dothedd
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Post by dothedd on Jan 5, 2011 13:13:21 GMT -5
NOVAVAX and the University of Massachusetts Medical School Announce
Preclinical Study Results for a Respiratory Syncytial Virus
(“RSV”) Vaccine Candidate
Rockville, MD (December 9, 2008) –Novavax, Inc. (NASDAQ:NVAX) and the University of Massachusetts
Medical School announced results from a preclinical study of a Respiratory Syncytial Virus (“RSV”) vaccine
candidate. Novavax has licensed exclusive worldwide rights from the University of Massachusetts Medical School
to certain technology for the development and commercialization of Paramyxovirus vaccines incorporating certain
Virus-Like-Particles (“VLPs”). This vaccine candidate is Novavax’s first recombinant VLP for the prevention of
RSV disease.
The preclinical study evaluated the immunogenicity and efficacy of the RSV VLP vaccine candidate in mice. The
VLP contains the matrix (i.e., “core”) protein of Newcastle Disease Virus decorated with a human RSV attachment
glycoprotein (Ga), which is important for inducing immunity against RSV. In this study, mice were immunized
with one of four doses of the RSV VLP vaccine candidate, inactivated RSV, live RSV, or a placebo. The antibody
responses to the RSV VLPs were robust and higher than the antibody responses to inactivated or live RSV. Further,
antibody titers increased with higher VLP doses.
Subsets of mice that had been immunized with either RSV VLPs via intraperitoneal inoculation or live RSV via
intranasal inoculation received a vaccine booster dose and were challenged with live RSV intra-nasally.
Unimmunized mice were evaluated as controls. The VLP-immunized mice were protected from RSV replication in
the lungs. Further, the lung tissue of these mice showed no evidence of enhanced inflammation after RSV
challenge/infection, which has been reported with a formalin-inactivated RSV vaccine.
In summary, the candidate VLP vaccine induced strong antibody responses against RSV, protected mice against
RSV replication in the lungs, and did not lead to enhanced inflammation of the airways. These data support
continued development of this and additional RSV VLP vaccine candidates containing other proteins (i.e., Gb and F)
important for immunity.
"I am pleased we have been able to demonstrate that virus-like particles, based on Newcastle disease virus proteins,
can be used as a platform for the development of human vaccines," said Trudy G. Morrison, PhD, professor of
molecular genetics & microbiology, who presented the results of the study, supported by Novavax, at the 2nd
Vaccine Congress in Boston today.
“Consistent with the strategy to expand our vaccine pipeline, this new program has the potential to address a
significant unmet medical need in both infants and elderly patients over 65 years of age,” said Dr. Rahul Singhvi,
Novavax's President and CEO. “The initial preclinical results from this first RSV vaccine candidate in partnership
with the University of Massachusetts Medical School further demonstrate the potential of our proprietary vaccine
and manufacturing technologies and represent an important opportunity to enhance shareholder value.”
About Respiratory Syncytial Virus
RSV is the most commonly identified cause of lower respiratory tract infection in infants and young children with
repeated infections causing moderate to severe cold-like symptoms throughout life. High risk individuals (including
the elderly over age 65 years, people with cardiovascular disease and children less than four years of age) may also
develop lower respiratory tract infections leading to bronchiolitis and pneumonia. It is estimated that more than 8.5
million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually
due to RSV infection in the US and major European countries. In the United States alone there are 177,500
hospitalizations in high risk adults including the elderly over age 65, resulting in annual medicals costs exceeding $1
billion. In addition, there are up to 125,000 infants in the US who are hospitalized annually due to RSV. There is
currently no approved vaccine for the prevention of RSV; the market potential for such a vaccine would be well in
excess of $1 billion annually.
About UMass Medical School
The University of Massachusetts Medical School is one of the fastest growing academic health centers in the
country and has built a reputation as a world-class research institution, consistently producing noteworthy advances
in clinical and basic research. The Medical School attracts more than $193 million in extramural research funding
annually. Research dollars enable UMMS scientists to explore human disease from the molecular level to large-scale
clinical trials. Basic and clinical research has led to new approaches for diagnosis, treatment and prevention of
disease. Visit www.umassmed.edu for additional information.
