Project One: Development and Testing of the HCA IVR

项目1是BUSM CRC的主要避孕开发项目。首要目标是 项目1的目的是提供人类避孕抗体(HCA)和原型HCA-阴道内 环(HCA-IVR)，已准备好进行人体临床试验。在项目的第一年，我们将致力于 与MAPP生物制药(抗体产业化核心)密切合作检测HCA IgG1和 在精子凝集和活力分析中，hca基因工程变体的避孕效果。 根据这些研究的结果，我们将挑选出表现最好的首席HCA候选人 在额外的精子功能测试评估中接受进一步测试的有效性 人阴道上皮模型中的毒性/炎症。我们的首席HCA(HCA*)将被选为 根据在精子功能测试中的表现和安全性评估。在接下来的几年里 该项目，HCA*将由抗体工业化核心公司制造并合并 转化为专门为持续释放HCA而设计的IVR*。HCA*-IVR 将在猕猴模型中进行临床前测试，以评估安全性、PK、体外疗效和 抗体和精子在下生殖道的分布。

Project 1 is the main contraceptive development project for the BUSM CRC. The overarching goal of Project 1 is to deliver a Human Contraceptive Antibody (HCA) and prototype HCA-intravaginal ring (HCA-IVR) that are ready for human clinical trials. In the first year of the project we will work closely with Mapp Biopharmaceutical (Antibody Industrialization Core) to test HCA IgG1 and engineered variants of HCA for contraceptive efficacy in sperm agglutination and motility assays. Based on the results of these studies, we will select lead HCA candidates showing maximum efficacy to undergo further testing in additional sperm function assays assessment for toxicity/inflammation in a human vaginal epithelium model. Our lead HCA (HCA*) will be selected based on performance in sperm function tests and the safety evaluation. In subsequent years of the project, HCA* will be manufactured by the Antibody Industrialization Core and incorporated into an IVR specifically designed for the purpose of sustained release of HCA*. The HCA*-IVR will undergo preclinical testing in a macaque model to assess safety, PK, ex vivo efficacy and antibody and sperm distribution in the lower genital tract.