Industrial production of milk extracellular vesicles for dual-use as a systemic radiotherapeutic medical countermeasure and cancer adjuvant therapy - the tiny cargo company has developed a novel…

The National Center for Advancing Translational Sciences awarded The Tiny Cargo Company, a for-profit small business in Roanoke, Virginia, a Cooperative Agreement totaling $985,974 on July 1, 2026, under the NCATS program (CFDA 93.350).

The award funds development and scaling of Xolacta, a milk-derived extracellular vesicle (MEV) therapeutic loaded with an esterified drug compound (ACT11-4OME) designed to promote regenerative healing of the gastrointestinal tract and bone marrow following high-dose ionizing radiation exposure. Xolacta addresses dual clinical needs: as a radiotherapeutic medical countermeasure and as an adjuvant treatment during radiation therapy. The company is pursuing FDA regulatory approval under the Animal Rule (PIND #167551) with support from the Biomedical Advanced Research and Development Authority (BARDA) BlueKnight program, with the U.S. Strategic National Stockpile identified as an initial customer.

The development leverages Tiny Cargo's exclusive license from Virginia Tech covering methods for industrial MEV purification from milk, MEV drug loading techniques, non-cold chain storage, enhanced tissue targeting, and oral delivery. The underlying platform extends beyond Xolacta to enable oral systemic delivery of other therapeutics and nutraceuticals via MEVs. Preclinical studies demonstrated that orally administered Xolacta increased survival in mice by more than 40 percent following lethal ionizing radiation (14 Gy).

Performance occurs in Virginia from July 1, 2026 through June 30, 2028.

Industrial production of milk extracellular vesicles for dual-use as a systemic radiotherapeutic medical countermeasure and cancer adjuvant therapy - the tiny cargo company has developed a novel therapeutic called xolactatm comprised of milk-derived extracellular vesicles (mevs) loaded with a drug that promotes regenerative healing of the gastrointestinal (GI) tract and bone marrow when given following exposure to high dose ionizing radiation (IR). Tiny cargo is actively meeting with the FDA (pind#167551) to gain regulatory approval under the animal rule for xolacta to meet the dire unmet needs of: a) radiotherapeutic medical countermeasure, and; b) dual-use radiotherapeutic adjuvant treatment during radiation therapy. Aided by our selection by barda to participate in the blueknight program, our initial customer will be the US strategic national stockpile - a potential multi-billion dollar order. Our patent portfolio includes an exclusive license from virginia tech on pending patents with confirmed FTO for: 1) methods for industrial purification of mevs from milk; 2) compositions and methods for MEV loading necessary for preparation of xolacta; 3) methods for non-cold chain storage of xolacta; 4) methods for enhancing MEV targeting and uptake in diseased tissues; and 5) methods for use of xolacta as an orally available radiotherapeutic. Importantly, beyond xolacta, tiny cargo's innovative MEV isolation method and ester-based drug loading approach provide a true platform for oral systemic delivery of other therapeutic and nutraceutical molecules by mevs. Our drug is a novel esterified composition called ΑCT11-4OME based on the CT-most 9 amino acids of GAP junctional CX43, a therapeutic of proven clinical efficacy when applied topically to radiation burns, which is currently in late-stage clinical testing. Importantly, tiny cargo has completed successful studies wherein orally administered xolacta increased survival of C57BL/6 mice by >40% following lethal IR (14 GY) - accompanied by regenerative healing of the GI tract and bone marrow in treated animals. These landmark results have led to more than $4M in funding to support toxicology testing, phase i clinical testing in humans and pivotal studies in a large animal model under the FDA animal rule. In this application we propose to advance xolacta storage properties, breaking reliance on cold-chain, as exemplified by covid vaccines. Our preliminary data indicates that mevs lyophilized in our proprietary formulation retain >95 % structure and bioactivity after 6 months storage at 20°c. Building on these results, tiny cargo seeks to: 1) optimize lyophilization of xolacta at industrial scale, potentially enabling storage of our product at 20°c for up to 12 months; and 2) establish GMP production of xolacta. Under guidance by the FDA, tiny cargo plans to clinically test xolacta, which will require pharmaceutical-grade therapeutic produced at scale to GMP standards. This will be done by tiny cargo at the worlds' first industrial milk extracellular vesicle production plant. GMP levels established at our industrial facility will guarantee consistent manufacture of active product under exacting environmental monitoring programs, including strict adherence to cleanroom standards. Pertinent to this objective, we have an active contract with jeff yuen & associates to ensure adherence to GMP guidelines during construction and operation of our plant. The GMP mevs will be used to both formulate xolacta and also provide GMP dairy ingredients to industrial giant fonterra, who wishes to sell our mevs as a novel dairy ingredient. Successful completion of the industrialization work of our two aims will facilitate entry into clinical testing and enable ongoing FDA review of orally administered xolacta as a systemic treatment for high-dose radiation, as well as potential revenue through sale of mevs to customers such as fonterra. Beyond development of xolacta as an RT MCM as detailed herein, tiny cargo is planning clinical programs that will enable dual-use regulatory approval of xolacta for treating side-effects of radiation therapy in cancer PA