GENELUX Corp

Genelux is a late clinical-stage biopharmaceutical company developing next-generation oncolytic viral immunotherapies for patients with aggressive and/or difficult-to-treat tumor types. The company's clinical and preclinical product candidates are designed to selectively kill tumor cells and trigger a strong immune response against a patient's tumor. These oncolytic immunotherapy product candidates are "off-the-shelf" personalized immunotherapies, meaning the same virus product is administered to different patients, but the resulting cellular immune response is expected to be specific to each patient's unique tumor. Genelux's lead product candidate is Olvi-Vec (olvimulogene nanivacirepvec), a proprietary, modified strain of the vaccinia virus (VACV). Using its proprietary selection technology and discovery and development platform (CHOICE), Genelux has built a library of isolated and engineered oncolytic VACV immunotherapeutic product candidates. These candidates have potential use in various tumor types, both as a single therapy and in combination with other treatments, and can be administered through regional (e.g., intraperitoneal), local, and systemic (e.g., intravenous) delivery routes. The company is currently executing a late-stage clinical program for Olvi-Vec to demonstrate its ability to resensitize tumors to platinum-based therapies in multiple indications. Olvi-Vec is being evaluated in three clinical trials: a Phase 3 registrational trial in the U.S. for patients with platinum-resistant/refractory ovarian cancer (PRROC), a Phase 2 clinical trial in the U.S. for patients with recurrent non-small cell lung cancer (NSCLC), and a Phase 1b/2 clinical trial in China for patients with recurrent small cell lung cancer (SCLC). The Phase 3 registrational trial, named OnPrime/GOG-3076, is specifically evaluating intraperitoneal administration of Olvi-Vec for PRROC patients.