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VasaPlex-based biologics for treatment of reperfusion injury after myocardial infarction

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL162161-01
Agency Tracking Number: R41HL162161
Amount: $498,271.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA20-265
Timeline
Solicitation Year: 2020
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-03-11
Award End Date (Contract End Date): 2023-03-09
Small Business Information
146 W SHORE RD
South Hero, VT 05486-4616
United States
DUNS: 078541683
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JEFFREY SPEES
 (802) 656-2388
 jeffrey.spees@uvm.edu
Business Contact
 JEFFREY SPEES
Phone: (802) 372-1199
Email: jspees@uvm.edu
Research Institution
 UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
 
85 SOUTH PROSPECT STREET
BURLINGTON, VT 05405-1704
United States

 Nonprofit College or University
Abstract

PROJECT SUMMARY
Coronary heart disease leading to acute myocardial infarction (MI; heart attack) is a principal cause of mortality
worldwide. Cornerstone treatments for MI are designed to restore blood flow (i.e. to “reperfuse”) blocked
coronary arteries. Despite reduced times to intervention, and successful stent placement, 30-50% of primary
Percutaneous Coronary Intervention (PCI) patients exhibit low- or “no-reflow”, a phenomenon linked to poor
outcomes, increased probability of heart failure, and death. Low/no-reflow occurs when macroscopic vessels
are opened by stenting or thrombolysis, but distal myocardial perfusion remains compromised.
“VasaPlex” (HGF:IgG complex) and “VasaPlex-F2” (FGF2:HGF:IgG complex) are vaso- and cardioprotective
biologic drugs we designed to increase vascular integrity and preserve cardiac tissue jeopardized by
reperfusion injury and low/no-re-flow. In a large animal (pig) model of acute MI with reperfusion, intracoronary
infusion of VasaPlex preserved 48 ± 12% of myocardial tissue at risk. We propose the following Specific Aims:
1. Determine effects of intracoronary treatment with VasaPlex or VasaPlex-F2 on cardiac structureand function 1 month after MI and PCI. Milestone: Obtain data for circulating biomarkers of cardiacinjury, tissue histology, and echocardiographic measures of cardiac function that demonstratesignificant long-term benefit conferred by VasaPlex and/or VasaPlex-F2-treatment in a pre-clinical,large animal model of MI with reperfusion.2. Develop standardized conditions to form and maintain VasaPlex-based products.Milestone: Obtain basic, foundational data for dissociation/association kinetics of our drug componentsand the effects of IgG Fc domain glycosylation; these data will help us to generate our products moreefficiently, improve product safety, and support IND filing and product commercialization.
Deliverables: In alignment with the goals of the NIH STTR program, Samba BioLogics, Inc., will provide new,
innovative and effective products that improve patient survival, outcomes and quality of life after MI.PROJECT NARRATIVE
Percutaneous Coronary Intervention (PCI) with angioplasty and stent placement is a standard of care
treatment to restore blood circulation (i.e. to reperfuse) the heart after myocardial infarction (i.e. MI, heart
attack). Notably, after MI and PCI, up to 50% of final infarct size in patients is attributed to reperfusion injury
and microvascular low/no-reflow downstream of the occlusive site where the blood clot formed. Our STTR
proposal seeks to evaluate and advance VasaPlex-based products that treat reperfusion injury and low/no-
reflow after MI; these biologics have potential to become game-changing, blockbuster drugs that increase
patient survival and improve outcomes and quality of life after MI.

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

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