Moderna says its mRNA flu vaccine cleared early studies, pivotal trial on its way

Stéphane Bancel (AP Images, Boston Herald)

Mod­er­na says that it’s on its way to hav­ing an mR­NA vac­cine against not one, but two dif­fer­ent sea­son­al virus­es.

The biotech re­leased the first ear­ly da­ta from its flu pro­gram Fri­day morn­ing, an­nounc­ing that all dos­es of the shot sig­nif­i­cant­ly boost­ed an­ti­bod­ies in younger and old­er adults with­out ‘sig­nif­i­cant safe­ty find­ings.’ A 500-per­son Phase II dose-con­firm­ing study is al­ready en­rolled, the com­pa­ny said, and prepa­ra­tions for a large piv­otal tri­al are un­der­way.

The re­sults are the open­ing sal­vo in a four-head­ed (so far) race to de­vel­op the first mR­NA flu vac­cine, as Mod­er­na tries to edge out BioN­Tech, Sanofi sub­sidiary Trans­late Bio, and Cure­Vac to get the first mR­NA vac­cine ap­proved. Al­though all four have pro­grams un­der­way, Mod­er­na is the first to an­nounce da­ta.

Those da­ta, though, are dif­fi­cult yet to parse. Mod­er­na said the 50 mi­cro­gram dose of the shot, de­signed like most flu vac­cines to in­oc­u­late against four dif­fer­ent strains of the virus, in­creased an­ti­bod­ies against the two In­fluen­za A strains by eight-fold and ten-fold, re­spec­tive­ly, and against the two in­fluen­za strains by three-fold and two-fold.

There was lit­tle dif­fer­ence in an­ti­bod­ies be­tween dose lev­els, the com­pa­ny said. Safe­ty da­ta echoed those from the Covid-19 vac­cine.

In a state­ment, the CEO Stéphane Ban­cel said the da­ta were ‘ro­bust’ and an ‘im­por­tant mile­stone.’ The com­pa­ny hopes it will even­tu­al­ly be ap­proved and then com­bined with its Covid-19 vac­cine, and its ex­per­i­men­tal RSV shot for a sin­gle sea­son­al virus vac­cine.

The true test for the shot, though, will be how well it holds up com­pared to the many flu vac­cines al­ready on the mar­ket.

Com­pa­nies work­ing on mR­NA vac­cines have long be­lieved mR­NA flu shots could be more po­tent and man­u­fac­tured faster than ex­ist­ing flu vac­cines, al­low­ing de­vel­op­ers to more close­ly match up the strains in the shot with the strains cir­cu­lat­ing in a giv­en sea­son. But as Sanofi CEO Paul Hud­son has ar­gued, be­cause there are al­ready es­tab­lished shots, the bar for ap­proval and wide­spread adop­tion may be high­er than it was for Covid-19.

Mil­lions of dol­lars, though, are be­ing spent on the idea that mR­NA can re­place ex­ist­ing flu shots en­tire­ly. Pfiz­er is help­ing BioN­Tech’s ef­forts and GSK has signed on­to Cure­Vac’s.

In­vestors and in­fec­tious dis­ease ex­perts will close­ly com­pare to­day’s da­ta with ear­ly re­sults out of on­go­ing Phase I tri­als from BioN­Tech and Trans­late in the com­ing months. For now, the in­vestors ap­pear large­ly bear­ish.

Mod­er­na $MR­NA is down 7.5% pre­mar­ket.

Andreas and Thomas Strüngmann (via Agreus Group)

While the ultimate fate of Novartis’ big generics arm Sandoz may still be up in the air, there’s no doubt it’s in play as a potential buyout target.

Overnight, Reuters picked up on a report out of Germany that EQT and the billionaire Strüngmann brothers — enjoying a huge windfall from the overnight success of BioNTech’s mRNA Covid vaccine — are kicking the tires at Sandoz. And Novartis CEO Vas Narasimhan confirmed it.

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Boris Johnson at a press conference Dec. 8, after discussions on restrictions as a result of the Omicron variant (Adrian Dennis/Pool via AP Images)

With reports of Omicron cases in over 50 countries, and at least 19 US states, some regions like the UK are now expecting a rapid rise of Omicron as community spread takes off.

While the UK has only seen about 800 Omicron cases so far, the government’s Health Security Agency warned that if the recent growth rate continues, ‘we expect to see at least 50 percent of Covid-19 cases to be caused by the Omicron variant in the next two to four weeks,’ according to the New York Times.

Angion’s lead organ damage drug took two strikes earlier this year, flopping as a repurposed effort for Covid-19 and whiffing in high-risk kidney transplant patients. The biotech reported a third on Thursday, raising serious questions about the program’s future.

In a Phase II study looking at some cardiac surgery patients at risk of kidney injury, Angion reported its ANG-3777 candidate missed badly on the primary endpoint. The results come about a month and a half after the kidney transplant study and less than five months after the Covid-19 trial, ostensibly leaving the candidate on the chopping block.

Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)

The new J&J has a fresh corporate face to show the public — several in fact.

As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.

Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.

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Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.

Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.

For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.

We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.

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Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it’s been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)

Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.

But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.

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The US House of Representatives voted almost unanimously on Wednesday evening (423-3) to pass a bill that will provide $500 million over five years to certain small drugmakers to cover the costs of R&D and to expand access to patients not eligible for clinical trials for potential amyotrophic lateral sclerosis drugs.

Rare neurodegenerative diseases, like ALS, have been historically very difficult to treat and to develop treatments for. But this bipartisan bill, introduced by Rep. Mike Quigley (D-IL) and dozens of cosponsors, will provide $100 million for each of fiscal years 2022 through 2026 to help HHS award grants to facilitate the development and access to ALS drugs intended to prevent, diagnose, mitigate, treat, or cure the disease.

Margaret Koziel has bounced back and forth between academia and biotech throughout her career — and after 25 years, she has landed her first position as part of a biotech’s top brass.

Koziel joined Axcella Therapeutics — founded by Flagship’s Noubar Afeyan, Geoffrey von Maltzahn and David Berry as Axcella Health — in 2019, and as of Monday, she is now in the C-suite as the biotech’s new CMO.
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