# NEURESTA DRUG SUBSTANCE MANUFACTURING

> **NIH NIH N01** · LEIDOS BIOMEDICAL RESEARCH, INC. · 2024 · $1,363

## Abstract

The overall objective of this SOW is for Leidos to support development of NgR(310)Fc [AXER-204] for treatment of spinal cord injury and produce quantities of hNgR(310)-Fc for use in human clinical studies, in technical and project management, records management, evaluation of quality systems, logistics and chemistry, manufacturing, and controls (CMC) development. An appropriate number of vials of Master Cell Bank (MCB) were provided to Leidos’ subcontractor to execute the work and manufacture the hNgR(310)Fc. The existing subcontractor (Cytovance Biologics) has completed process development and analytical development work, qualified relevant analytical assays, manufactured engineering lots on 100- L and 500-L scale and two GMP lots on 500-L scale under previous Leidos subcontract.

## Key facts

- **NIH application ID:** 11219236
- **Project number:** 75N91019D00024-P00010-759101900140-1
- **Recipient organization:** LEIDOS BIOMEDICAL RESEARCH, INC.
- **Principal Investigator:** lynn briscoe
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,363
- **Award type:** —
- **Project period:** 2019-09-16 → 2027-09-02

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219236

## Citation

> US National Institutes of Health, RePORTER application 11219236, NEURESTA DRUG SUBSTANCE MANUFACTURING (75N91019D00024-P00010-759101900140-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11219236. Licensed CC0.

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