{"id":15876,"date":"2023-07-25T13:57:00","date_gmt":"2023-07-25T05:57:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15876"},"modified":"2024-11-30T14:00:15","modified_gmt":"2024-11-30T06:00:15","slug":"ascletis-pharmas-asc22-combo-therapy-shows-promise-in-hiv-functional-cure-clinical-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15876","title":{"rendered":"Ascletis Pharma’s ASC22 Combo Therapy Shows Promise in HIV Functional Cure Clinical Trial"},"content":{"rendered":"\n

China-based Ascletis Pharma Inc., (HKG: 1672<\/a>) has announced that the Shanghai Public Health Clinical Center presented clinical results of ASC22 (envafolimab) in combination with chidamide as a novel combination therapy aimed at achieving a functional cure for human immunodeficiency virus (HIV) infection. The findings were showcased at the 12th International AIDS Society (IAS) Conference on HIV Science in Brisbane, Australia, and virtually.<\/p>\n\n\n\n

Phase II Trial Design and Efficacy Assessment<\/strong>
The investigator-initiated Phase II trial assessed the efficacy of ASC22 combined with chidamide on the viral reservoirs of latently infected cells in HIV-infected individuals. A total of 15 subjects living with HIV who had achieved virological suppression were enrolled in the study. Participants received a subcutaneous injection of ASC22 (1mg\/kg) once every four weeks (Q4W) in combination with 10mg chidamide administered orally twice a week (BIW) during the 12-week treatment period while maintaining antiretroviral therapy (ART). The subjects were followed up for 24 weeks to measure changes in the levels of cell-associated (CA) HIV RNA, plasma HIV RNA, total and integrated HIV DNA, and HIV-specific CD8+ T cell function.<\/p>\n\n\n\n

Well-Tolerated Combo Effectively Activates Latent HIV Reservoirs<\/strong>
The results demonstrated that the combination therapy was well tolerated and effectively activated latent HIV reservoirs. There was a significant increase in CA HIV RNA at week 8 and week 12 compared to the baseline, with an average rise of 4.27-fold and 3.41-fold, respectively (P=0.001, P=0.006) in the subjects. The HIV CA RNA to total DNA ratios also showed the same trend (P=0.038, P=0.017, respectively). Ascletis concludes that the findings indicate further investigations are warranted.<\/p>\n\n\n\n

Background on Envafolimab and Chidamide<\/strong>
Envafolimab was originated by Alphamab Oncology (HKG: 9966<\/a>), with 3D Medicines acting as co-development partner under a January 2019 deal. Ascletis gained rights to envafolimab for viral disease indications in another January 2019 deal, which was expanded to a global scale in November 2021 after initial trial successes against hepatitis B. Chipscreen\u2019s chidamide, a first-in-class subtype-selective histone deacetylase inhibitor, has been on the market in China as a treatment for the rare disease peripheral T-cell lymphoma since December 2014. A second indication approval was awarded in November 2019 for use in combination with hormonal therapy in previously treated ER+\/HER2- advanced breast cancer.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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