NVX-CoV2373 Coronavirus Vaccine Description
NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate made using Novavax’s proprietary nanoparticle technology, Matrix-M, which is an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.
Novavax’s 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 and helping an immunized person make antibodies against the virus.
Novavax identified NVX‑CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies.
Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company. The Coalition for Epidemic Preparedness Innovations is investing up to $388 million of funding to advance the clinical development of NVX‑CoV2373.
NVX-CoV2373 Coronavirus Vaccine Indication
NVX-CoV2373 is a vaccine candidate indicated as a SARS-CoV-2 coronavirus vaccine to prevent COVID-19 disease. In preclinical trials, NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection.
NVX-CoV2373 Coronavirus Vaccine Dosage
- Experimental: SARS-CoV-2 rS - 25 μg without Matrix-M
- Experimental: SARS-CoV-2 rS - 5 μg with 50 μg Matrix-M
NVX-CoV2373 Coronavirus Vaccine News
May 25, 2020 - Novavax, Inc. announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
May 11, 2020 - Novavax, Inc. announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’ coronavirus vaccine candidate against SARS-CoV-2. The additional funding from CEPI will also support the rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax’s proprietary Matrix-M™ adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies.
April 8, 2020 - Novavax, Inc, announced it has identified a coronavirus vaccine candidate, NVX-CoV2373. The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic.
March 10, 2020 - CEPI to provide an initial $4 million to accelerate vaccine development to prepare for Phase 1 clinical study.
NVX-CoV2373 Coronavirus Vaccine Clinical Trials
Clinical Trial NCT04368988: Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant. The Phase 1/2 clinical trial is being conducted in two parts.
The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.
The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety, and COVID‑19 disease reduction in a broader age range.
The estimated completion date: December 31, 2020.