Fortress Biotech(US:FBIO) Newsfilterยท2024-05-14 12:30Core Viewpoint - Fortress Biotech and its subsidiary Helocyte are advancing the development of Triplex, a vaccine aimed at preventing and treating cytomegalovirus (CMV) in liver transplant recipients, with the first patient dosed in a Phase 2 clinical trial funded by a $9 million NIH/NIAID grant, expected to receive an additional $12 million over the next four years [1][2][3]. Company Overview - Fortress Biotech is focused on acquiring and advancing biopharmaceutical assets to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue, with seven marketed products and over 20 programs in development [6]. - Helocyte is a clinical-stage company developing immunotherapies for cancer and infectious diseases, including CMV and HIV, with a significant focus on transplant recipients who are at high risk for CMV complications [5]. Clinical Trial Details - The Phase 2 trial, named "CMV vaccine in Orthotopic Liver Transplant" (COLT), involves up to 416 CMV seronegative liver transplant recipients to evaluate the safety and efficacy of two doses of Triplex [2]. - The primary objective is to assess the impact of pre-transplant Triplex vaccination on the duration of CMV antiviral therapy within the first 100 days post-transplant [2]. Triplex Vaccine Information - Triplex is a recombinant Modified Vaccinia Ankara viral vector vaccine designed to induce a robust T cell response to CMV, with previous studies indicating it is safe, well-tolerated, and highly immunogenic [4]. - The vaccine is currently involved in multiple ongoing clinical trials for various transplant indications and HIV, with plans for additional studies, including a Phase 2 trial for kidney transplant recipients [4]. Market Context - CMV poses significant risks in organ transplantation, with over 46,000 organ transplants performed in the U.S. in 2023, primarily kidney and liver transplants, highlighting the unmet medical need for effective therapies [5].