Longeveron® Granted Japan Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells (MSCs)

Core Viewpoint - Longeveron Inc. has received a patent from the Japan Patent Office for potency assay methods related to human mesenchymal stem cells, enhancing its intellectual property portfolio and supporting its clinical programs in regenerative medicine [2][3][4]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions [2][6]. - The company's lead product, laromestrocel (Lomecel-B™), is derived from mesenchymal stem cells (MSCs) isolated from the bone marrow of young healthy adult donors [5][6]. Patent Details - The Japan Patent No. 2022-563984, titled "Potency Assay," grants Longeveron patent rights in Japan until April 20, 2041, contingent on the payment of annuity fees [3]. - This patent covers methods for assessing MSCs derived from various sources, including bone marrow, adipose tissue, and induced pluripotent stem cells (IPSCs) [8]. Clinical Trials and Development - Longeveron has conducted clinical trials for laromestrocel in Alzheimer's disease, aging-related frailty, and hypoplastic left heart syndrome (HLHS), with positive initial results reported [4][8]. - The company is currently conducting a pivotal Phase 2b clinical trial for laromestrocel in HLHS, with results expected in the third quarter of 2026, which may lead to a Biologics License Application (BLA) with the U.S. FDA [4][9]. Regulatory Designations - The HLHS program has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations, while the Alzheimer's disease program has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations [9].