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

Rhea-AI Summary

Gilead Sciences (NASDAQ: GILD) presented new findings at CROI 2023 highlighting innovative approaches in HIV research. These include targeting the HIV viral reservoir and enhancing immune response without antiretroviral therapy (ART). Key results from four studies were discussed, showcasing promising strategies such as dual treatment with broadly neutralizing antibodies (bNAbs), which delayed viral rebound. Gilead emphasizes the importance of collaboration in advancing HIV cure research and commits to exploring various combination strategies. The company aims to contribute significantly to the fight against the HIV epidemic.

Positive

• Phase 2a TITAN trial showed dual treatment with bNAbs significantly delayed viral rebound.
• Combination immunotherapy demonstrated potential for maintaining virologic control in the absence of ART.
• Gilead's comprehensive approach indicates strong commitment and progress towards HIV cure research.

Negative

• Experimental compounds are investigational and not FDA approved, indicating risks associated with ongoing trials.

– 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 –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- 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.

View source 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

Source: Gilead Sciences, Inc.

FAQ

What are the results of the Gilead Sciences HIV cure research presented at CROI 2023?

Gilead presented findings showing that dual treatment with broadly neutralizing antibodies led to a significant delay in viral rebound. Combination strategies were also highlighted.

Which clinical trials were discussed in Gilead's recent press release on HIV research?

The press release covers results from the Phase 2a TITAN trial and several other studies evaluating combination immunotherapies.

What is the significance of the TITAN trial results for Gilead Sciences?

The TITAN trial results indicate promising potential for delaying HIV viral rebound, marking a significant advancement in HIV cure strategies.

How does Gilead plan to advance its HIV research?

Gilead aims to explore novel combination strategies through collaborations with various partners, advancing research towards an HIV cure.