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The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.
On Nov. 21, 2019, GlaxoSmithKline (GSK) announced that it has entered into an exclusive licensing agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), under which ViiV Healthcare, a specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, will develop an investigational, broadly neutralizing antibody (bNAb), N6LS, for the treatment and prevention of HIV-1.
Broadly neutralizing antibodies are antibodies that can recognize and block the entry of different strains of HIV into healthy cells. N6LS is an antiviral bNAb that works by binding to a specific site (gp120) on the surface of HIV, thus preventing its entry into uninfected immune system cells (CD4+ T-cells). This action can halt HIV replication, preventing HIV transmission, according to GSK.
ViiV Healthcare expects to initiate a Phase IIa study with N6LS using material manufactured by the NIAID Vaccine Research Center (VRC). The study will evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of the drug candidate in adults living with HIV.
“We are excited to advance N6LS 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. 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,” said Kimberly Smith, MD, head of Research & Development at ViiV Healthcare, in a company press release.
N6LS was originally discovered and developed by scientists at NIAID’s Laboratory of Immunoregulation and VRC. NIH and GSK entered into a cooperative research and development agreement to jointly identify and further develop new bNAbs, such as N6LS, that could serve as the next generation of treatment regimens for people living with HIV as well as preventative options for HIV transmission. This exclusive license agreement between the entities outlines a program for ViiV Healthcare’s development of N6LS as well as milestone payments and royalties to the NIAID.