Creating Tomorrow's Vaccines Today

Using the power of our technology to create tomorrow’s vaccines today.

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Name: 
NVX-CoV2373
Matrix-M
Therapeutic Area: 
Coronavirus
Phase 3

We have successfully produced NVX-CoV2373, a vaccine candidate that is designed to provide protection against COVID-19. Engineered from the genetic sequence of COVID-19, we used our recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. In combination with our proprietary Matrix-M™ adjuvant, NVX-CoV2373 has demonstrated in preclinical studies that it binds efficiently with human receptors targeted by the virus, a critical aspect for effective vaccine protection.

In April 2020, we announced that NVX-CoV2373 is highly immunogenic in animal models measuring spike protein–specific antibodies, which are antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein–specific antibodies with ACE-2 human receptor–binding, domain-blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased 8-fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans. The NVX-CoV2373 development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 clinical trial is a placebo-controlled, observer-blinded study of approximately 130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial began in May 2020 and will have preliminary immunogenicity and safety results in July 2020.

In June 2020, we were awarded a contract by the U.S. Department of Defense under which we receive funding of up to $70 million for the manufacturing of NVX-CoV2373. In May 2020, we announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373.

In July 2020, we were selected to participate in Operation Warp Speed (OWS), a U.S. government sponsored program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021, under which we receive funding of $1.6 billion. We will demonstrate we can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. OWS funds the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020. OWS funding supports our plans to file submissions for licensure with the FDA.

In August, Novavax announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID 19 vaccine with and without Matrix-M™ adjuvant in healthy adults 18-59 years of age. NVX CoV2373, the Company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia.

Name: 
NanoFlu™ - Seasonal Influenza Vaccine (Adults Aged 65+ Years)
Matrix-M
Therapeutic Area: 
Seasonal Influenza
Phase 3

In March 2020, we announced positive top-line results from our Phase 3 clinical trial of our nanoparticle seasonal quadrivalent influenza vaccine candidate, including our proprietary Matrix-M™ adjuvant (NanoFlu™). The trial was a randomized, observer-blinded, active-controlled trial in approximately 2,652 healthy older adults (aged 65 years and older) across 19 clinical sites in the United States. The trial evaluated the immunogenicity and safety of NanoFlu™ compared to a US-licensed quadrivalent vaccine, Fluzone® Quadrivalent. The trial’s primary objective was to demonstrate noninferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous seasonal influenza strains compared to a licensed seasonal vaccine and to describe its safety profile.

NanoFlu achieved all the primary endpoints, was well tolerated, and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events. NanoFlu also achieved statistical significance in key secondary endpoints. This positive data will support a US biologics license application (BLA), which will include process performance qualification (PPQ), a lot consistency clinical trial, and licensure of NanoFlu using the US Food and Drug Administration’s (FDA) accelerated approval pathway.

Name: 
ResVax™ - RSV F Vaccine (Infants via Maternal Immunization)
Matrix-M
Therapeutic Area: 
Respiratory Syncytial Virus (RSV)
Phase 3

ResVax™ is our aluminum-adjuvanted RSV F vaccine for infants via maternal immunization. RSV is the most common cause of lower respiratory tract infections (LRTI) and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In the United States, RSV is the leading cause of hospitalization of infants and, globally, is second only to malaria as a cause of death in children under 1 year of age. There are currently approximately 18 million children in the United States between 6 months and 5 years of age. In the United States, RSV is responsible for approximately 57,000 hospitalizations of children under 5 years of age annually, the vast majority of which occur in infants less than 1 year of age, and especially those under 6 months of age.

Data from our Prepare trial, which was initiated in December 2015, was announced in February 2019. The Prepare trial was conducted to determine whether ResVax reduced incidence of medically significant RSV-positive LRTI in infants through a minimum of the first 90 days of life and up through the first 6 months of life. While these data did not meet the trial’s primary efficacy endpoint, it did demonstrate efficacy against a secondary endpoint by reducing RSV LRTI hospitalizations in treated infants. ResVax is thus the first RSV vaccine to show efficacy in a Phase 3 clinical trial, and in addition, to show important effects against a variety of prespecified exploratory endpoints and post hoc analyses. This included an approximately 60% reduction in RSV-related severe hypoxemia and an approximately 74% reduction in RSV-related, radiographically confirmed pneumonia through Day 90. As in previous clinical trials, ResVax also showed favorable safety and tolerability results. In light of the fact that the trial failed to meet its primary endpoints, the FDA and European Medicines Agency (EMA) recommended that we conduct an additional Phase 3 clinical trial to confirm efficacy. The Bill & Melinda Gates Foundation (BMGF) has supported the Prepare trial for ResVax through a grant of up to $89.1 million; BMGF continues to financially support our efforts to conduct certain follow-up analyses of the Phase 3 data. We are currently in discussions with multiple potential commercial partners about the opportunity to bring ResVax to market globally. In addition, we are continuing to determine regulatory licensure requirements and pathways in the United States, the European Union, and other locations.

