Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.
A research consortium comprised of XL-protein GmbH, Wacker Chemie AG and Ludwig-Maximilians-Universität München (LMU) will develop a novel long-acting immunosuppressive anti-CD40 antibody fragment for the selective suppression of organ rejection, in particular in the area of cardiac xenotransplantation.