Stéphane Bancel, Moderna CEO (AP Images, Boston Herald)

Mod­er­na says its mR­NA flu vac­cine cleared ear­ly stud­ies, but com­par­isons with oth­er vac­cines dri­ve stock down

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 will con­firm dose lev­els and com­pare it to an ap­proved flu vac­cine, the com­pa­ny said, and prepa­ra­tions for a large piv­otal tri­al are un­der­way. Mod­er­na said it is al­so ad­vanc­ing new de­signs that can have po­ten­tial­ly broad­er cov­er­age of dif­fer­ent flu strains than cur­rent shots.

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 past the gate. Al­though all four have pro­grams un­der­way, Mod­er­na is the first to an­nounce da­ta.

Those da­ta, though, don’t give a clear an­swer on whether mR­NA can im­prove on pre­vi­ous tech­nolo­gies. 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, with fa­tigue, myal­gia (mus­cle ache), and headache the most com­mon side ef­fects.

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.

Out­side ex­perts praised the da­ta, but were cau­tious about how big an im­pact the sin­gle shot will have, es­pe­cial­ly giv­en Mod­er­na’s promise of “pre­mi­um pric­ing.”

“It looks very good,” Adol­fo Gar­cía-Sas­tre, di­rec­tor of the Cen­ter for Re­search on In­fluen­za Patho­gen­e­sis, said in an email.”There are many ap­proved flu vac­cines. I think if ap­proved, this will be just one more.”

An­a­lysts al­so raised ques­tions about what the side ef­fect pro­file could mean for the po­ten­tial com­bo vac­cine. SVB Leerink’s Mani Foroohar not­ed there were sig­nif­i­cant­ly more grade 3 side ef­fects than in oth­er flu vac­cines.

Com­bin­ing that with a Covid-19 boost­er and an RSV boost­er could po­ten­tial­ly make a shot that’s too re­ac­to­genic to be wide­ly used.

Should Mod­er­na “go back to the draw­ing board?” Foroohar asked on a con­fer­ence call.

Mod­er­na pres­i­dent Stephen Hoge cau­tioned against mak­ing com­par­isons be­tween shots be­fore head-to-head tri­als came out.

Stephen Hoge

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.

On the con­fer­ence call Fri­day morn­ing, Hoge es­ti­mat­ed the flu vac­cine mar­ket at $11 bil­lion. He said the com­pa­ny could cut sig­nif­i­cant­ly in­to that mar­ket by be­ing able to close­ly match cir­cu­lat­ing strains, cit­ing da­ta that sug­gest in some years flu vac­cine ef­fi­ca­cy drops as low as 19%.

He par­tic­u­lar­ly not­ed the im­pact of vari­a­tion in H3N2 on vac­cine ef­fi­ca­cy.

“This, we think, rep­re­sents one of the most sig­nif­i­cant op­por­tu­ni­ties for im­prov­ing vac­cine ef­fi­ca­cy,” he said.

But the com­pa­ny’s own da­ta on an­ti­bod­ies com­par­ing their shot to a dif­fer­ent tri­al to Sanofi’s ap­proved pro­tein-based flu vac­cine Flu­zone found the re­sults were large­ly sim­i­lar. CEO Stéphane Ban­cel fo­cused in­stead on strain-match­ing and the po­ten­tial for a two-in-one or three-in-one vac­cine.

“We be­lieve Mod­er­na can be the first com­pa­ny to mar­ket a vac­cine for covid-plus-flu,” he said.

Jef­feries an­a­lyst Michael Yee said the da­ta were “promis­ing” and “some­what in line with our ex­pec­ta­tions,” but he ac­knowl­edged the com­par­i­son da­ta leave room for de­bate. “There is go­ing to be de­bate on whether it’s tru­ly bet­ter than new­er high-ef­fi­ca­cy vac­cines from [Sanofi],” he said.

As Sanofi CEO Paul Hud­son has ar­gued, be­cause there are al­ready es­tab­lished shots, the bar for ap­proval and wide­spread adop­tion in flu may be high­er than it was for Covid-19. And not all vac­ci­nol­o­gists agree that mR­NA is a good match for flu, es­pe­cial­ly giv­en their harsh­er side ef­fects.

Hilde­gund Ertl

“They on­ly give short-lived im­mu­ni­ty to COVID (less than 6 months) af­ter two dos­es, with more side ef­fects than a reg­u­lar flu shot,” Hilde­gund Ertl, a vac­ci­nol­o­gist at the Wis­tar In­sti­tute who fo­cus­es on ade­n­ovirus vac­cines, said in an email. “They did a great job with the pan­dem­ic but I don’t see them as a long-term so­lu­tion for sea­son­al virus­es.”

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 12% pre­mar­ket.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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