Genelux and Newsoara Announce Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer

Core Insights - Olvi-Vec shows promise as a platinum resensitizing agent for various solid tumors, particularly in platinum-relapsed or platinum-refractory extensive small cell lung cancer [1][3][10] - The ongoing Phase 1b trial indicates a favorable safety profile and preliminary anti-tumor activity, with a 71% disease control rate observed [5][7][8] Company Overview - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing oncolytic immunotherapies, with Olvi-Vec as its leading candidate [15] - Newsoara BioPharma Co., Ltd. is a pre-commercial-stage biopharmaceutical company collaborating with Genelux on the Olvi-Vec clinical trials [16] Clinical Trial Details - The Olvi-Vec-SCLC-202 trial is a Phase 1b/2 study assessing the safety, tolerability, pharmacokinetics, and efficacy of Olvi-Vec in patients with extensive small cell lung cancer [10][12] - The trial is currently enrolling patients in China, with Shanghai Chest Hospital as the lead clinical site [10] Safety and Efficacy Findings - The systemic administration of Olvi-Vec demonstrated a manageable safety profile, with treatment-related adverse events primarily mild to moderate [5][6] - In the initial dose escalation cohorts, 71% of participants achieved disease control, with significant tumor reductions noted in several cases [7][8] Future Directions - Ongoing evaluation of Phase 1b results will inform the design of the Phase 2 portion of the clinical trial [9][13] - Genelux plans to provide updates on trial progress through future publications and conference presentations [4]