- Company continuing to work with the U.S. FDA on potential for accelerated approval pathway
- Novavax intends to partner on both candidates to advance to filing and commercialization
GAITHERSBURG, MD, USA I December 10, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.
“A combination vaccine for two vaccine-preventable diseases is an important step forward for public health and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships,” said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of Research and Development, Novavax. “Our goal is to get these assets to market as soon as possible, and we will work with the U.S. FDA to assess the possibility of an accelerated approval pathway.”
The Company is working with the U.S. Food and Drug Administration (FDA) to determine the potential of the current CIC and stand-alone influenza trial to support accelerated approval. While in the process of seeking alignment on accelerated approval criteria with the U.S. FDA, Novavax has decided to recruit an initial cohort of approximately 2,000 participants while continuing this dialogue. Novavax anticipates being able to provide more clarity and information on potential next steps by Q2 2025, including if additional clinical work would be needed to achieve registration for these assets.
The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax’s updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate and patented saponin-based Matrix-M adjuvant relative to separate administrations of Novavax’s updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine comparator. In addition, the trial also aims to further evaluate the immunogenicity and safety of Novavax’s stand-alone influenza vaccine, also containing Matrix-M.
The Company’s FY 2025 financial guidance for combined Research & Development and Selling, General and Administrative expense of approximately $500 million is inclusive of this CIC and stand-alone influenza initial planned Phase 3 clinical activity and is subject to revisions and updates as next steps are determined.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes its CIC and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.
SOURCE: Novavax
Post Views: 3,397
- Company continuing to work with the U.S. FDA on potential for accelerated approval pathway
- Novavax intends to partner on both candidates to advance to filing and commercialization
GAITHERSBURG, MD, USA I December 10, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.
“A combination vaccine for two vaccine-preventable diseases is an important step forward for public health and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships,” said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of Research and Development, Novavax. “Our goal is to get these assets to market as soon as possible, and we will work with the U.S. FDA to assess the possibility of an accelerated approval pathway.”
The Company is working with the U.S. Food and Drug Administration (FDA) to determine the potential of the current CIC and stand-alone influenza trial to support accelerated approval. While in the process of seeking alignment on accelerated approval criteria with the U.S. FDA, Novavax has decided to recruit an initial cohort of approximately 2,000 participants while continuing this dialogue. Novavax anticipates being able to provide more clarity and information on potential next steps by Q2 2025, including if additional clinical work would be needed to achieve registration for these assets.
The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax’s updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate and patented saponin-based Matrix-M adjuvant relative to separate administrations of Novavax’s updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine comparator. In addition, the trial also aims to further evaluate the immunogenicity and safety of Novavax’s stand-alone influenza vaccine, also containing Matrix-M.
The Company’s FY 2025 financial guidance for combined Research & Development and Selling, General and Administrative expense of approximately $500 million is inclusive of this CIC and stand-alone influenza initial planned Phase 3 clinical activity and is subject to revisions and updates as next steps are determined.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes its CIC and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.
SOURCE: Novavax
Post Views: 3,397
