GBS-NN/NN2

Phase 3Biologic

MMinervax ApS

GBS-NN/NN2 is one of 10 biologic programs targeting Streptococcus Agalactiae Infection. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Streptococcus Agalactiae InfectionActive, not recruiting

Pregnant WomenNot yet recruiting

Streptococcus Agalactiae InfectionPreclinical

Active, not recruiting

Pregnant WomenPhase 3

Not yet recruiting

Competition

Competitive Landscape

11 competitors in Pregnant Women

#DrugCompanyPhaseTrials

Vemlidy

Gilead

Approved

1 2

Tirosint

IInstitut Jerome Lejeune

Approved

1 3

Tdap Vaccine

Sanofi

Phase 3

1 4

GBS-NN/NN2

MMinervax ApS

Phase 3

2 5

Hecolin ).

IInternational Vaccine Institute

Phase 2

1 6

Nicotinamide

MMetro International Biotech, LLC

Preclinical

1 7

IV Acetaminophen

AAFT Pharmaceuticals, Ltd.

Preclinical

1 8

Choline Bitartrate

UUniversity of Minnesota

Preclinical

1 9

Antiemetic Drug

UUniversity of West Attica

Preclinical

1 10

Shanchol

EEuBiologics Co.,Ltd

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2029

PreclinicalActive, not recruiting

Streptococcus Agalactiae Infection

NCT06592586

Clinical

Trials by Indication[1]

Vaccine3 trials

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

Completed·MMinervax ApS·Phase 1·NCT05005247·27 enrolled

A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers

Terminated·MMinervax ApS··NCT06280157·29 enrolled

Group B Streptococcus Vaccine in Healthy Females

Completed·MMinervax ApS·Phase 1·NCT03807245·60 enrolled

Pregnant Women2 trials

GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age

Not yet recruiting·MMinervax ApS·Phase 2/3·NCT06494475·564 enrolled

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

Completed·MMinervax ApS·Phase 2·NCT05154578·269 enrolled

Elderly Participants1 trial

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

Completed·MMinervax ApS·Phase 1·NCT05782179·90 enrolled

Streptococcus Agalactiae Infection1 trial

A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy

Active, not recruiting·MMinervax ApS·Preclinical·NCT06592586·137 enrolled

Group B Streptococcal Infection1 trial

A Multi-centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Group B Streptococcus Vaccine (GBS-NN/NN2) in Women Who Are Pregnant and Living With HIV and Women Who Are Pregnant and do Not Have HIV

Completed·MMinervax ApS·Phase 2·NCT04596878·200 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for GBS-NN/NN2. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — GBS-NN/NN2 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for GBS-NN/NN2. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Minervax ApS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: MMinervax ApS

GBS-NN/NN2

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2029

Trials by Indication[1]

Vaccine3 trials

Pregnant Women2 trials

Elderly Participants1 trial

Streptococcus Agalactiae Infection1 trial

Group B Streptococcal Infection1 trial

References

Drug Info

Quick Facts

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