Last reviewed 2026-05-25 · How we verify

GEN-004 High Dose

Genocea Biosciences, Inc. · Phase 1 active Biologic ✓ Verified May 2026

GEN-004 High Dose is a Biologic drug developed by Genocea Biosciences, Inc.. It is currently in Phase 1 development.

GEN-004 High Dose is a vaccine being studied for its safety and immunogenicity in preventing Streptococcus Pneumoniae infections. The study, GEN-004-001, is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study conducted by Genocea Biosciences, Inc.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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-004 High Dose
Sponsor	Genocea Biosciences, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine (PHASE1)

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-004 High Dose CI brief — competitive landscape report
GEN-004 High Dose updates RSS · CI watch RSS
Genocea Biosciences, Inc. portfolio CI

Frequently asked questions about GEN-004 High Dose

What is GEN-004 High Dose?

GEN-004 High Dose is a Biologic drug developed by Genocea Biosciences, Inc..

Who makes GEN-004 High Dose?

GEN-004 High Dose is developed by Genocea Biosciences, Inc. (see full Genocea Biosciences, Inc. pipeline at /company/genocea-biosciences-inc).

What development phase is GEN-004 High Dose in?

GEN-004 High Dose is in Phase 1.

Manufacturer: Genocea Biosciences, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing