Novavax To Launch First-in-Human Trial of COVID-19 Vaccine in May

(Gaithersburg, MD, USA), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology and will initiate a first-in-human trial in mid-May.

Novavax focuses on the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. The company had recently initiated development of a vaccine program against COVID-19, with human results expected in July of 2020. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

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. Novavax’ proprietary Matrix-M adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies. 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.

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. Novavax has also entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials.

“We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus,” said Matthew Frieman, Ph.D., Associate Professor at the University of Maryland School of Medicine. “This is strong evidence that the vaccine created by Novavax has the potential to be highly immunogenic in humans which could lead to protection from COVID-19 and helping to control the spread of this disease.”

“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,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “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.”

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