New England Journal of Medicine Publishes Novavax' NanoFlu Clinical Trial Data
- 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.
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.
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.
Senior Manager, Investor & Public Relations
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 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
ERYTECH Confirms Strategic Focus of Eryaspase on Solid Tumors and Ceases Development in Acute Lymphoblastic Leukemia25.6.2018 00:06 | Pressemelding
Conference call on Monday, June 25th at 2:30 pm CET/8:30 am EDT Focuses development efforts on solid tumor indications Confirms planned launch of company-sponsored randomized Phase 2 trial in first-line pancreatic cancer, in addition to ongoing launch of Phase 3 trial in second-line pancreatic cancer. Expands eryaspase production capacity in the United States and France Plans to cease development in acute lymphoblastic leukemia (ALL), including withdrawal of European Marketing Authorization Application (MAA) LYON, France and CAMBRIDGE Mass., June 24, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications. The company also announced that it plans to cease its development pro
CORRECTING and REPLACING -- PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters23.6.2018 14:00 | Pressemelding
NEW YORK, June 23, 2018 (GLOBE NEWSWIRE) -- In a press release issued under the same headline earlier today by Arbitrade, please note that the correct date of the event is Thursday, June 28, 2018 at 8:00 a.m. EDT. The corrected release follows: This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the pr
15th Consecutive Nasdaq Closing Cross Sets Record for Number of Shares Traded During 2018 Russell US Indexes Reconstitution22.6.2018 23:19 | Pressemelding
NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) today announced the Nasdaq Closing Cross had a record day as it was used for the 15th consecutive year to rebalance Nasdaq-listed securities in the entire family of Russell U.S. Indexes, part of leading global index provider FTSE Russell, during their annual reconstitution. A record 1.188 billion shares representing $39.26 billion were executed in the Closing Cross in 0.935 seconds across some 2,591 Nasdaq-listed stocks. This compares to 2017, when Nasdaq executed 972 million shares representing $28.9 billion executed in 0.861 seconds across 2,499 Nasdaq-listed stocks. "Today, we saw a record-breaking performance for the Nasdaq Closing Cross, which benefits issuers and investors alike with transparent and efficient price discovery," said Tom Wittman, Head of Global Equities and Executive Vice President of Global Trading and Market Services at Nasdaq. "The rebalance is an important event to ensure that the Russell U.S. ind
PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters22.6.2018 22:29 | Pressemelding
NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the press briefing webcast are as follows: Please register now for the upcoming Arbitrade Conference Call: Date: Wednesday, June 27, 2018 Time: 8:00 a.m. EST We recommend that you connect to the meeting at l
Northland Power's Hai Long Offshore Wind Project Awarded Additional 744 Megawatts in Taiwan Auction22.6.2018 14:15 | Pressemelding
TORONTO, June 22, 2018 (GLOBE NEWSWIRE) -- Northland Power Inc. ("Northland") (TSX:NPI) today announced that the Taiwan Bureau of Energy ("BOE") has awarded 232 megawatts ("MW") to the Hai Long 2 offshore wind farm ("Hai Long 2") and 512 MW to the Hai Long 3 offshore wind farm ("Hai Long 3") under Taiwan's offshore wind auction program. These awards are separate from and in addition to the 300 MW in 2024 that Hai Long 2 was allocated by the Taiwan BOE on April 30, 2018 under Taiwan's Feed-in-Tariff ("FIT") program. Northland and its partner Yushan Energy Co. Ltd. ("Yushan Energy") own 60% and 40%, respectively, of Hai Long 2 and Hai Long 3. This is another significant step for Northland in Taiwan, with a second and third project progressing to connect to Taiwan's grid in 2025, subject to securing 20-year power purchase agreements. Taken together with the FIT award, the Hai Long 2 and Hai Long 3 offshore wind farms now total 1,044 MW of offshore wind capacity in Taiwan. Northland is bui
Williams Scotsman to Acquire ModSpace22.6.2018 13:09 | Pressemelding
Creates an industry-leading specialty rental services provider with over $1 billion of combined revenue and over 160,000 rental units across North America Leverages, and further strengthens, Williams Scotsman's scalable operating platform to capture an estimated $60 million of cost synergies Combines the best of both companies' go-to-market strategies, benefiting our customers and accelerating the expansion of Williams Scotsman's turnkey "Ready To Work" solutions across a broader asset base and enhanced branch network Total enterprise value of approximately $1.1 billion represents 6.6x ModSpace's Adjusted EBITDA for the twelve month period ended March 31, 2018, inclusive of forecast cost synergies and the expected value of acquired tax attributes1 ,2 BALTIMORE, June 22, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman") the leading specialty rental services provider of innovative modular space and portable storage solutions across North America, today anno
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom