Tonix Pharmaceuticals (US:TNXP) GlobeNewswire News Room·2025-04-09 11:00Core Viewpoint - The collaboration between Tonix Pharmaceuticals and Makana Therapeutics aims to utilize Tonix's TNX-1500 monoclonal antibody in conjunction with Makana's genetically engineered pig organs to enhance organ compatibility and reduce rejection in xenotransplantation [1][2]. Group 1: Collaboration Details - Tonix and Makana have established a research agreement to study TNX-1500 in combination with Makana's human-compatible organs for organ failure treatment [1]. - The collaboration will support preclinical studies for kidney, heart, and islet cell transplant programs, aiming for regulatory filings for potential human use [1][2]. - The goal is to submit an investigational new drug application (IND) to the FDA for compassionate use in patients undergoing xenotransplantation [1]. Group 2: Product and Technology Insights - TNX-1500 is an investigational humanized monoclonal antibody targeting CD40L, which plays a crucial role in immune system activation and transplant immunomodulation [2][8]. - Makana's genetically engineered pigs, particularly the SLA DR knockout pig, have shown improved compatibility and potential for producing viable organs for transplantation [2][3][4]. - The collaboration aims to leverage the best-in-class pharmacokinetics and pharmacodynamics of TNX-1500, which has demonstrated effectiveness in preventing rejection in animal studies [2][7]. Group 3: Industry Context - The field of xenotransplantation faces challenges in organ compatibility and rejection, making this collaboration significant for advancing clinical applications [2][5]. - Makana's focus on antigen discovery and deletion, rather than relying on transgenic modifications, positions it favorably for future commercialization of xenotransplantation products [6][5]. - The partnership is expected to streamline the development of safer and more effective transplantation solutions, addressing the critical shortage of available human organs [2][4].