NHLBI Vascular Innovations/Interventions and Therapeutic Advances (VITA)

Contract Award Number: HHSN268201700001C Contract Award Dollar Amount (Base Period): $535,149 Option Period 1: $580,069 Option Period 2: $603,551 Ultimate Contract Amount: $1,718,769 Contractor Awarded Name: Duke University School of Medicine Contractor Awarded DUNS: 044387793 Contractor Awarded Address: 2200 West Main Street, Suite 820 Durham, NC 27705 Description: Duke University School of Medicine will conduct a non-invasive diagnosis of pulmonary vascular disorders (PVD) with drug/device combination of hyperpolarized 129Xe MRI as a diagnostic test/imaging probe. This program is focused on the clinical translation and testing of this technology in human subjects to differentiate the finding on 129Xe MRI between PVD and other common heart and lung disease states with similar symptoms; and, develop diagnostic criteria for optimizing the sensitivity and specificity of 129Xe MRI for diagnosis of PDV. The established research technology of 129Xe MRI will be extended into early stage clinical testing for its unique ability to diagnose pulmonary vascular disease. Contract Award Number: HHSN268201700002C Contract Award Dollar Amount (Base Period): $792,047 Option Period 1: $825,009 Option Period 1: $341,116 Ultimate Contract Amount: $1,958,172 Contractor Awarded Name: DuPage Medical Technology, Inc. Contractor Awarded DUNS: 079748462 Contractor Awarded Address: 1316 Ridge Road Willowbrook, IL 60527 Description: DuPage Medical Technology, Inc. will further develop a novel anti-thrombotic agent, which potently inhibits occlusive thrombosis but has minimal adverse effect of bleeding, from the stage of proof-of-concept to IND approval for phase I clinical trial. Objectives include: 1) To develop innovative and cost-effective scale up methods for mass production of the new drug; 2) perform pre-IND toxicology studies using two different animal species; 3) perform pharmacological studies to evaluate efficacy of the new drug in treating thrombotic conditions targeted for clinical trials and its impact on hemostasis, in comparison with and in addition to current standard anti-platelet therapy, and 4) prepare and initiate pre-IND meetings with FDA and complete IND submission. Contract Award Number: HHSN268201700003C Contract Award Dollar Amount (Base Period): $383,865 Option Period 1: $226,023 Option Period 2: $195,294 Ultimate Contract Amount: $805,182 Contractor Awarded Name: Sujana Biotech, LLC Contractor Awarded DUNS: 079709941 Contractor Awarded Address: 20600 Chargrin Boulevard, Suite 210 Cleveland, OH 44122 Description: Sujana Biotech, LLC will develop a novel anti-thrombotic mAb with improved safety and improved or equivalent efficacy compared to current medications. The mAb, specific for leukocyte integrin Mac 1 (M2, CD11b/CD18), will inhibit binding to platelet glycoprotein Ibalpha (GPIba), a critical early step in pathological thrombus formation. The research will help define a novel molecular and cellular mechanism linking inflammation and thrombosis, providing new insights into fundamental biology of natural hemeostatic systems. Contract Award Number: HHSN268201700004C Contract Award Dollar Amount (Base Period): $658,400 Option Period 1: $642,399 Option Period 2: $651,939 Ultimate Contract Amount: $1,952,738 Contractor Awarded Name: The Regents of the University of Michigan Contractor Awarded DUNS: 073133571 Contractor Awarded Address: 3003 S. State Street Ann Arbor, MI 48109-1274 Description: The Regents of the University of Michigan will explore the hypothesis in an animal model closest to humans in controlled studies, that use of an E-selectin inhibitor in acute deep venous thrombosis (DVT), either alone or in combination with traditional anticoagulants, may lead to greater thrombus resolution, higher rates of preserved valve competence, reduced incidence of post thrombotic syndrome (PTS), and improved quality of life, while also reducing the risks of bleeding. Contract Award Number: HHSN268201700005C Contract Award Dollar Amount (Base Period): $484,404 Option Period 1: $682,111 Option Period 2: $628,793 Option Period 3: $63,194 Ultimate Contract Amount: $1,858,502 Contractor Awarded Name: The Regents of the University of California, San Francisco Contractor Awarded DUNS: 094878337 Contractor Awarded Address: 3333 California Street, Suite 315 San Francisco, CA 94143-0962 