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.
Phase 2b Trial Summary
- Goal: final selection of GEN-003 dose using new Phase 3-ready formulation
- Endpoints: viral shedding immediately post dosing, median reduction in genital lesion rate, median number of outbreak recurrences, and median duration of recurrences over the 12 months post dosing with GEN-003; percent recurrence free after first and last dose.
- Results: GEN-003 reduced the median genital lesion rate (or percent days with genital lesions) versus placebo by 49 percent (p=0.01) over the 12 months’ post dosing at the 60 µg per antigen / 50 µg of adjuvant dose. Importantly, these results were achieved at the Phase 3 dose and expected Phase 3 primary endpoint. Other clinical endpoints for this dose improved or were consistent with previously reported positive data. Significant reduction in viral shedding immediately post dosing at 60/50 dose. No changes were observed to the previously established safety profile of GEN-003.
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Information about GEN-003 for Patients
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