Longeveron Inc. has licensed a breakthrough cardiac stem cell technology from the University of Miami that could overcome one of the most significant safety barriers preventing the clinical implementation of induced pluripotent stem cell (iPS) therapies for heart disease. The clinical-stage biotechnology company announced it has secured US Patent 12,168,028 B2, which protects unique cardiomyogenic cells that may offer safer alternatives to existing cardiac regenerative approaches.
Addressing Critical Safety Concerns
The licensed technology centers on cells bearing the GHRH-Receptor (growth hormone-releasing hormone receptor), which can differentiate specifically into human cardiac muscle cells. This targeted approach addresses a fundamental problem that has plagued cardiac iPS cell therapy development: the risk of malignant ventricular arrhythmias after cell engraftment.
"This technology provides a solution to one of the most difficult barriers to the implementation of induced pluripotent stem cells (iPS) technology in the cardiovascular space," said Joshua Hare, MD, Co-founder, Chief Science Officer, and Chairman at Longeveron.
Traditional approaches to developing cardiomyocytes from iPS cells initially showed promise as a way to repopulate damaged heart muscle, offering an unlimited source of cardiac cells while avoiding the ethical concerns associated with embryonic stem cells. However, clinical development was significantly hampered when researchers discovered that these cells could cause dangerous heart rhythm abnormalities after transplantation into mammalian heart tissue.
Selective Cell Technology
The University of Miami-developed technology circumvents this complication through a selective process that identifies and isolates GHRHR+ cells from cardiomyogenic cell populations. This selection method specifically targets cells destined to become cardiomyocytes while eliminating cells with electrical automaticity—a property characteristic of cardiac conduction tissue cells that can trigger arrhythmias.
By selecting only cells that will contribute new contractile tissue without causing electrical disturbances, the technology enables safer cardiac cell engraftment. The resulting cells can integrate into heart tissue and provide therapeutic benefit without the risk of life-threatening rhythm disorders that have limited previous approaches.
Pipeline Expansion Opportunity
The licensing agreement represents a strategic expansion of Longeveron's regenerative medicine portfolio, which currently focuses on their lead investigational product laromestrocel (Lomecel-B), an allogeneic mesenchymal stem cell therapy. The company is actively pursuing clinical programs in hypoplastic left heart syndrome (HLHS), Alzheimer's disease, pediatric dilated cardiomyopathy, and aging-related frailty.
"With the significant clinical and regulatory progress we have made in hypoplastic left heart syndrome (HLHS) and Alzheimer's disease, and our recent IND approval for pediatric dilated cardiomyopathy, the opportunity to license this important and complimentary stem cell technology provides us a unique opportunity to expand our stem cell therapy pipeline," Hare explained.
Broad Therapeutic Applications
Longeveron believes the newly licensed technology has potential applications across a wide spectrum of cardiovascular conditions affecting both adult and pediatric populations. The company's existing expertise in rare pediatric cardiac conditions, combined with this new cardiac-selective stem cell approach, positions them to address multiple unmet medical needs in cardiovascular medicine.
The composition of matter patent protects the unique induced pluripotent-derived cardiomyogenic cells, providing Longeveron with intellectual property coverage for widespread therapeutic applications in heart diseases. This licensing agreement adds a complementary technology platform to the company's existing mesenchymal stem cell programs, potentially enabling combination approaches or standalone cardiac regenerative therapies.
