GlaxoSmithKline’s ViiV Healthcare division has announced plans to develop an investigational broadly neutralising antibody (bNAb) N6LS for the treatment and prevention of HIV-1.
The specialist HIV company has signed a deal with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
As part of the exclusive licensing agreement, the company says that it “looks forward to” initiating a phase IIa study with material manufactured by the NIAID Vaccine Research Centre in order to evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of N6LS in adults living with HIV.
The drug in focus - N6LS - is an antiviral bNAb that works by binding to a specific site on the surface of HIV that prevents its entry into uninfected immune system cells. In turn, by blocking HIV’s entry into human CD4+ cells, HIV replication is halted, and the HIV transmission process may be prevented.
The company says it is “excited” to advance the therapy from its current proof of concept stage to the next step in its development, “by studying this bNAb as a long-acting medicine that could potentially be used for both treatment and prevention of HIV” explained Kimberly Smith, head of research & development. “By continuing to research new ways that people living with HIV can reach undetectable viral loads, we build on our ten-year history of furthering innovative science in HIV and take another important step forward in ending the epidemic.”
In August ViiV announced results from its ATLAS-2M study, which met its primary endpoint, showing similar efficacy of its HIV treatment cabotegravir and Janssen’s Edurant (rilpivirine) administered every eight weeks compared to four-week administration. The company also submitted a regulatory application to the European Medicines Agency (EMA) in July, based on the global ATLAS and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies, which found that the investigative combo, injected monthly, was as effective as a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.