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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. 公佈了基於動物研究的候選產品 TNX-1500 的藥代動力學（PK）建模研究結果。TNX-1500 是一種正在開發的 FC 修飾的人源化抗 CD40L 單克隆抗體，用於預防器官和骨髓移植中的排斥反應，治療自身免疫性疾病。該研究預測，TNX-1500 在人體內的半衰期約爲三週，這支持了每月給藥的可能性。該公司預計，第一階段藥效學和藥效學試驗將在2024年第三季度取得主要成果。這項在食腐猴身上進行的 PK 研究顯示，不同劑量的 PK 呈線性，猴子的半衰期約爲 14 天。人類半衰期預測基於線性 PK 的單克隆抗體的異速比例。該公告還強調了由於其多種可能的適應症，TNX-1500 有可能成爲 “產品中的管道”。Tonix Pharmicals還在開發其他療法，包括中樞神經系統產品組合和免疫學開發組合。
2024 年 3 月 5 日，Tonix Pharmicals Holding Corp. 公佈了基於動物研究的候選產品 TNX-1500 的藥代動力學（PK）建模研究結果。TNX-1500 是一種正在開發的 FC 修飾的人源化抗 CD40L 單克隆抗體，用於預防器官和骨髓移植中的排斥反應，治療自身免疫性疾病。該研究預測，TNX-1500 在人體內的半衰期約爲三週，這支持了每月給藥的可能性。該公司預計，第一階段藥效學和藥效學試驗將在2024年第三季度取得主要成果。這項在食腐猴身上進行的 PK 研究顯示，不同劑量的 PK 呈線性，猴子的半衰期約爲 14 天。人類半衰期預測基於線性 PK 的單克隆抗體的異速比例。該公告還強調了由於其多種可能的適應症，TNX-1500 有可能成爲 “產品中的管道”。Tonix Pharmicals還在開發其他療法，包括中樞神經系統產品組合和免疫學開發組合。
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