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GEN-003 with Matrix M-2
GEN-003 with Matrix M-2 is a Biologic drug developed by Genocea Biosciences, Inc.. It is currently in Phase 1 development.
GEN-003 with Matrix M-2 is a therapeutic vaccine being studied for the treatment of Genital Herpes Simplex Type 2, Genital Herpes, and HSV-2 Infection. It is a combination of GEN-003 and Matrix M-2, which is being evaluated in a Phase I/IIa clinical trial for its safety and immunogenicity.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | GEN-003 with Matrix M-2 |
|---|---|
| Sponsor | Genocea Biosciences, Inc. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection (PHASE2)
- Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine (PHASE1, PHASE2)
- Evaluating New Formulation of Therapeutic HSV-2 Vaccine (PHASE2)
- Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study (PHASE2)
- Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GEN-003 with Matrix M-2 CI brief — competitive landscape report
- GEN-003 with Matrix M-2 updates RSS · CI watch RSS
- Genocea Biosciences, Inc. portfolio CI
Frequently asked questions about GEN-003 with Matrix M-2
What is GEN-003 with Matrix M-2?
Who makes GEN-003 with Matrix M-2?
What development phase is GEN-003 with Matrix M-2 in?
Related
- Manufacturer: Genocea Biosciences, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing