# Development of DRα1-MOG-35-55 for treatment of DR2 negative MS subjects

> **NIH NIH R44** · VIROGENOMICS BIODEVELOPMENT, INC. · 2021 · $996,926

## Abstract

Abstract:
Multiple Sclerosis (MS) is the most common neurologic disabling disease among young adults, affecting over
400,000 people in the United States and 2.5 million worldwide. Most MS individuals are initially diagnosed with
relapsing-remitting MS (RRMS) and then eventually transition to secondary progressive MS (SPMS). When MS
individuals enter SPMS, neurologic deficits progressively worsen over time. Approximately 15% of people with
MS are initially diagnosed with primary progressive MS (PPMS) and display increasing neurologic deficits without
periods of relapse or remission. Almost all the FDA approved therapeutics for MS are for patients with RRMS
and there are very limited therapeutic options for people with progressive MS. A key cytokine/chemokine thought
to drive the early inflammatory stage of MS to a chronic progressive phase is macrophage migration inhibitory
factor (MIF). We have designed a potent biological construct called RTL1000 and a second-generation
derivative, DRhQ, that bind tightly to the MIF receptor, CD74, and competitively inhibit MIF binding and its
downstream signaling. RTL/DRhQ treatment was also found to promote neuroprotection and reduce the severity
of acute and chronic EAE, a mouse model of MS. RTL1000 was found to be safe and well tolerated at doses
£60 mg in a Phase I safety trial in patients with either RRMS or SPMS. However, RTL1000 contains the
extracellular domains of the MS risk factor, HLA-DR2 and as such, the FDA limited RTL1000 administration in
the clinical trial to HLA-DR2 positive patients (~50% of total MS subjects). In order to treat both DR2 positive and
negative individuals with progressive MS, we have been advancing the development of DRhQ, which retains the
potent immunomodulatory activity of RTL1000 but is HLA invariant and thus, suitable for all patients. In this
Phase IIB SBIR application, we will continue to advance DRhQ toward a First-In-Human (FIH) Phase 1 clinical
trial by transferring manufacturing methods and know-how to a contract manufacturing organization (CMO) that
will enable production of DRhQ under GMP conditions, completing pre-clinical toxicology testing of DRhQ in two
animal species, and developing and optimizing assays to determine the bioanalytical and anti-drug antibody
responses in preclinical and clinical samples. The data collected during this Phase IIB project will be used to
support filing of a clinical Investigational New Drug (IND) application for a FIH study. The success of RTL1000
in reaching a Phase 1 clinical trial gives us confidence that we will achieve similar success with DRhQ.

## Key facts

- **NIH application ID:** 10146281
- **Project number:** 5R44AI122574-05
- **Recipient organization:** VIROGENOMICS BIODEVELOPMENT, INC.
- **Principal Investigator:** JEFFREY S KING
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $996,926
- **Award type:** 5
- **Project period:** 2016-02-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10146281

## Citation

> US National Institutes of Health, RePORTER application 10146281, Development of DRα1-MOG-35-55 for treatment of DR2 negative MS subjects (5R44AI122574-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10146281. Licensed CC0.

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