# Oral autoantigen therapy for the treatment of Multiple Sclerosis

> **NIH NIH R43** · SOYMEDS, INC. · 2022 · $294,973

## Abstract

Abstract
 Multiple Sclerosis affects millions of people worldwide and while the past decade has
seen a wave of disease-modifying drugs and immunomodulating therapies approved by the
FDA, these drugs are expensive and there is still no cure for the disease. Furthermore, the
chance of disability is fairly certain for many diagnosed patients.
 For several decades, antigen-specific treatments have been used in experimental
autoimmune encephalomyelitis (EAE) animal models to demonstrate their potential for
suppressing autoimmune responses. Successes with preventing (prophylaxis) and limiting
ongoing disease (therapeutic) have been documented using a wide variety of myelin proteins,
peptides, autoantigen-conjugates, and mimics when administered in a variety of ways (systemic
injections, intranasal, transdermal). While those successes were not translatable in the clinic,
we have learned a great deal about the roadblocks and hurdles that must be addressed if such
therapies are to eventually be realized. These include the use of autoantigens containing
multiple epitopes, the presentation of antigens in a tolerizing context, and a practical platform
that can generate the large amounts of autoantigens needed for therapy without extreme cost.
 The experimental approach in the accompanying SBIR Phase I application directly
addresses current limitations with oral tolerance therapy. We propose to manufacture two
autoantigens involved with multiple sclerosis – myelin oligodendrocyte protein (MOG) and
proteolipid protein (PLP) – as fusion proteins with reovirus sigma1 protein, using soybean as a
practical expression system for production and formulation. We also propose to make a
chimeric protein containing domains from myelin basic protein (MBP), MOG and PLP, also
fused to sigma1 protein. The logic behind our approach lies in the ability of the reovirus sigma1
protein to bind microfold cells covering mucosal lymphoid tissues. Autoantigens fused to
sigma1 protein target the immunogen to these cells and deliver the autoantigen in a “tolerizing
context” to limit an ongoing autoimmune response. In previous studies we demonstrated
efficacy of a soy-derived sigma1 fusion protein containing the myelin basic protein (MBP)
autoantigen. In the current study will expand our R&D to include expression and efficacy testing
of MOG-sigma1 and PLP-sigma1 autoantigens expressed in soybean. Our long term goal is to
develop a practical cocktail of MBP, MOG and PLP autoantigens that can be formulated for the
majority of patients that present with autoantibodies against any of these three proteins.

## Key facts

- **NIH application ID:** 10331867
- **Project number:** 5R43AI155401-02
- **Recipient organization:** SOYMEDS, INC.
- **Principal Investigator:** KENNETH J PILLER
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $294,973
- **Award type:** 5
- **Project period:** 2021-01-22 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10331867

## Citation

> US National Institutes of Health, RePORTER application 10331867, Oral autoantigen therapy for the treatment of Multiple Sclerosis (5R43AI155401-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10331867. Licensed CC0.

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