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Production in maize of low-cost heat stable forms of GLP-1 and GIP receptor agonists for treatment of diabetes and obesity

Award Number: R43DK148203
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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Production in maize of low-cost heat stable forms of GLP-1 and GIP receptor agonists for treatment of diabetes and obesity - Glucagon-like peptide (GLP-1) receptor agonists have been in widespread use as a treatment for type 2 diabetes since 2005 and obesity since 2014. More recently, a peptide with a similar function, exendin, was identified. These compounds, known as incretin mimetics, are found in a wide variety of tissues and influence glucose metabolism, insulin and glucagon secretion, gastric emptying, and appetite. By some estimates up to 40% of the world’s population are living with obesity and the market is estimated to be up to $100 billion by 2030. There is also extensive evidence that GLP-1 agonists have beneficial effects on numerous other conditions such as cardiovascular health, arthritis, substance abuse, pain management, and prevention of neurodegenerative diseases. These agonists are inherently prone to proteolysis, but extensive research has led to multiple approaches to improve stability. However, there are still significant limitations to the widespread use of GLP-1 agonists. Treatment can cost $300 to $2000 per month, which is prohibitive for much of the world’s population and there have been many reported shortages. We have developed a system in transgenic maize grain for the low-cost production of recombinant proteins resulting in commercialization of the first of these products. This approach can greatly reduce the production cost of the product while providing a system to rapidly scale-up production for a fraction of the upfront cost associated with facilities for cell culture systems. We now plan to use this for GLP-1 agonists resulting in an extremely low cost of production. In addition, maize grain can bioencapsulate recombinant proteins providing protection from proteases in the gut. We have demonstrated that this extra level of protection can enable the oral delivery of proteins that otherwise must be parenterally administered. We now plan to combine the use of 1) modified versions of GLP- 1 that have been shown to provide higher stability, 2) the bioencapsulation of proteins in maize to provide protection in the digestive system and 3) the high levels of recombinant protein accumulation in maize to enable oral delivery of small palatable tablets for administration. The extremely low cost of protein production in maize (< $0.01/dose for the active ingredient), the stability of the protein in grain and digestive tract make this approach likely to succeed and overcome previous barriers. The overarching objective of this proposal is to validate the use the maize platform to develop a low- cost, heat-stable orally delivered form of GLP-1 and GIP receptor agonists. This can lead to further optimization and the engagement of pharmaceutical partners to enable a much lower cost of treatments that can be accessible in resource-limited areas.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $288,221 )
2026	2026	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVE BLDG 83-1D	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/17/2026	NEW	$288,221
														Subtotal = $288,221

Grand Total All Awards = $288,221

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Production in maize of low-cost heat stable forms of GLP-1 and GIP receptor agonists for treatment of diabetes and obesity

Award Number: R43DK148203

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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