Some advancement on the herpes vaccine front: San Diego biotech Vical recently kicked off a Phase 1/2 trial of its Vaxfectin genital herpes vaccine – a therapeutic inoculation that’s melded vaccine and DNA technologies.
Here’s how it works: Vical’s approach directs the immune response in two ways: It teaches immune cells to develop weapons against the herpes virus, and the second component teaches the body how to hunt down and find the pathogen.
Here’s the rationale: The herpes virus typically holes up inside the neurons, dormant, but then emerges and becomes highly infective as the cells shed the virus. However – some individuals that are HSV2 positive don’t shed the virus, which means that something’s happening in their bodies to control the pathogen.
Vical is studying the genetics and immune responses in these people, which has informed their development of their vaccine, CEO Vijay Samant said.
“One of the things that distinguishes our technology is we’re using plasmid DNA, building chains to produce the antigens,” Samant said.
Earlier this month, Vical completed enrollment in its therapeutic Phase 1/2 genital herpes vaccine trial. It’s meant to evaluate the safety and efficacy of two forms of its Vaxfectin vaccine; it’s also meant to show at least a 30 percent decrease in the viral shedding rate after three doses of the vaccine. It’s going to release efficacy data by mid-2015.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
While promising, it should be noted that Vical’s got a lot riding on the efficacy of this vaccine – it stumbled last year when its main drug candidate, a melanoma immunotherapy vaccine called Allovectin, failed in late stage trial.
But the company has since pivoted, first laying off about 40 percent of its workforce and then changing the focus to infectious disease indications – namely, the genital herpes vaccine. With the race so tight in the development of the genital herpes vaccine – competitors Agenus and Genocea are neck-and-neck – it’ll be interesting to see which makes it out of the gate first.
