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Development of a New Carbohydrate-based Anticoagulant Drug

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL139187-02
Agency Tracking Number: R44HL139187
Amount: $1,244,412.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-07-04
Award End Date (Contract End Date): 2021-06-30
Small Business Information
250 BELL TOWER DR CB7063, Chapel Hill, NC, 27599-0001
DUNS: 078778864
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 VIJAYAKANTH PAGADALA
 (312) 402-6987
 pagadalav@glycantherapeutics.com
Business Contact
 JAMES PETERSON
Phone: (919) 302-6489
Email: jimpeterson@glycantherapeutics.com
Research Institution
N/A
Abstract
Low molecular weight heparinsLMWHsare partially depolymerized natural products of heparinwhich are isolated from porcine intestineA worldwide distribution of contaminated heparin inwas associated withdeaths in the USThis crisis revealed the vulnerability of the LMWH supply chainLMWHs are complex mixtureshaving average molecular masses ofDaltonscorresponding tosaccharide unitsThe efficient preparation of a synthetic LMWH could improve the safetyavailability and efficacyHoweverthe production of homogeneous LMWHs has not been possible due to difficulties in the chemical synthesisGlycan Therapeutics proposes to assess an innovative chemoenzymatic approach that would provide an unprecedented efficiency in the preparation of heparinOur product will be animalfreestructurally homogenoussafe for renal impaired patientsand have the ability of its anticoagulant activity to be neutralized by protamineIn the phase I STTR studieswe have identitifed a heparin dodecasaccharidemeras a candidate to substitute animal sourced LMWHWe also demonstrated the ability to synthesize thismer at the scale ofg in four batchesIn the presently proposed Phase II SBIR studieswe will assess the feasibility of a larger scale synthesisgramsto conduct IND enabling studiesAimwill develop a process to prepareg of themer via a series of efforts for improving enzyme productionreaction efficacy and simplifying purificationsAimwill examine the immunogenicity of themer in a murine modelWe will also conductday toxicity studies in rat and dog as well as related IND enabling studiesThe completion of this project will modernize this century old drug with improved safety and anticoagulant properties Project Narrative Heparin and low molecular weight heparinsLMWHsare mixtures of highly sulfated polysaccharides isolated from animal tissuesIn this projectGlycan Therapeutics plans to use an innovative chemoenzymatic technology to synthesize heparinsThe project is designed to improve the safety of heparin drugsand to reduce the cost of heparin synthesis

* Information listed above is at the time of submission. *

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