Evaluation of recombinant bovine lactoferrin and n-linked glycan effects on infant GUT health and immunity
Ended Project Grant Awarded Last action
- Award ID
- R41HD114267
- Recipient
-
Turtle Tree Labs Inc. UEI HXH4QFDQ2V41
- Awarding agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Obligated
- $933,969
Award facts
- Assistance listing
- 93.865 Child Health and Human Development Extramural Research
- Completion date
- Originally
- Place of performance
- Davis, CA, USA
Award details come from USAspending.gov.
Description
- Abstract
- Most infants currently rely on infant formula (if) to meet their nutritional needs. However, existing infant formula is functionally inferior because IT lacks breast milk bioactive proteins that are crucial to infant health and development. Consequently, formula-FED infants have increased risk of morbidity and mortality. Current technology limits the ability to add bioactive milk proteins to infant formula because manufacturing processes are resource intensive, costly, and difficult to scale. Thus, scalable technology to improve bioactive availability for fortification of infant formula is needed. Towards this goal, turtletree has developed precision fermentation technology to produce recombinant bovine lactoferrin (rblf), a critical bioactive milk protein demonstrated to support GUT health and immune function in infants. Not only will turtletree's technology allow for inclusion of lactoferrin in all infant formulas, but the use of precision fermentation will also dissociate bioactive milk protein production from animal agriculture, as required for COW's milk-derived lactoferrin (cmdlf), and the associated environmental stressors. In this proposal, we aim to answer two specific questions that will validate our ability to apply precision fermentation technology for infant health and commercialize rblf as an ingredient for addition to infant formula: 1) does the unique glycosolation profile of rblf impact the protein's immunomodulatory and GUT function as compared to cmdlf? 2) does rblf improve GUT health in an infant preclinical mouse model? Preliminary data supporting this proposal demonstrates the n-linked glycan profile is the only substantially unique structural element of rblf, characterized by dominance of high-mannose type glycans (~99%) compared to cmdlf (~45%). Thus, we reason a proper evaluation of rblf requires focused studies on physiological systems sensitive to glycan alterations, notably immune interactions (aim 1) and GUT development (aim 2). Comparative results between differentially glycosylated lactoferrin treatment groups will distinguish glycan effects. In aim 1, we will assess the role of lactoferrin n-linked glycosylation on immunomodulation mediated by the mannose receptor in order to understand glycan effect. In aim 2, we will execute an intervention of orally-delivered rblf to improve dysregulated GUT health in infant mouse pups. With the successful completion of both aims, we expect to demonstrate rblf promotes immune and GUT interactions that maintain biological activity and efficacy as compared to cmdlf. The scope of work is designed to support regulatory approval and expedite turtletree's path to market for the safe and effective application of advancing infant health.
Transactions
| Action | Obligated | Date |
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| Amendment | $0 | |
| Amendment | $0 | |
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| Amendment | $311,323 | |
| Amendment | $311,323 | |
| Original award | $311,323 |
Quick answers
Who received award R41HD114267?
R41HD114267 was awarded to Turtle Tree Labs Inc. by National Institute of Child Health and Human Development (National Institutes of Health) on September 19, 2023.
How much is award R41HD114267 worth?
$933,969 has been obligated on R41HD114267.
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