GlobeNewswire

New England Journal of Medicine Publishes Novavax' NanoFlu Clinical Trial Data

Share
  • NanoFluTM Phase 1/2 trial data published in a peer-reviewed letter to the editor in The New England Journal of Medicine
  • NanoFlu demonstrates significantly improved immune responses against a panel of homologous and drifted A(H3N2) influenza viruses compared to leading licensed egg-based, high-dose flu vaccine in older adults
  • Phase 2 trial of quadrivalent NanoFlu expected to begin in third quarter of 2018

GAITHERSBURG, Md., June 13, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that The New England Journal of Medicine (NEJM) published a peer-reviewed letter to the editor detailing the positive results from Novavax' Phase 1/2 clinical trial in older adults comparing its Matrix- M(TM) adjuvanted nanoparticle seasonal influenza vaccine candidate (NanoFlu) to the leading licensed egg-based, high-dose influenza vaccine (IIV3-HD). The letter is available online at www.nejm.org/doi/full/10.1056/NEJMc1803554.

"We are pleased to be able to share the detailed data from the NanoFlu Phase 1/2 clinical trial with the broader scientific community," said Stanley C. Erck, President and Chief Executive Officer of Novavax, Inc. "The low effectiveness of seasonal influenza vaccines, and in particular the A(H3N2) component of the vaccine, during the 2017-2018 season emphasizes the need for a more effective vaccine. Our non-egg-based, recombinant nanoparticle vaccine, when coupled with Matrix-M, potentially offers broader protection against rapidly evolving drift strain variants. We believe this addresses important public health challenges caused by influenza and offers a significant advantage over current influenza vaccines."

In February 2018, Novavax reported the positive top-line results from the NanoFlu Phase 1/2 clinical trial in older adults. Details of the data, as published in this letter, include that NanoFlu in comparison to IIV3-HD 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; and
  • Higher HAI responses against the homologous A(H1N1) strain and comparable responses against the homologous B/Brisbane strain.

"These results showcase the potential benefit NanoFlu could have for older adults, a population challenged by poor immune responses. This population faces an urgent unmet medical need for a more effective flu vaccine, as highlighted by the severe flu season of 2017-2018," said Dr. Vivek Shinde, Executive Director, Clinical Development at Novavax and lead author of the letter. "We look forward to advancing this vaccine into the planned Phase 2 clinical trial of quadrivalent NanoFlu in the third quarter of 2018."

About the Phase 1/2 Clinical Trial

Novavax, Inc. conducted a randomized, observer-blind, comparator-controlled trial of NanoFlu (in two trivalent formulations: 45µg or 180µg total HA) against IIV3-HD in 330 healthy adults aged 60 years or older. Immunogenicity was measured by HAI and neutralization antibody responses against a panel of vaccine-homologous, and historically and forward-drifted, influenza virus strains.

About NanoFlu(TM) and Matrix M(TM)

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are substantially the same as 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 Novavax

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent infectious diseases. Its RSV and NanoFlu vaccine candidates are Novavax' most advanced clinical programs and are at the forefront of its efforts to improve global health. For more information, please visit www.novavax.com.

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 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.

Contact:

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




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

About GlobeNewswire

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

https://globenewswire.com

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.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

GINA TRICOT ROLLS OUT RFID MAKING INVENTORY ACCURACY AND SUSTAINABILITY A PRIORITY  23.8.2019 11:00:00 CESTPress release

Nordic ID, a Finnish technology company, known for innovative PaaS-solutions for item tracking and management, partners with Swedish clothing company Gina Tricot for real-time inventory solutions to be rolled out in more than 180 stores. Gina Tricot and Nordic ID will roll out the cloud-based inventory solution to track all its merchandise and to create real time visibility to inventories at various locations. This will enable outstanding inventory accuracy and allow the Swedish fashion house to respond with needed actions even faster. With the help of the RFID-based inventory solution, stores can take inventory on average 1-2 times a week, allowing optimal stock balance. Sustainability is an integral part of Gina Tricot operations and this solution will give insights needed to further optimize processes. The Nordic ID inventory solution will also help to continuously track inter-store deliveries. By implementing RFID, Gina Tricot targets an inventory accuracy of 99,5 %. Typically inve

Oasmias depåbevis avnoterade från NASDAQ i USA23.8.2019 10:30:00 CESTPressemelding

Oasmia Pharmaceutical AB har tidigare kommunicerat att bolaget avser att avnotera sina amerikanska depåbevis från Nasdaq Capital Market ("NASDAQ") i USA. Avlistningen är nu genomförd. Huvudsyftet med avnoteringen är att minska komplexiteten i finansiell rapportering och administrativa kostnader. Oasmias stamaktier fortsätter att handlas på NASDAQ Stockholm. Innehavare av depåbevis/ADS som vill fortsätta att inneha Oasmia-aktier i form av ADS behöver inte vidta några åtgärder. Oasmia kommer att upprätthålla en amerikansk mottagningsfacilitet för att göra det möjligt för investerare att inneha Oasmia-aktier i form av ADS och fortsätta att handla dessa värdepapper på OTC-marknaden. Dessa ADS:er kommer automatiskt att övergå till det nya ADR-programmet i samband med avlistningen och handlas under en ny ticker som ska utses. De investerare som innehar amerikanska ADS:er/depåbevis har möjlighet att lösa in dessa mot stamaktier i Oasmia som handlas på Nasdaq Stockholm. Mer information finns p

Oasmia ADSs delisted from NASDAQ in the US23.8.2019 10:30:00 CESTPress release

Oasmia Pharmaceutical AB has previously communicated that the company intends to delist its American Depositary Shares (“ADS”) from the Nasdaq Capital Market (“NASDAQ”) in the US. The delisting is now effective. The main purpose of the delisting is to reduce complexity in financial reporting and administrative costs. Oasmia’s ordinary shares will continue to trade on Nasdaq Stockholm. Holders of ADSs that wish to continue to hold Oasmia shares in the form of ADSs do not have to take any action. Oasmia will maintain an American Depositary Receipt facility to allow investors to hold Oasmia shares in the form of ADSs, and to continue to trade those securities on the over-the-counter market. ADSs will automatically transition to the new ADR program in connection with the delisting and will be traded under a new ticker to be designated. Holders of ADSs may also choose to transition from holding ADSs to holding ordinary shares listed on Nasdaq Stockholm. Read more on Oasmia website. https://

Statkraft kjøper tysk elbilladeselskap23.8.2019 10:01:00 CESTPressemelding

(Teisnach/Düsseldorf/Oslo, 23. august 2019) Statkraft har kjøpt det tyske elbilladeselskapet E-WALD GmbH. Oppkjøpet styrker Statkrafts posisjon i det tyske og europeiske elbillademarkedet etter fjorårets investering i München-baserte eeMobility GmbH. E-WALD GmbH, også med base i Bayern, har en sterk posisjon innen hurtiglading og deling av elbiler. Selskapet driver rundt 300 ladestasjoner og tilbyr elbildeling av omlag hundre biler til selskaper og kommuner med totalt 7000 brukere. Oppkjøpet av E-WALD vil styrke Statkrafts posisjon i Tyskland og komplettere selskapets investering i eeMobility, som utvikler totalløsninger for lading av firmabiler. - E-WALD har et godt utgangspunkt for vekst innen elbillading i Tyskland, og vi ser frem til å bygge selskapet videre og støtte en ambisiøs vekststrategi, sier Bjørn Holsen, direktør for ny forretningsutvikling i Statkraft, Europas største produsent av fornybar energi. - Dette oppkjøpet markerer en viktig milepæl i selskapets utvikling og bekr

Statkraft acquires German EV charging company E-Wald GmbH.23.8.2019 10:01:00 CESTPress release

(Teisnach/Düsseldorf/Oslo, 23 August 2019) Statkraft has acquired the entire shareholding of electric vehicle (EV) charging company E-WALD GmbH. The acquisition further strengthens Statkraft’s position in the German and European EV charging market after it became a majority shareholder in eeMobility in Germany last year. The EV charging company E-WALD GmbH, based in Bavaria, Germany has a strong position in fast charging and electric car sharing services. It operates around 300 charging stations and offers EV leasing services for circa 100 fleet cars to corporations and municipalities with approximately 7000 customers in total. The acquisition of E-WALD will strengthen Statkraft’s position in Germany and complements the company’s position in eeMobility, which provides a full service offering of charging solutions for company car fleets. “E-WALD is well placed for growth within fast charging in Germany and we look forward to build the company further and support its ambitious growth str

Terms for switches in inflation-linked bond SGB IL 310223.8.2019 09:30:00 CESTPress release

The Swedish National Debt Office offers switch auctions in inflation-linked bond SGB IL 3102 with the aim of decreasing the outstanding volume to around SEK 25 billion before the bond’s time to maturity is shorter than one year. The switch auctions will be held on 20, 23 and 24 September. The offered bonds in the switch auctions are SGB IL 3112, SGB IL 3109 and SGB IL 3113. Switches versus SGB IL 3112 and SGB IL 3113 will be price risk neutral 1 while the switch versus SGB IL 3109 will be cash neutral2. Switch auctions Fri 20 September Risk neutral Mon 23 September Cash neutral Tue 24 September Risk neutral SNDO sells bond 3112 3109 3113 SNDO sells amount (SEK mn) 400 250 250 SNDO buys bond 3102 3102 3102 SNDO buys amount (SEK mn) 3 1 800 200 1 400 Time for yield on buy-back loan 10:45 10:45 10:45 Time for auction cut-off 11:00 11:00 11:00 Time for auction result 11:03 11:03 11:03 The switches were announced in the publication Central Government Borrowing – Forecast and Analysis 2019:2