‘Moderna Therapeutics is a white-knuckle ride’: Here’s what happens if you want to start a biotech company

Moderna Therapeutics, a biotech company that has raised hundreds of millions of dollars in funding, was conducting a study in eight of the largest American high schools when it halted the trial at the end of January. The study was testing a vaccine called MappX that was being developed to prevent infections caused by the Zika virus and for cancer vaccines. There was “little evidence” that the vaccine created enough “stimulatory antibodies” to be effective at reducing infections caused by Zika, a disease that can be contracted through the bite of an infected mosquito, Moderna wrote in a release.

Moderna’s decision came on the same day that Health and Human Services Secretary Alex Azar announced a $115 million emergency grant to Moderna, which is applying for Ebola and Zika vaccines to prevent future public health threats. And less than a week after Moderna received the grant, the Food and Drug Administration said it was conducting a clinical trial to see if the vaccine caused any “irregular heart rhythms” in children ages 5 to 12 years old.

Moderna, which was founded in 2010, raised $150 million in financing in 2016 and took $345 million in Series B funding in February, a source told Bloomberg. This week’s news came as a shock to those who expected to see Moderna’s application be approved and worth as much as $5 billion, as first reported by the New York Times.

Moderna’s approach is, in effect, the culmination of a step-by-step process from genetic research to drug development. It holds patents for a method of using patient’s own cells to restore damaged DNA, and is developing drugs based on that technology. Moderna’s work is not the first of its kind — U.S. drug companies have been employing the same approach for years to generate vaccines for diseases including HIV and malaria — but few pharmaceutical companies have kept up with Moderna’s pace. It now has 12 employees and plans to open a facility in New Jersey later this year, creating a thousand jobs by 2022, according to Bloomberg.

So how is Moderna different from other biotech companies? On the surface, Moderna’s business approach is cheaper. “The cost of our vaccine is around 10 cents,” Moderna’s scientific advisor, Mani Shankar, told the Times. Moderna’s vaccine has to be manufactured in a lab, eliminating the need for routine clinical trials. Moderna’s president, Adam Craig, told the Wall Street Journal that Moderna could produce a 10-cent vaccine and still recoup the costs of the research over five years. Moderna does not make any of its own drugs but instead aims to license its technology to big pharma. Dr. Vitus Heerema, a former Senior Scientist at Merck who is now at Moderna, previously told the Times that Moderna could create a Zika vaccine for as little as $30 million.

Moderna is not the only biotech company to encounter delays of major proportions. Last year, the FDA rejected a Blood Cancer vaccine for being “more effective and less unsafe” than other treatments. A woman who was enrolled in the study, filed a lawsuit in a Massachusetts federal court to halt the procedure. In July, the Cambridge, Massachusetts, firm, Alexion Pharmaceuticals halted its study for hemophilia when the trial participants contracted blood diseases that require blood transfusions, including leukaemia.

While it is important to note that the FDA has a very difficult time approving experimental drugs, it is still encouraging to see the agency willing to do so even in the face of massive funding barriers and challenges. The time commitment required to run clinical trials of an experimental drug, such as the ones Moderna is undertaking, is very demanding, and demands the best clinical trials specialists. It seems that today’s rule-of-law society, in the face of grotesque anti-science lobbying by the medical industry, will not let Big Pharma rush our scientific progress any more than it did before the Titanic hit the iceberg.

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