Novavax (NVAX - Free Report) announced that it has enrolled the first set of patients in a phase I/II clinical study of its coronavirus vaccine candidate, NVX-CoV2373. The study is being conducted in two portions phase I and II. The phase I portion will enroll approximately 130 healthy participants, aged 18 to 59 at two sites in Australia. Preliminary data from the phase I portion of the study is expected in July and the phase II portion is expected to begin quickly if the phase I data are promising. Novavax plans to conduct phase II portion in multiple countries including the United States. The study is being funded by The Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo.
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.
The news comes as several pharma/biotech companies speed up efforts to make a vaccine for COVID-19, which has infected more than 5.5 million and killed more than 3,40,000 people globally.
Apart from Novavax, Moderna (MRNA - Free Report) , Inovio Pharmaceuticals, Pfizer (PFE - Free Report) and partner BioNTech have initiated human/clinical studies on a coronavirus vaccine. Last week, Moderna announced encouraging data from phase I study on the coronavirus vaccine candidate and plans to start a phase II study soon. J&J (JNJ - Free Report) and Vaxart plan to initiate clinical study on a coronavirus vaccine in the second half of 2020.Several other vaccine candidates are in pre-clinical stage of development.
In the United States, two organizations, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) are providing funding to companies involved in making drugs/vaccines. Last week, AstraZeneca (AZN) received more than $1billion in funding from BARDA to help produce a coronavirus vaccine, which it is developing in is a phase I/II study with Oxford University. AstraZeneca has also agreed to provide the United States with up to 300 million doses of the vaccine, if approved. CEPI has also provided funding of millions of dollars to biotechs including Moderna, Novavax, CureVac and Inovio and several universities to accelerate the development of vaccines against COVID-19.
Meanwhile, other than vaccines, several drug/biotech companies are working on making new antibodies and drugs to combat the disease. The lead candidate is Gilead’s (GILD - Free Report) investigational antiviral candidate, remdesivir, which is being evaluated in phase III studies to treat COVID-19. Vir Biotechnology’s (VIR - Free Report) investigational monoclonal antibodies, VIR-7831 and VIR-7832, are expected to directly go to phase II clinical studies sometime in 2020.
Larger companies like Pfizer, Biogen, Lilly, Glaxo (GSK - Free Report) and Amgen have signed collaborations with smaller biotechs to co-develop antibody therapies to treat COVID-19. Separately, many marketed drugs like Sanofi,/Regeneron’sIL-6 inhibitor Kevzara, Roche’s IL-6 inhibitor, Actemra, Incyte/Novarts’ JAK1/JAK2 inhibitor, Jakafi, AstraZeneca’s BTK inhibitor, Calquence, Amgen’s PDE4 inhibitor, Otezla among others are being evaluated to treat respiratory complications associated with COVID-19 or to treat critically ill hospitalized COVID-19 patients, which is also the need of the hour.
Also, the FDA has granted emergency-use authorizations to hydroxychloroquine and remdesivir to treat the disease. Chloroquine is already approved for treating malaria, lupus and rheumatoid arthritis. Notably, hydroxychloroquine is currently being evaluated in studies for the treatment of COVID-19.
All eyes are on pharma/biotech sector to find a treatment/vaccine for COVID-19 as they are being considered the key to bring stalled global economies back on track.
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