Novavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May
- NVX-CoV2373 identified as SARS-CoV-2 candidate for Phase 1 clinical trial
- In preclinical studies, NVX-CoV2373 demonstrated high immunogenicity and stimulated high levels of neutralizing antibodies
- First-in-human Phase 1 clinical trial accelerated to mid-May with preliminary results in July
- GMP clinical production initiated at Emergent BioSolutions with ability to leverage capacity for large scale manufacturing
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 observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
“Our scientists identified an ideal vaccine candidate selected from a number of constructs and, in partnership with Dr.
“We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus,” said
The NVX-CoV2373 clinical 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 ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July.
As previously announced, in March,
“Because of the tireless efforts and commitment of the
A new strain of coronavirus, SARS-CoV-2, first appeared in late 2019 in
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Statements herein relating to the future of
Source: Novavax, Inc.