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Novel Drug Delivery Platform as Medical Countermeasure for treatment of Gastrointestinal Radiation Damage

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA272078-01A1
Agency Tracking Number: R41CA272078
Amount: $400,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-22
Award End Date (Contract End Date): 2024-08-31
Small Business Information
1601 IVY ST SE
Roanoke, VA 24014-1823
United States
DUNS: 103379362
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (803) 807-8255
Business Contact
Phone: (803) 807-8255
Research Institution
BLACKSBURG, VA 24061-6100
United States

 Nonprofit College or University

Project Summary/Abstract
The Tiny Cargo Company offers a unique, orally administered medical countermeasure for treatment and
prevention of the gastrointestinal (GI) side effects of cancer radiation therapy (RT). Our therapeutic is
comprised of milk-derived extracellular vesicles (mEVs) loaded with a safe and highly effective
radioprotective drug – a formulation that we call Milactatm. RT complications include nausea, vomiting,
pain and dyspepsia, mucosal barrier breakdown, and nutrient malabsorption - with long-term effects that
can also include cumulative and irreversible scarring of the gut. Presently, there are no treatments to
prevent or mitigate these side-effects of RT. Our world-wide exclusive license from Virginia Tech includes
pending patents for the composition and method of drug loading into mEVs of our radioprotective drug,
as well as methods for industrially scalable production and isolation of pharmaceutical-grade mEVs from
bovine milk. mEVs are subject to minimal regulation by the FDA and our radioprotective drug is a novel,
short 9 amino acid peptide (RPRPDDLEI) mimicking the C-Terminus of the human gap junction protein
Connexin 43. Our technical premise is that encapsulation of RPRPRDDLEI in mEVs will enable oral
delivery and protection of our fragile peptide therapeutic in digestive juices prior to uptake in GI-tract
cells. Our preliminary data indicates an optimized mEV-drug loading approach, demonstration of uptake
of mEVs by gut cells/tissues following oral administration and in vitro data that our RPRPDDLEI-mEV
formulation provides potent levels of radioprotection to cultures of the rat GI-tract derived primary cell
line IEC-6, comparable to Phase III Clinical Trial therapeutic αCT1. In two aims we will: 1) Undertake
testing in vivo of the prophylactic efficacy of our mEV-RPRPDDLEI formulation (i.e., Milacta) in a mouse
model of whole-body irradiation, and; 2) Determine the optimal dosing regimens (i.e. prophylactic, post-
irradiation, dual-treatment) for maximized radioprotection. Tiny Cargo’s technology meets an urgent
clinical need that could increase patient uptake and compliance with highly effective radiation-based
cancer mitigation strategies, as well as providing a medical technology that is likely to be of high strategic
interest to the US and our military. Moreover, our mEV-based and drug loading method represents a
platform technology that in the future could be adapted for other “difficult-to-drug” biologics, including
microRNAs and other therapeutic peptides, thereby providing new licensing and commercial
collaborative opportunities for Tiny Cargo as it develops its business plan and pipeline beyond mitigation
of the effects of radiation therapy in cancer patients.

* Information listed above is at the time of submission. *

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