AIDS 2014: Norway's Bionor produces possible biomarker to predict HIV vaccine effectiveness

Norway's Bionor Pharma and U.K. scientists claim they've identified a biomarker in some patients that may be connected with an improved response to a therapeutic HIV vaccine now under development.

The research team's findings (including work by folks from St. George's, University of London) stem from an analysis of an older Phase II clinical study of the potential Bionor vaccine known as Vacc-4x. They presented details of their thesis at the AIDS 2014 Conference in Melbourne, Australia.

The biomarker to watch in this case is C5/gp41. Through their analysis, researchers found that patients with high levels of antibodies to this peptide prior to vaccination had a much stronger response to Vacc-4x than other patients in the study. The larger study on which the team based their subset analysis found that patients treated with Vacc-4x experienced a 60% reduction in viral load. But patients with a much higher baseline of C5/gp41 antibodies saw an 88% reduction in viral load, the company said. Conversely, patients in the study with lower levels of C5/gp41 antibodies saw a much lower reduction in viral load levels.

The original Phase II study dates back to 2010 and involved 137 patients, the company said. More work is already planned to see if researchers can validate whether antibodies to C5/gp41 can serve as a valid biomarker for improved response to Vacc-4x. This would be a larger prospective trial, pending regulatory approval, the company said.

Until that larger trial can take place, the biomarker finding remains theoretical. But scientists are hopeful. HIV vaccines remain a mixed endeavor, but if the larger research bears out, a personalized medicine approach to HIV therapeutic vaccine, plus the C5/gp41 biomarker, could help at least a certain group of patients respond well to a targeted treatment.

And it could propel Bionor Pharma, an Oslo operation that has gone through various iterations but traces its origins to 1985 as a developer of diagnostic tests for viral diseases, as well, according to its website.

"Our key focus is to enhance the effects of Vacc-4x in the treatment of HIV, and the identification of a biomarker is fundamental in the development of Vacc-4x as a monotherapy," Bionor CEO Anker Lundemose said in a statement.

- read the release
- here's the Business Standard's take

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