Business Wire

Johnson & Johnson Announces Encouraging First-in-Human Clinical Data for Investigational HIV Preventive Vaccine

Jaa

Johnson & Johnson today announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).

“Finding a preventive vaccine has proven to be one of the biggest scientific challenges in the 35-year quest to end the HIV pandemic. A successful preventive vaccine for HIV will need to provide broad protection against a wide range of viral strains,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator for APPROACH. “These promising, early-stage results suggest that these vaccines utilizing mosaic immunogens should be evaluated further for their potential ability to achieve this historic goal.”

Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year. An effective HIV vaccine is elusive due to the unique properties of the virus – including its genetic diversity and ability to mutate rapidly.

Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. These immunogens are delivered through viral vectors, including Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components such as soluble proteins to form mosaic-based prime-boost vaccine regimens that first prime and then boost the immune system, with the aim of producing stronger and longer-lasting immunity to HIV.

Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.”

In pre-clinical studies, regimens incorporating mosaic vaccines demonstrated protection against infection with an HIV-like virus. The most effective prime-boost regimen in these studies reduced the per-exposure risk of infection by 94 percent and resulted in 66 percent complete protection after six exposures.

Based on immunologic responses observed in APPROACH, as well as protection observed in pre-clinical studies, a lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140 soluble protein has been selected as the basis for further evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this study move forward, Janssen and its global partners anticipate initiating this investigation in southern African countries in late 2017 or early 2018.

About the APPROACH Study

APPROACH (HIV-V-A004/NCT02315703) is a multi-center, randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in 393 healthy HIV-uninfected adults in the US, Rwanda, Uganda, South Africa and Thailand. It is evaluating the safety, tolerability and immunogenicity of various mosaic-based, prime-boost vaccine regimens for HIV-1. These vaccine regimens contain two prime doses of the mosaic viral vector Ad26.Mos.HIV and two boosts of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminum phosphate. Vaccination schedules have been completed for all study participants and 12-month follow-up after the 4th dose is underway.

Results presented at IAS 2017 suggest that all vaccine regimens appeared to be well-tolerated. Injection site pain, headache and fatigue were the most common reported adverse events. The primary analysis post 3rd vaccination showed that most active vaccine regimens elicited antibody responses in 100% of study participants. Antibody titers against autologous Clade C and heterologous cross-clade Env antigens increased in groups boosted with gp140 protein, irrespective of vector. After the 4th vaccination, humoral and cellular responses further increased.

The APPROACH study was sponsored by Janssen with support from partner organizations including Beth Israel Deaconess Medical Center (BIDMC); the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute; the International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN).

About Janssen’s HIV Preventive Vaccine

Janssen’s HIV-1 AdVac®-based vaccine regimen, along with the company’s investigational Ebola and inactivated polio vaccine candidates, utilize Janssen’s PER.C6® production cell line technology, which has the potential to reduce costs by increasing vaccine production at lower reactor volume.

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040. Janssen’s HIV vaccine program has also received funding from the United States Military HIV Research Program and the Ragon Institute.

Please visit www.jnj.com/HIV for further details on the breadth of HIV science being presented by Johnson & Johnson companies and its partners.

About Johnson & Johnson

Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,400 employees at more than 230 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding development of a potential preventive vaccine for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at  www.sec.gov www.jnj.com  or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

– Ends –

Contact information

Johnson & Johnson
MEDIA CONTACTS:
Ronan Collins
+47 488 42500
Rcollin5@its.jnj.com
or
Katie Buckley
+ 44 797 195 6179
Kbuckle8@its.jnj.com
or
Gavin Hart
+1 917 686 9221
Ghart9@its.jnj.com
or
INVESTOR RELATIONS:
Lesley Fishman
+1 732 524 3922
or
Joseph J. Wolk
+ 1 732 524 1142

Tietoja julkaisijasta

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 21:15Tiedote

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 18:13Tiedote

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 15:00Tiedote

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 15:00Tiedote

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 14:27Tiedote

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 14:00Tiedote

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