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Entering Phase 2: Moderna Therapeutics Races to Create COVID-19 Vaccine

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More than two months after the World Health Organization officially declared the coronavirus outbreak a pandemic, experts trying to envision ways to safely return life in the United States to normal have agreed that having a vaccine is a crucial component of any plan.

As of May 11, the coronavirus pandemic has claimed the lives of 283,271 worldwide, with more than 4 million confirmed cases in more than 200 countries.

Moderna Therapeutics, a Cambridge-based biotechnology company founded in 2010, is now at the forefront of coronavirus vaccine development. The company recently received FDA approval to move onto Phase 2 of vaccine testing, in addition to 500 million dollars’ worth of grants from the Biomedical Advanced Research and Development Authority, a government organization that assists companies through the development process of drugs and vaccines.

The company employs messenger RNA to create medicines that enable a patient’s cells to create proteins to treat disease. Messenger RNA — dubbed “the software of life” on the company’s website — provides instructions to cells to make proteins for various functions in the body.

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Timothy A. Springer, a professor at Harvard Medical School and founding investor in Moderna Therapeutics, said his fellow faculty member, Derrick J. Rossi, asked him if he would be interested in investing in a company using Rossi’s research on modified RNA.

“Modified RNA seemed a very exciting new technology with lots of potential,” Springer said. “I said, ‘Yes, I would love to invest, and I’d also like to help you get it started.’”

“Derrick Rossi — who was a professor at Harvard, a young professor — he had made a finding about how you could add certain types of RNA to cells and make them kind of like what’s called a stem cell,” Robert S. Langer, a co-founder of the company and professor at MIT, said.

Rather than just using this strategy for what Langer calls “tissue engineering,” Langer suggested using it for drugs and vaccines as well.

“One of the beauties of messenger RNA is that you can make it and you can make it quickly,” Langer said. “But then what happens is you can just inject a little bit of it in a nanoparticle, you inject it into the body, and then the body is actually the factory that makes it.”

ENTERING TRIALS

According to the World Health Organization, there are currently eight candidate coronavirus vaccines in clinical evaluation. Moderna is one of the first companies to receive approval for Phase 2 of clinical evaluation.

The National Institute of Health announced in late March that it would begin Phase 1 study of Moderna’s vaccine.

“There were 45 healthy volunteers. The NIH ran the trial, and that trial is still proceeding, but they expanded the population of what was prior — healthy 18- to 55-year-olds — has now been expanded to include 56- to 70-year-olds and 71-year-olds and above,” Raymond C. Jordan, the head of corporate affairs for Moderna, said in an interview with The Crimson.

“We’ve also been cleared by the FDA to enter what’s called a Phase 2 trial. And that trial will go into hundreds — roughly 600 healthy volunteers — across the full spectrum of age from 18 years old, right up through the older and elderly population,” Jordan added.

Moderna is also already scaling up its own production capacity and partnering with a manufacturing organization to further increase capacity.

“We’re doing this before having all of the final efficacy data that we would want from the earlier trials,” Jordan added.

Moderna CEO Stéphane Bancel said that, in a best case scenario, people may be able to start receiving vaccinations as early as September.

“This is a timeline assuming everything goes well. Any bumps on the road would just push the time out obviously,” Bancel said. “Last week we got the green light from the FDA to start the Phase 2, around 600 subjects, and the plan is to start the Phase 3 early summer.”

“We’re expecting to be able to make up to tens of millions of doses a month this year, and as many as a billion doses in 2021,” Jordan said.

Barry R. Bloom, a professor of immunology and global health at the School of Public Health, explained that the process of development, approval, and mass production for vaccines traditionally takes much longer. The fastest vaccine was for mumps and rubella, which took four years, while other vaccines — like varicella, which took 27 years — have taken much longer.

But according to Bloom, even before the pandemic, the Biomedical Advanced Research and Development Authority had been coordinating an expedited vaccine approval process with the National Institute of Health.

“The unique part of BARDA was that it not only dealt with scientists, which is what NIH largely does — it dealt with 300 companies. So that becomes a way to save another major problem in the timeframe,” said Bloom, explaining that the need to mass produce so many doses in so little time presents significant difficulties.

Moderna has benefited from this expedited process.

“In 65 days, they [Moderna] had the vaccine from the DNA sequence, cDNA sequence, healthy RNA, to getting the first shots into Phase 1 — people’s arms — which is astonishing and unprecedented,” Bloom said.

Though Moderna is among several companies racing to develop a vaccine, Springer — the Medical School professor — said Moderna brings something to the table the others do not.

“I think Moderna does have a very strong advantage over the rest of the field,” he said. “It’s multifold. They have hugely invested in the technology underlying RNA science, which hasn’t really previously been studied throughout industry.”

“They're using modified RNA,” he said. “It requires a very deep understanding.”

Thoughtful recruiting was key to Moderna’s efforts, Springer said, adding that biochemist and molecular biologist Melissa J. Moore, whom he described as “one of the most outstanding RNA scientists in the world,” serves as the company’s Chief Scientific Officer.

‘NOT OUR FIRST RODEO’

In addition to technology, Bancel said that Moderna’s team has valuable experience in developing vaccines quickly, including against MERS, another coronavirus.

Bancel said his team has already shown “the ability to move very, very fast.”

“It was not our first rodeo — this is our tenth vaccine to go into clinical studies,” he added.

Noubar B. Afeyan, another co-founder of Moderna, explained how the company must adapt its operations during this new project.

“This has, in a significant way one could argue, interrupted many things and required a lot of resource allocation, the scarcest version of which is our management attention,” Afeyan said. “We are implementing processes as a company that would usually be necessary much later in the development, but we have no choice because we’ve been thrust into that mode sooner.”

Indeed, Bancel said his team has been working hard to adapt to these unusual times.

“Often we get emails at two o’clock in the morning or on weekends,” Bancel said. “People are working very hard — the team at Moderna has been — seven days a week.”

There is some concern over what would happen if the current strain of coronavirus were to mutate, but Jordan and Langer feel the vaccine could be easily adapted.

“If you think for instance of the flu — the sort of annual flu, the seasonal flu vaccines — once you’ve got the platform for addressing it, you can change it each year without having to go through a full process of clinical trials,” Jordan said.

Bloom emphasized the importance of successfully developing a vaccine in order to end the pandemic.

“Historically, the only way to interrupt that timeframe, which is dictated by the virus, is to have a vaccine that interrupts transmission and provides immunity. That’s it,” he said.

“There are no other alternatives.”

—Staff writer Natalie L. Kahn can be reached at natalie.kahn@thecrimson.com.

—Staff writer Taylor C. Peterman can be reached at taylor.peterman@thecrimson.com. Follow her on Twitter @taylorcpeterman.

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