Novavax Announces Positive Topline Data from Phase 2 Older Adult Trial and Provides Path Forward for RSV F Vaccine Programs
- Phase 2 data in older adults (E205) demonstrate adjuvants and 2-dose regimens significantly increase the magnitude, duration and quality of the RSV F Vaccine immune response
- New data demonstrate that Novavax' construct is a stable prefusogenic RSV F antigen, distinctive from other candidates, that elicits potent neutralizing antibody responses to multiple key epitopes
- Path forward for a Phase 2 efficacy trial in 2018 based on signal in COPD population identified in prior older adult clinical trials
- Phase 3 Prepare(TM) trial accelerating and now includes 80 sites across 11 countries allowing continuous enrollment across global seasons
GAITHERSBURG, Md., July 24, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive topline data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults, new preclinical data on its RSV F Vaccine construct, additional findings from the prior Phase 2 and Phase 3 clinical trials in older adults (E201 and E301), and an operational update on the Phase 3 clinical trial of the RSV F Vaccine for infants via maternal immunization, known as Prepare(TM). The Company anticipates initiating a Phase 2 efficacy trial in older adults in 2018.
Topline data from the Phase 2 older adult safety and immunogenicity trial (E205) demonstrate the benefit of adjuvant formulations and two-dose regimens. The objective of the Phase 2 randomized, observer-blinded, placebo-controlled trial was to assess safety and immunogenicity of one and two-dose regimens of the RSV F Vaccine, with and without aluminum phosphate or Novavax' proprietary Matrix-M(TM) adjuvant, in 300 older adults. Participants were enrolled and vaccinated outside of the RSV season to best assess immunogenicity of the treatment arms. Immunogenicity outcomes indicate both aluminum phosphate and Matrix-M adjuvants significantly increased the magnitude, duration and quality of the immune response relative to a control of 135 microgram dose of the RSV F antigen alone (the formulation used in the prior Phase 3 older adults efficacy study). Similarly, two-dose regimens significantly increased immune responses and suggests two doses of the RSV F Vaccine with adjuvant may augment durability of the immune response to the vaccine. The data strongly support the inclusion of adjuvanted formulations of the RSV F Vaccine in future older adult trials. All formulations and regimens were safe and well-tolerated.
Recent scientific advances in protein structure imaging and immune measures have led to new insights about the structure and immune responses elicited by the Novavax RSV F antigen. These new findings identify Novavax' vaccine construct as a stable prefusogenic RSV F protein nanoparticle. In addition, new analyses have confirmed and expanded the data, demonstrating that the vaccine induces a repertoire of broadly neutralizing RSV F antibodies in humans that are more potent than palivizumab (Synagis®). These new structural and immunological analyses validate the RSV F Vaccine as a highly immunogenic antigen with the potential to provide protection against RSV disease.
Older adult Phase 3 trial data in a recent post-hoc analysis indicate the RSV F Vaccine was associated with a 61% reduction in hospitalizations due to chronic obstructive pulmonary disease (COPD) exacerbations. Review of the E201 database showed a similar signal supporting this finding. COPD exacerbations represent an unmet medical need and a significant healthcare cost burden. Novavax plans to initiate a Phase 2 efficacy trial in older adults in 2018, that will evaluate COPD exacerbations as a prospective endpoint.
Prepare, the Phase 3 trial of the RSV F Vaccine for infants via maternal immunization, conducted in collaboration with the Bill and Melinda Gates Foundation, continues its momentum into the third global season of enrollment. Prepare's global footprint has grown from 16 sites in five countries in its first global RSV season of enrollment to 80 sites in 11 countries. The clinical trial infrastructure and experience developed over the last two seasons establish the foundation to efficiently enroll and execute this first of its kind global maternal immunization clinical trial.
"Since September, we have worked to confirm that our RSV F Vaccine elicits a broadly neutralizing antibody response. Through our E205 trial, we have demonstrated adjuvant strategies that magnify and enrich the quality of that underlying antibody response. When combined with the COPD data seen in both E301 and E201, we believe protecting individuals from COPD exacerbation presents a very exciting path forward in older adults," said Gregory Glenn, M.D., President of R&D.
"The new data that further characterizes the RSV F Vaccine and the benefit of adjuvants, combined with the hospitalization data in the COPD population, places us in a strong position to partner our RSV program," said Stanley C. Erck, President and CEO. "We also look forward to continued momentum in Prepare trial enrollment and to developing our plans for the next steps in our RSV older adult program over the next 12 months."
Conference Call and Webcast
|Date:||Monday, July 24, 2017|
|Time:||4:30 p.m. U.S. Eastern Time (ET)|
|Dial-in number:||(877) 212-6076 (Domestic) or (707) 287-9331 (International)|
|Webcast:||www.novavax.com, "Investors"/ "Events"|
| Conference call and webcast replay:
|Dates:||Starting at 7:30 p.m. ET, July 24, 2017, until 7:30 p.m. ET, October 24, 2017|
|Dial-in number:||(855) 859-2056 (Domestic) or (404) 537-3406 (International)|
|Webcast:||www.novavax.com, "Investors"/ "Events", until October 24, 2017|
Prepare is a global pivotal Phase 3 clinical trial of RSV F Vaccine candidate for the protection of infants via maternal immunization. The Prepare trial is a randomized, observer-blinded, placebo-controlled trial in healthy pregnant women. Participants are being vaccinated at a number of global clinical sites in advance of each region's RSV season. Novavax previously announced it was awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of this RSV F Vaccine, which includes Prepare, product licensing efforts and World Health Organization ("WHO") prequalification of our RSV F Vaccine.
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, respectively.1 In the US, RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age. 2,3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4,5 Currently, there is no approved RSV vaccine available.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.
1 Nair, H., et al., (2010) Lancet. 375:1545 - 1555
2 Hall, C.B. et al. (2013) Pediatrics; 132(2):E341-348
3 Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
4 Glezen, W.P. et al. (1986) Am J Dis Child; 140:543-546
5 Glenn, G.M. et al. (2016) JID; 213(3):411-12
Andrea N. Flynn, Ph.D.
Director, Investor Relations
Russo Partners, LLC
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
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
Mash named as one of the Fintech 5022.6.2018 12:36 | Pressemelding
At an event held on Wednesday June 20th at the Silicon Valley Bank in London, UK, Mash was selected from over 1800 companies to the FinTech50 2018 list, joining FinTech giants like N26, Monzo, Raisin and Revolut on the list of Europe’s hottest FinTech companies. James Hickson, Group CEO of Mash commented, “This has been a transformational year for Mash and our momentum continues. The FinTech50 is the Oscars of our industry and as such, the competition for a place was incredibly high - only 14 new companies made it to the list with Mash being selected from over 1800 nominations. To be recognized as one of Europe’s leading Fintech companies is an incredible honor and a reflection of our dedicated team and our go forward ambition to be a major player in Europe. We extend an enormous thank you to the award committee for their support and our team for their incredible efforts” Tommi Lindfors, Chairman and founder of Mash Group, was pleased with the recognition: “The Fintech50 list recognize
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom