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.

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.

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.