Sexually transmitted infections are highly prevalent, and over 40% of pregnancies are unplanned. We are producing new antibody-based multipurpose prevention technology products to address these problems and fill an unmet need in female reproductive health. We used a Nicotiana platform to manufacture monoclonal antibodies against two prevalent sexually transmitted pathogens, HIV-1 and HSV-2, and incorporated them into a vaginal film (MB66) for preclinical and Phase 1 clinical testing. These tests are now complete and indicate that MB66 is effective and safe in women. We are now developing an antisperm monoclonal antibody to add contraceptive efficacy to this product. The antisperm antibody, H6-3C4, originally isolated by Shinzo Isojima from the blood of an infertile woman, recognizes a carbohydrate epitope on CD52g, a glycosylphosphatidylinositol-anchored glycoprotein found in abundance on the surface of human sperm. We engineered the antibody for production in Nicotiana; the new antibody which we call “human contraception antibody,” effectively agglutinates sperm at concentrations >10 μg/ml and maintains activity under a variety of physiological conditions. We are currently seeking regulatory approval for a Phase 1 clinical trial, which will include safety and “proof of principle” efficacy endpoints. Concurrently, we are working with new antibody production platforms to bring the costs down, innovative antibody designs that may produce more effective second-generation antibodies, and delivery systems to provide extended protection.

中文翻译：

---

设计基于单克隆抗体的避孕和多用途预防技术†。


性传播感染非常普遍，超过 40% 的怀孕是计划外的。我们正在生产基于抗体的新型多用途预防技术产品，以解决这些问题并满足女性生殖健康方面未满足的需求。我们使用Nicotiana平台生产针对两种常见性传播病原体 HIV-1 和 HSV-2 的单克隆抗体，并将其整合到阴道薄膜 (MB66) 中进行临床前和一期临床测试。这些测试现已完成，表明 MB66 对女性有效且安全。我们现在正在开发一种抗精子单克隆抗体，以增加该产品的避孕功效。抗精子抗体 H6-3C4 最初由 Shinzo Isojima 从不孕妇女的血液中分离出来，可识别 CD52g 上的碳水化合物表位，CD52g 是一种糖基磷脂酰肌醇锚定的糖蛋白，在人类精子表面大量存在。我们设计了用于在烟草中生产的抗体；这种新抗体被我们称为“人类避孕抗体”，可在浓度>10 μg/ml下有效凝集精子，并在各种生理条件下保持活性。我们目前正在寻求监管部门批准一期临床试验，其中将包括安全性和“原理证明”功效终点。同时，我们正在与新的抗体生产平台合作以降低成本，创新的抗体设计可以生产更有效的第二代抗体，并与递送系统合作以提供扩展的保护。