Thursday, July 30, 2015 8:36:59 AM
GAITHERSBURG, Md., July 30, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services under the Company’s contract with HHS-BARDA (HHSO100201100012C). The trial demonstrated that the Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research (CBER) criteria for accelerated approval.
Novavax’ technology platform enables the creation of recombinant, strain-specific VLPs. Novavax’ Seasonal Influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens. This dose-ranging clinical trial was designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adults. The primary outcomes of the trial assessed safety and tolerability of the Seasonal Influenza VLP and quantified immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers. The secondary outcomes evaluated neuraminidase-inhibiting antibody titers for all four influenza strains.
“Titers of antibodies that inhibit hemagglutination by the influenza virus – called hemagglutination-inhibiting or HAI antibodies – remain the best-accepted correlates of the protection provided by influenza vaccines. We were very pleased to see that our Seasonal Influenza vaccine candidate elicited increases in HAI titers for all four viral strains that would allow our vaccine to fulfill CBER’s criteria for accelerated approval,” said Louis F. Fries III, M.D., Chief Medical Officer, Novavax. “Novavax has made a concerted effort to improve the antigens in our Seasonal Influenza vaccine. In particular, for the two viral strains (out of the four) for which we had sought immunogenic improvement, we showed robust HAI titer responses, approximately 50% greater than those in our prior phase 2 trial. Further, we measured neuraminidase-inhibiting (NAI) antibody responses against seasonal influenza viruses for the first time, and were able to detect significant NAI antibody responses to all four influenza strains, including strong responses against the B virus strains.”
Novavax President and CEO, Stanley C. Erck, said, “These positive topline data from the Phase 2 trial of our Seasonal Influenza vaccine candidate represent an important achievement in this program. We look forward to a complete review of these data with our partner BARDA to determine next steps in the development of this product. Our collaboration with BARDA also includes the development of our novel H7N9 Influenza vaccine candidate in combination with Matrix-M™. We expect the next steps in our collaboration will be the initiation of a Phase 2 clinical trial of the H7N9 vaccine candidate in the adult population in the first quarter of 2016.”
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ 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.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax, Inc.
Recent NVAX News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 08:05:24 PM
- Form DFAN14A - Additional definitive proxy soliciting materials filed by non-management and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/20/2024 06:42:06 PM
- Shah Capital Withdraws Proxy Campaign Against Re-Election of Directors at Novavax’s 2024 Annual Meeting • GlobeNewswire Inc. • 05/20/2024 10:35:00 AM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 05/20/2024 10:09:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 01:15:54 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/14/2024 09:02:00 PM
- Form DFAN14A - Additional definitive proxy soliciting materials filed by non-management and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/13/2024 08:10:01 PM
- Novavax to Participate in BofA Securities 2024 Health Care Conference • PR Newswire (US) • 05/13/2024 08:02:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 06:39:41 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/10/2024 12:07:32 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 12:05:26 PM
- Novavax Surges 57% Post $1.4 Billion Sanofi Deal; Apple Boosts Data Centers with AI and Internal Chips, and More News • IH Market News • 05/10/2024 12:02:56 PM
- Novavax Reports First Quarter 2024 Financial Results and Operational Highlights • PR Newswire (US) • 05/10/2024 06:15:00 AM
- Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines • PR Newswire (US) • 05/10/2024 06:00:00 AM
- Form DFAN14A - Additional definitive proxy soliciting materials filed by non-management and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/08/2024 08:53:29 PM
- Form DFAN14A - Additional definitive proxy soliciting materials filed by non-management and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/07/2024 09:21:35 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 05/07/2024 06:43:55 PM
- Novavax to Host Conference Call to Discuss First Quarter 2024 Financial Results and Operational Highlights on May 10, 2024 • PR Newswire (US) • 05/07/2024 01:25:00 PM
- Tesla’s April Sales Down 18% in China, Amazon’s Multi-Billion Dollar Cloud Expansion in Singapore, and More News • IH Market News • 05/07/2024 11:44:00 AM
- Form DFAN14A - Additional definitive proxy soliciting materials filed by non-management and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 08:43:09 PM
- Shah Capital Launches Campaign Urging Stockholders to Vote AGAINST the Re-Election of All of Novavax’s Directors Up for Election at its 2024 Annual Meeting • GlobeNewswire Inc. • 05/06/2024 10:22:33 AM
- Shah Capital nominates two highly qualified independent director candidates for Novavax • GlobeNewswire Inc. • 04/15/2024 10:00:00 AM
- Novavax Presents Data on Updated COVID-19 Vaccine and Progress to Date on its COVID-19-Influenza Combination Vaccine Candidate at World Vaccine Congress 2024 • PR Newswire (US) • 04/01/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/06/2024 12:30:14 AM
- Novavax to Participate in TD Cowen's 44th Annual Health Care Conference • PR Newswire (US) • 02/29/2024 09:02:00 PM
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM