T cell immunity is believed to be particularly critical to treating the clinical symptoms of genital herpes and controlling transmission of the infection. Our lead candidate, GEN-003, is a first-in-class, protein subunit T cell-enabled therapeutic vaccine intended to reduce the duration and severity of clinical symptoms associated with moderate-to-severe genital herpes, and to control transmission of the infection.
Created using our ATLAS platform, we designed GEN-003 to attack the genital herpes virus by inducing both a T cell and B cell (antibody) immune response via two antigens - ICP4 and gD2 – as well as a proprietary adjuvant Matrix-M™.
Our goal with GEN-003 is to target the large unmet medical need of genital herpes sufferers: protection similar to that seen with chronic oral antiviral therapy without the daily pill burden, a sustained impact on clinical disease and reductions in viral shedding, and the convenience of once-yearly maintenance dosing.
In our clinical program to date, GEN-003 has demonstrated statistically significant results and meaningful progress towards achievement of this target product profile:
Phase 1/2a Trial Summary:
- Goals: establish GEN-003 proof of concept and initial dose exploration
- Endpoints: reduction in viral shedding and genital lesions
- Results: GEN-003 demonstrated durable reductions in both lesion and viral shedding rates vs. baseline, with the 30 µg per protein / 50 µg of adjuvant showing the best results; GEN-003 elicited a broad range of immune responses, durable to at least 12 months; GEN-003 was well tolerated.
Phase 2 Trial Summary:
- Goal: optimize dose of GEN-003 by exploring different combinations of protein and adjuvant
- Endpoints: reduction in viral shedding and genital lesion rates, time to first outbreak, percent reduction free at 6 and 12 months
- Results: GEN-003 demonstrated improved and sustained impact on viral activity, showing potential for durable efficacy longer than 12 months; 60 µg per protein paired with either 50 µg or 75 µg of adjuvant performed best; clinical efficacy demonstrated across potential Phase 3 endpoints; data indicate GEN-003 stimulates a multi-faceted T cell immune response to genital herpes and strong antibody response; GEN-003 well tolerated.
Ongoing Phase 2b Trial:
- Goal: final selection of GEN-003 dose using new Phase 3-ready formulation
- Endpoints: reduction in viral shedding, genital lesion rates, time to first outbreak, time to next outbreak, percent reduction free at 6 and 12 months, total number of outbreaks
- Results: 6-month data results demonstrate statistically significant improvements versus placebo across multiple clinical endpoints; significant reduction in viral shedding immediately post dosing; 60/50 dose confirmed for Phase 3 clinical program.
- Results to Come: 6-month viral shedding data and 12-month clinical results expected in 2017
Pending our end-of-Phase 2 meeting with regulatory authorities, we anticipate launching our GEN-003 Phase 3 program in the fourth quarter of 2017.
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Information about GEN-003 for Patients
Please click here for information for patients about GEN-003.