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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.
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.
2024 年 3 月 5 日，Tonix Pharmicals Holding Corp. 公布了基于动物研究的候选产品 TNX-1500 的药代动力学（PK）建模研究结果。TNX-1500 是一种正在开发的 FC 修饰的人源化抗 CD40L 单克隆抗体，用于预防器官和骨髓移植中的排斥反应，治疗自身免疫性疾病。该研究预测，TNX-1500 在人体内的半衰期约为三周，这支持了每月给药的可能性。该公司预计，第一阶段药效学和药效学试验将在2024年第三季度取得主要成果。这项在食腐猴身上进行的 PK 研究显示，不同剂量的 PK 呈线性，猴子的半衰期约为 14 天。人类半衰期预测基于线性 PK 的单克隆抗体的异速比例。该公告还强调了由于其多种可能的适应症，TNX-1500 有可能成为 “产品中的管道”。Tonix Pharmicals还在开发其他疗法，包括中枢神经系统产品组合和免疫学开发组合。
2024 年 3 月 5 日，Tonix Pharmicals Holding Corp. 公布了基于动物研究的候选产品 TNX-1500 的药代动力学（PK）建模研究结果。TNX-1500 是一种正在开发的 FC 修饰的人源化抗 CD40L 单克隆抗体，用于预防器官和骨髓移植中的排斥反应，治疗自身免疫性疾病。该研究预测，TNX-1500 在人体内的半衰期约为三周，这支持了每月给药的可能性。该公司预计，第一阶段药效学和药效学试验将在2024年第三季度取得主要成果。这项在食腐猴身上进行的 PK 研究显示，不同剂量的 PK 呈线性，猴子的半衰期约为 14 天。人类半衰期预测基于线性 PK 的单克隆抗体的异速比例。该公告还强调了由于其多种可能的适应症，TNX-1500 有可能成为 “产品中的管道”。Tonix Pharmicals还在开发其他疗法，包括中枢神经系统产品组合和免疫学开发组合。
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