Novavax will incorporate its Matrix-M adjuvant with NVX-CoV2373 to enhance immune responses and stimulate increased levels of neutralising antibodies
US-based clinical-stage vaccine company Novavax has identified a vaccine candidate for coronavirus, dubbed NVX-CoV2373, a stable, prefusion protein developed through the advanced nanoparticle technology.
The biotechnology firm said that its Matrix-M adjuvant will be incorporated with NVX-CoV2373 to enhance immune responses and stimulate increased levels of neutralising antibodies. It intends to start a first-in-human trial in May 2020.
Novavax research and development president Gregory Glenn said: “Our scientists identified an ideal vaccine candidate selected from a number of constructs and, in partnership with Dr. Matthew Frieman, demonstrated that NVX-CoV2373 produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies.
“In addition, we have worked closely with our colleagues at Emergent BioSolutions to transfer our production technology that allows the manufacture of GMP vaccine for clinical trials. With preliminary CEPI funding, these heroic efforts, combined with the candidate’s excellent early results, put us in position to have preliminary human data in July.”
Novavax will develop NVX-CoV2373 in a combination of Phase 1 or Phase 2 approach
NVX-CoV2373 is said to be highly immunogenic in animal models measuring spike protein-specific antibodies, which blocks the binding of the spike protein to the receptor and wild-type virus neutralising antibodies.
Novavax said that the clinical development plan for NVX-CoV2373 combines a Phase 1 or Phase 2 approach, allowing rapid advancement during the current coronavirus pandemic.
The Phase 1 trial is a placebo-controlled observer-blinded study to assess dosage amount and number of vaccinations, in around 130 healthy adults, which is planned to start in mid-May and preliminary immunogenicity and safety results are expected in July.
The company has previously announced the partnership with Emergent BioSolutions to provide contract development and manufacturing services, including the supply of GMP vaccine product for use in its clinical trials.
Novavax president and chief executive officer Stanley C Erck said: “Because of the tireless efforts and commitment of the Novavax team and our collaborators, we are preparing to initiate the NVX-CoV2373 Phase 1 trial in mid-May, weeks ahead of schedule.
“This progress demonstrates the ability of our recombinant nanoparticle technology to rapidly create vaccine candidates for emerging viruses like SARS-CoV-2. In addition, the performance of NVX-CoV2373 in multiple preclinical studies and testing gives us increased confidence in its potential to protect against COVID-19 disease.”