Update on Live Biotherapeutic Trials to Prevent Vaginal Dysbiosis and HIV

Identification: Cohen, Craig


Update on Live Biotherapeutic Trials to Prevent Vaginal Dysbiosis and HIV
Craig R. Cohen1, Laurel Lagenaur2, Thomas Parks2, Anke Hemmerling1
1Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco (UCSF), USA; 2Osel, Inc. Mountain View, CA, USA
The vaginal microbiota has long been considered a factor impacting women's risk for acquiring HIV, but the extent of this contribution and the underlying mechanisms have not been well defined. Given the apparent protection from infections afforded by a Lactobacillus-dominant microbiota, and the limited efficacy of antibiotics in establishing such a community, a different intervention strategy may be necessary. A strain of L. crispatus (LACTIN-V) developed as a live biotherapeutic product (LBP) to prevent the recurrence of bacterial vaginosis (BV) has shown excellent safety and tolerability, and close to 80% colonization in early studies. In addition, L. jensenii 1153-1666 genetically modified to produce modified cyanovirin-N, a potent HIV inhibitor has completed preclinical development. Macaques challenged with a repeat challenge of simian/HIV (SHIV) treated with L. jensenii 1153-1666 demonstrated a 63% decrease in infection compared to placebo. Our team at UCSF and Osel, Inc. have recently completed enrollment of a Phase 2b trial of LACTIN-V to prevent BV recurrence and anticipate results in July 2019. In addition, our team is planning a Phase 2 clinical trial of LACTIN-V in Durban, South Africa to determine its effect on genital mucosal immune factors associated with an increased risk of HIV-acquisition in women. In regards to formulated L. jensenii 1153-1666 (MucoCept), we have submitted an investigational new drug (IND) application the U.S. Food and Drug Administration (FDA) to conduct a first-in-human trial. This presentation will provide an update on these LBPs with a focus on their potential to reduce HIV acquisition in women.
Funded by the National Institutes of Health (NIAID U01AI23082) and (DMID HHSN272201300014I)


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