INO-3106 is an investigational immunotherapy being developed by Inovio to treat human papillomavirus (HPV)-positive aerodigestive cancer.

How INO-3106 works

HPV infection can be the cause of some cases of aerodigestive cancer, which involves tumors forming in the mouth, throat, voice box, or sinuses. INO-3106 targets tumors specifically caused by HPV type 6 (HPV-6).

INO-3106 is a DNA-based cancer vaccine, produced using Inovio’s proprietary SynCon technology. A cancer vaccine acts to help “educate” the immune system on particular antigens (or foreign substances associated with a disease that triggers an immune response) so that it can track down and remove the tumor cells. INO-3106 is a plasmid, a piece of circular DNA that can promote the expression of an inserted gene, containing certain genes of HPV-6 called E6 and E7.

Following the administration of INO-3106, the immune system will recognize the E6 and E7 proteins as foreign and mount a response against them. This triggers the production of cytotoxic T lymphocytes (CTLs), or killer T-cells, a type of immune cell that will identify and destroy cells expressing the antigen. This should result in a targeted decrease of the HPV-6-infected tumor cells.

INO-3106 in clinical trials

In September 2014, Inovio initiated a Phase 1 clinical trial (NCT02241369) to assess the safety, tolerability, and immunogenicity (ability to trigger an immune response) of INO-3106 alone or in combination with INO-9012.

INO-9012 is a DNA plasmid containing the immune activator IL-12. The activity of IL-12 may boost the immune response produced by INO-3106, as one of its roles is to increase the production of CTLs.

The trial is using a dose escalation method in an estimated six patients to determine the maximum tolerated dose of INO-3106. Its primary goal is to monitor for adverse events for up to two years following the vaccination. It will also confirm the level of immune response against HPV-6 tumor cells produced by INO-3106. It is currently recruiting participants with HPV-6-associated aerodigestive precancers and cancers at the University of Pennsylvania.

The company hopes the results of the trial will allow them to apply to the U.S. Food and Drug Administration for orphan drug status for the treatment of aerodigestive cancers.

Other information

INO-3106 is delivered into cells using Inovio’s Cellectra device, which involves an injection into the muscle and electroporation (a small electrical pulse).


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