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of
infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company
produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches.
Additional information about Novavax is available at www.novavax.com and in the Company’s various filings with
the Securities and Exchange Commission.Respiratory Syncytial Virus (RSV) Vaccine
Comparison of antibody responses to RSV G Protein after
immunization with VLP-H/G, UV-RSV and live RSV
Respiratory syncytial virus (RSV) is the primary cause of serious respiratory disease in infants and young children worldwide. The virus is also increasingly recognized as a significant pathogen in elderly populations. Bronchiolitis or pneumonia results in 25-40% of RSV infections of infants and between 0.5 and 2% of these infections result in hospitalization. Despite the incidence and severity of these infections, there is no RSV vaccine available. Immunoprophylaxis remains the only effective defense against this viral disease.
Virus- like particles (VLPs) are increasing being considered as safe, effective vaccine candidates. VLPs are particles released from cells expressing the major structural proteins of a virus. These particles are structurally similar to authentic virus and possess native conformational epitopes displayed in an array typical of virus particles. However, VLPs do not contain a genome and are, therefore, incapable of a spreading infection.
We have previously demonstrated that cells expressing the major structural proteins of Newcastle disease virus (NDV) release VLPs very efficiently and these VLPs stimulate robust immune responses in mice.
RSV presentation December, 2009Rockville, MD (July 22, 2009)
Novavax, Inc. (NASDAQ:NVAX) announced today final selection of a Respiratory Syncytial Virus (RSV) vaccine candidate that will be advanced into additional preclinical
studies to support an Investigational New Drug (IND) application. As previously announced, Novavax has
been evaluating a number of RSV vaccine candidates, all of which have successfully induced antibody
responses in mice. Novavax scientists have now engineered a new vaccine candidate which has been
shown to protect mice against RSV disease and can be produced at sufficient yields to allow commercial
manufacture. This new candidate is directed against a protein on the surface of the virus, the “F” or
“fusion” protein, which is the protein that the virus uses to infect and fuse with cells in the respiratory tract
and cause disease.
The new RSV-F vaccine candidate consists of novel three-dimensional particles containing the F protein.
The structure of the F protein in these particles is identical to the configuration in which it exists on the
surface of the native virus. The particle nature of the vaccine holds the promise for inducing a broad set of
immune responses including antibody and cell mediated immune responses to prevent infection of the
respiratory tract and attack respiratory cells that may already be infected with RSV.
The first preclinical study of this new vaccine candidate in mice showed that it induced production of
antibodies that neutralized live RSV. In addition, the vaccine protected mice against replication of RSV in
the lungs. The study included groups of mice that received two injections of RSV-F vaccine at doses of 1,
10, or 30 micrograms with and without adjuvant. The study showed that the RSV-F vaccine induced
neutralizing antibody responses at all doses evaluated. The highest titers were observed with vaccine
formulations that contained an aluminum-based adjuvant. Following vaccination, mice were exposed to
live RSV through the nose. Even without adjuvant, the lowest dose (1.0 mcg) of RSV-F vaccine prevented
RSV infection in the lungs of these mice. However, protection from RSV infection was not observed in
unvaccinated mice. Based on these favorable pre-clinical data obtained with this RSV-F vaccine candidate
and the ability to produce it at commercial yields, the Company has selected it for advanced preclinical
development.
Today, the only therapy against RSV disease is a monoclonal F antibody. The antibody reduces RSVrelated
hospitalizations in infants and young children at high risk of severe disease. However, several
injections are required and the lifespan of the antibody in the body has a limited duration. Therefore, a
vaccine that induces long lasting protection against RSV-F would be highly desired by healthcare
providers. There is currently no approved vaccine for the prevention of RSV and the market potential for
such a vaccine could exceed $1 billion annually.
