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Novavax Announces Its First-in-Human Coronavirus Vaccine Trial Will Begin in Mid-May

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Shares of Novavax traded 20% higher setting a new 52-week high price after the company reported that it has accelerated initiation of a Phase 1 clinical trial for its coronavirus vaccine candidate NVX-CoV2373. The study will commence in mid-May with preliminary results expected in July 2020.

Late-stage biotechnology company Novavax Inc. (NVAX:NASDAQ), which is focused on developing next-generation vaccines to address infectious diseases, today announced it has identified a coronavirus vaccine prefusion protein candidate named NVX-CoV2373 utilizing the firm's proprietary nanoparticle technology and will initiate a first-in-human trial in mid-May. The firm additionally advised that "its proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies."

The company stated that in prior animal models measuring spike protein-specific antibodies, NVX-CoV2373 was shown to be highly immunogenic. The firm explained that "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."

The company's President of Research and Development Gregory Glenn, M.D., commented, "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."

Matthew Frieman, Ph.D., associate professor at the University of Maryland School of Medicine, added, "We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus...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."

The company mentioned that "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 will study 130 healthy adults and evaluate dosage levels and the number of vaccinations.

Earlier this year in March, the firm reported that it formed an agreement with Emergent BioSolutions to provide contract development and manufacturing services and to supply Novavax with GMP vaccine product for clinical trial use. The company indicated that this relationship offers the potential to leverage Emergent's rapid deployment abilities and expertise that will allow Novavax capacity to produce vaccine product at scale. The firm also noted that it received $4 million in funding from the Coalition for Epidemic Preparedness Innovations in support of its vaccine discovery efforts.

Novavax's President and CEO Stanley C. Erck remarked, "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."

The firm noted that the newest coronavirus strain, SARS-CoV-2, first appeared in China in late 2019 prior to spreading worldwide and that the COVID-19 disease continues to cause severe pneumonia-like symptoms in many infected individuals. The company further explained that coronaviruses spread from animals to humans and include diseases such as MERS and SARS in addition to COVID-19.

Novavax is a late-stage biotechnology company headquartered in Gaithersburg, Md., with additional facilities located in Rockville, Md., and Uppsala, Sweden. 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, seasonal influenza and Ebola virus and other infectious diseases.

Novavax has a market capitalization of around $767.8 million with approximately 51.53 million shares outstanding and a short interest of about 10.40%. NVAX shares opened 15% higher today at $17.15 (+$2.25, +15.109%) over yesterday's $14.90 closing price and reached a new 52-week high price this morning of $18.25. The stock has traded today between $16.30 and $18.25 per share and is currently trading at $17.56 (+$2.66, +17.85%).

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