– Innovative Investigational Approaches
Include Targeting of the HIV Viral Reservoir and Enhancing Immune
Response in the Absence of Antiretroviral Therapy –
– Findings Support Continued Evaluation of
Novel Strategies including Broadly Neutralizing HIV Antibodies,
Vaccine Candidates, and TLR Agonists –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results
from four collaborative studies evaluating novel investigational
combinations and strategies with the potential to target the HIV
viral reservoir or enhance immune response to maintain virologic
control in the absence of antiretroviral therapy (ART). These
latest findings represent an ongoing multi-pronged approach in
Gilead’s HIV cure research program. The data were presented at the
Conference on Retroviruses and Opportunistic Infections (CROI) 2023
in Seattle.
Findings from the HIV cure research program include results from
three studies evaluating strategies to maintain virologic control
in the absence of ART. Results from the Phase 2a TITAN trial show
that dual treatment with the broadly neutralizing HIV antibodies
(bNAbs; 3BNC117 and 10-1074) led to a significant delay in viral
rebound. A Phase 1/2 proof-of-concept study conducted by the
University of California San Francisco, with support from Gilead
Sciences and amfAR, The Foundation for AIDS Research, provides
evidence that combination immunotherapy consisting of a vaccine, an
immune modulator, and bNAbs (10-1074 and VRC07-523LS) may provide
virologic control. A separate AELIX-003 Phase 2 trial showed that a
combination of a vaccine and an immune modulator induced a strong T
cell response.
“The results from the TITAN study exemplify the progress that
research partnerships can bring in the pursuit of a cure for HIV
and demonstrate the potential of combination strategies to play a
critical role in that effort,” said Ole Søgaard, MD, Professor in
the Department of Infectious Diseases at Aarhus University in
Denmark. “Additional clinical research into the potential of bNAbs
is warranted and may help in the discovery of novel approaches that
transform HIV management for patients.”
A fourth pre-clinical study in a macaque model conducted in
collaboration with Gritstone bio, Inc. showed that simian
immunodeficiency virus (SIV) ChAd and samRNA vaccines in
combination with immune modulators induced a strong immune
response.
“The insights generated by the studies presented at CROI this
year are advancing scientific knowledge on potential paths to a
cure for HIV and expanding global understanding of what role
broadly neutralizing antibodies, vaccines, and immune modulators
may play in the future of HIV for people living with the virus,”
said Devi SenGupta, Executive Director, HIV Clinical Development,
Gilead Sciences. “Gilead will continue exploring novel combination
strategies in our pursuit to help end the HIV epidemic for
everyone, everywhere.”
Curing HIV remains the ultimate aspiration of Gilead’s HIV
research and development efforts. Gilead has a comprehensive cure
research and development program that is advancing with speed and
conviction. As Gilead progresses further with testing
investigational curative regimens, the company’s partnerships and
collaborations are more important than ever in this complex effort.
Gilead aims to ensure its research and development efforts
contribute to the entire scientific community’s search for a cure.
Gilead’s work to develop a cure for HIV is one part of the
company’s larger role in the global efforts to end the HIV epidemic
and part of its focus on person-centric innovation.
HIV cure research studies presented at CROI include:
Abstract Title
Presentation
#Number
The impact of 3BNC117, 10-1074 and
lefitolimod on HIV-1 persistence – the TITAN trial
Oral
#136
Heterologous ChAd/samRNA vaccine induces
robust T-cell responses in macaques
Poster
#323
A placebo controlled randomized trial of
the HTI immunogen vaccine and vesatolimod (Late-breaker)
Poster
#433
Rebound dynamics following immunotherapy
with an HIV vaccine, TLR9 agonist, and bNAbs (late-breaker)
Poster
#435
Vesatolimod pharmacodynamic response is
associated with time to HIV rebound (Late-breaker)
Poster
#437
Lefitolimod, vesatolimod, teropavimab, zinlirvimab, 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.
The TITAN trial (NCT03837756) was funded in part through the
Gilead Cure Grants Program. For more information, please visit:
https://clinicaltrials.gov/ct2/show/NCT03837756.
About Gilead Sciences’ HIV Cure
Research Program
Curing HIV is a formidable challenge, but one that remains the
focus and ultimate aspiration of Gilead’s HIV research and
development efforts. We are mapping the path forward to a cure for
HIV through close collaborations with industry, academic and
community partners to ensure our research efforts can contribute to
the entire scientific community’s search for a cure. Together with
our partners, we are committed to helping end the epidemic by
driving the next generation of cure strategies that will transform
care and improve outcomes for all people living with HIV.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases and address unmet
needs in virology, oncology and inflammation.
For 35 years, Gilead has been a leading innovator in the field
of HIV, driving advances in treatment, prevention and cure
research. Gilead researchers have developed 12 HIV medications,
including the first single-tablet regimen to treat HIV, the first
antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the
risk of acquiring HIV infection, and the first long-acting
injectable HIV treatment medication administered twice-yearly. Our
advances in medical research have helped to transform HIV into a
treatable, preventable, chronic condition for millions of
people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships and collaborations, the
company also aims to improve education, expand access and address
barriers to care, with the goal of ending the HIV epidemic for
everyone, everywhere. Gilead was recognized as the number one
philanthropic funder of HIV-related programs in a report released
by Funders Concerned About AIDS.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking
Statements
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 Gilead’s ability to initiate, progress or complete
clinical trials or studies within currently anticipated timelines
or at all, and the possibility of unfavorable results from ongoing
or additional clinical trials or studies, including those involving
and other bNAbs, and experimental compounds of our partner;
uncertainties relating to regulatory applications and related
filing and approval timelines, and the risk that any regulatory
approvals, if granted, may be subject to significant limitations on
use; and any assumptions underlying any of the foregoing. These and
other risks, uncertainties and factors are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022, as filed with the U.S. Securities and Exchange
Commission. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The reader is cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
Gilead and the Gilead logo are registered
trademarks of Gilead Sciences, Inc., or its related companies. All
other trademarks are the property of their respective owner(s).
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) and LinkedIn, 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/20230220005346/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
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