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Development of dekaparin to replace animal-sourced heparin

Award Number: R44HL139187
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2017
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Development of dekaparin to replace animal-sourced heparin - Low molecular weight heparins (LMWHs) are partially depolymerized natural products of heparin, which are isolated from porcine intestine. A worldwide distribution of contaminated heparin in 2007 was associated with 85 deaths in the US. This crisis revealed the vulnerability of the LMWH supply chain. LMWHs are complex mixtures, having average molecular masses of 3500-6000 Daltons, corresponding to 12-20 saccharide units. The efficient preparation of a synthetic LMWH could improve the safety, availability and efficacy. However, the production of homogeneous LMWHs has not been possible due to difficulties in the chemical synthesis. Glycan Therapeutics proposes to assess an innovative chemoenzymatic approach that would provide an unprecedented efficiency in the preparation of heparin. Our product will be animal- free, structurally homogenous, safe for renal-impaired patients, and have the ability of its anticoagulant activity to be neutralized by protamine. In the phase I STTR studies, we have identitifed a heparin dodecasaccharide (12-mer) as a candidate to substitute animal-sourced LMWH. We also demonstrated the ability to synthesize this 12-mer at the scale of 20 g in four batches. In the presently proposed Phase II SBIR studies, we will assess the feasibility of a larger scale synthesis (200 grams) to conduct IND-enabling studies. Aim 1 will develop a process to prepare 50 g of the 12-mer via a series of efforts for improving enzyme production, reaction efficacy and simplifying purifications. Aim 2 will examine the immunogenicity of the 12- mer in a murine model. We will also conduct 14-day toxicity studies in rat and dog as well as related IND-enabling studies. The completion of this project will modernize this century-old drug with improved safety and anticoagulant properties.


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: 2024 ( Subtotal = $746,918 )
2024	2024	GLYCAN THERAPEUTICS CORPORATION	617 HUTTON ST	RALEIGH	NC	27606	WAKE	USA	Blood Diseases and Resources Research	001	4	9/17/2024	COMPETING CONTINUATION	$747,280
2024	2020	GLYCAN THERAPEUTICS CORPORATION	617 HUTTON ST	RALEIGH	NC	27606	WAKE	USA	Blood Diseases and Resources Research	000	3	11/21/2023	NON-COMPETING CONTINUATION	-$362
														Subtotal = $746,918

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	GLYCAN THERAPEUTICS LLC	617 HUTTON ST STE 101	RALEIGH	NC	27606	WAKE	USA	Blood Diseases and Resources Research	000	3	10/26/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,248,861 )
2020	2020	GLYCAN THERAPEUTICS LLC	617 HUTTON ST STE 101	RALEIGH	NC	27606	WAKE	USA	Blood Diseases and Resources Research	000	3	6/19/2020	NON-COMPETING CONTINUATION	$1,248,861
														Subtotal = $1,248,861

Issue Date FY: 2019 ( Subtotal = $1,244,412 )
2019	2019	GLYCAN THERAPEUTICS LLC	617 HUTTON ST STE 101	RALEIGH	NC	27606	WAKE	USA	Cardiovascular Diseases Research	000	2	7/3/2019	COMPETING CONTINUATION	$1,244,412
														Subtotal = $1,244,412

Grand Total All Awards = $3,240,191

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Development of dekaparin to replace animal-sourced heparin

Award Number: R44HL139187

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2017

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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