Late-stage biotechnology company Novavax Inc. (NVAX:NASDAQ), which is focused on developing vaccines to address serious infectious diseases, today released an update on the current status of its COVID-19 vaccine program. The company explained that it leading vaccine candidate called NVX‑CoV2373 is "a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix‑M™."
The company highlighted that it has now completed enrollment for a pivotal Phase 3 trial in the U.K. and also completed the enrollment for a Phase 2b efficacy trial in South Africa. In addition, Novavax advised that it expects that another Phase 3 study in the U.S. and Mexico will commence within just a few weeks.
Novavax President and CEO Stanley C. Erck remarked, "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic...We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide."
The firm noted that the two fully enrolled late-stage efficacy trials for NVX-CoV2373 have already dosed greater than 20,000 participants. The company stated that the predetermined primary endpoints in the studies were formulated to meet the requirements of global regulatory agencies to facilitate regulatory approvals and to make sure that the studies and vaccine were designed to benefit people across global populations.
The company stated that its Phase 3 trial of NVX-CoV2373 in the U.K. has enrolled a total of 15,000 participants and the interim data from this study is very likely to be available in Q1/21, though the exact timing is dependent upon the region's overall COVID-19 rate. Novavax said that the interim data, when received, is expected to provide the basis for license applications in the U.K., the EU and other countries.
Novavax also is concurrently conducting a Phase 2b trial of NVX-CoV2373 in South Africa. The study is also fully enrolled with 4,422 voluntary participants, of which 245 individuals are medically stable, HIV-positive participants. The company said that this trial includes many older adults and racially and geographically diverse populations. The firm said that as with the U.K. study it anticipates that the interim data will be available in Q1/21. Novavax pointed out that "this trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation and that the Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial."
The company stated that it anticipates that that it will begin its pivotal Phase 3 clinical trial for NVX-CoV2373 in the U.S. and Mexico in the coming weeks. The firm said it has identified more than 100 separate trial sites. The firm advised that it will use the data from its prior Phase 2 trial that was conducted in the U.S. and Australia for designing the study protocol and dosing levels.
Novavax commented that it was previously awarded $1.6 billion in funding from the U.S. government under the Operation Warp Speed to expedite delivery of millions of doses of COVID-19 vaccines.
The company noted that "NVX‑CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies."
Novavax is a late-stage biotechnology company headquartered in Gaithersburg, Md. The firm is focused on improving global health through discovery, development and commercialization of novel vaccines to prevent serious infectious diseases. The company's product pipeline includes clinical vaccine candidates for respiratory syncytial virus (RSV), seasonal influenza, Ebola virus, middle east respiratory syndrome (MERS), severe acute respiratory syndrome (SARS) and other infectious diseases.
Novavax began the day with a market cap of around $8.0 billion with approximately 63.66 million shares outstanding and a short interest of about 14%. NVAX shares opened 5% lower today at $119.26 (-$6.43, -5.12%) from Friday's $125.69 closing price. The stock has traded today between $118.50 and $147.50 per share and is currently trading at $139.68 (+$13.98, +11.12%).[NLINSERT]
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