Oryzon Genomics, S.A. announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I/II trial with iadademstat plus immune checkpoint inhibitors in first line small cell lung cancer (SCLC) patients with extensive disease. This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors. The trial (NCT06287775) is entitled ?A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive Stage Small Cell Lung Cancer?.

This Phase I/II clinical study will be conducted and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, where Dr. Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) will be the main PI for this trial and will be implemented by a number of prestigious cancer centers in the US, including the MSKCC, the JHU Sidney Kimmel Comprehensive Cancer Center and many others. The trial plans to enroll 45-50 patients and will be carried out under a Cooperative Research and Development Agreement (CRADA) that Oryzon has in place with the NCI.