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Novavax Begins Clinical Study for Coronavirus Vaccine
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Novavax, Inc. (NVAX - Free Report) announced that it has initiated a phase I/II clinical study on its coronavirus vaccine candidate, NVX-CoV2373, which has been made using the company’s proprietary nanoparticle technology. Preliminary immunogenicity and safety data from the study is expected in July.
Notably, NVX-CoV2373 includes Novavax’s proprietary Matrix-M adjuvant to improve immune responses and stimulate high levels of neutralizing antibodies.
The study is being conducted in two parts. The phase I portion will evaluate the candidate in approximately 130 healthy volunteers aged from 18 to 59 years at two sites in Australia.
If the results of the phase I part show positive outcomes, then the company will quickly begin the phase II portion of the study, which will be conducted across multiple countries and assess immunity, safety and COVID-19 disease reduction in a broader age bracket of patient population.
Earlier this month, the Coalition for Epidemic Preparedness (CEPI) provided an additional funding of up to $388 million to Novavax for the clinical development of NVX-CoV2373. The above-mentioned study is being supported by this aid.
In March, the CEPI awarded an initial funding of $4 million to back Novavax’s efforts for developing the vaccine candidate.
NVX-CoV2373 showed high immunogenicity in pre-clinical studies after a single immunization. Moreover, microneutralization titers, which were already high after the first dose, increased eight-fold with the second dose. Higher the microneutralization titers, more likely is the vaccine to be effective in humans.
Shares of Novavax were up 16.7% in pre-market trading on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 1058.6% so far this year compared with the industry’s increase of 7.9%.
We remind investors that in April 2020, Novavax identified its potential coronavirus vaccine candidate, NVX-CoV2373.
Significantly, the company has an agreement with Emergent BioSolutions (EBS - Free Report) to manufacture and supply GMP vaccine product for use in its clinical studies.
The CEPI is financing several biotechs for developing a coronavirus vaccine including Moderna (MRNA - Free Report) and Inovio Pharmaceuticals. Several big players including Sanofi, Pfizer (PFE - Free Report) and J&J joined the mission to develop a vaccine against COVID-19.
Meanwhile, global leaders and the World Health Organization are committed to work together to fight against the COVID-19 pandemic, which already infected more than 5 million people across the globe and the number is growing by the day.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Novavax Begins Clinical Study for Coronavirus Vaccine
Novavax, Inc. (NVAX - Free Report) announced that it has initiated a phase I/II clinical study on its coronavirus vaccine candidate, NVX-CoV2373, which has been made using the company’s proprietary nanoparticle technology. Preliminary immunogenicity and safety data from the study is expected in July.
Notably, NVX-CoV2373 includes Novavax’s proprietary Matrix-M adjuvant to improve immune responses and stimulate high levels of neutralizing antibodies.
The study is being conducted in two parts. The phase I portion will evaluate the candidate in approximately 130 healthy volunteers aged from 18 to 59 years at two sites in Australia.
If the results of the phase I part show positive outcomes, then the company will quickly begin the phase II portion of the study, which will be conducted across multiple countries and assess immunity, safety and COVID-19 disease reduction in a broader age bracket of patient population.
Earlier this month, the Coalition for Epidemic Preparedness (CEPI) provided an additional funding of up to $388 million to Novavax for the clinical development of NVX-CoV2373. The above-mentioned study is being supported by this aid.
In March, the CEPI awarded an initial funding of $4 million to back Novavax’s efforts for developing the vaccine candidate.
NVX-CoV2373 showed high immunogenicity in pre-clinical studies after a single immunization. Moreover, microneutralization titers, which were already high after the first dose, increased eight-fold with the second dose. Higher the microneutralization titers, more likely is the vaccine to be effective in humans.
Shares of Novavax were up 16.7% in pre-market trading on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 1058.6% so far this year compared with the industry’s increase of 7.9%.
We remind investors that in April 2020, Novavax identified its potential coronavirus vaccine candidate, NVX-CoV2373.
Significantly, the company has an agreement with Emergent BioSolutions (EBS - Free Report) to manufacture and supply GMP vaccine product for use in its clinical studies.
The CEPI is financing several biotechs for developing a coronavirus vaccine including Moderna (MRNA - Free Report) and Inovio Pharmaceuticals. Several big players including Sanofi, Pfizer (PFE - Free Report) and J&J joined the mission to develop a vaccine against COVID-19.
Meanwhile, global leaders and the World Health Organization are committed to work together to fight against the COVID-19 pandemic, which already infected more than 5 million people across the globe and the number is growing by the day.
Zacks Rank
Novavax is a Zacks Rank #3 (Hold) stock, currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>