When Genocea ($GNCA) unveiled its genital herpes vaccine in 2012, its goal was to develop a first-in-class therapeutic vaccine for the disease and compete with the daily oral antivirals that have been the gold standard for years. Now, as the Cambridge, MA-based biotech reports positive 12-month Phase II results, it can say with confidence that one course of its vaccine works as well over one year as the oral medication, CEO Chip Clark told FierceVaccines.
The candidate, dubbed GEN-003, consists of proteins and an adjuvant, and it targets a T-cell response to the herpes simplex virus type 2. One regimen of GEN-003 includes three injections spaced three weeks apart. Genocea aims to reduce viral activity, which is measured by the viral shedding rate--the rate at which the virus moves to the surface of the skin and physically sheds--and the genital lesion rate.
The two best-performing doses reported 64% and 52% reduction in viral shedding at 12 months and 65% and 47% reduction in genital lesions. Genocea is already testing these two doses in a Phase IIb trial to select its candidate to advance to Phase III in the second half of 2017, Clark said. Genocea plans to release more data at an upcoming conference, the company said in a statement. The data puts it on course for a Biologics License Application in 2019 and a launch in 2020, Clark said.
In the more immediate future is a trial combining GEN-003 with oral antivirals to see if they work better together than on their own. While GEN-003 could replace the pills and free herpes patients from taking daily oral medication for the rest of their lives, some patients only take the pills when they are having an outbreak and abandon them otherwise. If GEN-003 and the oral antivirals work well together, the latter could become a more convenient alternative for these patients and eliminate gaps in their treatment, Clark said.
Genocea also has a chlamydia vaccine and a preventive vaccine for genital herpes in preclinical trials. It put its pneumococcal vaccine on the back burner last October after discouraging topline Phase II results. Lexington, MA-based Agenus ($AGEN) is also developing a genital herpes vaccine, but GlobalData analyst Daian Cheng said in May last year that Genocea's candidate is stronger, both clinically and commercially, than Agenus'.
- here's the release
- here's FierceBiotech's take