SAMBA BIOLOGICS INC. — Department of Health and Human Services STTR Phase I: NHLBI

Description

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.