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
NEC and Samsung Announce 5G Partnership Agreement24.10.2018 04:00 | Tiedote
NEC Corporation (NEC) (TOKYO: 6701) and Samsung Electronics Co., Ltd., today announced a partnership of joint effort to strengthen their next generation business portfolio including 5G. The partnership brings together the best-in-class technology and expertise in 5G, merging NEC and Samsung’s leadership in 5G and IT solutions. It also provides mobile carriers with flexible 5G solutions that are localized for each region with customized services to meet mobile carriers’ demands efficiently. Since 5G will enable unprecedented services and business models, it is inevitable for mobile carriers to demand customized solutions and flexible network architecture. Through this partnership, both companies will satisfy these growing demands effectively by joining the best forces and capabilities from each company. "5G development based on standardization will help to accelerate business transformation throughout global markets,” said Atsuo Kawamura, Executive Vice President and President of the Ne
Coronation Fund Managers Goes Live with SmartStream’s Corporate Actions Solution24.10.2018 02:01 | Tiedote
SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announced that Coronation Fund Managers, one of the largest independent fund managers in South Africa, has gone live with TLM Corporate Actions OnDemand – automating the complete corporate actions lifecycle. Llewellyn Smith, COO at Coronation states: “We continue to make investments in our business, specifically in technology that enhances our clients’ service experience, and which allows us to achieve greater operational efficiencies. Through SmartStream’s tailored solution, we achieve automation of our corporate actions operational processes. Given that this project ran in parallel with a number of strategic initiatives, its successful implementation was essential. We value SmartStream’s corporate actions expertise which guided us through the procedure in less than four months”. Coronation is using the TLM® Corporate Actions OnDemand solution to process mandatory and voluntary ev
EASA Approves AerTrak ADS-B Out System for Boeing 737 NG Series Aircraft24.10.2018 00:47 | Tiedote
AerSale ®, a global supplier of mid-life aircraft, engines, used serviceable material, and MRO services, announced today that the European Aviation Safety Agency (EASA) has approved the company’s AerTrak™ ADS-B Out system on Boeing 737 NG series aircraft (10065422). Earlier this year, the Federal Aviation Administration (FAA) approved AerTrak for Boeing 737 NG series aircraft (ST04009NY) and Boeing 757-200 series aircraft (ST04011NY) to comply with the FAA’s Automatic Dependent Surveillance-Broadcast (ADS-B) Operations rule. The Boeing 757-200 series aircraft Supplemental Type Certificate (STC) is now pending EASA and National Civil Aviation Agency of Brazil (ANAC) validation. “With this validation, we demonstrate our commitment to our European customer base,” said Iso Nezaj, Chief Technical Officer at AerSale. “Operators can now choose a fully-compliant ADS-B Out system visible to all—with no certification fees. We’re working to expand AerTrak to cover additional aircraft types and lo
Greene Tweed Receives Patent for Rapid Gas Decompression-Resistant Fluoroelastomers and Molded Articles24.10.2018 00:00 | Tiedote
The U.S. Patent Office has awarded Greene Tweed Patent Number 10,011,690 for Rapid Gas Decompression-Resistant Fluoroelastomer Compositions and Molded Articles. The innovative elastomer technology was developed by a team that included inventor Ron Campbell, PhD, Principal Scientist and Technology Leader for Elastomers in Greene Tweed’s Advanced Technology Group, to provide a competitive advantage in the Energy market and expand technology protected under a previous patent. Rapid gas decompression (RGD) often occurs when high-pressure gas molecules migrate into an elastomer at a compressed state. When the pressure surrounding the elastomer is suddenly released, the compressed gas inside the elastomer tries to expand and exit the elastomer, thus causing RGD (also known as explosive decompression). Most elastomers experience severe blistering or cracking when the force of these expanding gases overcome the strength of the surrounding material; however, materials engineered to withstand RG
Morinaga Milk Study Suggests Infant-Type Human-Residential Bifidobacteria May Benefit Infant Health by Improving Digestion of Peptides in Milk and Grains23.10.2018 21:00 | Tiedote
Scientists at Morinaga Milk Industry Co., Ltd. (TOKYO:2264) have long theorized that Human-Residential Bifidobacteria (HRB) are superior to non-Human-Residential Bifidobacteria (non-HRB) in promoting good health outcomes. The results of a new study strengthen the evidence for this theory, showing that infant-type HRB may be able to break down incompletely digested peptides in the infants’ gastrointestinal systems and thus contribute to their overall health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181023005015/en/ Fig 1. Food-derived opioid peptides are potential risk factors for human health (Graphic: Business Wire) Human-Residential Bifidobacteria for Humans Morinaga Milk has been conducting research on bifidobacteria for many years, and studies over the past decades have shown that bifidobacteria play a vital role in various aspects of human health. There are two major groups of bifidobacteria: Human-Residential Bif
myPOS Founder Christo Georgiev Announces Two Upcoming myPOS Stores in Barcelona and Paris23.10.2018 19:22 | Tiedote
Christo Georgiev, fintech entrepreneur and founder of myPOS, has confirmed his intention to open two new flagship stores in major European cities by the end of the year. The opening is part of an initiative to bring the product closer to potential customers, giving them a hands-on experience and a live demonstration of what myPOS has to offer. The two new stores will be opened in Barcelona, Spain and Paris, France – two of the most important markets for myPOS. “Our Spanish and French customers have always placed a tremendous amount of trust in us, and we in turn have worked hard to justify it,” Georgiev says. “Opening physical locations in Barcelona and Paris is an extension of that relationship. It’s important to test a product with your own hands before you choose to trust it, and if that’s true for TVs and phones why can’t it apply to POS terminals?” The Barcelona store will open as soon as November, followed shortly by the Paris one before the end of the year. myPOS has already ope
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