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Gilead Presents New Data From HIV Cure Research Program and Collaborations Exploring Novel Investigational Combinations and Strategies

Wednesday, February 22, 2023

Gilead Sciences, Inc. 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.

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