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GL-ONC1

GL-ONC1 is a genetically stable oncolytic virus strain designed to locate, enter, colonize and destroy cancer cells without harming healthy tissues or organs. GL-ONC1 is based on vaccinia virus, 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 several 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.

GL-ONC1 has successfully completed preclinical testing and GMP production (Good Manufacturing Practices) of clinical-quality material. GL-ONC1 is currently being prepared for clinical trials in humans.

Proposed mechanism of action

• Vascular Introduction and Tumor Penetration

  After GL-ONC1 is administered intravenously, the viral particles travel through the blood stream, distributing themselves throughout the body. Viral particles that encounter healthy tissues and organs are eliminated by the body’s immune system. Remaining viral particles are able to evade the patient’s immune response by entering tumors and metastases through gaps (fenestrations) in the tumor vasculature. The “immuno-privileged” tumor microenvironment provides a virtual “safe haven” where the virus can survive and replicate without interference.

• Viral Infection of Tumor Cells and Replication

  Once inside the tumor, viral particles invade tumor cells and replicate rapidly in the cells’ cytoplasm. Since the DNA of this virus does not enter the nucleus of the cell, it cannot integrate into the cell’s genome, thereby eliminating the risk of mutation of the host DNA. Viral replication activates marker genes such as GFP, causing infected cancer cells to emit light. Scientists use this light emission to monitor viral infection and eventually the regression of tumors and metastases.

• Amplification and Oncolysis

  Viral replication ultimately causes tumor cells to self-destruct and release mature viral particles into the tumor. These newly-released viral particles repeat the process by infecting and killing neighboring tumor cells. A virus-driven "micro-pharmaceutical factory™" forms inside each tumor cell. It continually manufactures therapeutic and diagnostic compounds until every tumor cell is destroyed.

• Viral Particle and Tumor Antigen Release

  The oncolytic process also harnesses the body’s immune system to fight the cancer. As viral particles begin destroying tumor cells, tumors release tumor antigens and tumor cell debris into the bloodstream.

• Immune Stimulation

  The newly-released tumor antigens and tumor cell debris trigger the formation of antibodies. The immune system further helps attack the tumor from the outside.

• Tumor Regression and Virus Elimination

  The “micro-pharmaceutical factory” produces until tumors and metastases are almost completely destroyed. Once the protective tumor microenvironment is gone, remaining viral particles or dead tumor cells are destroyed by newly-recruited immune cells. GL-ONC1 has rid the body of tumors and metastases without leaving behind viral particles or harming healthy tissues or organs.