- In just over three weeks, biotech Moderna designed and manufactured the first batch of an experimental coronavirus vaccine that it plans to soon send to the National Institutes of Health for use in initial clinical testing.
- The vaccine, which relies on Moderna's messenger RNA technology, is currently undergoing analytical testing prior to its release to the NIH, the company said Monday. Beginning clinical study is only a first of many steps in proving a new vaccine, but the pace at which Moderna and the NIH have moved is more rapid than what researchers accomplished during the SARS outbreak in 2002 and 2003.
- Moderna was one of a handful of drugmakers to announce a vaccine development program following identification of the coronavirus outbreak in Wuhan, China last month. The company looks to be capitalizing on the attention it's since received, also announcing Monday plans to raise $500 million via a stock offering.
A key part of Moderna's pitch for why messenger RNA should be considered the foundation for a new class of medicines is the speed at which new drug candidates can be designed.
So far, the highly valued biotech appears to be matching its claims, moving from finalization of the desired genetic sequence for its mRNA-based coronavirus vaccine to manufacture of the first clinical batch in just 25 days.
Moderna's candidate, which was designed in collaboration with the NIH, focuses on a spike protein present on the surface of coronaviruses — like the one identified in China as well as SARS and MERS — that enables infection of human cells.
"There have been no glitches so far," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at a press conference held by the White House on Feb. 7.
Barring any unexpected delays, he added, "we will be in people in a Phase 1 trial in the next two-and-a-half months."
If that timeline holds, Moderna and the NIH will have moved much faster than did researchers responding to the SARS outbreak of 2002. Then, 20 months passed between obtaining the genetic sequence of the virus to a Phase 1 study.
Chinese researchers publicly shared the sequence of the Wuhan coronavirus, also called 2019-nCoV, on January 10. Since then, the outbreak has spread widely to 24 other countries. More than 40,000 people have been infected, and more than 900 have died, according to Feb. 10 figures from the World Health Organization.
Production of Moderna's vaccine was funded by the Coalition for Epidemic Preparedness Innovations, which has partnered with other biotechs and is coordinating some development efforts aimed at 2019-nCoV.
Many of the dozen of so drugmakers that have announced coronavirus development efforts to date are smaller, and won't always have the resources to mount clinical study of any candidates that result. Such announcements by biotechs often follow viral outbreaks, and don't usually result in proven treatments.
Testing vaccines like Moderna's in humans can pose challenges too, particularly if rapid disease spreading makes setting up a randomized, controlled trial difficult or if infections slow and the outbreak subsides before tests can conclude.
A database maintained by the WHO shows 81 studies currently planned, 37 of which have begun recruiting patients. Most of those listed feature traditional Chinese medicines, although some involve existing antivirals against HIV or influenza. None appear to be testing vaccines.
Remdesivir, an experimental antiviral developed by Gilead against Ebola, has received particular attention, due in part to preclinical data suggesting it could be active against SARS and MERS. A Washington man who was infected by coronavirus appeared to get better following treatment with remdesivir through compassionate use, according to a case report published in the New England Journal of Medicine last month.
Two Phase 3 trials testing remdesivir against coronavirus are set to begin in China, comparing the drug to placebo in patients hospitalized with, respectively, severe infections as well as mild-to-moderate infections.
Both studies are being led by Chinese investigators, although Gilead is providing input on study design and conduct, a company spokesperson confirmed to BioPharma Dive.
Antibody-based treatments are also being investigated, including an effort by Regeneron and the U.S. government to produce a drug cocktail against the virus.