GL-ONC1 is an anticancer vaccine being investigated for the treatment of several types of cancers. It is being developed by Genelux.

This type of treatment is called an immunotherapy because, instead of directly destroying cancer cells, it stimulates the body’s own immune system to fight cancer.

How GL-ONC1 works

GL-ONC1 is a vaccine containing a modified virus designed to enter cancer cells, multiply inside those cells, and destroy them without harming healthy tissues or organs.

The virus inside GL-ONC1 already has been safely used in millions of people as an anti-smallpox vaccine. To become an anticancer treatment, the virus is modified in the laboratory to be even safer and more active against tumors.

Besides the virus, GL-ONC1 also contains a protein that emits light, which allows images of the tumor to be collected in a non-invasive way, helping in the diagnosis and identification of the tumor, and follow-up and monitoring.

GL-ONC1 in clinical trials

Preclinical studies showed that treatment with GL-ONC1 efficiently eliminated more than 40 types of cancers, and that it was more effective when used in combination with other treatments, such as chemotherapy and radiation therapy, as reported by the company.

GL-ONC1 is currently being studied in Phase 1 and Phase 1/2 clinical trials.

Results from the first Phase 1 clinical trial of GL-ONC1 (NCT00794131) in 27 patients with several types of cancers indicated that GL-ONC1 was safe, had low toxicity, and successfully found and entered tumor cells.

Another Phase 1 clinical trial (NCT01584284) aimed to determine the maximum tolerated dose and safety of GL-ONC1 given simultaneously with chemoradiotherapy to 19 patients with head and neck cancer. Results were published in the scientific journal Clinical Cancer Research and showed that this combination treatment was safe, with the most common adverse reactions being rigors, fever, fatigue, and rash.

Ongoing studies include a Phase 1/2 clinical trial (NCT02759588) in patients with ovarian cancer. This study is recruiting participants in Florida and is expected to be completed by March 2019. It is evaluating the safety, tolerability, and activity of GL-ONC1.

Another Phase 1 clinical trial is ongoing (NCT02714374) in California, but no longer recruiting participants, to investigate GL-ONC1 given before surgery to patients with several types of advanced cancers.

A third Phase 1 clinical trial (NCT01766739) is ongoing in New York, but no longer recruiting participants, for patients with malignant pleural effusion, which is an accumulation of fluid in the chest cavity caused by the cancer.

Future clinical trials are planned, including a Phase 2 study in ovarian cancer.


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