# Tolera Bio — Executive Summary
### Antigen-specific tolerance, one patient at a time.

**Series Seed · $8M · seeking lead investor**
Ruth-Anne Pai, PhD — Founder & CEO (immunologist; living with EoE)

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**THE PROBLEM.** Eosinophilic esophagitis (EoE) is a chronic, food-driven immune disease affecting ~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, tezepelumab, budesonide, PPIs) is a broad, chronic-dosing symptom suppressor.** None is antigen-specific; none induces durable tolerance. Patients face a lifetime of injections, steroids, or restrictive diets.

**THE SOLUTION.** Tolera Bio builds a **personalized pMHC-II tolerance vaccine.** From one biopsy + blood draw at diagnosis, we identify the patient's HLA type and causal food-reactive clone and manufacture 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, applied to food antigens. **One course, not lifelong dosing.**

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

**VALIDATION.** A 9-construct panel across dairy/wheat/soy folds at **ipTM 0.87–0.90 (15/15 peptides in-groove)**. The dairy anchor (β-casein aa59–78, HLA-DRB1*07:01) is **tetramer-validated in the literature** (Dilollo/Spergel/Hill 2025). Wheat and soy epitopes are computational priors; wet-lab validation is a funded Seed milestone.

**MARKET.** ~$2.2B/yr US TAM (moderate–severe, biologic-eligible). A one-course vaccine priced at ~$150k pays back in **<4 years** vs. ~$40k/yr lifelong biologics and saves payers **~$250k/patient over a decade** — the value-based-pricing argument incumbents cannot make. A companion diagnostic adds a second, earlier revenue line.

**REGULATORY.** One **platform IND** (not one per patient), on the individualized-product framework validated by neoantigen vaccines and the disease-modification precedent of teplizumab (Tzield, 2022). Path: Orphan Drug → Fast Track → Breakthrough → test RMAT. Endpoints (histologic remission, EREFS, DSQ) are already FDA-validated for EoE.

**THE ASK — $8M Seed** funds human functional validation, murine proof-of-concept, GLP tox, GMP/IND lots, the companion diagnostic, and regulatory filings to a **cleared IND and first-in-human dosing** — the single largest de-risking step available today. A subsequent **$35M Series A** funds through the **Phase 2 durable-remission proof-of-concept**, the value inflection for partnering or Series B.

**WHY US.** A patient-scientist founder who designed the platform and lives the disease — an advantage in trial design, recruitment, endpoint selection, and community trust.

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*Preclinical-stage platform. Non-dairy binding values are computational priors pending validation. Financial/market figures are stated assumptions, not guidance. The food-trigger assay concept is patented (Hill/Spergel) — FTO/licensing item. Not medical advice.*