Dr. Penny Heaton, Chief Medical Officer and Vice President of Development at Novavax, stated: “A
vaccine against the RSV-F protein is an ideal candidate to progress into advanced preclinical testing.
Studies of the monoclonal RSV-F antibody show it protects against hospitalizations for severe RSV
disease, suggesting that a vaccine which induces neutralizing antibody against RSV-F has the potential to
be a powerful weapon against this disease.”
ABOUT RESPIRATORY SYNCYTIAL VIRUS
RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young
children. Repeated infections occur throughout life causing moderate to severe cold-like symptoms. More
severe lower respiratory tract disease is also seen in elderly adults over age 65 years similar to the severe
illness witnessed in children. It is estimated that RSV infects more than 8.5 million adults annually,
including the elderly over age 65 years. This virus is responsible for approximately 900,000
hospitalizations annually in the United States and major European countries. In the United States alone,
RSV leads to 177,500 hospitalizations in high risk adults resulting in annual medicals costs exceeding $1
billion.
ABOUT NOVAVAX
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company creating novel vaccines,
including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary
virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant
vaccines utilizing new and efficient manufacturing approaches. Additional information about Novavax is
available at www.novavax.com and in the company’s various filings with the Securities and Exchange
Commission.
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dothedd
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Post by dothedd on Jan 5, 2011 16:28:17 GMT -5
Novavax Reports Positive Results From Pre-Clinical Safety Study Of Respiratory Syncytial Virus (RSV) Vaccine Candidate
By PR Newsw
08/12/10 - 08:00 AM EDT
ROCKVILLE, Md., Aug. 12 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) reported today that results from a pre-clinical toxicology study of its vaccine candidate to prevent respiratory syncytial virus (RSV), showed the vaccine to be safe and well-tolerated at all doses tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion (RSV-F) protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
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dothedd
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Post by dothedd on Jan 6, 2011 1:29:13 GMT -5
NOVAVAX Receives FDA Clearance to Launch Phase I RSV Vaccine
Clinical Trial
Rockville, MD – December 16, 2010 – Novavax, Inc. (Nasdaq: NVAX) announced today that the company’s Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.
Preclinical studies of Novavax’s vaccine candidate to prevent RSV infection were conducted in cotton rats, a well-accepted animal model of RSV infection and disease. Results showed induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement. After the RSV challenge, no detection of disease was observed in any of the animals immunized with the vaccine candidate at any dose level tested. Novavax’s vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
“We are excited to advance our vaccine candidate for RSV into clinical testing,” said Dr. Rahul Singhvi, President and CEO of Novavax. “This is a significant accomplishment and represents the second major internally discovered vaccine program based on our core platform technologies. RSV is the leading cause of viral death in infants and a common illness in elderly adults. A safe and effective vaccine is especially needed in these populations since RSV infection does not provoke lasting immunity.”
About Respiratory Syncytial Virus
RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young children worldwide. Repeated infections occur throughout life causing moderate to severe cold-like symptoms. More severe lower respiratory tract disease is also seen in elderly adults over age 65 years, similar to the severe illness witnessed in children. It is estimated that RSV infects more than 8.5 million adults annually, including the elderly over age 65 years. This virus is responsible for approximately 900,000 hospitalizations annually in the United States and major European countries. In the United States alone, RSV leads to more than 175,500 hospitalizations annually in high-risk adults resulting in annual medicals costs exceeding $1 billion.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, using advanced proprietary virus-like-particle
(VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.
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dothedd
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Post by dothedd on Jan 6, 2011 1:35:30 GMT -5
NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate
Vaccine candidate completely protects mice from RSV replication in the lungs
Rockville, MD (December 22, 2010) – Novavax, Inc. (NASDAQ:NVAX) and scientists at the University of Massachusetts Medical School, led by Dr. Trudy Morrison, published in the January 2011 issue of THE JOURNAL OF VIROLOGY, a report indicating that a novel virus-like particle (VLP) vaccine candidate against respiratory syncytial virus (RSV) protects mice from a live virus challenge. This vaccine candidate has been created with technology that Novavax has licensed exclusively from the University of Massachusetts Medical School.
