# Development of Anti-ceramide scFv as Mitigator of the Radiation GI Syndrome

> **NIH NIH R44** · CERAMEDIX HOLDING, LLC · 2020 · $994,084

## Abstract

Project Summary/Abstract
Inhibition of ceramide protects mice from death from the Radiation GI Syndrome (RGS). Administration of anti-
ceramide single-chain Fv (scFv) 24 h post radiation exposure increases survival in intestinal stem cells and
dramatically improves overall survival in mice. These data indicate that anti-ceramide scFv represents the first
effective mitigator of lethal RGS. To advance the development of anti-ceramide scFv towards an
Investigational New Drug application filing, we propose to 1) characterize the PK/PD relation with efficacy in
mice; and 2) utilize PK/PD to select doses of anti-ceramide scFv to evaluate in a pilot efficacy study in a non-
human primate (NHP) model of the RGS. Successful completion of the proposed aims will provide rationale for
evaluation of anti-ceramide scFv safety in humans and full evaluation of efficacy in a larger powered NHP trial.
Single-chain antibody fusion proteins are smaller derivatives of full length antibodies, and thus offer the
advantage of rapid entering into the bloodstream efficacy and increased penetration into tissue compared to
full-length antibodies, and from a product development standpoint these fusion proteins can be produced easily
and at minimal cost. As such, a neutralizing anti-ceramide single-chain antibody fusion protein represents a
promising candidate to fulfill the Project BioShield mandate for development of countermeasures to mitigate
acute radiation syndromes within the first 24 h after a nuclear disaster.

## Key facts

- **NIH application ID:** 9920659
- **Project number:** 5R44AI106283-05
- **Recipient organization:** CERAMEDIX HOLDING, LLC
- **Principal Investigator:** Arthur Tinkelenberg
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $994,084
- **Award type:** 5
- **Project period:** 2014-06-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9920659

## Citation

> US National Institutes of Health, RePORTER application 9920659, Development of Anti-ceramide scFv as Mitigator of the Radiation GI Syndrome (5R44AI106283-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9920659. Licensed CC0.

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