Drug intelligence / Profile preview

OM-85 (OM Pharma, 186d0e)

Development stage
Phase 4
Lead developer
OM Pharma
Modality
Whole Cell Cancer Vaccines → Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

OM-85 (marketed as Broncho-Vaxom) is a standardized lyophilized bacterial lysate consisting of eight common respiratory pathogens: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, and Moraxella catarrhalis. It functions as an oral immunomodulator by activating Toll-like receptors (primarily TLR2, TLR4, and TLR9) on dendritic cells and macrophages within the gut-associated lymphoid tissue (GALT). This activation triggers a cascade that enhances both innate and adaptive immune responses, including the maturation of dendritic cells, increased production of secretory IgA in the respiratory tract, and a shift in the T-helper cell balance toward a Th1 profile. Developed by OM Pharma, Broncho-Vaxom Kinder is the pediatric formulation (3.5 mg) indicated for the prevention of recurrent respiratory tract infections and the reduction of wheezing episodes in children. It is widely used as a form of oral immunotherapy to reduce the frequency and severity of respiratory infections and the subsequent need for antibiotics.

Brand names
Broncho-VaxomBroncho-Vaxom KinderBroncho-Vaxom ChildrenBroncho-MunalPaxoralVaxom
Other names
bacterial lysatelyophilized bacterial lysatebacterial lysate of 8 species
02

Targets

TLR2 (Toll-like Receptor 2)TLR4 (Toll-like receptor 4)TLR9 (Toll-like receptor 9)

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