The publication describes the production and testing of a novel RSV VLP vaccine candidate. Immunization with this genetically engineered RSV VLP vaccine stimulated immune response against key vaccine targets, the RSV G attachment and RSV F fusion proteins. The antibody responses achieved with this vaccine candidate were equal to or better than levels resulting from infection with live RSV. This RSV G+F VLP vaccine stimulated both anti-G and anti-F protein serum antibodies typical of a more Th1-biased response characteristic of natural infection with RSV.
When challenged with live RSV, animals immunized with RSV VLPs were completely protected from replication of the virus in the lungs and showed no signs of enhanced respiratory disease.
“This study indicates that immunization with a VLP vaccine results in functional and protective immune responses against RSV. Induction of such functional, protective immunity has been a key challenge in RSV vaccine development. RSV is the leading global cause of infant and childhood respiratory disease, and these encouraging preclinical safety and efficacy data suggest that an RSV VLP vaccine is a promising approach and should be developed further,” said Greg Glenn, M.D., Novavax’s Chief Scientific Officer.
About Respiratory Syncytial Virus
RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis
(inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.
It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV; the market potential for such a vaccine would be well in excess of $1 billion annually.
About the University of Massachusetts Medical School
The University of Massachusetts Medical School is one of the fastest growing academic health centers in the country and has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $255 million in extramural research funding annually. Research dollars enable UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research has led to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.
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dothedd
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Post by dothedd on Jan 6, 2011 1:38:02 GMT -5
NOVAVAX Launches Phase I Clinical Trial to Evaluate its Novel Vaccine Against Respiratory Syncytial Virus (RSV)
Vaccine candidate targets world’s leading cause of infant death and childhood respiratory disease
Rockville, MD – January 4, 2011 – Novavax, Inc. (Nasdaq: NVAX) announced today that it has begun patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim top-line data from the trial will be available in the third quarter of 2011.
Remarking on this key accomplishment for the Company, Dr. Rahul Singhvi, Novavax’s President and CEO, said, “The launch of this trial is timely because there are no vaccines currently approved for RSV disease, which is the most important viral cause of lower respiratory tract infection in infants and children worldwide and is a major cause of respiratory illness in elderly adults. The initiation of the trial for this RSV vaccine candidate marks a key milestone for Novavax, as the Company now has a clinical candidate in a second major disease target in addition to influenza.”
Novavax has evaluated its RSV vaccine candidate in well-accepted animal models of toxicity and disease and found it to be safe at all doses tested. Preclinical results have shown induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement and no detection of disease in any of the animals immunized with the vaccine at any dose level tested. Novavax’s vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.
About Respiratory Syncytial Virus
RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed
to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.
It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.
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dothedd
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Post by dothedd on Feb 3, 2011 12:47:11 GMT -5
 Respiratory Syncytial Virus (RSV) Vaccine
Comparison of antibody responses to RSV G Protein after
immunization with VLP-H/G, UV-RSV and live RSV
Respiratory syncytial virus (RSV) is the primary cause of serious respiratory disease in infants and young children worldwide. The virus is also increasingly recognized as a significant pathogen in elderly populations. Bronchiolitis or pneumonia results in 25-40% of RSV infections of infants and between 0.5 and 2% of these infections result in hospitalization. Despite the incidence and severity of these infections, there is no RSV vaccine available. Immunoprophylaxis remains the only effective defense against this viral disease.
Virus- like particles (VLPs) are increasing being considered as safe, effective vaccine candidates. VLPs are particles released from cells expressing the major structural proteins of a virus. These particles are structurally similar to authentic virus and possess native conformational epitopes displayed in an array typical of virus particles. However, VLPs do not contain a genome and are, therefore, incapable of a spreading infection.
