GL-ONC1: ONCOLYTIC CANCER THERAPY AND DIAGNOSTIC

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

GL-ONC1 has been evaluated in four completed Phase 1/1b human clinical trials with 89 cancer patients. GL-ONC1 was tested against a wide range of cancer types, with various methods of administration (i.e. intravenously or regionally), either as a single agent therapy or in combination with conventional therapy. There are three (3) important readouts: importantly, these readouts are transferable across different sites, primary investigators, protocols and cancer types!

(i) Safety. GL-ONC1 is well-tolerated, without significant adverse side effects, without concerns about environmental spread, and without reaching a “Maximum Tolerated Dose”.

(ii) Mechanism of Action. Through clinically-preferred routes of administration, the virus has been delivered successfully to the tumor, infected and selectively killed tumor cells – such as those that establish deadly new metastases, and initiated an anti-tumoral immune response.

(iii) Clinical Benefit. Although the completed Phase 1/1b studies were designed primarily for safety, GL-ONC1 has been shown to have encouraging evidence of efficacy, with anti-tumor activities including tumor reduction/durable stabilization of disease and other documented clinical benefits for patients.