The entire world is waiting for some good news on a vaccine for the novel coronavirus. So far the global pandemic has claimed more than 300,000 lives all over the world with more than 90,000 deaths in the US alone. Several biotech companies have been working on a vaccine for COVID-19. Apart from the major healthcare companies like Sanofi and Gilead Sciences, smaller companies are also running in this race. The clinical-stage biotech company Moderna (NASDAQ: MRNA) has been in the limelight since it started to work on the coronavirus vaccine in January of this year. Today, shares of Moderna jumped to a new yearly high as it reported positive interim data from COVID-19 vaccine’s Phase 1 study.
Phase 1 data outcomes
The Massachusetts, Cambridge-based biotech firm tested three dosing regimens of mRNA-1273, its coronavirus vaccine, in healthy adults aged between 18 and 55 and the vaccine was generally safe and well tolerated. No grade 4 adverse events or serious adverse events have been reported. One participant who received the middle-sized dose experienced redness around the injection site and three participants who received the highest dose showed grade 3 systemic symptoms following the second dose.
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Preclinical results
The National Institute of Allergy and Infectious Diseases (NIAID), which collaborated with Moderna on January 23, conducted a viral challenge study in mice. In this study, the vaccine prevented the replication of the virus in the lungs of the mice.
Development plan
Moderna, which went public in December 2018, announced its partnership in January with the Coalition for Epidemic Preparedness Innovations (CEPI) and NIAID for the development and testing of the vaccine. In March, the first patient was dosed in the Phase 1 study led by NIAID. Early this month, Moderna got the go-ahead signal from FDA for Phase 2 study, which is expected to begin shortly. Phase 3 study of the trial is expected to start in early 2Q20.
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“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said CEO Stephane Bancel.
Others in the race
While some biotech companies are concentrating on the treatment of coronavirus infection, companies like Moderna are focused on the vaccine side. Apart from Moderna, there are quite a few companies that are competing to discover a vaccine, and now they are in either Phase 1 or in the preclinical stage. Some notable players in the Phase 1 stage include INOVIO Pharmaceuticals (NASDAQ: INO), Beijing-based Sinovac, Germany’s BioNTech and the companies in the preclinical stage include Johnson & Johnson (JNJ), CureVac, Novavax and Sanofi & GlaxoSmithKline.
MRNA stock had more than tripled its value since the beginning of this year with almost all the analysts rated it as “Buy”.
Read what Moderna management discussed on the conference call