ROCKVILLE, MD, USA I September 11, 2013 I Novavax, Inc. (NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.
In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: “RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders”), Novavax’ RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching 184ug/ml. Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.
In a separate preclinical study (Poster B-501a: “Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge”), investigators evaluated whether palivizumab-competing antibodies induced by the RSV F vaccine could provide passive protection in a relevant model. Palivizumab (Synagis(R)), a monoclonal antibody currently used to prevent RSV disease, was previously studied in the cotton rat model, which provided guidance for later licensing studies.
“These presentations reflect our progress in defining the importance of the palivizumab-like antibody and confirm that the RSV F vaccine induces promising immune responses in the elderly population,” said Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax. “These two studies are important because they demonstrate the potential of our vaccine candidate to prevent a major public health problem in the elderly and also provide protection to infants through passive maternal immunization. These are critical unmet needs which we plan to address in later-stage efficacy studies.”
Both posters are available under the “Publications and Presentations” section of the Novavax website at www.novavax.com.
About RSV
RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and causing approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. Currently, there is no approved RSV prophylactic vaccine available.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using Innovative proprietary recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax’ network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company’s website, novavax.com.
SOURCE: Novavax
Post Views: 212
ROCKVILLE, MD, USA I September 11, 2013 I Novavax, Inc. (NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.
In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: “RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders”), Novavax’ RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching 184ug/ml. Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.
In a separate preclinical study (Poster B-501a: “Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge”), investigators evaluated whether palivizumab-competing antibodies induced by the RSV F vaccine could provide passive protection in a relevant model. Palivizumab (Synagis(R)), a monoclonal antibody currently used to prevent RSV disease, was previously studied in the cotton rat model, which provided guidance for later licensing studies.
“These presentations reflect our progress in defining the importance of the palivizumab-like antibody and confirm that the RSV F vaccine induces promising immune responses in the elderly population,” said Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax. “These two studies are important because they demonstrate the potential of our vaccine candidate to prevent a major public health problem in the elderly and also provide protection to infants through passive maternal immunization. These are critical unmet needs which we plan to address in later-stage efficacy studies.”
Both posters are available under the “Publications and Presentations” section of the Novavax website at www.novavax.com.
About RSV
RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and causing approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. Currently, there is no approved RSV prophylactic vaccine available.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using Innovative proprietary recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax’ network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company’s website, novavax.com.
SOURCE: Novavax
Post Views: 212
