SUSTAINED RELEASE OF VRC07 FROM CAPSULE-INTRAVAGINAL RING FOR PREVENTING HIV TRANSMISSION

Sustained delivery of broadly neutralizing antibodies (bNAb) to the female reproductive tract offers exceptional promise for preventing HIV transmission, combining safety, efficacy and unparalleled specificity. The approach can be further combined with other monoclonal antibodies (mAb) to create a product providing multi-purpose protection. Towards this goal, Mucommune has developed unique capsule-intravaginal ring (IVR) platform that can provide sustained release of mAbs for over 30 days while protecting the encapsulated mAb from degradation in the vaginal environment. In Phase II portion of this FastTrack application, we will advance the lead VRC07-IVR formulation from Phase I into key preclinical studies. We will establish cGMP-compliant manufacturing processes, and produce VRC07-IVR at a quality suitable for GLP tox studies in sheep. We will evaluate the efficacy of VRC07-releasing IVR in blocking vaginal HIV transmission in non-human primate studies. Finally, we will execute GLP vaginal sheep tox study. Our work will directly support the preclinical development necessary to advance VRC07-IVR into clinical development as a safe and effective intervention that can protect against vaginal HIV transmission with convenient monthly dosing.