回复 4楼流浪汉的帖子Our lead candidate in genital herpes is GEN-003, a first-in-class, protein subunit T cell-enabled therapeutic vaccine, or immunotherapy, designed to reduce the duration and severity of clinical symptoms associated with moderate-to-severe genital herpes, and to control transmission of the infection.
T cell immunity is believed to be particularly critical to the control of genital herpes. Genocea’s lead clinical candidate is GEN-003, a first-in-class immunotherapy intended to treat genital herpes by inducing both a T cell and B cell (antibody) immune response. GEN-003 includes the antigens ICP4 and gD2, as well as the proprietary adjuvant Matrix-M™.
GEN-003 has demonstrated first-in-class results to date by showing statistically significant reductions in the clinical signs of genital herpes and viral shedding.
In October 2015 Genocea announced positive 6-month durability results for a Phase 2 dose optimization clinical trial for GEN-003.
At the best performing dose of 60 µg per protein / 75 µg of Matrix-M2™ adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study. This reduction was an improvement upon the attractive product profile established in Phase 1/2a trial.
In a planned secondary analysis to assess the impact on genital lesion rates, a patient-reported measurement of clinical disease, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent.
The proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies.
A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups
End of Phase 2 meeting with FDA expected in late 2016
The initiation of the Phase 2 clinical trial was based on positive results from a Phase 1/2a study.
Final analysis of the data from the Phase 1/2a trial showed that, for the best performing 30µg dose group, there was a sustained reduction in the viral shedding rate. After completion of dosing for this group, the viral shedding rate fell by 52% versus baseline and, at six months after the final dose, the shedding rate remained at 40% below baseline. At 12 months, the viral shedding rate returned to baseline for this dose group.
The reduction in the genital lesion rate after completion of the third dose was greatest for the 30µg dose group at 48%. After six months, the reduction from baseline in genital lesion rate for this dose group was 65% and, after 12 months, the genital lesion rate was 42% lower than baseline.
GEN-003 was safe and well tolerated over the 12 months of this trial.
If approved, we believe GEN-003 would be the first therapeutic vaccine to address genital herpes – or any infectious disease. Please click here for more information on our clinical trial.
Information about GEN-003 for Patients