Name: 
RSV F Vaccine (Older Adults 60+ Years)
Matrix-M
Therapeutic Area: 
Respiratory Syncytial Virus (RSV)
Phase 2

Older adults (aged 60 years and older) are at increased risk for RSV disease due in part to immunosenescence, the age-related decline in the human immune system. RSV infection can also lead to exacerbation of underlying comorbidities such as chronic obstructive pulmonary disease, asthma, and congestive heart failure. In the United States alone, a reported RSV incidence rate of 5.5% in older adults would account for approximately 2.5 million infections per year. We estimate that approximately 900,000 medical interventions are caused by RSV disease in this US population each year. We followed up the 2015 Phase 3 clinical trial of our RSV F vaccine, which failed to meet its prespecified primary or secondary efficacy endpoints, with a 2017 Phase 2 clinical trial in older adults, in order to assess safety and immunogenicity of 1- and 2-dose regimens of our RSV F vaccine, with and without aluminum phosphate or our proprietary Matrix-M™ adjuvant. Immunogenicity results from the 2017 trial indicate that both adjuvants increase the magnitude, duration, and quality of the immune response versus the nonadjuvanted RSV F vaccine. We continue to assess the development opportunities for our RSV F vaccine in older adults.

Name: 
RSV F Vaccine (Pediatrics 6 Months to 5 Years)
Matrix-M
Therapeutic Area: 
Respiratory Syncytial Virus (RSV)
Phase 1

By the age of 5 years, nearly all children will have been exposed to RSV and will likely develop natural immunity against the virus; however, children under 5 years of age remain vulnerable to RSV disease, offering a strong rationale for a pediatric vaccine that could offer enhanced protection. In 2015, we announced positive results in our Phase 1 clinical trial evaluating the safety and immunogenicity of our RSV F vaccine in healthy children between 2 and 6 years of age. We continue to assess the development opportunities for our RSV F vaccine for children.

Name: 
Combination Seasonal Influenza/RSV F Vaccine (Older Adults 60+ Years)
Matrix-M
Therapeutic Area: 
Combination Seasonal Influenza/Respiratory Syncytial Virus
Preclinical

With the ongoing development of our NanoFlu™ and RSV F vaccines, a strong rationale exists for developing a combination respiratory vaccine that is designed to protect susceptible populations against both diseases. Although testing is at an early stage, we believe that a combination vaccine against both seasonal influenza and RSV may be achievable.

Name: 
Ebola GP Vaccine
Matrix-M
Therapeutic Area: 
Ebola Virus
Phase 1

We have developed an EBOV glycoprotein vaccine candidate (Ebola GP vaccine) expressed in insect cells, using our core recombinant baculovirus technology. In 5 separate studies, carried out in collaboration with the National Institute of Allergy and Infectious Diseases, active immunization with the Ebola GP vaccine was shown to be highly immunogenic and efficacious in preventing lethal disease in non-human primates challenged with EBOV. Our 2015 Phase 1 clinical trial demonstrated that our Ebola GP vaccine is highly immunogenic in humans, well tolerated, and, in conjunction with our proprietary Matrix-M™ adjuvant, showed marked antigen dose-sparing and induced significant increases in neutralizing antibody titers. Although not in active development, our Ebola GP vaccine is a viable development opportunity in the event of dedicated funding or a partnership arrangement.

Name: 
Middle East Respiratory Syndrome (MERS) Vaccine
Matrix-M
Therapeutic Area: 
Middle East Respiratory Syndrome (MERS)
Preclinical

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, as well as a vaccine candidate against SARS in 2005. In 2012, within weeks of obtaining the sequence of the circulating MERS strain, we successfully produced a vaccine candidate. Our MERS candidate was based on the major surface spike protein, which we had previously identified as the antigen of choice in our work with our SARS vaccine candidate. In 2014, in collaboration with the University of Maryland School of Medicine, we published results showing that our MERS and SARS vaccine candidates both blocked infection in laboratory studies. Although not in active development, our MERS and SARS vaccine candidates remain viable opportunities to develop independently or in conjunction with other coronavirus development activities.

Name: 
Severe Acute Respiratory Syndrome (SARS) Vaccine
Matrix-M
Therapeutic Area: 
Severe Acute Respiratory Syndrome (SARS)
Preclinical

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, as well as a vaccine candidate against SARS in 2005. In 2012, within weeks of obtaining the sequence of the circulating MERS strain, we successfully produced a vaccine candidate. Our MERS candidate was based on the major surface spike protein, which we had previously identified as the antigen of choice in our work with our SARS vaccine candidate. In 2014, in collaboration with the University of Maryland School of Medicine, we published results showing that our MERS and SARS vaccine candidates both blocked infection in laboratory studies. Although not in active development, our MERS and SARS vaccine candidates remain viable opportunities to develop independently or in conjunction with other coronavirus development activities.