Summary by Futu AI
On March 5, 2024, Tonix Pharmaceuticals Holding Corp. announced the results of a pharmacokinetic (PK) modeling study of its product candidate TNX-1500, based on animal studies. TNX-1500 is an Fc-modified humanized anti-CD40L monoclonal antibody in development for preventing rejection in organ and bone marrow transplantation and treating autoimmune disorders. The study predicts a half-life of approximately three weeks for TNX-1500 in humans, supporting the potential for monthly dosing. The company expects topline results from the Phase 1 PK and pharmacodynamic trial in the third quarter of 2024. The PK study, conducted in cynomolgus monkeys, showed linear PK across various doses and a half-life of approximately 14 days in monkeys. The human half-life prediction was based on allometric scaling for monoclonal antibodies with linear PK. The announcement also highlighted the potential for TNX-1500 to be a 'pipeline in a product' due to its multiple possible indications. Tonix Pharmaceuticals is also developing other therapeutics, including a CNS portfolio and immunology development portfolio.