We Are Making Tomorrow’s Meningitis Vaccine.

Meningitis is a serious, often deadly disease.

OMVax is developing a new, better vaccine for the MenB serogroup using specially engineered Novel Outer Membrane Vesicles (NOMV). While NOMV are naturally occurring, OMVax enhances its NOMV improve immunogenicity and afford broader meningitis strain coverage:

  • Mutant Factor H Binding Protein: Factor H Binding Protein (FHbp) is a membrane protein that is produced by the meningitis bacterium to shield it from the immune system. The use of mutant FHbp blocks the immune shielding mechanism and provides a target for antibodies that can mediate bacterial elimination.

  • Genetically Attenuated Endotoxin: Reduces the risk of severe immune reactions.

  • Elimination of Molecules Similar to Those Found in Humans: Eliminates the risk of autoimmunity and improves vaccine safety.

  • No Detergents: Often used to remove endotoxins, detergents strip other immunogenic membrane proteins. Since detergents aren’t needed due to the attenuated endotoxin, the structure of membrane proteins is preserved, improving vaccine effectiveness and coverage.

Diagram of Novel Outer Membrane Vesicle

Novel Outer Membrane Vesicle.

OMVax’s MenB vaccine technology will deliver higher and broader immunity with a less painful injection that is also more economical.

Key Milestones at OMVax

2018 - 2019

Non-clinical studies and development:

  • Over-expressed FHbp in NOMV with genetically attenuated endotoxin.

  • Developed mutant FHbps with reduced Factor H binding that elicit broader protection than wild-type FHbp

  • Demonstrated superior immunogenicity and serum bactericidal activity (SBA) of NOMV-FHbp vaccine compared to licensed vaccines in mice and infant rhesus macaques.

  • Demonstrated NOMV-FHbp also elicited serum SBA against N. gonorrhoeae

2020 - 2024

Fermentation and purification process developed and transferred to CMO to prepare NOMV-FHbp vaccine for clinical trials:

  • Constructed vaccine production strains and Master Cell Banks.

  • Developed high NOMV yielding fermentation process for N. meningitidis making commercial production of NOMV possible.

  • Established qualified assays for OMVax product release.

  • Confirmed immunogenicity and SBA of manufactured NOMV-FHbp vaccine against a panel of diverse MenB strains

  • Patent filing

Safety:

  • GLP rabbit toxicology testing completed with no adverse events or toxicity observed.

  • USP <151> Rabbit Pyrogen Test of NOMV-FHbp met requirements at twice expected human dosage.

  • Research MAT testing to demonstrate potentially reduced reactogenicity based on low inflammatory cytokine stimulation in whole human blood.

2025 - 2026

Clinical trial application:

  • Phase 1: A randomized, observer-blind, comparator-controlled, sequential dosage-escalation study of the safety, tolerability, and immunogenicity of the investigational OMVax NOMV-FHbp vaccine with aluminum hydroxide in healthy adults ages 18 to 40.

2027 - 2028

Phase 2:

  • Introduction of single vial formulation, dose and schedule finding, age de-escalation.

Phase 3:

  • Demonstration of safety, efficacy, and lot consistency.

OMVax is moving into a phase 1 trial with expected safety and efficacy readouts.

Meningitis vaccines constitute a $3 billion market, growing at over 10% per year. Reach out to OMVax for a copy of the fundraising deck: