Developing Therapies Designed
to Restore Immune Tolerance
Treg Therapeutics is advancing a patented immune tolerance platform designed to promote regulatory immune responses that may restore immune balance, addressing the underlying mechanisms of autoimmune disease rather than broadly suppressing immune function.
Here’s a short (13-minute) overview of our technology that we believe is going to change the world!
Limitations of Current Therapies
Autoimmune diseases affect hundreds of millions of people worldwide and represent one of the largest unmet needs in medicine. Despite meaningful advances, important limitations remain across all approved therapy classes.
Approved therapies work by blocking immune pathways that also protect against infection and cancer. Patients on chronic immunosuppression carry meaningful long-term safety risk. No approved therapy selectively addresses only the pathogenic immune response.
Leading biologic therapies cost $36,000 to $156,000 per patient annually and require continuous dosing. Side effect burden and loss of effectiveness drive 20 to 60 percent of patients to switch therapies within one to three years, depending on drug class.
Current therapies manage symptoms rather than addressing the underlying loss of immune tolerance. Patients experience variable disease control over time, and no approved therapy is designed to promote durable immune homeostasis.
The TILAC Platform
TILAC (Tolerance Induction via Linked Adjuvant/Cytokine conjugate) is designed to shift the dendritic cell environment from immunogenic to tolerogenic signaling, the key decision point determining whether the immune system drives inflammation or suppresses it. This tolerogenic environment is designed to promote expansion of regulatory T cells that may attenuate disease-associated inflammation.
Antigen-agnostic design
TILAC does not require identification or delivery of disease-specific antigens. The patient’s own endogenous pathogenic antigens drive the tolerogenic response in situ, without biological contribution from the patient.
Established clinical safety components
Both primary components of the TILAC platform are FDA-approved with clinical safety profiles built on decades of widespread use, supporting a de-risked regulatory pathway for first-in-human evaluation.
Common mechanism across indications
Autoimmune diseases share a common pathogenic pathway involving dysregulation of immune tolerance. TILAC’s design takes advantage of this commonality, supporting potential application across multiple indications from a single platform.
20 years of preclinical development
The platform originates from two decades of research at East Carolina University, with preclinical evaluation across multiple established animal models of autoimmune disease.
Pipeline
Seven programs spanning dermatological autoimmune, systemic autoimmune, and transplantation indications, advancing sequentially from a single platform. A key strategic advantage: once the lead program’s nonhuman primate toxicology study is complete, subsequent programs are expected to access an abbreviated path from animal model to IND, substantially reducing the cost and timeline for each new asset.
| Program | Category | Discovery | Animal Models | NHP Tox | Phase 1/2 | Partnering |
|---|---|---|---|---|---|---|
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TREG-Derm-1
Lead asset
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Dermatological Autoimmune 1
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TREG-Derm-2
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Dermatological Autoimmune 2
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TREG-Derm-3
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Dermatological Autoimmune 3
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TREG-AI-1
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Systemic Autoimmune 1
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TREG-AI-2
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Systemic Autoimmune 2
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TREG-AI-3
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Systemic Autoimmune 3
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TREG-Tx-1
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Transplantation 1
|
Patent Portfolio
A growing patent estate protects the TILAC composition of matter and methods of use across multiple indications. The core portfolio is in force through 2036, with additional patents pending and further filings planned as the platform expands.
Core Issued Patents
- Composition of matter and methods of use for alum-based adjuvants as microcarriers for anti-inflammatory cytokines in autoimmune disease treatment
- First divisional expands claims for alum plus Interferon plus autoantigen formulation and methods of use
- Second divisional application expands composition of matter for alum plus Interferon formulation and methods of use
Patents Pending and In Progress
- Multiple additional patent applications currently pending across new indications and formulation approaches
- Methods of immune tolerance induction for dermatological autoimmune diseases
- Disease-specific formulations and delivery methods, with further filings planned as each indication’s data package matures
- Ongoing patent strategy coordinated with clinical and business development milestones
The core patent estate provides a foundational exclusivity window, with the overall portfolio designed to extend well beyond it through a layered strategy of additional filings.
The patent estate is actively expanding. New filings are coordinated with each program’s development milestone to maximize coverage depth and lifecycle protection.
Technology is exclusively licensed from East Carolina University. The license agreement covers the full scope of TILAC platform applications.
Detailed patent schedules and pending application summaries are available to qualified investors and potential partners in the confidential data package.
Recent Industry Transactions
Pharma appetite for immune tolerance assets has remained strong, averaging three or more disclosed transactions per year since 2023. The deals below illustrate the range of upfront values and total deal structures for tolerance platform assets at comparable stages, spanning CAR-Treg cell therapies, tolerizing vaccines, and tolerogenic nanoparticle platforms.
| Year | Transaction | Modality | Upfront | Total Potential |
|---|---|---|---|---|
| 2023 | Quell Therapeutics + AstraZeneca | CAR-Treg cell therapies | $85M | >$2B + royalties |
| 2023 | Sonoma Biotherapeutics + Regeneron | Gene-modified Treg therapies | $75M | $45M additional milestones |
| 2024 | Repertoire Immune Medicines + Bristol Myers Squibb | Tolerizing vaccines | $65M | $1.8B + royalties |
| 2024 | COUR Pharmaceuticals + Genentech | Tolerogenic nanoparticles | $40M | >$900M + royalties |
Investment Opportunity
36 – 40 months
$7.2M Total Fund Raising
Seed · 24-month runway
Funds NHP toxicology study completion, preclinical work on the second dermatological program, and FDA authorization to proceed.
Series A · 30-month runway
Funds Phase 1/2a human clinical study in the lead program through human proof-of-concept and first licensing discussions.