Description: The University of California, San Francisco will standardize the manufacturing and packaging of a resolving-eluting perivascular wrap, confirm desired biologic effects using a novel synthetic RvD1 analogue with enhanced bioavailability and conduct large animal pre-GLP and GLP studies to define safety and efficacy of this approach. At the conclusion of the study, milestones will have been met toward a pre-IND stage and will outline the remaining regulatory and financial hurdles to achieve FDA approval for early stage human studies to address the significant unmet need of surgical bypass graft failure. Contract Award Number: HHSN268201700006C Contract Award Dollar Amount (Base Period): $318,434 Option Period 1: $323,436 Option Period 2: $323,412 Ultimate Contract Amount: $965,282 Contractor Awarded Name: The Board of Trustees of the University of Illinois Contractor Awarded DUNS: 098987217 Contractor Awarded Address: 1737 West Polk Street Chicago, IL 60612 Description: The University of Illinois will determine the mechanisms underlying the beneficial and adverse effects of clinical agents targeting nicotinamide phosphoribosyltransferase (NAMPT) as a basis for the design of safe, non-toxic drugs that would be of clinical use in the treatment of diseases such as pulmonary arterial hypertension. Contract Award Number: HHSN268201700007C Contract Award Dollar Amount (Base Period): $322,865 Option Period 1: $299,165 Option Period 2: $306,746 Ultimate Contract Amount: $928,776 Contractor Awarded Name: The Board of Trustees of the University of Illinois Contractor Awarded DUNS: 098987217 Contractor Awarded Address: 1737 West Polk Street Chicago, IL 60612 Description: University of Illinois at Chicago seeks to develop highly effective novel drug-based therapy for the treatment of vascular leakage and accompanying inflammation in Acute Respiratory Distress Syndrome (ARDS). The goal is to generate novel therapeutic agents with optimal physicochemical and biochemical properties and in vivo efficacy along with identifying one or more highly potent therapeutic agents to treat pathological vascular leakage in ARDS that can be brought to clinical fruition. Contract Award Number: HHSN268201700008C Contract Award Dollar Amount (Base Period): $303,922 Option Period 1: $301,530 Option Period 2: $275,980 Ultimate Contract Amount: $881,432 Contractor Awarded Name: University of Miami School of Medicine Contractor Awarded DUNS: 052780918 Contractor Awarded Address: 1320 South Dixie Highway Suite 650, LC2960 Coral Gables, Florida 33146-2926 Description: University of Miami School of Medicine seeks to test feasibility and efficacy of adhesion molecule-based extracellular and cellular components in mouse limb ischemia and gangrene models. The strategies will focus on improving both the hospitability of the tissue microenvironment and precision targeting of bone marrow (BM)-derived, repair-competent stem/progenitor cells (tissue repair cells (TRC)). The preclinical study is translatable for developing and optimizing safe and effective gene- and stem cell-based therapies for clinical trials and may offer a new paradigm for advancing and transforming the field of non-invasive treatment for peripheral arterial disease patients with critical limb ischemia. Contract Award Number: HHSN268201700009C Contract Award Dollar Amount (Base Period): $206,135 Option Period 1: $199,686 Option Period 2: $194,928 Ultimate Contract Amount: $600,749 Contractor Awarded Name: Vascumab, LLC Contractor Awarded DUNS: 07965309 Contractor Awarded Address: 23 Business Park Drive Branford, CT 06405 Description: Vascumab will deliver a selective orally active HDAC4/5 inhibitor clinical candidate for the treatment of pulmonary arterial hypertension (PAH). This project will cover the work necessary to deliver an intermediate objective: a selective inhibitor at lead development that is effective in the SU-5416/hypoxia and monocrotaline rat models of PAH have acceptable pharmacokinetics and is safe in a rat exploratory toxicological study. PAH is a progressive fatal disease caused in part by aberrant proliferation of pulmonary artery endothelial and smooth muscle cells, which leads to high blood pressure in the pulmonary artery endothelial and smooth muscle cells, which leads to high blood pressure in the pulmonary arteries and the right side of the heart leading eventually to right sided heart failure.