Tolera Bio is advancing a first-in-class antigen-specific platform that selectively eliminates the cells driving autoimmune disease — while preserving the healthy immunity patients depend on.
The Burden
Autoimmune diseases represent a large and growing global health burden — many driven by pathogenic B cells and the long-lived plasma cells they produce. Today's standard of care depletes the immune system broadly, leaving patients exposed and disease activity unresolved.
Source · NIAID, NASEM 2022
140+ autoimmune diseases
Most without a curative therapy.
01
Long-lived plasma cells silently sustain autoantibody production, fueling disease relapse despite repeated B cell depletion.
02
Patients face decades of immunosuppression with limited durable remission and significant treatment-related morbidity.
03
Existing therapies broadly suppress the immune system or fail to eliminate the source of disease — leaving patients vulnerable.
What if we could eliminate the cells causing autoimmune disease — without dismantling the immunity that keeps patients well?
The Platform
Tolera Bio's antigen-specific platform redirects the patient's own immune machinery to selectively eliminate the autoreactive cells responsible for disease — preserving the protective immunity that keeps patients well.
Engineered to recognize the precise immune cells driving disease — sparing the broader immune repertoire that protects against infection.
A scalable platform designed to be re-pointed across multiple autoantibody-driven diseases with rapid program advancement.
Mechanistic safety evaluation is integrated from the earliest design decisions through pre-clinical execution.
Lead program is anchored to a well-defined autoantibody disease with clear biomarkers and rapid clinical readouts.
Competitive Landscape
B cell depletion, FcRn inhibition, CAR-T, and anti-CD38 each address pieces of the problem — but none combine target specificity with elimination of disease-causing cells while preserving healthy immunity.
Side-by-side comparison
YesPartialNo
Criterion
Tolera
Discovery
CD38
Phase 1/2
CAR-T
Phase 1
FcRn
Phase 3
B-cell
Approved
Antigen-specific
Spares immunity
Eliminates source
Specificity
Cost
TBD
~$150–250k / yr
$750k–$1M+
~$200–300k / yr
~$50k / 6 mo
Drawback
First-in-class
Impacts long-lived protective immunity
Cytokine release · complex manufacturing
Does not target autoreactive cells
Risk of broad immune suppression
Criterion | Tolera Tolera Bio Antigen-specific platform Discovery | Anti-CD38 e.g. Daratumumab Phase 1/2 | CAR-T CD19 / CD20 Phase 1 | FcRn inhibitors e.g. Efgartigimod Phase 3 | B-cell depletion e.g. Rituximab Approved |
|---|---|---|---|---|---|
Antigen-specific Targets only the disease-causing cells | |||||
Spares healthy immunity Preserves protective antibodies & immune cells | |||||
Eliminates source cells Removes the cells producing autoantibodies | |||||
Specificity Breadth of immune impact | |||||
Stage | Discovery | Phase 1/2 | Phase 1 | Phase 3 | Approved |
List-price range | TBD | ~$150–250k / yr | $750k–$1M+ | ~$200–300k / yr | ~$50k / 6 mo |
Key drawback | First-in-class | Impacts long-lived protective immunity | Cytokine release · complex manufacturing | Does not target autoreactive cells | Risk of broad immune suppression |
Comparative data summarized from publicly disclosed mechanisms, clinical stage, and list-price ranges. For competitive context only — Tolera Bio program details shared under NDA.
Where We Are
Our lead program is in active pre-clinical development — anchored to a well-defined autoantibody-driven disease with clear biomarkers and rapid clinical readouts.
Phase 01
In progressIdentifying and characterizing biological hypotheses through rigorous mechanistic studies and model-based evidence.
Phase 02
In progressStructured in vitro and in vivo experiments to build evidence on safety, activity and biological plausibility.
Phase 03
NextEvaluating scientific and operational requirements for IND-enabling work as part of long-term program strategy.
Phase 04
FutureForward-looking. Subject to scientific, regulatory and operational developments.
Forward-looking statements and any implied timelines reflect current planning and are subject to change.
Leadership & Advisors
A founding team and advisory board with proven results across immunology, cell therapy, and clinical biomarker development.
Founder · Inventor
Founder · Operations
Scientific Advisors
Scientific Advisor
Clinical & Market Strategy
Protein Engineering Advisor
Discovery & Pre-Clinical Strategy
Full bios and CVs available upon request.
Get in Touch
We welcome inquiries from potential partners, collaborators, and investors. Program-specific details — including targets, modalities, and candidate data — are shared under NDA with qualified parties.
Direct
+1 (669) 284-4439Proprietary notice. Program-level scientific details — including targets, modalities, indications, and candidate data — are shared exclusively with qualified partners under a signed NDA.