2335218
Project Grant
Overview
Grant Description
Sttr Phase I: Novel bio-intervention to attenuate neurological damage following traumatic brain injury.
The broader impacts of this Small Business Innovation Research (SBIR) Phase I project hold global consequences in healthcare and scientific advancement.
Foremost, it addresses an unmet medical need.
Traumatic brain injury (TBI) is a leading cause of injury-related death and disability with an estimated annual world-wide incidence of 69M people.
Project success will improve the quality of life of millions and lessen TBI’s social and economic burden.
This intervention will stem TBI’s progression to follow-on neurodegenerative diseases such as Parkinson’s and other forms of dementia which, in turn, will broaden our scientific understanding of neurodegenerative pathways and reveal potential other novel drug targets.
This technology also offers a mechanism that provides a drug agnostic delivery system across the blood-brain barrier (BBB).
It has direct implications for US military combat readiness and veterans, noting 19% of deployed troops (Iraq & Afghanistan) suffered TBI.
This project’s success will be most beneficial for Black and Hispanic patients, who are more susceptible to the after-effects of TBI.
Importantly, this construct may hold therapeutic utility in myriad other disorders, including Alzheimer’s, Parkinson’s, ALS, stroke, myocardial infarction, insulin resistance, etc.
As a first-to-market product, the commercial potential to treat TBI is considerable.
The proposed project will test a novel fusion protein construct (NFP), which can cross the BBB and deliver a biologically active, targeted therapeutic payload to repair mitochondrial DNA (mtDNA) damage in neurons.
Significantly, restoring neuronal mtDNA integrity enables proper encoding of proteins required for cellular energy production and reestablishes bioenergetic levels to avert programmed cell death pathways and ensuing neurodegeneration.
The project will advance understanding of the extent of bioenergetic dysfunction and its role in neurodegenerative progression.
To achieve technical success in the setting of TBI, NFP must be able to maintain structural integrity within the circulatory system, traverse brain capillary endothelial cells, penetrate neuronal cells, and then target and enter mitochondria to deliver the protein payload at the site of mtDNA damage.
The goals of the proposed R&D program will verify NFP’s technical capability for such complex navigation and demonstrate its ability to attenuate neurological damage following TBI – to be confirmed through in vivo animal evaluation of TBI biomarker assays and analysis of behavioral changes.
Program objectives will also achieve optimization of the protein’s component structure, quantify target site bioavailability, and identify a time-related dosing profile, with intervention occurring at differing time points from initial insult.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.
Subawards are planned for this award.
The broader impacts of this Small Business Innovation Research (SBIR) Phase I project hold global consequences in healthcare and scientific advancement.
Foremost, it addresses an unmet medical need.
Traumatic brain injury (TBI) is a leading cause of injury-related death and disability with an estimated annual world-wide incidence of 69M people.
Project success will improve the quality of life of millions and lessen TBI’s social and economic burden.
This intervention will stem TBI’s progression to follow-on neurodegenerative diseases such as Parkinson’s and other forms of dementia which, in turn, will broaden our scientific understanding of neurodegenerative pathways and reveal potential other novel drug targets.
This technology also offers a mechanism that provides a drug agnostic delivery system across the blood-brain barrier (BBB).
It has direct implications for US military combat readiness and veterans, noting 19% of deployed troops (Iraq & Afghanistan) suffered TBI.
This project’s success will be most beneficial for Black and Hispanic patients, who are more susceptible to the after-effects of TBI.
Importantly, this construct may hold therapeutic utility in myriad other disorders, including Alzheimer’s, Parkinson’s, ALS, stroke, myocardial infarction, insulin resistance, etc.
As a first-to-market product, the commercial potential to treat TBI is considerable.
The proposed project will test a novel fusion protein construct (NFP), which can cross the BBB and deliver a biologically active, targeted therapeutic payload to repair mitochondrial DNA (mtDNA) damage in neurons.
Significantly, restoring neuronal mtDNA integrity enables proper encoding of proteins required for cellular energy production and reestablishes bioenergetic levels to avert programmed cell death pathways and ensuing neurodegeneration.
The project will advance understanding of the extent of bioenergetic dysfunction and its role in neurodegenerative progression.
To achieve technical success in the setting of TBI, NFP must be able to maintain structural integrity within the circulatory system, traverse brain capillary endothelial cells, penetrate neuronal cells, and then target and enter mitochondria to deliver the protein payload at the site of mtDNA damage.
