The COVID-19 vaccine developer Moderna on Wednesday pitched investors on its future vaccine development plans, which will take the Massachusetts biotech far beyond this pandemic.
Much of the world has come to know Moderna over the past year, as its COVID-19 vaccine program became one of the first to be rolled out to the public starting in December 2020. The biotech’s vaccine is built on messenger RNA, genetic information that instructs cells how to build certain proteins.
On Wednesday, at the company’s second annual vaccines day, Moderna CEO Stephane Bancel and other top executives laid out what comes next for the $60 billion company.
Moderna CEO Stephane Bancel attends a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House on March 2, 2020. Andrew Harnik/AP Images
In an advance interview on Tuesday evening, Bancel told Insider about the latest on each of these top programs: RSV, CMV, influenza, HIV, and combination vaccines.
“Most people think we are only a COVID-19 company,” Bancel said.” But we have many other exciting vaccines that I believe are going to change the world in very profound ways.”
Most of these programs will take on some of the biggest challenges facing vaccine research, such as HIV, or pit Moderna directly against longtime industry giants that have dominated the vaccine space, like the
flu shot market with Sanofi and GlaxoSmithKline.
Moderna, chief commercial officer Corinne Le Goff said on Wednesday, is “poised to become a disruptive force in the vaccine market.”
Developing an RSV vaccine is a top priority Moderna offices in Cambridge, Massachusetts. David L. Ryan/The Boston Globe via Getty Images
Near the top of Moderna’s vaccine priorities is RSV, or respiratory syncytial virus.
Before COVID-19, the top two respiratory killers were influenza and RSV, respectively, Bancel said. Even though RSV hits most people as a mild illness, it can be particularly dangerous for infants and the elderly, according to the US Centers for Disease Control and Prevention.
Vaccine developers have been trying to develop a shot against RSV for two decades now without success. Moderna believes its mRNA approach will work.
They could face stiff competition, as a range of other vaccine giants, including Pfizer, GlaxoSmithKline, and Johnson & Johnson, are all also working on experimental RSV shots.
On Wednesday, Moderna released updated data from an early-stage human study, called a Phase 1 trial. While the study enrolled volunteers of all ages — including cohorts of children and the elderly — this data just came from the group of younger adults.
Among younger adults who already had RSV neutralizing antibodies, the virus-killing proteins that form the backbone of the immune system, a single dose of Moderna’s shot, called mRNA-1345, boosted antibody levels by at least 11-fold from baseline levels, the company said.
That shows a marked improvement from a previous RSV vaccine candidate developed by Moderna that was tested in an small-scale trial.
“We still have very strong conviction that this is a winner,” Bancel said. He added a final-stage study that could lead to approval if successful is “on track to start as soon as we get the greenlight from the regulators.”
CMV could be Moderna’s next available vaccine
Cytomegalovirus, or CMV, may be less well-known than other viruses. But Moderna’s potential CMV vaccine could be the biotech’s next vaccine to reach market, if successful.
CMV has the most impact on newborns, where the mother can pass on the virus to the baby. The CDC says most of these infections never actually show health problems, but some newborns do — and they can have severe, long-term effects, such as hearing loss, developmental and motor delay, or vision loss.
On Wednesday, the company provided updated data from a Phase 2 study that was started in January 2020. The data showed significant boosts in neutralizing antibodies after three vaccine doses.
Moderna expects to launch a Phase 3 trial this year for that vaccine. That study will enroll about 8,000 women from 16 to 40 years old across the US, Europe, and Asia.
Moderna plans to start human trials for its influenza vaccine in 2021 A Palestinian medic displays a vial of the Moderna COVID-19 vaccine, at the health ministry, in the West Bank city of Bethlehem, Wednesday, Feb. 3, 2021. AP Photo/Oded Balilty, File
Moderna is also accelerating a seasonal flu program, planning to start initial human testing this year.
Even though the biotech plans to go fast on other vaccines, Bancel acknowledged it’s not realistic for the flu program to be approved in 2021. But he wouldn’t rule out 2022 for potential approval.
“Is a couple years possible? I think yes,” he said. “Is it a slam dunk? No.”
Moderna hopes its mRNA approach will eventually upend the flu vaccine industry, where the current annual jabs typically are only 40% to 60% effective in any given year.
Finding a way to vaccinate against HIV
Moderna is also jumping into one of the most difficult and frustrating areas of vaccine research, announcing earlier this year it will attempt to develop an HIV vaccine.
Bancel acknowledged the challenge in this space, particularly a four-decade-long history of failure. But he also said there is “incredible scientific work” happening now on HIV that is leading to new vaccination ideas.
The biotech outlined Wednesday two strategies in fighting HIV.
The first collaboration is with the Bill and Melinda Gates Foundation and the nonprofit International AIDS Vaccine Initiative. The goal is to develop an mRNA-based vaccine that can elicit broadly neutralizing HIV antibodies, the company said.
They plan to use an “iterative human testing” approach to do so, where clinical trials will further inform how scientists design and formulate the vaccine candidate.
The other approach is with the US National Institutes of Health’s Vaccine Research Center, which was Moderna’s co-developer on the COVID-19 vaccine.
Moderna expects both strategies will start initial human testing this year.
The holy grail: combo vaccinations Medical syringes are seen with Moderna company logo displayed on a screen in the background i Nur Photo/Getty Images
As if the prospects for an HIV vaccine or a high-efficacy flu shot aren’t enough, what gets Bancel particularly excited is the potential to bring it all together.
The CEO said one of Moderna’s ultimate goals in vaccinology is to develop combination vaccines. These shots would be able to immunize people against multiple diseases.
Bancel outlined the vision of a Moderna vaccine that includes a COVID-19 booster, seasonal flu protection, and RSV.
“We believe that in a couple years, the right product to have is COVID variant, up to date, combined with seasonal flu, high efficacy, up to date, combined with RSV, in a single shot you go get at your CVS every year,” Bancel said. “I believe this vaccine will transform the world in term of hospitalization.”
The timeline is hazy on when exactly such a vaccine could start human testing, but Bancel said he thinks it will be much shorter than five or 10 years away.
“It would transform respiratory disease forever,” Bancel said.
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