We have previously demonstrated that cells expressing the major structural proteins of Newcastle disease virus (NDV) release VLPs very efficiently and these VLPs stimulate robust immune responses in mice. RSV presentation December, 2009www.novavax.com/go.cfm?do=Page.View&pid=20
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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Post by dothedd on May 1, 2014 16:40:06 GMT -5
RSV Press Releases
2008
• NOVAVAX Announces Preclinical Data for Respiratory Syncytial Virus Vaccine Candidate
12/08/08•
• NOVAVAX and the University of Massachusetts Medical School Announce Preclinical Study Results for a Respiratory Syncytial Virus (“RSV”) Vaccine Candidate
12/09/08
2009
• NOVAVAX Announces Preclinical Study Results for a Respiratory Syncytial Virus (“RSV”) Vaccine Candidate Directed Against the Fusion (F) Protein
02/27/09
• NOVAVAX Announces Selection of a Respiratory Syncytial Virus Vaccine Candidate for Advanced Preclinical Studies
07/22/09
• NOVAVAX Awarded NIH Grant For Respiratory Syncytial Virus (RSV) Vaccine Program
10/13/09
2010
• NOVAVAX Announces Positive Preclinical Results for its Respiratory Syncytial Virus (RSV) Vaccine Candidate
01/12/10
• Novavax Reports Positive Results from Pre-clinical Safety Study of Respiratory Syncytial Virus (RSV) Vaccine Candidate
08/12/10
• NOVAVAX Receives FDA Clearance to Launch Phase I RSV Vaccine Clinical Trial
12/16/10
• NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate
12/22/10
2011
• NOVAVAX Launches Phase I Clinical Trial to Evaluate its Novel Vaccine Against Respiratory Syncytial Virus (RSV)
01/03/11
• NOVAVAX to Report Top-Line Results from Phase I Respiratory Syncytial Virus Vaccine Clinical Trial on October 3rd at 5th Vaccine and ISV Annual Global Conference
09/26/11
• NOVAVAX Reports Positive Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
10/03/11
• NOVAVAX Announces Conference Call to Discuss Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
10/10/11
2012
• NOVAVAX to Present Results from Phase I RSV Study at XIV International Symposium on Respiratory Viral Infections
03/22/12
• Novavax to Review RSV Program at New International Conference on Modern Vaccines
06/27/12
• NOVAVAX Reports on Progress with RSV Vaccine at New International Conference on Modern Vaccines
07/05/12
• NOVAVAX and PATH Announce Partnership on RSV Vaccine
07/18/12
• Novavax Presents RSV Vaccine Data at the 8th Annual International Respiratory Virus Symposium
09/27/12
• Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine Candidate
10/08/12
• Novavax Initiates Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly Adults
10/15/12
• Novavax’ Phase I RSV Vaccine Data Published in Vaccine
12/06/12
2013
• Novavax Reports Progress on RSV Vaccine at the XV International Symposium on Respiratory Viral Infections
03/18/13
• Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age
04/02/13
• Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate
10/07/13
2014
• Novavax Announces Continuation of RSV Vaccine Partnership with PATH
01/13/14
• Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age
04/28/14 |
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dothedd
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Post by dothedd on May 1, 2014 18:12:57 GMT -5
Gaithersburg, MD (April 28, 2014) -
Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age
• Vaccine candidate was well-tolerated with no vaccine-related serious adverse events
• Highest immune responses observed with a single dose of vaccine combined with
aluminum phosphate adjuvant
• Women with the lowest baseline levels of RSV neutralizing antibodies had the largest
increases following immunization, consistent with prior data
• Palivizumab-like antibodies exceeded levels observed in previous trials
• High levels of antibodies developed within 14 days after immunization and persisted over
the 91-day observation period
• Data permit selection of vaccine formulation and regimen for planned Phase 2 clinical
trial in pregnant women
Gaithersburg, MD (April 28, 2014) - Novavax, Inc. (Nasdaq: NVAX) today announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax’ RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response (measured by levels of serum IgG antibody specific for the F protein). The study enrolled 720 healthy women between the ages of 18 and 35 years, who received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant. These top-line data relate to the safety and immunogenicity over the 91-day period following first immunization and support Novavax’ maternal immunization strategy.
