLC and has orphan drug status in the U.S. for both SCLC and AML.
