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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Nearly 1 Billion People Worldwide Have Sleep Apnea, International Sleep Experts Estimate21.5.2018 21:15 | Tiedote
A new data analysis presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference indicates that the prevalence of sleep apnea impacts more than 936 million people worldwide – nearly 10 times greater than previous estimates. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005096/en/ Woman wearing CPAP, the gold standard treatment for sleep apnea (Photo: Business Wire) The study “Global Prevalence of Obstructive Sleep Apnea (OSA)” was conducted by an international panel of leading researchers seeking to provide a clear scope of the impact of the chronic sleep-disordered breathing condition. The previous estimation of OSA prevalence (100 million) came from a 2007 World Health Organization study that used methods and data available at the time. By analyzing technology improvements in detecting OSA and underreported statistics from other areas of the world, this latest study depicts an impacte
Pietro Rosa TBM Signs Long-Term Agreement with Pratt & Whitney21.5.2018 18:13 | Tiedote
Pietro Rosa TBM (Turbine Blade Manufacturing) today announced that it has signed a 10-year, long-term agreement (LTA) with Pratt & Whitney, a division of United Technologies Corp., to supply airfoil products for both commercial and military engines. The LTA, which may extend to the entire Pietro Rosa TBM Group in Europe and the United States, will support Pratt & Whitney’s F135, PW2000 and the Geared Turbofan™ (GTF) family of engines. This agreement represents a significant step in the collaboration between the two companies, enabling the Pietro Rosa TBM Group to utilize its advanced engineering capabilities and the vertical integration of hot forming, machining and surface finishing technologies. “We’re pleased to sign this agreement with Pietro Rosa,” said Art Erikson, executive director of Strategic Sourcing, Pratt & Whitney. “We have tremendous growth ahead, and suppliers like Pietro Rosa that sign up to our contractual governance, commitment to cost competitiveness and continuous
NioCorp Awards Contract to Rockwell Automation on Groundbreaking Critical Minerals, Mining and Processing Facility in Nebraska21.5.2018 15:00 | Tiedote
NioCorp Developments Ltd. (TSX: NB, OTCQX: NIOBF), a developer of superalloy metals, has awarded a major contract to Rockwell Automation (NYSE: ROK) to engineer, design and procure process automation and instrumentation for NioCorp’s proposed critical minerals, mining and processing facility in Elk Creek, Nebraska. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005228/en/ Three superalloy metals – niobium, scandium and titanium – are expected to be produced by the facility as early as 2021. These critical materials are used in the aerospace, defense, automotive, clean energy, commercial aviation and mega-infrastructure sectors. Generally, these superalloys enable increased strength and lighter weight in transportation and other systems, leading to better fuel efficiency and lower greenhouse gas and other air emissions, according to NioCorp. “We selected Rockwell Automation and its partners to automate our process equip
Ultra-Low Power Lattice sensAI Leads Mass Market Enablement of Artificial Intelligence in Edge Devices21.5.2018 15:00 | Tiedote
Lattice Semiconductor Corporation (NASDAQ: LSCC) today unveiled Lattice sensAI™ – a complete technology stack combining modular hardware kits, neural network IP cores, software tools, reference designs and custom design services – to accelerate integration of machine learning inferencing into broad market IoT applications. With solutions optimized for ultra-low power consumption (under 1 mW–1 W), small package size (5.5 mm2 –100 mm2), interface flexibility (MIPI® CSI-2, LVDS, GigE, etc.), and high-volume pricing (~$1-$10 USD), Lattice sensAI stack fast-tracks implementation of edge computing close to the source of data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005011/en/ (Graphic: Business Wire) “Lattice sensAI addresses the unmet need for flexible, low cost, ultra-low power AI silicon solutions suited for rapid deployment across a wide range of emerging, mass market IoT applications,” said Deepak Boppana, senior
Biosimilars could facilitate early access to life changing biological treatments for patients says Celltrion Healthcare21.5.2018 14:27 | Tiedote
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring greater clinical benefit to patients.1,2,3,4,5,6 However, only a limited number of patients have access to biological treatment due to the high-cost of biologics and current reimbursement policies determined by pharmacoeconomic evaluations. Since the introduction of biosimilars, the overall cost of biological treatments has reduced in Europe, allowing an increased number of patients to access this important treatment option earlier in their course of treatment.7 Professor Jørgen Jahnsen said, “For the treatment of inflammatory bowel disease, biological treatments are proven to be the most efficacious medical therapy and their ea
Dole’s Joint Venture Recycling Company Celebrates 25 Years21.5.2018 14:00 | Tiedote
Dole Food Company announced today that Recyplast S.A., an innovative plastic recycling company based in Costa Rica and with joint ownership including a subsidiary of Dole Fresh Fruit, recently surpassed 25 years in its mission to dramatically reduce and reuse agricultural waste. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005160/en/ Raul Martinez (right), General Manager of Dole Standard Fruit de Costa Rica, receives a plaque from Jose Miguel Ramirez, General Manager of Recyplast, in recognition of the contribution of Dole's banana plantations in the correct handling, storage, and provision of field plastic waste. The plastic recycling facility pioneered the collection of field plastics after use in banana growing operations in Costa Rica. This reuse and recycling process includes reclamation of plastic bags that protect bananas from weather and insects, as well as the collection of plastic twine used to prop the ba
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