Novavax Initiates Phase 2 Clinical Trial of NanoFlu™ in Older Adults
- First participants enrolled in Phase 2 clinical trial of quadrivalent NanoFlu formulations
- Top-line immunogenicity and safety data expected in the first quarter of 2019
- Phase 2 results will support meeting with the U.S. Food and Drug Administration (FDA) and Phase 3 clinical trial design
GAITHERSBURG, Md., Sept. 25, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX) today announced the initiation of a Phase 2 dose and formulation confirmation clinical trial in older adults of NanoFlu, its nanoparticle seasonal influenza vaccine candidate.
“Initiating this Phase 2 clinical trial of NanoFlu is an important milestone for Novavax,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “With top-line results expected in the first quarter of 2019, we plan to discuss these data with the FDA at an ‘End of Phase 2’ meeting and to agree on the appropriate Phase 3 clinical trial design to support licensure via accelerated approval. We continue to believe NanoFlu is a differentiated flu vaccine capable of better addressing a global public health problem, and can thereby capture a significant share of the multi-billion-dollar seasonal influenza vaccine market.”
This randomized, observer-blinded, active-controlled trial will assess the safety and tolerability of different doses and formulations of NanoFlu, both adjuvanted with its proprietary Matrix-M™ adjuvant and unadjuvanted, as compared to two U.S.-licensed comparators. The trial will enroll approximately 1,375 healthy older adults across clinical sites in the U.S. and is designed to select a dose/formulation of NanoFlu that Novavax will bring forward into its future pivotal Phase 3 immunogenicity clinical trial.
“The dual problems of antigenic drift and antigenic changes resulting from egg-based vaccine production have, in recent years, resulted in generally poor influenza vaccine effectiveness with potentially severe medical consequences, particularly in older adults. A substantially improved seasonal influenza vaccine is a widely recognized, high-priority unmet medical need,” said Gregory Glenn, M.D., President of Research and Development of Novavax. “We look forward to evaluating NanoFlu in this trial, and subsequently moving into a pivotal Phase 3 clinical trial in the second half of 2019 with the goal of introducing a more effective flu vaccine option.”
More information about the newly initiated trial can be found at www.clinicaltrials.gov.
Previously Reported Phase 1/2 Clinical Trial Results with NanoFlu
In February 2018, Novavax reported positive top-line results from its Phase 1/2 clinical trial in older adults of a NanoFlu trivalent formulation. As compared to Fluzone HD, NanoFlu demonstrated an acceptable safety profile and short-term reactogenicity. With regard to immunogenicity, NanoFlu induced:
- Hemagglutination inhibition (HAI) immune responses that were 28% to 64% greater against the homologous and four generations of drifted wild-type A(H3N2) influenza strains;
- Higher HAI responses against the homologous A(H1N1) strain and comparable responses against the homologous B/Brisbane strain; and
- Strong neutralizing antibody responses that correlate with HAI results.
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.2
1 Resolution of the World Health Assembly (2003) WHA56.19.28
2 Influenza Vaccines Forecasts. Datamonitor (2013)
About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that drives improved health globally through the discovery and development of innovative vaccines to prevent serious respiratory diseases. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is poised to help prevent the second leading cause of death in children under one year of age worldwide. Novavax is also advancing NanoFlu, its quadrivalent influenza nanoparticle vaccine, to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2017 and the Quarterly Report on Form 10-Q for the period ended June 30, 2018 as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Senior Manager, Investor & Public Relations
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
BrandSafway™ Announces Acquisition of Century Elevators22.2.2019 20:00:00 | Pressemelding
Enhances motorized access capabilities in industrial and commercial construction markets throughout the Gulf Coast and beyond Kennesaw, Georgia, USA, Feb. 22, 2019 (GLOBE NEWSWIRE) -- KENNESAW, Georgia; February 22, 2019 – In a move to expand its motorized capabilities and offer a full suite of access technologies throughout the Gulf Coast, Brand Safway is pleased to announce the acquisition of Century Elevators, effective February 22, 2019. The leading rack and pinion elevator specialist in North America, Century Elevators provides construction and industrial elevators, material hoists, and transport platforms in the Gulf Coast region and beyond. Century Elevators is also the exclusive distributor of PEGA Hoist Ltd. products throughout North America and Böcker Maschinenwerke GmbH (Boecker) equipment in the United States. “Century Elevators is a very welcome addition to BrandSafway,” said Dave Witsken, president of Energy and Industrial at BrandSafway. “With the outstanding experience
