Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) CEO Dr. Seth Lederman talked with Proactive's Stephen Gunnion about the company's collaboration with Massachusetts General Hospital, affiliated with Harvard Medical School, to advance the clinical development of TNX-1500. Lederman explained that the partnership supports an Investigator Initiated Phase 2 clinical trial focused on kidney transplant recipients. Study initiation is contingent on institutional review board (IRB) approval and FDA clearance of the investigator-initiated investigational new drug application (IND). The study will assess TNX-1500, an anti-CD40 ligand monoclonal antibody, alongside a low-dose regimen of tacrolimus. The goal is to reduce or potentially eliminate the need for conventional immunosuppressive therapy. “We believe that the relatively low dose of tacrolimus should not have the same side effects that are associated with the higher dose,” Lederman said. The company views TNX-1500 as a differentiated approach to transplant immunology, aiming for immunomodulation rather than traditional immunosuppression. If successful, the product could become a standalone therapy. “Ultimately, the TNX-1500 could be monotherapy,” he noted, with the current study designed for regulatory expediency. Lederman also highlighted longer-term potential, noting that TNX-1500 may have applications beyond transplantation, including autoimmune conditions such as lupus. Key features include once-monthly dosing and what the company believes is best-in-class potency, supported by completed pharmacokinetic and pharmacodynamic studies. #TonixPharmaceuticals #TNX1500 #KidneyTransplant #Immunotherapy #ClinicalTrials #TransplantMedicine #BiotechStocks #SethLederman #AutoimmuneResearch #PharmaNews