Novavax, Inc. NVAX announced that it has identified a potential coronavirus vaccine candidate, NVX-CoV2373. The company plans to initiate a phase I study to evaluate the candidate, which has been made using the company’s proprietary nanoparticle technology, in May.
The company’s candidate has progressed well in its pre-clinical stage, which helped the company to prepare for a human clinical study weeks ahead of the previously announced schedule. For rapid development of the vaccine candidate, the company is designing the study as a phase I/II study with preliminary immunogenicity and safety data from the study anticipated in July. The phase I portion of the study will evaluate the candidate in approximately 130 patients for assessment of dosage amount and number of vaccinations.
Shares of Novavax were up 15.3% on Apr 8, following the announcement of accelerated timeline for a clinical study. In fact, the company’s shares have surged 331.7% so far this year against the industry’s decline of 9.7%. The significant increase in the company’s share price is driven by its efforts to develop a coronavirus vaccine as well as successful completion of a late-stage study on its seasonal influenza vaccine candidate, NanoFlu.
NVX-CoV2373 has shown 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 protective in humans.
In March, the Coalition for Epidemic Preparedness (“CEPI”) awarded an initial funding of $4 million to support Novavax’s efforts to develop a COVID-19 vaccine. The company is in discussion with CEPI regarding additional funding to cover clinical development costs.
Novavax also has an agreement with Emergent BioSolutions EBS related to manufacture and supply of GMP vaccine product for use in its clinical studies. The company believes that Emergent’s rapid deployment capabilities and expertise will help it to scale its vaccine production.
With the coronavirus pandemic infecting more than 1.5 million people worldwide and killing almost 90,000, several large and smaller pharma/biotech companies are racing against time to successfully develop a treatment or vaccine to combat the disease.
Moderna MRNA is a leading player in the coronavirus vaccine field. It initiated a phase I study on its mRNA-based vaccine candidate last month. J&J JNJ also announced plans to initiate a phase I clinical study on its potential coronavirus vaccine candidate in September. Translate Bio is also planning to co-develop a mRNA-based vaccine in collaboration with Sanofi.
Apart from vaccines, a few other companies are developing drugs or testing their marketed drugs in studies to treat the coronavirus disease, COVID-19. These include Gilead’s antiviral candidate remdesivir, Roche’s rheumatoid arthritis (“RA”) drug Actemra and Regeneron/Sanofi’s RA drug, Kevzara. Data from a phase III study evaluating remdesivir is expected later this month.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Novovax is a Zacks Rank #3 (Hold) stock currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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