# Development of BIO 300 for mitigation and/or treatment of radiation pneumonitis and fibrosis

> **NIH NIH U19** · UNIVERSITY OF MARYLAND BALTIMORE · 2020 · $397,977

## Abstract

Project Summary/Abstract – Project 4 Radiation Pneumonitis/Fibrosis
 There is a critical, unmet need to develop medical countermeasures (MCM) for the mitigation of the
delayed effects of acute radiation exposure (DEARE), namely radiation pneumonitis/fibrosis, in victims
successfully treated for acute radiation sickness following a radiological or nuclear incident. The overall objective
of project 4 is to complete activities necessary to bring BIO 300 (“BIO 300”) nanosuspension (Humanetics
Corporation, Edina, MN) towards approval under the U.S. Food and Drug Administration (FDA) Animal Rule
regulatory pathway for the indication to increase survival in individuals acutely exposed to pulmonary-toxic doses
of radiation [e.g. delayed effects of acute radiation-exposure (DEARE)-lung]. Our published data indicates BIO
300 (400 mg/kg, QD, oral gavage) confers a significant improvement in survival from DEARE-lung when
treatment is started 24 hours after exposure to life-threatening doses of radiation and continued for six weeks
(5). Further, clinical data demonstrate an excellent safety profile when BIO 300 is administered as a daily oral
regimen (500 - 1500 mg) over a minimum duration of six weeks.
 Project 4 is highly interactive with the other Projects and Cores within the INTERACT Consortium. Studies
in Aim 1 are designed to optimize the BIO 300 dosing regimen to maximize the likelihood of survival from DEARE-
lung. Higher drug exposure has been observed in murine and non-human primate models when BIO 300 is
administered by intramuscular (IM) injection versus oral administration. Therefore, IM administration may further
improve the therapeutic benefit of BIO 300 on 220-day survival and mitigation of lung damage beyond that
observed with oral dosing. Specific Aim 2 will be conducted in collaboration with Core B-Multispecies Efficacy
and Pharmacometric Modeling. Experiments in this aim are designed to identify and validate plasma-based
pharmacodynamic (PD) biomarkers associated with BIO 300 mediated ERb activation and downstream effects
on cellular senescence in rodents and NHP. A systems biology approach incorporating pharmacometric
modeling will be utilized, and will incorporate known BIO 300-mediated effects on PD biomarkers in cancer
patients undergoing clinical radiation therapy to relate the proposed mechanism of action of BIO 300 in animal
models to the presumed mechanism in humans. The role of cellular senescence in DEARE-lung is further
explored in Aim 3 through the testing of senolytic agents alone or in combination with BIO 300. Further, Aim 3
will address knowledge gaps relevant to the pathophysiological mechanisms underlying ARS evolving towards
DEARE and testing of novel senolytic agents (BCL-xL-P) through strong collaborations with Projects 1, 2, and
3. Power calculations and statistical analysis for Project 4 will be performed by the biostatistician in Core A -
Administrative Core. The proposed Aims are only achievable through a cooperat...

## Key facts

- **NIH application ID:** 9938792
- **Project number:** 1U19AI150574-01
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** ZELJKO VUJASKOVIC
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $397,977
- **Award type:** 1
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9938792

## Citation

> US National Institutes of Health, RePORTER application 9938792, Development of BIO 300 for mitigation and/or treatment of radiation pneumonitis and fibrosis (1U19AI150574-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9938792. Licensed CC0.

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