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Principal Investigator: Vijayakanth Pagadala
Organization: GLYCAN THERAPEUTICS CORPORATION
Fiscal Year: 2024
Award: $747,280
Funding agency: National Heart Lung and Blood Institute
The goal of this proposal is to develop dekaparin, a synthetic glycan, to replace animal-derived
low molecular weight heparins (LMWHs). 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 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 presently proposed SBIR Phase IIB
grant application, we will conduct the synthesis of dekaparin under the GMP conditions and
complete the formulation, which will clear the IND requirements by FDA. Glycan Therapeutics
will also develop a 505(b)(2) regulatory strategy to shorten the regulatory pathway. The
completion of this project will modernize this century-old drug with improved safety and
anticoagulant properties.
Terms: <Affect><African><African Swine Fever Virus><Animal Sources><Animals><Anticoagulant Agents><Anticoagulant Drugs><Anticoagulants><Antidotes><Applications Grants><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cessation of life><Chemical Structure><China><Classical Swine Fever><Clinical><Clinical Trials><Complex Mixtures><Congresses><Death><Development><Disease Outbreaks><Drugs><Economics><Enoxaparin><Ensure><Epidemic><Family suidae><Formulation><Funding><Glycans><Goals><Grant><Grant Proposals><Heparin><Heparinic Acid><Hog Cholera><Human><Humulin R><Impairment><Insulin><Intestinal><Intestines><Investigational Drugs><Investigational New Drugs><Kidney><Kidney Urinary System><LMWH><Letters><Lovenox><Low-Molecular-Weight Heparin><Mainland China><Marketing><Medication><Medicine><Minor><Modern Man><Modernization><NO2><Natural Products><Nitrogen Dioxide><Nitrogen Peroxide><North Carolina><Novolin R><Outbreaks><Pathway interactions><Patients><Penetration><Pharmaceutical Preparations><Pharmacodynamics><Phase><Pigs><Politics><Polysaccharides><Preparation><Production><Property><Protamines><Recombinants><Regular Insulin><Regulatory Pathway><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SBIR><Safety><Secure><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Small Business Innovation Research><Small Business Innovation Research Grant><Suidae><Sulfate><Swine><Swine Fever><Technology><Therapeutic><Theriacs><Toxic effect><Toxicities><Wart-Hog Disease Virus><Work><animal tissue><blood thinner><bowel><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><cost effective><dalton><depolymerization><design><designing><developmental><drug/agent><economic><improved><innovate><innovation><innovative><manufacture><manufacturing process><meeting><meetings><molecular mass><naturally occurring product><pathway><pharmacophore><porcine><preparations><renal><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><success><suid><supply chain><thrombopoiesis inhibitor>