- Recently published NanoFlu™ preclinical data provide strong rationale for Phase 1/2 clinical trial based on robust antibody titers and improved protective responses against both current and drifted strains
- Data from trial expected by the end of 2017
GAITHERSBURG, MD, USA I September 19, 2017 I Novavax, Inc., (Nasdaq:NVAX) today announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M™ adjuvant (NanoFlu™) in older adults.
The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
“The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD,” said Gregory Glenn, M.D., President of Research and Development. “We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.
“Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection.”
“The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic,” said Stanley C. Erck, President and CEO. “Seasonal influenza remains a significant threat to older adults, with nearly three million infections and over 250,000 hospitalizations annually1. Our goal is to deliver a differentiated flu vaccine to the greater than $3 billion global seasonal influenza commercial market2 and we look forward to delivering clinical data from this trial by the end of the year.”
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.
Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit. More information on accelerated approval can be found here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm074794.htm
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™ 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. Average of 3 past seasons, 2010-2013; includes vaccine averted cases. C. Reed et al. Estimating Influenza Disease Burden from Population-Based Surveillance Data in the United States. PLOS One. 2015, DOI:10.1371/journal.pone.0118369
2. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2025, October 2016
SOURCE: Novavax
Post Views: 59
- Recently published NanoFlu™ preclinical data provide strong rationale for Phase 1/2 clinical trial based on robust antibody titers and improved protective responses against both current and drifted strains
- Data from trial expected by the end of 2017
GAITHERSBURG, MD, USA I September 19, 2017 I Novavax, Inc., (Nasdaq:NVAX) today announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M™ adjuvant (NanoFlu™) in older adults.
The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
“The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD,” said Gregory Glenn, M.D., President of Research and Development. “We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.
“Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection.”
“The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic,” said Stanley C. Erck, President and CEO. “Seasonal influenza remains a significant threat to older adults, with nearly three million infections and over 250,000 hospitalizations annually1. Our goal is to deliver a differentiated flu vaccine to the greater than $3 billion global seasonal influenza commercial market2 and we look forward to delivering clinical data from this trial by the end of the year.”
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.
Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit. More information on accelerated approval can be found here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm074794.htm
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™ 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. Average of 3 past seasons, 2010-2013; includes vaccine averted cases. C. Reed et al. Estimating Influenza Disease Burden from Population-Based Surveillance Data in the United States. PLOS One. 2015, DOI:10.1371/journal.pone.0118369
2. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2025, October 2016
SOURCE: Novavax
Post Views: 59
