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
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from a preclinical study conducted in collaboration with researchers at Beth Israel Deaconess Medical Center evaluating the combination of a proprietary investigational oral toll-like receptor 7 (TLR7) agonist, GS-9620, and a proprietary investigational broadly neutralizing antibody (bNAb), PGT121, as part of an HIV eradication strategy. Data from the study conducted in simian-human immunodeficiency virus (SHIV)-infected rhesus monkeys on suppressive antiretroviral therapy (ART) demonstrated that a combination treatment of GS-9620 and PGT121 resulted in a subset of animals maintaining viral suppression after ART discontinuation. These data, discussed during a press conference at the 2018 Conference on Retroviruses and Opportunistic Infection (CROI) in Boston, support further clinical investigation of combination strategies involving bNAbs and a TLR7 agonist which may have the potential to achieve long-term viral suppression without the need for daily ART.
“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 Dan H. Barouch, MD, PhD, Professor of Medicine, Harvard Medical School, and Director, Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center. Dr. Barouch, who led the study, is also a member of the Ragon Institute of MGH, MIT and Harvard. “In this proof-of-concept preclinical study, 45 percent of the animals that received both GS-9620 and PGT121 did not demonstrate viral rebound after stopping ART, suggesting that this combination may be able to target the viral reservoir in virally suppressed monkeys.”
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 Norbert W. Bishofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “GS-9620 is currently in a Phase 1b dose-escalation study in ART-suppressed people living with HIV and we have advanced GS-9722, a derivative of PGT121, into Phase 1 testing.”
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 Bill & Melinda Gates Foundation and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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 December 31, 2017, 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.
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.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Ryan McKeel, 650-377-3548
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
GSMA: Forty CEOs Back Launch of Digital Declaration at Davos24.1.2019 08:00 | Tiedote
The GSMA today launched the ‘Digital Declaration’ at the World Economic Forum in Davos. The declaration captures key principles that serve as a guide to acting ethically in the digital era, helping companies deliver what matters most to digital citizens, industry and governments. The 40 business leaders who have already committed to the declaration span several industry sectors and include representatives from: Bharti Airtel, China Mobile, China Telecom, Deutsche Telekom, Ericsson, IBM, KDDI, KT, LG Electronics, Mobile World Capital Barcelona, Nokia, NTT DOCOMO, Orange, Samsung Electronics, Sharp, SK Telecom, Sony Corporation, STC Group, Telefónica, Turkcell, Verizon, Vodafone and Xiaomi. The initiative has arisen against a backdrop of businesses and consumers experiencing unprecedented change in the digital world. It is expected that by 2022, 60 per cent of GDP will be digitised1. The imminent arrival of 5G networks will further accelerate this change. At the same time consumers are r
Papa John’s Appoints Marvin Boakye as First Chief People Officer23.1.2019 18:02 | Tiedote
Papa John’s International, Inc., (NASDAQ: PZZA) one of the world’s largest pizza delivery companies, announced today the appointment of Marvin Boakye as its first Chief People Officer. He will serve as a member of the Papa John’s Executive Leadership Team and report to President and CEO Steve Ritchie. Boakye has more than 20 years of human resources experience, as well as expertise in change management and culture transformation. He has held human resources leadership roles for organizations across the United States, Canada and Latin America. Boakye joins Papa John’s after serving as vice president of human resources at petroleum company Andeavor in San Antonio, Texas, which was recently acquired by Marathon Petroleum. Prior to Andeavor, he was chief human resources officer for MTS Allstream, a telecommunications company now part of Bell Canada, and held senior human resources positions at Goodyear, Pulte Group and The Home Depot. “Boakye’s expertise will help us to continue to push Pa
Global Technology Association ISACA Launching Future-focused Initiatives in Its 50th Anniversary Year23.1.2019 17:22 | Tiedote
Now more than 450,000 engaged professionals and 140,000 members strong, global information technology association ISACA was founded by seven individuals as the EDP Auditing Association in California at the dawn of the information systems era—1969. Serving audit, governance, risk and cybersecurity professionals and their enterprises, today ISACA has a presence in 188 countries. Headquartered near Chicago, Illinois, USA, ISACA also established an entity in Beijing, China, last year, and acquired the CMMI Institute in 2016. In 2019—its 50th anniversary year—ISACA has adopted the theme, “Honoring Our Past. Innovating Our Future.” The organization has multiple initiatives planned to mark this milestone, including: Transforming IT Audit initiative—In February 2019, ISACA will launch a Transforming IT Audit microsite with resources to help IT auditors successfully navigate the future of the profession, including emerging areas like AI and blockchain, and featuring results from ISACA’s new glo
Wipro Ranked Third Fastest Growing Global IT Services Brand in 201923.1.2019 17:18 | Tiedote
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, has been ranked the third fastest growing global IT services brand in 2019 in a study conducted by Brand Finance, the world’s leading brand valuation firm. Wipro is also among the top 10 most valuable brands in the global IT services sector. According to Brand Finance’s IT Services annual report for 2019, which features 15 leading brands in the segment, Wipro has a total brand value of USD 4.002 billion, up 25% on year, emerging as one of the strongest brands in the category with an AA+ Brand rating. Brand Finance, in their official press release noted that Wipro’s significant investments in digital transformation capabilities, niche acquisitions, and a recent brand refresh, have propelled it to the third fastest growing brand in the segment. The report analyses the brand value and brand strength of the 5000 largest brands across 38 sectors in t
Velodyne Lidar and YellowScan Lead Drone Surveying Market for Highway Capacity Expansion23.1.2019 16:00 | Tiedote
Velodyne Lidar, Inc. today announced that the YellowScan Surveyor from YellowScan has utilized Velodyne’s groundbreaking sensor technology to generate precise mapping data for an infrastructure construction project on one of Central Europe’s busiest roadways. YellowScan Surveyor, an unmanned aerial vehicle (UAV) surveying system, improves upon previous time-intensive manual surveying processes by providing a more efficient method for collecting landscape data with increased precision and detail. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190123005054/en/ Ventus-Tech using YellowScan Surveyor, which includes Velodyne Lidar’s Puck™, to generate precise mapping data. (Photo: Business Wire) The project was conducted by Ventus-Tech using YellowScan Surveyor to collect data along a 47-kilometer segment of the M1 highway (E60, E65, E75) in northwestern Hungary. The data, gathered by 88 UAV flights over one month, enabled engine
PMI Among Elite Group of Companies to Score A for Climate Change23.1.2019 15:00 | Tiedote
Philip Morris International Inc. (PMI) (NYSE: PM) has been highlighted as a global leader on corporate climate action by environmental impact nonprofit CDP, achieving a place on the CDP Climate Change A List for the fifth consecutive year. As the only tobacco company to have scored an A, PMI has been recognized for cutting emissions, mitigating climate risks and developing the low-carbon economy, based on its 2018 disclosure to CDP. “Climate change is one of major concerns for humanity, and companies can make a difference. Just like we are leading our industry’s transformation toward a smoke-free future, we are focused on bettering every part of our business and supply chain to become a leader in sustainable business practices,” said André Calantzopoulos, Chief Executive Officer, PMI. The company’s efforts to reduce the environmental footprint of its operations focus on sustainable design in new facilities, energy efficiency in manufacturing processes, greener purchasing of electricity
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme