NASDAQ OMX

Novavax Continues Phase 3 Trial of the RSV F Vaccine for Infants via Maternal Immunization and Provides Update on Phase 1/2 Trial of the NanoFlu(TM) Vaccine

Dela
  • RSV F Vaccine informational analysis completed in fourth quarter of 2017
  • RSV F Vaccine interim analysis expected mid-2018 with approximately 4,600 enrollees
  • Filing of RSV F Vaccine BLA anticipated by late 2019
  • NanoFlu Vaccine data package to be completed and released in February 2018

GAITHERSBURG, Md., Dec. 18, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced the Phase 3 trial of its RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization will continue. Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)).

RSV F Vaccine for Infants via Maternal Immunization

"Novavax has completed an informational analysis of our Phase 3 trial of the RSV F Vaccine for infants via maternal immunization using threshold criteria for a commercial product. As a result, we are accelerating our Phase 3 trial enrollment into 2018. Our maternal immunization program is supported by an $89 million grant from the Bill and Melinda Gates Foundation and has also been granted Fast Track designation by the U.S. Food and Drug Administration," said Stanley C. Erck, President and CEO. "We have enrolled over 3,000 volunteers to date and anticipate that the current pace of enrollment would trigger an interim analysis in mid-2018, with an expected Phase 3 primary endpoint readout in early 2019. This timing would allow us to submit a biologics license application (BLA) by the end of 2019."

NanoFlu Vaccine

A number of key scientific developments regarding influenza vaccines for the current season have occurred and relate to our NanoFlu program, including:

  • A November 29, 2017, editorial in the New England Journal of Medicine 1 detailed public health concerns related to the poor efficacy of existing seasonal influenza vaccines that is due, in part, to genetic changes or drift in the hemagglutinin (HA) protein, leading to low vaccine efficacy
  • Based on analyses from the Southern Hemisphere, the effectiveness of the seasonal influenza vaccine was as low as 10% for the A(H3N2) strain2
  • A November 6, 2017, Proceedings of the National Academy of Sciences 3 publication identified that the circulating influenza A(H3N2) virus contains an HA structure that has been lost in the corresponding vaccine strain during adaptation to be grown in eggs ("egg-adapted") as part of the typical seasonal influenza vaccine manufacturing process, which, in turn, affects vaccine efficacy for egg-based vaccines
  • Novavax' NanoFlu vaccine candidate is designed specifically to address these challenges
  • The wild-type viruses necessary to assess immunogenicity of the vaccines to circulating strains have been difficult to obtain, grow and maintain genetic stability
  • Therefore, a complete Phase 1/2 data package expected in February 2018

"Recent information published presents both an opportunity and a challenge for our NanoFlu Vaccine program. First, we have the unique opportunity to determine whether our recombinant, adjuvanted NanoFlu vaccine can address egg-adapted virus mismatch. We can also observe whether our vaccine-induced antibodies can neutralize circulating viruses with antigenic drift in humans, as we demonstrated in our ferret study earlier this year," said Greg Glenn, M.D., President, R&D. "Our team has been able to optimize our assays to address this challenge and we expect to present NanoFlu immunogenicity data that includes HA inhibition and microneutralization assays comparing wild-type virus and egg-based reagents."

About RSV

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively4. In the US, RSV is the leading cause of hospitalization of infants5. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common6,7. Currently, there is no approved RSV vaccine available.

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 pediatrics and older adults, but also in the general population largely because of infection by unique strains of influenza for which most humans have not developed protective antibodies. An estimated one million deaths each year are attributed to influenza8. 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 the 2012-2013 season to $5.3 billion by the 2021-2022 season9.

About Fast Track

The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A Fast Track designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a Biologics License Application (BLA) on a rolling basis as data become available, which permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. In addition, priority review (6 month review versus standard 10 month review) is a potential benefit that may be available to Novavax' RSV F vaccine in the future.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.

References

1. Paules, C. I. et al. Chasing seasonal influenza - The need for a universal influenza vaccine. NEJM, 2017. DOI: 10.1056/NEJMp1714916.
2. Sullivan, S. G. et al. Low interim influenza vaccines effectiveness, Australia, 1 May to 24 September 2017, Eurosurveillance, 2017, 22(43): pii=17-00707. https://doi.org/10.2807/1560-7917.ES.2017.22.43.17-007073. Zost, S.J., et al. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. PNAS, 2017, 12578-12583, doi: 10.1073/pnas.1712377114.
4. Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
5. Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
6. Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
7. Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015, http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
8. Resolution of the World Health Assembly. (2003) WHA56.19.28
9. Influenza Vaccines Forecasts. Datamonitor (2013)

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, 2016 and the Quarterly Report on Form 10-Q for the period ended September 30, 2017, both 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:         

Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor & Media Relations
ir@novavax.com
240-268-2000
               
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull@russopartnersllc.com 
maggie.beller@russopartnersllc.com
212-845-4271




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

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Canada's CoinField cryptocurrency exchange going international with commission-free trading app moonGO through a new partnership23.7.2018 11:30Pressmeddelande

moonGO(TM) app is the fastest and most reliable way to buy/sell and store cryptocurrencies. The app allows users to convert cryptos directly to EUR/USD to be loaded into their moonGo(TM) card and be used anywhere worldwide whether they're shopping online or spending it at a physical retailer who accepts credit cards. VANCOUVER, British Columbia, July 23, 2018 (GLOBE NEWSWIRE) -- CoinField, the most advanced cryptocurrency exchange in Canada is now extending its services worldwide thanks to a new partnership with Malta's Manticore Ventures to create moonGO(TM), a powerful app designed for traders who thrive on agility, flexibility and security. With moonGO(TM), users can set up their trading accounts in about 60 seconds, withdraw fiat currency as Euro or US dollars in the form of moonGO(TM) cards, and use the moonGO(TM) cards to make purchases online or at any retailer that accepts credit cards. The moonGO(TM) app will take CoinField's sterling reputation outside of Canada and make its

UK drafts new M. genitalium guidelines: Resistance Guided Therapy to tackle antibiotic resistance23.7.2018 09:00Pressmeddelande

BASHH aiming to raise awareness of Mgen and curb rising antibiotic resistance LONDON, July 23, 2018 (GLOBE NEWSWIRE) -- The British Association of Sexual Health and HIV (BASHH) draft guidelines for the sexually transmitted infection Mycoplasma genitalium (Mgen) were posted for consultation on July 8th, 20181[link]. The guideline recommends Resistance Guided Therapy as best practice when treating an Mgen infection, with a strong recommendation for diagnostic tests to direct appropriate antibiotic treatment. Mgen is highly resistant to antibiotics, up to 50% of infections are already resistant to the first-line treatment, azithromycin.2,3 This rate may rise if infections are treated without knowledge of resistance status. The success of Resistance Guided Therapy as treatment for Mgen was published in Clinical Infectious Diseases, June 20182 [link].Cure rates increased from under 68% to over 92% by switching the first-line drug and using the SpeeDx Resistance Plus® MG* test to triage pati

LeoVegas AB: Inbjudan till presentation av LeoVegas delårsrapport för andra kvartalet 201823.7.2018 08:00Pressmeddelande

LeoVegas delårsrapport för det andra kvartalet för 2018 kommer att publiceras klockan 08:00 den 1:a augusti 2018. En webbsänd telefonkonferens kommer att hållas klockan 09:00 samma dag där Gustaf Hagman, VD och medgrundare samt Viktor Fritzén, CFO, presenterar resultatet. Det kommer att finnas möjlighet att ställa frågor via webbsändningen där även presentationsmaterialet går att följa. Webbsändningen nås på adressen: https://edge.media-server.com/m6/p/zupwii5n För att delta i telefonkonferensen via telefon, vänligen ring in på något av följande nummer: SE: +46 (0) 8 5664 2753 UK: +44 (0) 330 336 9128 US: +1 646 828 8144 Bekräftelse kod: 5362090 Webbsändningen, som även kan ses i efterhand, och presentationsmaterialet kommer att finnas tillgängligt på LeoVegas webbplats www.leovegasgroup.com under Investor Relations. För ytterligare information, vänligen kontakta: Gustaf Hagman, Group CEO och medgrundare: +46 (0) 8 410 367 66, gustaf.hagman@leovegas.com Philip Doftvik, Head of Investor

LeoVegas AB: Invitation to presentation of LeoVegas second quarter 201823.7.2018 08:00Pressmeddelande

LeoVegas interim report for the second quarter for 2018 will be published at 08:00 CET on August 1, 2018. A webcast telephone conference will be held at 09:00 CET the same day, where Gustaf Hagman, CEO and Co-founder, and Viktor Fritzén, CFO, will present the results. A possibility will be given to ask questions via the webcast and follow the presentation live. The webcast will be accessible at: https://edge.media-server.com/m6/p/zupwii5n To participate in the conference call by phone, please call one of the following numbers: SE: +46 (0) 8 5664 2753 UK: +44 (0) 330 336 9128 US: +1 646 828 8144 Confirmation code: 5362090 The webcast, which afterwards also will be available on demand, and presentation material will be published on LeoVegas website, www.leovegasgroup.com under Investor Relations. For further information, please contact: Gustaf Hagman, Group CEO: +46 (0) 8 410 367 66, gustaf.hagman@leovegas.com Philip Doftvik, Head of Investor Relations and corporate finance: +46 73 512 0

Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41Pressmeddelande

TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of

eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30Pressmeddelande

SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum