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Moderna’s Bancel highlights speed, flexibility of mRNA platform as COVID-19 vaccine heads to Phase II

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As Moderna readies a Phase II trial of its COVID-19 vaccine just 12 weeks after the virus was sequenced, CEO Stéphane Bancel told BioCentury that the speed of the company mRNA platform could also be an advantage in tackling viral mutations. The biotech, whose shares continued to climb Thursday, also bolstered its team by adding a trio of infectious disease veterans.

Moderna Inc. (NASDAQ:MRNA) gained $4.24 to $53.19 Thursday, bringing its market cap to $19.7 billion. The company has seen its value almost triple in just over two months.

Moderna closed at $18.59 on Feb. 24, equaling a $6.9 billion market cap, the day before NIH announced its plans to run the Phase I trial of mRNA-1273. In mid-March, Moderna became the first company to have a COVID-19 vaccine in the clinic.

Joining the company as it makes its push to start a pivotal trial of the vaccine this summer are Jacqueline Miller, SVP, infectious disease development and Patrick Bergstedt, SVP, commercial vaccines. Miller was VP and head, clinical R&D and epidemiology at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), and Bergstedt was head of global marketing and commercial operations within the vaccines unit of Merck & Co. Inc. (NYSE:MRK).

“One of the beautiful things about mRNA is the speed at which you can design a new product and go again.”

Stéphane Bancel, Moderna

Moderna also hired Charbel Haber as SVP, regulatory affairs. He was VP, global safety and regulatory sciences at Biogen Inc. (NASDAQ:BIIB) and, earlier in his career, associate director of vaccine regulatory affairs at MedImmune and manager of worldwide regulatory affairs for vaccines and biologics at Merck.

Moderna is searching for a successor to longtime CFO Lorence Kim, who is stepping down, the company said.

Outmaneuvering mutations

That a virus mutation could derail spike-focused COVID-19 vaccine and antibody candidates has always been possibility, and a Los Alamos National Laboratory team highlighted the risk last week in a preprint reporting a SARS-CoV-2 spike mutation.

Bancel told BioCentury that while RNA viruses such as SARS-CoV-2 mutate more frequently than DNA viruses, the efficacy of Moderna’s vaccine would only be affected if a mutation occurred within the spike protein, and specifically affected binding. If a mutation did, “one of the beautiful things about mRNA is the speed at which you can design a new product and go again,” he said.

Moderna shipped its first batch of vaccine to NIH about six weeks after SARS-CoV-2 was sequenced -- a process Bancel said could be even faster for a second vaccine.

And any updated version, Bancel said, could vaccinate against the old strain as well as any new mutated strains, because Moderna’s platform allows it to combine multiple mRNAs in a single vaccine.

Bancel pointed to the company’s Phase II CMV vaccine, which has six different mRNAs.

“We have already shown that we can safely make clinical grade material with more than one mRNA,” he said.

Next steps

Moderna said Thursday it’s been cleared by FDA to start a Phase II trial of mRNA-1273, which will enroll 600 healthy volunteers across two cohorts: one in adults ages 18-55, and a second in adults 55 and older.

Moderna secured mass manufacturing capacity for mRNA-1273 last week through a deal with Lonza Group Ltd. (SIX:LONN), which will start supplementing the biotech’s vaccine production starting in July. Lonza amplifies Moderna’s manufacturing 10-fold, Bancel said, and has the capacity to manufacture 100 million 50 μg doses per year (see “Lonza to Manufacture COVID-19 Vaccine”).

A Phase III trial is expected to begin early this summer. While Moderna is still finalizing the protocol, Bancel said the study will likely enroll at least 5,000 individuals.

A BLA approval could come next year.

At least six COVID-19 vaccines have made it to Phase I trials. Along with Moderna, two other groups could receive Emergency Use Authorization (EUA) as early as this fall: Pfizer Inc. (NYSE:PFE) and partner BioNTech SE (NASDAQ:BNTX), as well as the University of Oxford and Vaccitech Ltd. (see “End of the Beginning”).

And a vaccine from a Chinese entity also could be ready for emergency use in “special groups” by September, according to George Gao, director general of China’s Center for Disease Control and Prevention. Gao did not identify whose vaccine he was discussing.

The trial clearance puts Moderna at a similar pace with Oxford, which plans to start Phase II/III testing in 5,000 individuals as early as this summer. The successes of both programs can be traced back to each group’s past with another coronavirus -- Middle East respiratory syndrome (MERS).

Oxford’s vaccine has its roots in a MERS project funded in part by Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine, ChAdOx1 nCoV-19, delivers genetic sequences from SARS-CoV-2 using the same recombinant adenovirus vector as the MERS candidate, which was shown to be safe and induce neutralizing antibodies against MERS in humans (see “AstraZeneca to Make COVID-19 Vaccine with Oxford”).

Bancel said that while the company “always has backup products for every product we do,” Moderna is confident in mRNA-1273 because it builds on previous experience with MERS.

The company worked with NIH’s National Institute of Allergy and Infectious Diseases for two years on a MERS vaccine, which showed “strong protection” in a challenge model in rabbits, Bancel said.

“This preclinical work, coupled with the fact that every other vaccine we’ve done -- and we’ve done nine before this one -- have always translated from preclinical model to the clinic, gives us confidence that mRNA-1273 should work,” Bancel said. “From a scientific standpoint, we are lucky we have worked on coronaviruses before. I would not have this optimistic of a view if this was our first coronavirus vaccine ever.”

Bancel said two pieces of data should be available in the coming weeks that will give a better indication of mRNA-1273’s efficacy: results from an animal challenge study, and neutralizing antibody data from the Phase I study.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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