Novavax

Novavax, Inc., is an American biotechnology company based in Gaithersburg, Maryland that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for Ebola, influenza, respiratory syncytial virus (RSV), and other emerging infectious diseases. During 2020, however, the company redirected its efforts to focus on development and approval of a vaccine for COVID-19. Novavax has indicated it recognizes a continued need for innovative vaccines in other therapeutic areas and reports it has taken steps to ensure continued advancement of its influenza vaccine.
History.
Novavax was founded in 1987 to focus on experimental vaccine development, but as of early 2021 has not yet completed commercialization of any vaccine product.
In June 2013, Novavax acquired the Matrix-M adjuvant platform with the purchase of Swedish company Isconova AB and renamed its new subsidiary Novavax AB.
In 2015, the company received an $89 million grant from the Bill & Melinda Gates Foundation to support the development of a vaccine against human respiratory syncytial virus for infants via maternal immunization.
In March 2015 the company completed a Phase I trial for its Ebola vaccine candidate, as well as a phase II study in adults for its RSV vaccine, which would become ResVax. The ResVax trial was encouraging as it showed significant efficacy against RSV infection.
2016 saw the company's first phase III trial, the 12,000 adult Resolve trial, for its respiratory syncytial virus vaccine, which would come to be known as ResVax, fail in September. This triggered an eighty-five percent dive in the company's stock price. Phase II adult trial results also released in 2016 showed a stimulation of antigencity, but failure in efficacy. Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials. The company's difficulties in 2016 led to a three part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a Zika virus vaccine.
Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.
In 2019, late-stage clinical testing of ResVax, failed for a second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm. As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted.
The company positions "NanoFlu" for the unmet need for a more effective vaccine against influenza, particularly in the elderly who often experience serious and sometimes life-threatening complications. In January 2020, it was granted fast track status by the U.S. Food and Drug Administration (FDA) for "NanoFlu".
External sponsorships.
In 2018, Novavax received a US$89 million research grant from the Bill and Melinda Gates Foundation for development of vaccines for maternal immunization.
In May 2020, Novavax received from the Coalition for Epidemic Preparedness Innovations to fund early-stage evaluation in healthy adults of the company's COVID-19 vaccine candidate NVX-CoV2373 and to develop resources in preparation for large-scale manufacturing, if the vaccine proves successful. CEPI had already invested $4 million in March.
Drugs in development.
Earlier experimental vaccines.
ResVax is a nanoparticle-based treatment using a recombinant F lipoprotein or saponin, "extracted from the Quillaja saponaria [or?] Molina bark together with cholesterol and phospholipid." It is aimed at stimulating resistance to respiratory syncytial virus infection, targeting both adult and infant populations.
In January 2020, Novavax was given Fast Track status by the FDA to expedite the review process for "NanoFlu", a candidate influenze vaccine undergoing a Phase III clinical trial scheduled for completion by mid-2020.
COVID-19 vaccine candidate.
In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2. NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus. Novavax's work is in competition for vaccine development among dozens of other companies.
In January 2021, the company released phase 3 trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants. It has applied for emergency use in the US and UK but will be distributed in the UK first.
Vaccine Adjuvants.
Nanovax also develops proprietary immune-stimulating saponin-based adjuvants at a wholly owned Swedish subsidiary, Novavax AB. One of these, Matrix-M™, is used in the Novavax experimental vaccine for COVID-19.