GL-ONC1, Genelux Corporation’s leading investigational product candidate, is a genetically stable oncolytic virus designed to locate, enter, colonize and destroy cancer cells without harming healthy tissues or organs. GL-ONC1 is based on vaccinia virus (Lister strain), which was used safely in millions of people as the vaccine against smallpox. Scientists at Genelux have modified this virus to increase its safety, tumor selectivity and anti-tumor activity without limiting its ability to replicate in cancer cells.

In preclinical testing, the virus has efficiently eliminated more than 40 types of solid human tumors. GL-ONC1 also carries a unique fusion protein designed to provide non-invasive, real-time imaging capabilities, including tumor diagnosis and localization, microscopic analysis of tumor biopsies, cancer staging and follow-up treatment monitoring. In preclinical testing, GL-ONC1 has shown remarkable effectiveness not only as a single agent therapy (Monotherapy) but also to work synergistically in combination with chemotherapy, radiation therapy as well as monoclonal antibodies.

GL-ONC1 has successfully completed GMP production (Good Manufacturing Practices) of clinical-quality material and is currently being studied in Phase I and Phase I/II clinical trials in human cancer patients. Data from the company’s first-in-man human clinical trial indicate GL-ONC1 is safe at therapeutic dose levels, successfully targets and enters tumors after intravenous injection, and that there are early indications of anti-tumor activity. Additional Phase I/II trials as well as planned Phase II studies will further establish optimal dosing in cancers most responsive to therapy with GL-ONC1.

GL-ONC1 Clinical Results

A Genelux-sponsored Phase 1 (First-in-Man, Safety & Dosing) study was conducted at Royal Marsden Hospital (Surrey, UK) and featured intravenous administration of GL-ONC1 in 27 patients with advanced solid tumor cancers, Final results of the study were presented during poster sessions by the study’s principal investigators at ASCO (June 2012). Click here for ASCO Poster Presentation.

Highlights include:

  • > GL-ONC1 is well-tolerated with minimal toxicity
  • > GFP expression was observed in man for the first time
  • > Systemically-administered GL-ONC1 survived the immune system and arrived at the tumor
  • > There were early signs of anti-tumor activity in a variety of tumor types

Conclusion: GL-ONC1 is well tolerated with minimal toxicity and preliminary evidence of anti-tumor activity.