Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer
Overview
Genelux Corporation a late-stage clinical immuno-oncology company, today announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies.
Words from the CEO: Genelux
- Today's milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options,"" said Thomas Zindrick, President, CEO and Chairman of Genelux.
- This Phase 2 trial, in addition to our ongoing Phase 1b/2 trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma Co. Ltd., signifies the key advancement of Olvi-Vec to potentially be an important systemically administered oncolytic virus treatment option, setting the stage for the future of this promising field.""
VIRO-25 Clinical Trial
- The VIRO-25 clinical trial (NCT06463665), is an open-label, randomized study in NSCLC designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of ICI compared with docetaxel in patients with advanced or metastatic NSCLC who have shown first disease progression while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.
- Olvi-Vec’s previous data suggests a manageable safety profile, and this trial looks to further confirm the hypothesis that Olvi-Vec may resensitize to platinum in multiple tumor types. Genelux expects interim data readout in mid-2025.
About Olvi-Vec
- Olvi-Vec is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity.
- Genelux is developing Olvi-Vec for the treatment of multiple cancers based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response.
- To date, Olvi-Vec has been administered to more than 150 patients in seven clinical trials.
- In these studies, Olvi-Vec was observed to be generally well tolerated and the data provided evidence of clinical benefit.
- Genelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types.
Company Products
- The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus.
- Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer.
- The core of Genelux's discovery and development efforts revolves around its’ proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec
