In June 2013, Novavax acquired the Matrix-MTMadjuvant platform with the purchase of Swedish company Isconova AB and renamed it 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 firing of 30% of their workforce; pouring more effort into getting ResVax to market; and introduction of a Zika virus vaccine into the clinic. 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.
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
ResVax is a nanoparticle-based treatment using a recombinant F lipoprotein, aimed at stimulating resistance to respiratory syncitial virus infection, targeting both adult and infant populations. In January 2020, Novovax 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 molecule. Novavax's work is in competition for vaccine development among dozens of other companies. In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. Under the partnership, Emergent BioSolutions will manufacture the vaccine at large-scale at their Baltimore facility. The first human safety studies of the candidate, named NVX-CoV2373, started in May 2020 in Australia. In July, the company announced it might receive $1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 —if clinical trials show the vaccine to be effective. A spokesperson for Novavax stated that the $1.6 billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense, where Gen. Gustave F. Perna has been selected as COO for Warp Speed.