- Patented platform with an FDA-accepted IND, a rare combination of IP maturity and regulatory validation at seed stage
- Licensing model designed to deliver expedited ROI with minimal investor dilution relative to full self-commercialization paths
- Platform components carry established FDA safety profiles, substantially lowering clinical risk relative to novel molecular entities
- The immune tolerance space has averaged 3 or more pharma transactions per year at $40 to $85M upfront since 2023, validating buyer appetite
- One NHP study unlocks an abbreviated development path for the entire portfolio, compressing cost and timeline across seven programs
Request Investor Materials
Qualified investors may request access to the full confidential investor presentation, including detailed mechanism of action, unpublished preclinical data (available under NDA), financial projections, and deal structure.
We welcome inquiries from accredited investors, family offices, venture capital firms, and biopharmaceutical companies with strategic interest in autoimmune therapeutics and immune tolerance platforms.
We seek partners with strategic emphasis on autoimmune disease, resources to expedite clinical development, and a history of successful licensing collaborations.
Management Team
The management team brings experience across drug discovery, preclinical and clinical development, biopharma operations, and business development. Clinical collaborators at University Hospitals Cleveland Medical Center provide exceptional strength in trial design and investigational product manufacturing.
C-suite executive with a track record in translational R&D and clinical-stage program leadership. Deep expertise in autoimmune disease biology and immune tolerance, with 20 years focused on translating tolerogenic science from bench to clinic. Extensive experience in FDA/ICH-compliant manufacturing and academic-industry partnerships.
Over 40 years of research at the intersection of autoimmune disease and immunological tolerance. Originator of the TILAC platform through two decades of protein engineering and tolerogenic vaccine research at East Carolina University. Professor of Microbiology & Immunology, ECU.
CPA and Harvard MBA with extensive experience as principal financial officer in early-stage ventures. M&A experience across medical, energy, and communications sectors including two IPO processes. Responsible for capital structure and investor relations infrastructure.
40 years of medical device and life sciences leadership. Founder of CryoLife (NYSE: CRY), Luminal Solutions, and 3D Surgical Solutions. Multiple CEO roles across start-up and multimillion-dollar enterprises. Deep experience in company formation, strategic licensing, and institutional investor engagement.
30 years of biopharma experience across Technical Operations, Process Development, Manufacturing, Quality, and Supply Chain. Prior executive leadership at Biogen and subsequent global biotech executive roles. Expertise in CMC regulatory strategy, strategic partnerships, and CDMO management.
Career spanning GE Renewables, Lucideon, and Markforged. Brings engineering, commercial development, and strategic sales expertise from both high-growth start-ups and established enterprises. Leads business development and commercial partner outreach.
Chair, Department of Dermatology, UHC. National leader in dermatological immunology. Key architect of the lead program Phase 1/2a clinical trial design.
Director, Psoriasis Center, UHC. Experienced clinical trialist with deep expertise in dermatological outcome assessment and biologic therapy management.
Psoriasis Lab Director, UHC. Leads translational immunology research underpinning the lead program, including Treg characterization and cytokine profiling protocols.
VP, Buderer Drug Company. Investigational product formulation, compounding, and supply chain expertise for the Phase 1/2a study. IND-compliant investigational product production.
News & Milestones
A chronological record of company progress and anticipated milestones. This page is updated as events occur.
Investor Overview Released
Treg Therapeutics released an updated investor overview for the NCBC June 2026 presentation, highlighting platform progress and advancement plans for the lead program.
NCBC Investor Presentation
Treg Therapeutics presented at the North Carolina Biotech Conference, introducing the TILAC platform and the lead program clinical development plan to investor and partner audiences.
NCBC Loan: Mid-Term Objectives Completed
Treg Therapeutics completed mid-team milestones for the NCBC loan program, securing $100K in additional funding and advancing toward the full first-tranche target.
NCBC Loan: Final Objectives Completed
Completion of all final NCBC loan objectives, securing the full $250K raise and opening the path to additional funding channels for the company.
NHP Study Preparation Completed
Manufacturing, regulatory, and logistical preparations completed for initiation of the GLP nonhuman primate toxicology study.
Nonhuman Primate Toxicology Study Initiated
Initiation of GLP NHP toxicology study supporting advancement of the lead program into first-in-human evaluation.
NCBC Loan: Additional Funding Feedback
Expected feedback on an additional NCBC loan of up to $300K, which would meaningfully advance progress toward completing the targeted $1.5M Tranche 1 seed round.
NHP Safety Data
Top-line safety observations expected from the nonhuman primate study. Positive results unlock an abbreviated NHP pathway for all subsequent portfolio programs.
Regulatory Submission and FDA Authorization to Proceed
Compilation and submission of the toxicology and preclinical data package, with FDA authorization to proceed expected upon successful study completion.
Phase 1/2a Clinical Trial Initiation
Planned initiation of first-in-human evaluation of the lead program at University Hospitals Cleveland Medical Center.
Human Proof-of-Concept Readout
Evaluation of safety, biological activity, and clinical signals from the Phase 1/2a study. Licensing discussions anticipated upon positive data.
Portfolio Expansion
Sequential advancement of additional dermatological and systemic programs, each benefiting from the abbreviated NHP pathway established by the lead program.
Contact Us
For investor inquiries, partnership discussions, or media requests, please reach out directly or use the form. All inquiries are treated as confidential. The full investor presentation is available to qualified parties upon request.
The complete investor presentation, including unpublished mechanistic data, preclinical study reports, and financial projections, is available under NDA to qualified investors and strategic partners.
All inquiries are treated as confidential.