Despite mRNA powerhouses Pfizer and Moderna continuing to tower over the COVID-19 vaccine market, there still are plenty of biotechs hoping to carve off a slice. When they took to the stage at the Jefferies Healthcare London Conference this week, these newer players were asked the same billion-dollar question: What sets you apart?
One of the companies trying to get a hearing is Novavax. On the sidelines of the conference, Chief Medical Officer Filip Dubovsky, M.D., explained to Fierce Biotech that while the mRNA and viral vector vaccines that make up the majority of the COVID market “all work by delivering a nucleic acid sequence into your body … our approach is really a much more classical approach, where we make the proteins outside the body.”
The Gaithersburg, Maryland-based company has been around for over 20 years, at one point focused on developing vaccines for the perennially tricky indication of respiratory syncytial virus, which ultimately failed in phase 3 (more on that later). When COVID-19 hit, the company was awaiting phase 3 results for a potential influenza vaccine and had been dabbling in the SARS and MERS space for a few years.
“By the time that we got to the pandemic, we had a tremendous amount of experience with [our] platform with coronaviruses and how to use this recombinant protein nanoparticle technology in a variety of applications that we could use as the basis for that [COVID-19] vaccine,” Chief Commercial Officer and Chief Business Officer John Trizzino tells Fierce Biotech.
The vaccine in question, which the company continues to call its “prototype,” may not be a household name to rival Pfizer’s Comirnaty, but it has been approved in 43 countries, including the U.S., where it finally received emergency authorization from the FDA in July this year, followed by the green light as a booster dose in October.
Earlier in the month, the company posted phase 3 data confirming that a booster dose of the prototype was effective against a range of variants. In the same readout, Novavax’s monovalent BA.1 vaccine candidate, dubbed NVX-CoV2515, was shown to induce greater neutralizing responses than the prototype in people not previously exposed to COVID-19.
While it looks like Novavax has been late to the party when it comes to gaining COVID market share, Trizzino claims the company is playing the long game. Novavax hopes that once the smoke has cleared from the pandemic, national regulators and paying customers will be more discerning about which vaccine they use for their annual booster campaigns.
“Taken as a whole, I would put us up against mRNA,” Trizzino says. “For repeat boosting, for reactogenicity issues—do I want less of a sore arm? Do I not want to be out of work or out of school for a couple of days? Do I want to have a better opportunity of having cross-strain protection?”
“I think that there's a place for us in an annual seasonal COVID market going forward,” he adds.
As well as NVX-CoV2515, Novavax has a bivalent shot in the works. In the past, the company has sounded less enthusiastic about this approach, but Trizzino says the option is there in case the market demands it. Given the choice, however, they’d rather point to the broad protection offered by their other shots than chase after specific strains.
If pointing to the data doesn’t work, maybe the company should consider simply highlighting the weirdness of its technology’s source materials: They make the proteins for the COVID-19 vaccine in insect cells, while their Matrix-M adjuvant is derived from the bark of a tree found in South America.
Flora and fauna aside, the company sees its technology as having been validated by the COVID vaccine’s regulatory successes, giving Novavax the confidence to accelerate its broader pipeline. The company is most excited by the influenza shot Nanoflu, which demonstrated in a phase 3 in 2020 that it could go head-to-head with Sanofi’s Fluzone Quadrivalent. While work on the flu program took a back seat during the pandemic, the company is now pushing ahead with the shot as well as combining the vaccine with its approved COVID-19 asset for a combo shot that is about to enter another phase 2 study to decide on the final formulation it’ll use for late-stage trials.
“I was a little fearful influenza wouldn't be back to its normal cadence and I wouldn't be able to do an efficacy study,” Dubovsky says. “But this year it came roaring back.”
And remember those failed RSV candidates? It turns out the company hasn’t given up on them either. “COVID has taught us a lot of lessons,” says Trizzino. “The older adult vaccine for RSV was a single dose, not adjuvanted—that was a mistake.” Novavax now plans to return to the clinic with a new version of the vaccine, complete with a revamped dosing regimen and an adjuvant.
They’re managing expectations, though. As former CMO for clinical affairs at AstraZeneca, Dubovsky points out that there’s a reason no one has managed to get an RSV vaccine to market. “I joke that I have more failed RSV vaccine studies under my belt than anyone else,” he says.
Earlier in the pipeline, Novavax is still exploring potential candidates for respiratory diseases like SARS and MERS. To this end, Trizzino isn’t shy about the fact that the company is on the lookout for partners. So does he mean finding other vaccines that would benefit from Novavax’s adjuvant, or licensing external assets to swell their own vaccine portfolio?
“Yes and yes,” Trizzino responds. “Our sweet spot is respiratory and infectious diseases, and so we know that space really well.”
Then there are emerging infectious diseases like Ebola, malaria or monkeypox, where the company may also spy an opportunity. “Typically these have been tropical diseases, and suddenly they are finding their way outside of the tropics,” Trizzino adds. “So we have to assess: What are those areas that we want to pursue?”