ORYZON Receives FDA Clearance for Iadademstat and Immune Checkpoint Inhibitors Trial in 1L Extensive Stage SCLC

Oryzon Genomics, a biopharmaceutical firm specializing in epigenetic therapies for diseases with significant medical needs, has received approval from the U.S. FDA to begin a Phase I/II clinical trial. The trial will test the combination of iadademstat, an epigenetic drug, with immune checkpoint inhibitors for the treatment of first-line extensive-stage small cell lung cancer (SCLC) patients. 

The study, known as NCT06287775, will be led by the National Cancer Institute (NCI) and Dr. Noura Choudhury from Memorial Sloan Kettering Cancer Center (MSKCC), with participation from several renowned cancer centers across the U.S. The trial aims to enroll 45-50 patients and is part of a Cooperative Research and Development Agreement (CRADA) between Oryzon and the NCI. Dr. Carlos Buesa, CEO of Oryzon, expressed optimism about the trial's potential to enhance the current standard of care for SCLC patients by leveraging the unique anti-cancer properties of iadademstat. 

Oryzon, established in 2000 in Barcelona, is a leader in European epigenetics and focuses on personalized medicine in central nervous system disorders and oncology. The company has an advanced clinical portfolio, including two LSD1 inhibitors, vafidemstat for CNS disorders and iadademstat for oncology, which are in various Phase II clinical trials. Iadademstat, an oral molecule and selective inhibitor of the epigenetic enzyme LSD1, has shown safety, tolerability, and preliminary antileukemic activity in clinical trials. It is also being evaluated in combination with other treatments for various cancers, including a Phase II basket study with the Fox Chase Cancer Center. The company has received orphan drug designation for iadademstat in SCLC in the U.S. and for AML in both the U.S. and EU. 

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