Oryzon Genomics - FDA green light for SCLC combination trial

With the FDA investigational new drug (IND) application clearance, Oryzon can commence its Phase I/II cooperative research and development agreement (CRADA) trial sponsored by the National Cancer Institute (NCI; part of the National Institutes of Health) with Dr Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) as the principal investigator. This trial will evaluate iadademstat in combination with immune checkpoint inhibitors (ICIs) for the treatment of first-line extensive-stage small-cell lung cancer (SCLC). This is a key development for Oryzon as interim results from this study will influence the design of the company-sponsored Phase Ib/II STELLAR trial. The IND application for this is likely to be filed by end-2024 (trial commencing in 2025). ICIs atezolizumab and durvalumab are currently approved as first-line treatments in SCLC and Oryzon expects a combination with iadademstat to enhance immune activity in patients, increasing therapeutic efficacy. The CRADA-MSKCC trial will enrol 40–50 patients, with updates expected through 2024.