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Five more years
LONDON—ViiV Healthcare and the University of North Carolina at Chapel Hill (UNC-Chapel Hill) are extending their work relationship, having inked a five-year, $20-million renewal of their partnership to develop a cure for HIV.
Per the terms of the deal, the two organizations will continue to collaborate at the HIV Cure Center and maintain their joint ownership of Qura Therapeutics, which was established in 2015 to manage the intellectual property, commercialization, manufacturing and governance necessities of the collaboration. Qura is a public-private partnership between ViiV Healthcare and UNC-Chapel Hill that it says is “redefining the traditional way of conducting research and creating a new model to seek the breakthroughs needed to tackle an extraordinarily challenging global health issue.”
“Five years ago when we announced this innovative collaboration, we were inspired by the possibility that with the right resources and research teams, we would be able to make a meaningful impact towards a cure for HIV,” said Deborah Waterhouse, CEO of ViiV Healthcare. “Although there is still much left to do, this public-private partnership is making a difference. We are excited to continue this partnership with UNC-Chapel Hill for another five years and look forward to the contribution our unique skills and shared commitment could make to finding a cure for HIV.”
The approach currently being pursued under this agreement aims to flush out copies of HIV that evade antiretroviral therapy by hiding in immune cells, with a focus on closely targeting the HIV virus while minimizing off-target effects on the rest of the body. A recent Nature paper, “Systemic HIV and SIV latency reversal via non-canonical NF-κB signalling in vivo,” details how activating a specific signaling pathway can reactivate dormant HIV so that it can be therapeutically targeted.
“Without the Qura partnership we would not have been able to get this far, this fast,” said David Margolis, MD, Director of the UNC HIV Cure Center and Sarah Graham Kenan Distinguished Professor of Medicine, Microbiology & Immunology, and Epidemiology at the UNC School of Medicine. “We have accomplished a great deal in less than five years and hope to accomplish a good deal more in the years to come to help people living with HIV around the world.”
In other HIV-related news for ViiV Healthcare, the company shared 48-week data from its Phase 3 ATLAS-2M study of an every-two-month regimen of investigational long-acting, injectable cabotegravir and rilpivirine. The data demonstrated that dosing every two months produces similar efficacy and safety to monthly dosing. ViiV Healthcare is co-developing this treatment regimen under a collaboration with Janssen Sciences Ireland UC.
Non-inferiority with the monthly treatment regimen was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 copies per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population). The every-two-month arm had a rate of 9/522 or 1.7 percent, while the one-month arm had a rate of 5/523 or 1.0 percent, with a confidence interval of 95 percent. Rates of virologic suppression were also similar, with the two-month regimen showing a rate of 94.3 percent compared to 93.5 percent for the one-month arm. In the two-month arm, 5.2 percent experienced serious adverse events and 2.3 percent withdrew due to adverse events, which was comparable to the one-month arm results of 3.6 percent and 2.5 percent, respectively.
The every-two-month regimen was widely preferred by participants who entered the study on a daily oral standard-of-care regimen and by patients who underwent the monthly regimen, with 98 percent of study participants preferring the less-frequent dosing schedule.
“There is a need for more convenient, simplified treatments to help address challenges such as pill burden, pill fatigue, drug and food interactions, and stigma that detrimentally affect adherence for people living with HIV,” said Dr. Turner Overton, primary investigator for ATLAS-2M and a professor in the Department of Medicine at the University of Alabama at Birmingham. “The results from this study demonstrate the potential for an alternative to traditional daily, oral regimens.”