About Regencor
We aim to transform the lives of patients after myocardial infarct
WHY WE DO WHAT WE DO
Myocardial Infarction is the leading cause of cardiac tissue damage & subsequent development of heart failure.
6.2M
Global incidence of acute myocardial infarction (MI)
35%
Of people with a first MI will progress to heart failure within 5 years, even with optimal medical management
29M
Estimated number of heart failure patients worldwide
With no new drugs on the market, MI and post-MI heart failure remain deadly diseases with no curative or preventive treatment options.
Company Overview
Regencor is a privately held regenerative medicine company spun out of Stanford University, advancing first in class treatments for cardiovascular disease. The company’s proprietary biologic REG101 stimulates regeneration of heart muscle cells, post heart attack, via non-invasive delivery thereby:
Restoring contractile function
Reducing scar volume
Preventing progression to heart failure
REG101 is currently:
Evaluated in IND-enabling studies
Manufactured with a platform process that is standard for antibody and protein therapeutics.
REG101 is expected to enter human trials in late 2025.
Regencor has a robust portfolio of issued and pending composition of matter patents being prosecuted in all major world markets. A complete list of these is available under CDA.
LEADERSHIP
Thomas Okarma, MD, PhD
Executive Chairman & Co-founder
Dr. Okarma brings over 30 years’ experience as CEO of three publicly traded companies, including Geron Corporation, where he was responsible for the world’s first FDA authorized IND for human embryonic stem cells, a milestone in biotechnology.
While at Geron, he also managed the development of Imetelstat, the world’s only telomerase inhibitor drug recently approved by FDA.
Dr. Okarma was also a Senior Vice President of Rhone Poulenc Rorer, following their acquisition of his first company, Applied Immune Sciences.
Under Dr. Okarma’s leadership, Regencor has attracted and retained highly trained and experienced employees, consultants, and CROs/CMOs.
Pilar Ruiz-Lozano, PhD
Founder & Chief Scientific Officer
As a member of the Faculty at Stanford School of Medicine and the Sanford-Burnham-Prebys Institute, she pioneered the development of tissue engineering and epicardial biology to treat heart disease.
She led the discovery of the cardiac regenerative properties of recombinant REG101 and the development of delivery modalities that are now licensed by Regencor, Inc.
Sean Edwards
President & CEO
Sean serves as the President and Chief Executive Officer of Regencor and has over two decades of experience as an executive and lawyer helping businesses and clients navigate sophisticated strategic, legal and regulatory issues.
Mr. Edwards has served in executive management roles with a number of life sciences companies across a wide range of therapeutic areas from fibrotic disease to dermatology to women’s health. He has experience in institutional financings, cross-border licensing and M&A. Sean has led teams responsible for taking drug candidates through the FDA and oversaw the launch of national and international brands in the physician dispensed and OTC drug channels.
Sean received his undergraduate degree from Princetion University and his law degree from the University of San Diego and is a licensed member of the State Bar of California
Mark Mercola, PhD
Co-Founder, Director and Chair of Scientific Advisory Board
Dr. Mercola is Professor of Cardiovascular Medicine at Stanford and formerly was Professor of Bioengineering at the University of California, San Diego, the Sanford-Burnham-Prebys Institute and Harvard Medical School.
He pioneered the use of stem cell models of heart disease for drug development. He was a co-discoverer of the regenerative properties of REG101.
Anke Kretz-Rommel, PhD
Acting Chief Development Officer
Experienced R&D leader with a passion to impact human health.
Demonstrated track-record of taking first in class and best in class protein therapeutics from conception through IND enabling studies and clinical POC across multiple therapeutic areas with small internal teams and global CROs and advisors.
CTO at Bird Rock Bio - sold to Skye Bioscience
SVP R&D at Anaphore and RuiYI; Alexion Pharmaceuticals
SCIENTIFIC ADVISORY BOARD
Mark Mercola, PhD
Co-Founder, Director and Chair of Scientific Advisory Board
Dr. Mercola is Professor of Cardiovascular Medicine at Stanford and formerly was Professor of Bioengineering at the University of California, San Diego, the Sanford-Burnham-Prebys Institute and Harvard Medical School. He pioneered the use of stem cell models of heart disease for drug development. He was a co-discoverer of the regenerative properties of FSTL1.
Nabil Dib, MD, FACC
Member of Scientific Advisory Board
Dr. Dib is the Director of Cardiovascular Research at Dignity Health in Phoenix, Arizona, and is the Founder and President of the International Society for Cardiovascular Translational Research. A Harvard-trained cardiologist, he is internationally recognized as an interventional cardiologist and pioneer in coronary infusion technologies.
Dr. Dib has participated as an investigator in over 65 clinical trials of cardiovascular devices, and cell and gene therapies for cardiovascular disease.
He is the inventor of the ND Infusion Catheter, a widely used FDA cleared medical device for the introduction of cells, biologicals and pharmaceuticals directly into coronary arteries.
Philip Janiak
Member of Scientific Advisory Board
Dr. Janiak is currently the CEO of Coteria Pharmaceuticals, a private biotechnology company focusing on novel treatments for heart failure, sarcopenia and obesity subpopulations. He received his PhD degree in Cardiovascular Pharmacology from the University of Iowa and graduated from the faculty of Pharmacy at the Paris XI University. He served as the Head of Cardiovascular Research at Sanofi until 2020, where he co-invented Ivabridine.
During his career he developed extensive experience in the management of international R&D groups and in leading multiple research collaborations with such biopharmaceutical companies as MyoKardia and the IMI2 Project. He is an inventor on 8 issued patents and an author of over 55 publications in international peer-reviewed journals.
Kenneth W. Mahaffey, M.D.
Member of Scientific Advisory Board
Dr. Mahaffey is a Professor of Medicine in the Division of Cardiovascular Medicine, and the Associate Dean for Clinical Research, at Stanford University School of Medicine. A Duke University-trained cardiologist, he is a journal reviewer for over 12 prominent cardiovascular journals and has authored over 500 peer-reviewed articles in prestigious international cardiology journals. He is recognized as an international leader in the design and execution of large scale cardiovascular clinical trials. He has worked with FDA and is a consultant for the Endocrinologic and Metabolic Drugs Advisory Committee.
His primary area of research interest is the design and execution of multi center cardiovascular clinical trials, focusing on analysis of key cardiac outcome measures using large patient databases. His current research activities include the standardization of the definition of myocardial infarction used in clinical trials, the adjudication of suspected clinical endpoints by Clinical Event Committees, and the efficient operational conduct of large multinational clinical trials in cardiology.
Funding Partners
Current Support for Regencor includes SBIR funding from the Department of Health and Human Services, NIH.
CIRM awards $3.9 Million to Regencor for development of delivery of FSLT1