Biotechnology Awards 2020

4 GHP / 2020 Biotechnology Awards , Still a very small organisation, Regencor has three individuals who run the company and manage a suite of CROs, CMOs, accounting and legal firms, plus a group of seven key consultants. While the management team will significantly expand in the near future, its current small size ensures that the principles of operation held by the founders and the CEO are fully and consistently transmitted to its contractors and consultants. Thomas goes into more details about what it is exactly that the firm does. “We are developing the EpicaPatch, a bioabsorbable collagen matrix containing non-glycosylated recombinant human Follistatin-like 1 protein (rhFSTL1) for cardiac muscle regeneration following myocardial infarction (MI) or heart attack. The protein is delivered via a collagen patch to patients undergoing coronary artery bypass grafts (CABG). The patch is fixed to the surface of the heart overlying the infarct zone at the time of CABG placement. We are also developing MyoBeads, bioabsorbable PLGA microspheres containing the identical Follistatin-like 1 protein (rhFSTL1) for cardiac muscle regeneration following MI in patients undergoing percutaneous coronary intervention (PCI). The Myobeads are delivered to the infarct zone through the same catheter that just performed the balloon angioplasty at the time of PCI. Regencor’s mission is to regenerate the human heart after infarction in order to improve cardiac function, Regencor Inc. Leading Innovators in Cardiac Muscle Regeneration 2020 & Most Pioneering Biotech CEO 2020 Regencor is a US biotechnology company focused on the regeneration of the human heart following a heart attack. Having recently been recognized in GHP’s Biotechnology Awards 2020, we caught up with the firm’s Chairman, President and CEO, Thomas Okarma who provided us with further insight into the award-winning products Regencor plans to deliver. Jan2042514 reduce progression to heart failure, and thereby lower costs associated with treating ischemic heart disease. Thomas elaborates: “While morbidity and mortality associated with acute myocardial infarction have been dramatically reduced by means of medical interventions and coronary revascularization procedures (which are now standard of care for MI patients worldwide) ironically, these advances have led to nearly equally dramatic increases in morbidity and mortality from chronic congestive heart failure. Heart attacks result in scarred, non-contractilemyocardium, which does not regenerate and inevitably leads to heart failure. While coronary revascularization saves lives and limits infarct size, it cannot reverse scar or regenerate lost heart muscle. None of the current treatments for infarction or heart failure are regenerative. We intend to transform coronary revascularization, currently a $90B market in the US alone, by adding cardiac regeneration to the existing benefits of revascularization. “We have just progressed to Phase 2 of our $4 MM NIH SBIR grant which funds preclinical development of the EpicaPatch in large infarcted swine. Our global composition of matter patent application that claims the non-glycosylated isoform of human recombinant FSTL1 in multiple biological formats for cardiac regeneration has been allowed in the US. The patent covering the EpicaPatch has issued in the US. Last summer, we won the Amgen Golden Ticket Award which covers the fees for our incubator space and opens the door to a potential collaboration.” The guiding philosophy of Regencor’s management team development is to not hire too early in the company’s development, as Thomas explains: “We have thus far relied upon grant funding, scientific publications, patent issuances, first in class CROs and CMOs, our advisory board and corporate partnering discussions to achieve product definition and validation. This strategy has positioned the company well for the potential consummation of an early corporate partnership and a Series A financing at an attractive valuation. At the closing of the planned Series A financing, we will be well positioned to attract the kind of top-tier, motivated and experienced talent to guide the company on its next phase of corporate development.” Looking ahead to what the future holds for the firm, the team’s exit strategy currently is to partner, or be acquired, after the demonstration of human safety and efficacy for both formulations. Bringing the interview to a close, Thomas is keen to highlight the strategy the firm currently has in place, and the results that will be provided if all goes according to plan. “At Regencor, we have adopted a two-stage clinical development plan to accelerate the goal of demonstrating human proof of concept. Our First In Man protocols to demonstrate safety and feasibility will take place in Australia and New Zealand under their accelerated First In Man program. If successful, these data will be incorporated into our US IND application and may enable us to execute a more advanced Phase 1/2 trial in the US than would otherwise be possible without the A/NZ data package. Thus, we hope to have two positive human trials for each formulation to provide compelling clinical evidence for our approach that would attract a global pharmaceutical partner relatively early in our product development cycle.” Contact Details Company: Regencor Inc. Web Address: www.regencor.com