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|Gilead Announces Data from New Preclinical Study Evaluating a Combination of an Investigational TLR7 Agonist and an Investigational HIV Envelope Targeting Antibody in SHIV-Infected, Virally Suppressed Monkeys|
– Data Support Continued Clinical Investigation of GS-9620 and GS-9722 as Part of an HIV Eradication Strategy –
“HIV has the ability to hide in certain immune cells, which is called
the latent viral reservoir and which represents a key barrier to curing
HIV. New HIV therapies that aim to wake up and target the viral
reservoir have the potential to play an important role in long-term
viral suppression without ART,” said
In the study, 44 SHIV-infected rhesus monkeys started ART on day 7 post-infection. After 96 weeks of continuous ART, the animals were divided into four equal groups that received either 5 doses of PGT121 (10 mg/kg infusion every two weeks for 10 weeks) (n=11), 10 doses of GS-9620 (0.15 mg/kg by oral gavage every two weeks for 20 weeks) (n=11), both PGT121 and GS-9620 (n=11), or neither (placebo) (n=11). Animals continued to receive ART throughout this period and for 16 weeks afterwards. ART was discontinued at week 130 and viral rebound was monitored in plasma.
After ART discontinuation, 11 of 11 animals in the placebo arm experienced viral rebound with a median rebound time of 21 days, nine of 11 animals that received only PGT121 demonstrated viral rebound and 10 of 11 animals that received only GS-9620 showed viral rebound. In contrast, five of 11 animals that received the combination of PGT121 and GS-9620 demonstrated no viral rebound for at least 168 days, and the other six animals in the combination group rebounded but then began re-suppressing the virus without ART.
“We remain committed to researching and developing HIV eradication
strategies, and we are encouraged by these data presented at CROI from a
preclinical animal model of HIV infection showing that the combination
of GS-9620 and PGT121 may potentially induce viral remission in the
absence of ART,” said
The proprietary bNAbs PGT121 and GS-9722, as well as the TLR7 agonist GS-9620, are investigational agents and their safety and efficacy have not been established. There is no cure for HIV or AIDS.
This research was supported by the
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors. In addition, we may
observe unfavorable results from clinical trials involving proprietary
investigational TLR7 agonist, GS-9620, and proprietary investigational
broadly neutralizing antibody (bNAb), GS-9722, as part of an HIV
eradication strategy. In addition, Gilead may make a strategic decision
to discontinue development of GS-9620, GS-9722 and other proprietary
investigational TLR7 agonists and bNAbs if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. As a result, GS-9620, GS-9722 and other proprietary
investigational TLR7 agonists and bNAbs may never be successfully
commercialized. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Annual Report on Form 10-K for the year ended
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