The goals of the proposed R&D program will verify NFP’s technical capability for such complex navigation and demonstrate its ability to attenuate neurological damage following TBI – to be confirmed through in vivo animal evaluation of TBI biomarker assays and analysis of behavioral changes.
Program objectives will also achieve optimization of the protein’s component structure, quantify target site bioavailability, and identify a time-related dosing profile, with intervention occurring at differing time points from initial insult.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.
Subawards are planned for this award.
Awardee
Funding Goals
THE GOAL OF THIS FUNDING OPPORTUNITY, "NSF SMALL BUSINESS INNOVATION RESEARCH (SBIR)/ SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS PHASE I", IS IDENTIFIED IN THE LINK: HTTPS://WWW.NSF.GOV/PUBLICATIONS/PUB_SUMM.JSP?ODS_KEY=NSF23515
Grant Program (CFDA)
Awarding Agency
Place of Performance
Daphne,
Alabama
36527-5280
United States
Geographic Scope
Single Zip Code
Mito-Biotherapeutics was awarded
Project Grant 2335218
worth $274,855
from in August 2024 with work to be completed primarily in Daphne Alabama United States.
The grant
has a duration of 8 months and
was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships.
The Project Grant was awarded through grant opportunity NSF Small Business Innovation Research / Small Business Technology Transfer Phase I Programs.
SBIR Details
Research Type
STTR Phase I
Title
STTR Phase I: Novel Bio-Intervention to Attenuate Neurological Damage Following Traumatic Brain Injury
Abstract
The broader impacts of this Small Business Innovation Research (SBIR) Phase I project hold global consequences in healthcare and scientific advancement. Foremost, it addresses an unmet medical need. Traumatic brain injury (TBI) is a leading cause of injury-related death and disability with an estimated annual world-wide incidence of 69M people. Project success will improve the quality of life of millions and lessen TBI’s social and economic burden. This intervention will stem TBI’s progression to follow-on neurodegenerative diseases such as Parkinson’s and other forms of dementia which, in turn, will broaden our scientific understanding of neurodegenerative pathways and reveal potential other novel drug targets. This technology also offers a mechanism that provides a drug agnostic delivery system across the blood-brain barrier (BBB). It has direct implications for US military combat readiness and veterans, noting 19% of deployed troops (Iraq & Afghanistan) suffered TBI. This project’s success will be most beneficial for Black and Hispanic patients, who are more susceptible to the after-effects of TBI. Importantly, this construct may hold therapeutic utility in myriad other disorders, including Alzheimer’s, Parkinson’s, ALS, stroke, myocardial infarction, insulin resistance, etc. As a first-to-market product, the commercial potential to treat TBI is considerable.
The proposed project will test a novel fusion protein construct (NFP), which can cross the BBB and deliver a biologically active, targeted therapeutic payload to repair mitochondrial DNA (mtDNA) damage in neurons. Significantly, restoring neuronal mtDNA integrity enables proper encoding of proteins required for cellular energy production and reestablishes bioenergetic levels to avert programmed cell death pathways and ensuing neurodegeneration. The project will advance understanding of the extent of bioenergetic dysfunction and its role in neurodegenerative progression. To achieve technical success in the setting of TBI, NFP must be able to maintain structural integrity within the circulatory system, traverse brain capillary endothelial cells, penetrate neuronal cells, and then target and enter mitochondria to deliver the protein payload at the site of mtDNA damage. The goals of the proposed R&D program will verify NFP’s technical capability for such complex navigation and demonstrate its ability to attenuate neurological damage following TBI – to be confirmed through in vivo animal evaluation of TBI biomarker assays and analysis of behavioral changes. Program objectives will also achieve optimization of the protein’s component structure, quantify target site bioavailability, and identify a time-related dosing profile, with intervention occurring at differing time points from initial insult.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
Topic Code
PT
Solicitation Number
NSF 23-515
Status
(Complete)
Last Modified 10/8/24
Period of Performance
8/15/24
Start Date
4/30/25
End Date
Funding Split
$274.9K
Federal Obligation
$0.0
Non-Federal Obligation
$274.9K
Total Obligated
Activity Timeline
Transaction History
Modifications to 2335218
Additional Detail
Award ID FAIN
2335218
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
DRXMSBLNU5R1
Awardee CAGE
9J0R2
Performance District
AL-01
Senators
Tommy Tuberville
Katie Britt
Katie Britt
Modified: 10/8/24