Flu vaccines have historically represented poor economic propositions. But Germany’s Biontech has got Pfizer to sign on the dotted line in a deal covering just such an asset, using mRNA technology to develop a prophylactic that could quickly be adapted to each seasonally dominant strain.
Moderna, the mRNA leader, is working on something similar, but remarkably it has rubbished the idea’s commercial potential, calling it a proof of concept for the rest of its infectious disease pipeline. Biontech’s chief business officer, Sean Marett, disagrees, stating: “There is definitely a market need for improved flu vaccines.”
Perhaps the difference of opinion arises not because of the unmet need but because of doubts about whether this can translate into a business.
Speaking to Vantage last year Moderna’s chief executive, Stephane Bancel, said flu vaccines represented a low biology risk, with well-defined endpoints. But he cautioned: “Those have no commercial potential. Zero.” He added that Moderna was not working on flu vaccines for commercial gain, but rather in an effort to prove the science and derisk the company.
Mr Marett will not comment on Moderna’s strategic decisions, but says Biontech “really, really [sees] an opportunity here.” The need is driven by the fact that current flu vaccines might not give 100% protection in certain populations, such as the elderly.
But could mRNA be the solution? After all the complexity of RNA technologies means that they are seen as relatively expensive. Yet in the deal announcement Pfizer is quoted as saying that mRNA holds the potential to manufacture “at a lower cost than contemporary flu vaccines”.
“It’s a reasonable assumption,” Mr Marett tells Vantage. Current vaccine manufacturing requires eggs to be injected and grown, followed by virus extraction and protein purification. “With mRNA you don’t have any of that. All you need is the antigen of choice.”
In Biontech’s case that antigen has yet to be determined, as is the type of mRNA used and its delivery. But the key is flexibility: “Once you optimise the backbone you’re slotting in and out different epitopes or antigens; you can do that quite quickly. That allows for prevention in the event there’s a pandemic.”
This certainly suggests that, commercial considerations aside, Pfizer and Biontech will have a broader outlook that Moderna, whose flu vaccine efforts are limited to the H10N8 and H7N9 pandemic strains, via the two assets mRNA-1440 and mRNA-1851.
As a sign of the seriousness of the alliance, Mr Marett says Pfizer’s is the first equity investment Biontech has taken from a pharma company since it did a T-cell receptor deal with Lilly three years ago. But he will not specify Pfizer’s up-front financial commitment; all that is being disclosed is that the signing fee, equity stake and “near-term” research funding amount to $120m.
How near is near term? “It’s an aggressive programme,” says the exec.
So aggressive is the mRNA timeline, in fact, that other Biontech activities have had to be scaled back. Among these is a solid tumour CAR-T project, believed to target Claudin-6, which was initially due to enter the clinic in 2016 but is still at the preclinical stage.
“It’s a question of prioritisation,” says Mr Marett, pointing to the clinical funds that have been assigned to mRNA; Biontech’s pipeline shows four mRNA trials recruiting, and two completed. “We’ve put CAR-T on a slower trajectory. Unless something catastrophic happens we will be in the clinic in 2019.”
This shows the breadth of Biontech’s business – a key difference between the German group and Moderna, a pure RNA player. Within the RNA field, too, there are differences, such as the numbers of neoantigens targeted by the companies’ respective oncology assets, and the types of mRNA technologies they are each working on.
But as far as influenza goes Mr Marett gives credit where it is due. “We’ve got some catching up to do,” he admits.