Highlights of the interim results:
*The RSV-F vaccine candidate was well-tolerated, with no vaccine-related serious adverse events, at all doses and formulations. The safety profile was consistent with data from prior Phase 1 and 2 studies.
*Significant increases in RSV-F antibody levels were observed across all doses and formulations, consistent with prior studies. Peak RSV-F antibody levels were observed in the group that received a single dose of vaccine containing 120 µg of antigen with one third of the aluminum phosphate dose used in prior studies.
*Clear increases in RSV neutralizing antibodies were also shown across all doses and formulations, and were strongest in women entering the study with the lowest baseline levels, in confirmation of prior studies. * Vaccine-induced palivizumab-like antibody levels demonstrated strong concordance with anti-RSV-F antibody responses. A single 120 µg antigen dose generated peak palivizumab-like antibody levels of approximately 400 µg/mL, the highest levels seen in any study. * Kinetic analysis of the antibody responses showed rapid increases in antibody levels in all vaccine formulations and dosing regimens. A single 120 µg antigen dose generated peak RSV-F and palivizumab-like antibody levels within 14 days of immunization, and high levels of both were sustained through the 91-day observation period.
“Our vaccine has again performed in a highly consistent manner from a safety and immunogenicity perspective. In testing for an optimal formulation, we have delivered improved immunogenicity in a one-dose regimen. We believe such a regimen will improve patient convenience, vaccine uptake and compliance, thus decreasing the burden of RSV disease. In addition, we believe that the rapid and sustained antibody response displayed by a single-dose formulation of our vaccine provides significant flexibility for administration during pregnancy,” said Gregory Glenn M.D., Senior Vice President Research and Development at Novavax. “Together with our previous clinical trial in women of childbearing age, these data support our first maternal immunization trial, currently projected for the 4th quarter of 2014. We have requested a Type C meeting with the FDA this summer, at which time we will discuss our suite of pre-clinical and clinical data in support of our application to proceed to studies in pregnant women.”
This clinical trial is being conducted in collaboration with PATH, an international nonprofit organization that drives transformative innovation to save lives and improve health. PATH committed funding of approximately $3.5 million to support this trial with the aim of advancing the development of an RSV vaccine to protect infants through maternal immunization in low-resource countries. Novavax expects to present the entire date-set at an appropriate scientific forum in the future.
About RSV
RSV is a respiratory pathogen that afflicts 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.
Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and 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.
It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available for either of these populations.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative roprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company’s website, novavax.com.
About PATH
PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. PATH accelerates innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness its entrepreneurial insight, scientific and public health expertise, and passion for health equity. By obilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, they deliver measurable results that disrupt the cycle of poor health. Learn more at www.path.org.
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dothedd
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Post by dothedd on May 1, 2014 18:16:07 GMT -5
Gah! That's a lot of text! Can you summarize?
Below is the link to the WEBSITE if you are interested!
www.novavax.com/
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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Post by dothedd on Feb 25, 2015 22:09:04 GMT -5
Pediatric Research (1976) 10, 75–78; doi:10.1203/00006450-197601000-00015
Cell-mediated Immunity to Respiratory Syncytial Virus Induced by Inactivated Vaccine or by Infection
Hyun Wha Kim1, Sanford L Leikin1, Julita Arrobio1, Carl D Brandt1, Robert M Chanock1 and Robert H Parrott1
1George Washington University, Research Foundation of Children's Hospital Medical Center, Washington, D.C. and Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
Correspondence: R. H. Parrott, M.D., Children's Hospital National Medical Center, 2125 13th St., N.W., Washington, D.C. 20009 (USA).
www.nature.com/pr/journal/v10/n1/abs/pr197615a.html
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