GEN-003 for Genital Herpes

GEN-003 is a Phase 3-ready investigational immunotherapy for the treatment of genital herpes infections.


  • Potentially first-ever therapeutic vaccine for a chronic infection and first advance in the treatment of genital herpes in more than 20 years
  • Targeting a large, unsatisfied global population with limited existing treatment options
  • Potential to have a sustained impact on clinical disease and reduce viral shedding
  • Could address existing antiviral therapies’ compliance challenges through once-yearly maintenance dosing
  • Novel mechanism of action creates potential for additive benefit when used in combination with existing antiviral therapies
  • Strong IP protection

Clinical Status

  • Phase 3 ready with completed end of Phase 2 meetings with FDA; clear path to BLA
  • Phase 2b study demonstrated statistically significant virologic and clinical efficacy at Phase 3 dose of 60 µg per antigen / 50 µg of adjuvant
  • Phase 2b study also validated improved process material/Phase 3-ready formulation
  • 12- and 24-month clinical, virological, and immunogenicity data support once-yearly maintenance dosing

Market Research/Potential (1)

  • Extensive market research based on the GEN-003 demonstrated clinical profile indicates that patients, payers, and physicians all view GEN-003 favorably
  • Patients rate GEN-003 highly on overall impression, interest in using and willingness to request from physician; and they express a willingness to pay for access to GEN-003 even if it means slightly higher out of pocket costs
  • Healthcare providers find the novel MOA appealing, see a strong benefit through ensuring compliance with therapy, and potential efficacy gain from combination use with antivirals; they feel that GEN-003 could lower barriers for initiation of and adherence to therapy and improve real-world effectiveness
  • Payers indicate high willingness to cover GEN-003 given likely low relative annual cost of therapy and benefits provided
  • Market research supports ~2.0 billion global market potential assuming conservative penetration and pricing

(1) Genocea-sponsored market research