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Discovering the Mechanism of Action of a peptide drug, OPT101, that targets CD40 mediated inflammation in type 1 diabetes

Award Number: R01DK131196
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: 03/10/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Discovering the Mechanism of Action of a peptide drug, OPT101, that targets CD40 mediated inflammation in type 1 diabetes - Abstract: Controlling the autoimmune inflammation in type 1 diabetes (T1D) has proven difficult. Currently there are clinical trials to attempt controlling T1D that are having only marginal impact. Desired primary outcomes include increasing of C-peptide, as a marker for beta cell restoration, decrease insulin requirements, decreases in HbA1c, as a measure of systemic inflammation and maintenance of peripheral blood lymphocyte counts. Current therapies have slowed C-peptide loss marginally but not halted or reversed loss. None of the other primary goals have yet been achieved in any of the current clinical trials. We created a novel approach to control pathogenesis in T1D using a small peptide to modulate CD40 mediated inflammation. We completed pre-clinical studies in mice that include toxicology/pharmacodynamic/pharmacokinetic studies on a peptide that prevents diabetes onset in NOD mice and reverses hyperglycemia in 60% of diabetic NOD mice. We have begun a veterinary clinical trial generating data that show, unlike current clinical trial treatments, this approach increases C-peptide over time, reduces, by up to 90%, insulin requirements, reduces glycated fructosamine, the veterinary equivalent of HbA1c, and does not cause immune suppression or lymphocyte loss. We were granted a “Safe-to-Proceed” notice from the FDA to begin Phase 1a/1b clinical trials in humans using this drug. This grant application is to perform mechanism of action studies on this drug. We hypothesize that the drug, KGYY15 (OPT101 for FDA) binds to beta cell CD40 to prevent beta cell damage. We further hypothesize that KGYY15 binds to peripheral blood T cells (TH40 cells specifically defined by us), B cells and macrophages/dendritic cells to tolerize thus preventing further damage. We also will explore developing this drug approach for islet transplants. Successful completion of this grant will provide important information about how this drug works specifically during T1D.


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 = $0 )
2026	2025	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	1/8/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $396,060 )
2025	2025	THE REGENTS OF THE UNIV. OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/3/2025	NON-COMPETING CONTINUATION	$396,060
														Subtotal = $396,060

Issue Date FY: 2024 ( Subtotal = $422,463 )
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/3/2024	NON-COMPETING CONTINUATION	$26,403
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/24/2024	NON-COMPETING CONTINUATION	$396,060
														Subtotal = $422,463

Issue Date FY: 2023 ( Subtotal = $440,065 )
2023	2023	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/17/2023	NON-COMPETING CONTINUATION	$440,065
														Subtotal = $440,065

Issue Date FY: 2022 ( Subtotal = $440,065 )
2022	2022	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/9/2022	NEW	$440,065
														Subtotal = $440,065

Grand Total All Awards = $1,698,653

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Discovering the Mechanism of Action of a peptide drug, OPT101, that targets CD40 mediated inflammation in type 1 diabetes

Award Number: R01DK131196

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: 03/10/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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