Open Compute Project Announces Updated Market Forecast22.2.2019 16:39:00 | Pressemelding
Open Source Foundation Exceeds 2018 Forecast for Non-Board Member Adoption, Tops $2.56 billion and expected to surpass $10 billion by 2022. Austin, Texas, Feb. 22, 2019 (GLOBE NEWSWIRE) -- The Open Compute Project Foundation (OCP) announces today the high level results of a follow up assessment of the market impact of the Open Compute Project worldwide. For a second year, OCP has engaged IHS Markit, a world leader in critical information, analytics and solutions, to determine the adoption and impact of OCP gear in the technology industry. Since its inception, OCP has worked to drive innovation in and around the data center industry, bringing together thousands of engineers from nearly two hundred member organizations. The demands on the modern datacenter continue to expand with the growth of IOT, security and edge computing, as well as increasing energy consumption requirements. IHS Markit interviewed OCP members, suppliers and service providers, as well as incorporated their own in-de
Magna Announces Fourth Quarter and 2018 Results and Raises Quarterly Cash Dividend by 11%22.2.2019 11:00:00 | Pressemelding
Fourth Quarter 2018 Highlights Record fourth quarter sales of $10.1 billion up 5% from the fourth quarter of 2017 Cash from operations of $1.6 billion Returned $585 million to shareholders through share repurchases and dividends Raised quarterly cash dividend by 11% to $0.365 per share Full Year 2018 Highlights Record sales of $40.8 billion, up 12% from 2017 Record diluted earnings per share of $6.61, an increase of 13% Record cash from operations of $3.7 billion Returned approximately $2.3 billion to shareholders through share repurchases and dividends AURORA, Ontario, Feb. 22, 2019 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX: MG; NYSE: MGA) today reported financial results for the fourth quarter and year ended December 31, 2018. THREE MONTHS ENDED DECEMBER 31, YEAR ENDED DECEMBER 31, 2018 2017 (2) 2018 2017 (2) Reported Sales $ 10,137 $ 9,684 $ 40,827 $ 36,588 Income from operations before income taxes $ 607 $ 765 $ 2,951 $ 2,985 Net income attributable to Magna International I
IMImobile announces integration of WhatsApp Business solution into its enterprise cloud communications platform IMIconnect22.2.2019 10:37:00 | Pressemelding
The WhatsApp Business solution will be made available across its enterprise cloud communications platform IMIconnect allowing businesses to launch business-to-consumer communications on WhatsApp LONDON, Feb. 22, 2019 (GLOBE NEWSWIRE) -- Global cloud communications software and solutions provider IMImobile PLC, today announced the integration of the WhatsApp Business solution into its enterprise cloud communications platform IMIconnect. The WhatsApp Business solution enables businesses to connect with over 1.5 billion users in a simple, reliable, and private way across 180 countries worldwide. As a WhatsApp Business solution provider, the IMIconnect platform will enable enterprises to seamlessly integrate the WhatsApp Business solution into their customer communications strategies, and drive engagement through intelligent and context-aware messaging. “We are excited to announce the integration of the WhatsApp Business solution today in our IMIconnect platform. We understand that today’s
Nordic Innovators Cloudstreet and Domos Partner to Deliver an End-to-End, Application-Aware 5G Experience to the Home22.2.2019 09:00:00 | Pressemelding
Cloudstreet’s carrier-grade API and Network Slicing platform with Domos’ Machine Learning Solution for home networks delivers intelligent connectivity out of the box Barcelona, Spain., Feb. 22, 2019 (GLOBE NEWSWIRE) -- Finland’s Cloudstreet, the US-patented Network Slicing Company, and Norway’s Domos, a leader in Machine Learning technologies for the smart home, are pleased to announce that they have teamed up to create the industry’s first end-to-end, intelligent application and context-aware network slicing solution for home networks. The solution will be on display February 25-28 at the Mobile World Congress in Barcelona in Hall 5, stand 5C41. A perfect example of MWC’s aspirational theme, “Intelligent Connectivity”, the solution closes the loop on delivering a 5G experience to fixed wireless home networks. The combined technologies solve two key, last-mile problems that have plagued mobile-enabled home networks: 1) How to build application-awareness into the network without comprom
General Electric Company: Doc re. GE Files Form 8-K22.2.2019 08:00:00 | Pressemelding
FAIRFIELD, Conn., Feb. 22, 2019 (GLOBE NEWSWIRE) -- Company General Electric Company ISIN US3696041033 Symbol London: GEC | Paris: GNE Headline Doc re: GE files Form 8-K February 21, 2019 On February 21, 2019, General Electric Company (the "Company") filed a Form 8-K with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to RNS. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. http://www.rns-pdf.londonstockexchange.com/rns/8048Q_1-2019-2-21.pdf CONTACT: GE Jennifer Erickson +001 646 682 5620 firstname.lastname@example.org This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact email@example.com or visit