Type: Stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and incorporating its proprietary saponin-based Matrix-M adjuvant.
Status: Novavax on May 11 joined the Coalition for Epidemic Preparedness Innovations (CEPI) in announcing up to $384 million in additional funding for the company toward clinical development and large-scale manufacturing of NVX-CoV2373. The funding multiplies CEPI’s investment in the vaccine candidate, which began with a $4 million award in March. Novavax’s total $388 million in CEPI funding accounts for 87% of the total $446 million awarded by the Coalition toward COVID-19 vaccine R&D.
CEPI agreed to fund preclinical as well as Phase I and Phase II studies of NVX-CoV2373. Novavax has disclosed on ClincalTrials.gov plans for 2019nCoV-101 (NCT04368988), a two-part randomized, observer-blinded, placebo-controlled Phase I/II trial designed to evaluate the immunogenicity and safety of the vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 years of age.
In the 131-patient Phase I portion, at least one and up to two vaccine constructs will be evaluated in up to two cohorts, which may be enrolled in parallel. Topline results are expected in July. Based on an interim analysis of Phase I safety and immunogenicity data, the trial will be expanded to Phase II. The Phase I portion is set to start this month in Australia, followed by Phase II clinical trials to be conducted in multiple countries. If the Phase I/II trial is successful, CEPI said, it anticipates supporting further clinical development that would advance NVX-CoV2373 through to licensure.
Novavax identified its COVID-19 vaccine candidate in April. The company said NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, 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 also seen after a single immunization.
In March, Emergent Biosolutions disclosed it retained an option to allocate manufacturing capacity for an expanded COVID-19 program under an agreement with Novavax to provide “molecule-to-market” contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate.
Earlier in March, Emergent announced similar services to support clinical development of Novavax’s COVID-19 vaccine candidate, saying March 10 it agreed to produce the vaccine candidate and had initiated work, anticipating the vaccine candidate will be used in a Phase I study within the next four months. In February, Novavax said it had produced and was assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: