Eosinophilic esophagitis (EoE) is a chronic, food-driven immune disease — ~167,500 people in the US and rising. It is fundamentally antigen-specific: a food peptide, presented on an MHC-II molecule, to a pathogenic T-cell clone. Yet every approved and pipeline therapy (dupilumab, cendakimab, budesonide, PPIs) is a broad, chronically-dosed symptom suppressor. None is antigen-specific; none induces durable tolerance. Patients face a lifetime of injections, steroids, or restrictive diets.

From one biopsy + blood draw, the workflow identifies the patient's HLA type and causal food-reactive clone and manufactures an N-of-1 vaccine that re-educates only that clone — Signal-1 anergy + multivalent nanoparticle Tr1/IL-10 induction. The individualized-neoantigen-vaccine model of oncology, applied to food antigens: one course, not lifelong dosing.

A shared, GPU-validated MHC-II backbone with a swappable peptide cassette — only the peptide changes per patient, so N-of-1 manufacturing is tractable (vein-to-vaccine target 6–10 weeks). The same engine extends to celiac and other food/auto-antigen disease.

A 9-construct dairy/wheat/soy panel folds at ipTM 0.87–0.90, 15/15 peptides in-groove. The dairy anchor (β-casein aa59–78, HLA-DRB1*07:01) is supported by a reported tetramer-validated epitope.* Wheat/soy are computational priors; wet-lab validation is a near-term milestone.

~$2.2B/yr US TAM (biologic-eligible). Base-case ~$1.0B mature revenue at a ~$150k one-course price — ~23% below Tzield's actual $194k/course. Project Tolera is the only antigen-specific, one-course entrant; every competitor is broad-mechanism and chronic. A companion diagnostic adds an earlier, independent revenue line.

Tzield (2022) proved the FDA will approve a disease-modifying immune therapy; neoantigen vaccines proved per-patient biologics clear CMC. Tzield — a first-in-class tolerance asset — drew a $2.9B Sanofi acquisition on a single indication.