Oryzon Genomics has initiated a Phase I/II trial evaluating iadademstat, an LSD1 inhibitor, combined with immune checkpoint inhibitors (atezolizumab or durvalumab) as a first-line treatment for extensive-stage small cell lung cancer (SCLC). Sponsored by the National Cancer Institute (NCI), this trial marks the first clinical investigation of iadademstat with ICIs and builds upon preclinical data suggesting iadademstat can enhance the visibility of SCLC cells to the immune system. The trial, led by Dr. Charles Rudin at Memorial Sloan Kettering Cancer Center (MSKCC), aims to enroll 45-50 patients across several US cancer centers.
This trial addresses a critical need in SCLC treatment, where current therapeutic options offer limited efficacy, especially for patients with extensive-stage disease. The combination of iadademstat with ICIs holds promise for improving outcomes by leveraging the drug’s potential to prime the immune system for a more effective anti-tumor response. Positive results could significantly alter the treatment landscape for SCLC and potentially pave the way for accelerated regulatory pathways.
The Phase I/II trial will assess the safety, tolerability, and efficacy of iadademstat in combination with either atezolizumab or durvalumab. The trial is being conducted under a Cooperative Research and Development Agreement (CRADA) between Oryzon and the NCI. Prior research suggests low LSD1 expression correlates with improved patient response and survival in SCLC, further supporting the rationale for this combination therapy.
Positive results from this trial could position iadademstat as a key component of future SCLC treatment regimens. This could lead to further clinical development and potential regulatory filings, ultimately providing a much-needed new treatment option for patients with this aggressive form of lung cancer. The trial’s outcome also carries significant implications for Oryzon, potentially validating its epigenetic approach to cancer therapy and bolstering its oncology pipeline.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
