Nasdaq GlobeNewswire

Novavax Initiates Phase 2 Clinical Trial of NanoFlu™ in Older Adults

Del
  • 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.

About Influenza

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.

About Novavax

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.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

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.

Contacts:     

Investors
Novavax, Inc.
Erika Trahan
Senior Manager, Investor & Public Relations
ir@novavax.com
240-268-2000

Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

TESARO Announces Data Presentations at ESMO 2018 Congress20.10.2018 07:30Pressemelding

Data presented indicate that TSR-042 (anti-PD-1 antibody) is well tolerated and has robust activity in patients with MSI-H endometrial cancer PRIMA safety data for individualized niraparib dose regimen presented Top-line results for PRIMA trial of niraparib in first-line ovarian cancer regardless of biomarker status expected in late 2019 MUNICH, Germany, Oct. 20, 2018 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today summarized updated Phase 1 GARNET data of TSR-042 (anti-PD-1 antibody) in patients with recurrent or advanced microsatellite instability high (MSI-H) endometrial cancer presented during the European Society for Medical Oncology (ESMO) Congress. Blinded, pooled interim safety data from the Phase 3 PRIMA trial of niraparib in patients with first-line ovarian cancer regardless of biomarker status were also presented in a poster discussion session and additional data from the QUADRA trial of niraparib for treatment of late-li

The Navigators Group, Inc. Announces Expiration of Hart-Scott-Rodino Waiting Period for Proposed Merger19.10.2018 22:01Pressemelding

STAMFORD, Conn., Oct. 19, 2018 (GLOBE NEWSWIRE) -- The Navigators Group, Inc. (NASDAQ:NAVG) (“Navigators” or the “Company”) announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with its previously announced merger with a direct wholly owned subsidiary (“Merger Sub”) of The Hartford Financial Services Group, Inc. (“The Hartford”), expired at 11:59 p.m. Eastern Time on October 18, 2018. The expiration of the waiting period under the HSR Act satisfies one of the conditions to the closing of the merger, which remains subject to other closing conditions in the Agreement and Plan of Merger, dated as of August 22, 2018, by and among the Company, The Hartford and Merger Sub. About Navigators The Navigators Group, Inc. (NASDAQ: NAVG) (“Navigators” or the “Company”) is a global specialty insurance holding company. We provide customized insurance solutions designed to protect clients from the complex risk

ATTO Technology introduces the XstreamCORE® FC 7600 32Gb Fibre Channel to 12Gb SAS Hardware Accelerated Storage Controller19.10.2018 15:00Pressemelding

AMHERST, N.Y., Oct. 19, 2018 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage, network connectivity and infrastructure solutions for data-intensive computing environments for 30 years, announces availability of the ATTO XstreamCORE® FC 7600 storage controller. ATTO XstreamCORE FC 7600 is a standalone, accelerated storage controller that connects any external SAS device, such as a JBOD of HDDs or SSDs, a RAID array or external tape devices, and presents them isolated to individual hosts or shared over a Fibre Channel SAN fabric. It includes ATTO exclusive technologies, ATTO xCORE hardware acceleration processor and ATTO intelligent Bridging Architecture™, that combine to keep latency astonishingly low at three microseconds. For less than the price of a performance server, XstreamCORE FC 7600 enables up to 64 Fibre Channel connected clients to remotely access and share up to 240 SAS/SATA SSD or HDD devices via JBOD or JBOF at direct attached speeds with consistent, d

Biome Grow Introduces PEI Brand, Red Sands Craft Cannabis Co.19.10.2018 13:30Pressemelding

TORONTO, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Biome Grow Inc. (“Biome” or the “Company”) (CSE:BIO) (FSE:6OTA) is pleased to introduce its fifth subsidiary company and brand, Red Sands Craft Cannabis Co. (“Red Sands”). Red Sands is located in Prince Edward Island (PEI) and will service both the local and tourist markets in that province with locally produced and regionally grown cannabis products. The Red Sands Craft Cannabis Co. brand reflects PEI’s iconic red sand beaches and the craft goods and services that are produced locally. Visually, it balances the vibrant, energetic colours with the calm nature that PEI is known for, setting the stage for the tailored cannabis products that Red Sands will offer. Though the smallest Canadian province both in terms of land area and population, with approximately 153,000 residents living on the Island, the province has a robust tourism industry. In 2017, the province set records with more than 1,000,000 overnight stays, by an estimated 1.56 million

CORRECTION - Elite Petro & Gas broadens financial services and signs a deal with Tabarak Investment Capital Limited18.10.2018 23:35Pressemelding

DUBAI, United Arab Emirates, Oct. 18, 2018 (GLOBE NEWSWIRE) -- Today the President of Elite Petro & Gas, Mr. George Matharu and the President of Tabarak Investment Capital Limited (Investment Bank), Dr. Mohamed Ahmadi announced a deal in which the two companies will use their combined resources to execute physical commodity trades, and provide banking and finance facilities for oil and gas transactions. The alliance between the two entities will also allow compliance related activities to be carried out from two major international hubs of London and Dubai. This increases the international presence of both companies. Additionally, Elite Petro & Gas (“EPG”) has recently formed relationships with the owners of a number of high profile European, South American and Chinese projects, which EPG and Tabarak can work on together. Tabarak Investment Capital Limited is a regulated investment bank by Dubai Financial Services Authority and incorporated in the Dubai International Financial Centre.

Partnership Between Zaiput Flow Technologies and ThalesNano Set to Improve Process Intensification18.10.2018 15:21Pressemelding

BUDAPEST, Hungary and WALTHAM, Mass., Oct. 18, 2018 (GLOBE NEWSWIRE) -- Zaiput Flow Technologies, a global leader in separation, and ThalesNano, the world leader in bench-top flow chemistry reactors, recently signed a distribution agreement and entered into a technology partnership that exploits the benefits of their combined technologies. Under the distribution Zaiput liquid-liquid phase separators and back pressure regulators are available via ThalesNano in Europe and a number of other countries on a non-exclusive basis, either separately or as part of a bundled offering with ThalesNano’s own microflow reactors. Within the framework of the technology partnership the companies will collaborate to promote adoption of the combined use of their technologies. “We are very excited to work with ThalesNano to offer better-integrated flow chemistry systems to our customers and streamline the work of both novice and experienced users in the flow chemistry space,” said Zaiput CEO, Dr. Andrea Ad

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom