-- Results Presented at CROI 2020 Support
Further Evaluation of Vesatolimod as Part of Investigational
Curative Regimens Aimed at Achieving ART-Free Control of HIV
--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results
from a Phase 1b trial evaluating the company’s investigational
toll-like receptor 7 (TLR7) agonist vesatolimod as part of a human
immunodeficiency virus (HIV) cure research program. These findings
mark the first clinical data showing TLR7 stimulation by
vesatolimod is associated with a modestly increased time to viral
rebound compared to placebo, as well as enhanced immune function
and decreased levels of intact HIV DNA. These results will be
presented at the Conference on Retroviruses and Opportunistic
Infections (CROI) 2020, along with additional preclinical studies
evaluating the potential of combination regimens with vesatolimod
to achieve viral remission in the absence of antiretroviral therapy
(ART).
“This is the first study done in people that has shown with an
immunotherapy that you can enhance immune function resulting in
both a smaller viral reservoir and an increased time to viral
rebound after treatment is interrupted. The effects are modest, and
no one came close to any definition of a cure, but the data
suggests real progress might be made when the drug is used in
combination with other approaches,” said principal investigator
Steven Deeks, Professor of Medicine at the University of
California, San Francisco (UCSF).
“While HIV treatment has advanced dramatically over the past
three decades, people living with HIV still face a lifetime of
therapy and potential complications,” said Diana Brainard, MD,
Senior Vice President, HIV and Emerging Viruses, Gilead Sciences.
“Curing HIV remains the ultimate long-term goal for Gilead’s HIV
research and development efforts. The breadth of our research
presented at CROI 2020 furthers the collective scientific knowledge
on potential pathways to achieve a ‘functional cure’, or long-term
viral suppression in the absence of ART, for people living with
HIV.”
Abstracts on cure research strategies presented at CROI 2020
include:
Oral 3982: Safety and Analytic Treatment Interruption
Outcomes of Vesatolimod in HIV Controllers
This randomized, double-blind, placebo-controlled study
evaluated 25 people living with HIV who had demonstrated partial
viral suppression (HIV RNA of 50 to 5,000 copies per mL) prior to
starting ART, a group referred to as “HIV controllers”.
Participants received 10 biweekly doses of the investigational TLR7
agonist vesatolimod or placebo while continuing ART, followed by a
treatment interruption in which they stopped therapy and were
carefully monitored for viral rebound and safety.
The study found that vesatolimod was associated with a longer
period of viral suppression following treatment interruption
compared with placebo. The median time to viral rebound (>50
copies/mL) was 4.1 weeks for the vesatolimod group compared with
3.9 weeks for placebo (p=0.036). For rebound to >200 copies/mL,
the median time was five weeks for vesatolimod compared with four
weeks for placebo (p=0.024). Four individuals in the vesatolimod
group had no virologic rebound (>50 c/mL) for six or more
weeks.
Vesatolimod is an investigational agent and has not been
approved anywhere globally; its safety and efficacy has not been
established.
Oral 4545: Combined Active and Passive Immunization in
SHIV-Infected Rhesus Monkeys
A separate study evaluated the potential of combining an
investigational therapeutic vaccination, investigational broadly
neutralizing antibodies (bNAbs), and Gilead’s investigational TLR7
agonist vesatolimod as an HIV cure strategy to activate and
eliminate the latent HIV reservoir. HIV bNAbs are a class of
antiviral and immunotherapy agents that were originally derived
from HIV-infected individuals with a strong anti-HIV antibody
response that are being developed to target HIV.
In the study, 49 Simian-Human Immunodeficiency Virus
(SHIV)-infected rhesus monkeys were given tenofovir disoproxil
fumarate/emtricitabine/dolutegravir (TDF/FTC/DTG) as ART. After 24
weeks, animals were assigned into four groups to determine the
effect of active and passive immunization: a group that received
Ad26/MVA therapeutic vaccination (n=12), a group that received the
broadly neutralizing antibody (bNAb) PGT121 (n=12), a group that
received both Ad26/MVA and PGT121 (n=10), and sham controls (n=15).
All groups except the sham controls additionally received 10 doses
of vesatolimod. At week 86, ART was discontinued, and viral rebound
was monitored for 140 days. In 6 out of 10 animals, vesatolimod
combined with therapeutic vaccination and the PGT121 bNAb resulted
in both delayed viral rebound and post-rebound virologic control
following ART discontinuation, as compared to 0 out of 15 of the
sham control animals. These results support further study of this
multi-pronged approach.
Poster 4549: PGT121 and Vesatolimod in Chronically
Treated SHIV-Infected Rhesus Monkeys
This study evaluated the efficacy of the investigational
combination of broadly neutralizing antibodies (bNAbs) with
vesatolimod in SHIV-infected rhesus monkeys who had been treated
with continuous daily suppressive ART (TDF/FTC/DTG) for 30 months
after one year of chronic infection. Twenty-four SHIV-infected
rhesus monkeys were assigned into three groups: a group that
received PGT121 and vesatolimod (n=8), a group that received an
Fc-modified version of this antibody GS-9721 and vesatolimod (n=9),
and a sham control (n=7). At week 42 following initial antibody
dosing, which was 24 weeks after the final antibody and vesatolimod
doses, ART was discontinued, and viral rebound was monitored for
140 days. Following ART discontinuation, 100 percent (7 of 7) of
sham controls exhibited rapid viral rebound, with a median rebound
time of 21 days, while the combination of vesatolimod and either
PGT121 or GS-9721 prevented viral rebound in 41 percent of
subjects. These results suggest the potential therapeutic efficacy
of combining bNAbs with TLR7 stimulation in targeting the viral
reservoir in rhesus monkeys that initiated ART during the chronic
infection phase.
“These data help inform strategies aimed at a functional cure
for HIV,” said co-author Dan H. Barouch, MD, PhD, Professor of
Medicine at Harvard Medical School and Director of the Center for
Virology and Vaccine Research at Beth Israel Deaconess Medical
Center. “These findings help focus research efforts in support of
the goal to help transform care for people living with HIV.”
Additional studies focused on HIV cure research presented at
CROI 2020 include:
- Oral 3126: Safety & Pharmacokinetics of GS-9722 in
HIV-Negative Participants & People with HIV
- Poster 1708: Impact of GS-986, PGT121 & N6-LS on CNS Immune
Activation in SHIV-infected Macaques
- Poster 3797: NOD2 & TLR8 Agonists Enhance IL-15-Mediated
Activation of HIV Expression
Vesatolimod, the bNAbs PGT121 and GS-9721, and the other
experimental compounds noted are investigational and are not
approved by the U.S. Food and Drug Administration or any other
regulatory authority. Their safety and efficacy have not been
established.
There is no cure for HIV infection or AIDS.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
For more than 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 12 million people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company’s manufacturing partners.
Forward-Looking Statement
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,
including the possibility of unfavorable results from ongoing and
additional clinical trials involving vesatolimod, GS-9722 and other
investigational compounds, and the possibility that we are unable
to complete one or more of such trials on the currently anticipated
timelines or at all. In addition, it is possible that Gilead may
make a strategic decision to discontinue development of these
investigational compounds, and as a result, they may never be
successfully commercialized. All statements other than statements
of historical fact are statements that could be deemed
forward-looking statements. 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 December 31, 2019, as filed with
the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation to update any such forward-looking
statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc. or its related companies.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20200310005875/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Brian Plummer, Media (650) 524-7708
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