Dual Prevention Pill (DPP) Regimen

A 28-day contraceptive pill regimen that also provides protection against HIV. 21 pills will contain Truvada and EE/LNG; 7 pills will contain Truvada only. API compatibility (TDF/FTC with EE/LNG and excipients) confirmed. Acceptability studies with over-encapsulated Truvada and COC planned in Zimbabwe and South Africa to start in Q1 2021. Prototype development on hold while seeking additional funding.

Novel mAb contraceptive + TDF IVR

Formulation of a novel, nonhormonal contraceptive agent based on a multivalent monoclonal antibody (mAb) that blocks sperm from swimming through mucus and accessing the egg with antiretroviral (ARV) agents with demonstrated clinical efficacy in preventing HIV in a behavior-monitoring IVR.

Dapivirine + Pritelivir + Levonorgestrel 3D Printed IVR

Our paramount innovation is use of digital light synthesis – a novel 3D printing process known as continuous liquid interface production (CLIP™) – for rapid, scalable, and cost-effective manufacturing of geometrically and mechanically tunable, rationally designed intravaginal rings as platforms for multi-drug delivery.

Copper Intravaginal Ring (Cu-IVR)

Development of prototypes of long- and short-acting versions of an innovative female-controlled, non-hormonal copper vaginal contraceptive method that may also reduce risk for acquisition of sexually transmitted infections and will be suitable for Phase I human clinical testing.

EFdA-P + Progestin Intravaginal Film

A next generation MPT film platform for once a month intravaginal administration of 4′-Ethynyl-2-fluoro-2′-deoxyadenosine (EFdA) or the EFdA prodrug (EFdA-P) and a progestin (levonorgestrel (LNG) or etonogestrel (ENG)) to achieve the dual goal of preventing HIV infection and pregnancy.

TFV/EFV Nanoparticles-in-film

This product introduces a new vaginal delivery system comprising the incorporation of tenofovir (TFV) and efavirenz (EFV)-loaded poly(lactic-co-glycolic acid) nanoparticles (NPs) into a polymeric film base (TFV/EFV NPs-in-film). TFV/EFV NPs-in-film was tested for its ability to deliver incorporated drugs. The delivery system provided enhanced genital distribution of drugs over 24 hours in mice, allowing higher genital concentrations of both drugs, namely as compared to their delivery in a liquid vehicle. Levels of EFV were also enhanced as compared to a film containing the drug directly dispersed in the film polymeric matrix. TFV/EFV NPs-in-film were further shown to be safe upon daily vaginal delivery for 14 -days to mice.