Drug intelligence / Profile preview

Peru-15 + cholera toxin B subunit

Development stage
Phase 1
Lead developer
Celldex Therapeutics
Modality
Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Oral
01

Overview

Peru-15 + cholera toxin B subunit is an oral vaccine candidate consisting of a live-attenuated strain of *Vibrio cholerae* O1 El Tor Inaba (Peru-15) and the cholera toxin B subunit (CTB). The Peru-15 strain is genetically engineered to be non-toxigenic by deleting the *ctxA* gene, which encodes the toxic A subunit of the cholera toxin, while retaining the *ctxB* gene to allow for the expression and secretion of the immunogenic, non-toxic B subunit. This combination provides a dual mechanism of protection: the live-attenuated bacteria colonize the small intestine to induce vibriocidal antibodies that prevent bacterial attachment and proliferation, while the CTB protein induces antitoxic immunity. These antitoxic antibodies neutralize the native cholera toxin by blocking its ability to bind to the GM1 ganglioside receptors on intestinal epithelial cells, thereby preventing the activation of adenylate cyclase and the subsequent severe secretory diarrhea characteristic of cholera. Originally developed at Harvard University and licensed to AVANT Immunotherapeutics (now Celldex Therapeutics), this vaccine was designed as a single-dose oral solution to provide rapid and long-lasting immunity.

Brand names
CholeraGarde
Other names
Vibrio cholerae O1 El Tor Inaba Peru-15Live-attenuated cholera vaccine Peru-15Peru-15 + CTB
02

Targets

GM1 (GM1 ganglioside)CtxA2 (Cholera toxin A2 domain)

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