Anti-HIV Broadly Neutralizing Monoclonal Antibody (bnAbs) Drug Substance (DS) Clinical Trial Material Production and Release

VRC已经生产了抗HIV bnAbs VRC 01，VRC 01 LS，VRC 07 - 523 LS，N6 LS和10 E8 VLS，并正在开发其他几种bnAbs，同时启动多项I期临床试验。VRC 01目前正在美国进行II期临床试验（抗体介导的预防（AMP）试验（http：www.hvtn.org/en/science/HVTN- studies/AMPstudy.html）），南美洲和非洲。该bnmAb的一部分是在前几年生产的，但由于临床试验受试者数量的扩大和临床试验计划的扩大，不足以完成AMP试验和其他HIV mAb临床试验。因此，I期和II期试验需要额外的DS批次VRC 01、VRC 01 LS、VRC 07 - 523 LS和10 E8 VLS。根据本任务订单生产的DS将使未来的制剂灌装用于临床试验。

The VRC has produced the anti-HIV bnAbs VRC01, VRC01LS, VRC07-523LS, N6LS, and 10E8VLS and has several other bnAbs in development, while initiating multiple Phase I clinical trials. VRC01 is currently in a Phase II clinical trial (the Antibody-Mediated Prevention (AMP) Trial (http://www.hvtn.org/en/science/HVTN- studies/AMPstudy.html) in the U.S., South America and Africa. A portion of this bnmAb was produced in prior years, but is not sufficient for completion of the AMP trial and other HIV mab clinical trials due to expansion of clinical trial subject numbers and expanded clinical trial plans. Therefore, additional DS lots of VRC01, VRC01LS, VRC07-523LS, and 10E8VLS for Phase I and Phase II trials is needed. The DS produced under this task order will enable future drug product fills to be used in the clinical trials.