Kathrin Jansen, Pfizer via Twitter

Pfiz­er rolls out next-gen pneu­mo­coc­cal vac­cine with FDA win, beat­ing Mer­ck­'s 15-va­lent can­di­date to the punch

Mer­ck and Pfiz­er have been locked in a years­long bat­tle for a next-gen pneu­mo­coc­cal vac­cine win­ner, with the lat­ter look­ing to one-up — or should we say sev­en-up — its stan­dard 13-va­lent shot. Now, Pfiz­er has nosed out a win with the FDA’s back­ing, leav­ing Mer­ck and its 15-va­lent shot wait­ing in the wings.

Pfiz­er said on Tues­day that the FDA has ap­proved its Pre­vnar 20 for adults 18 years and old­er — just over a month be­fore Mer­ck’s PDU­FA date for its V114. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is sched­uled to meet in Oc­to­ber to dis­cuss and up­date rec­om­men­da­tions on the use of pneu­mo­coc­cal vac­cines, ac­cord­ing to Pfiz­er.

“With a sin­gle in­jec­tion, PRE­VNAR 20 pro­vides adults with strong and mean­ing­ful pro­tec­tion against serotypes re­spon­si­ble for the ma­jor­i­ty of cir­cu­lat­ing pneu­mo­coc­cal dis­ease around the world,” Kathrin Jansen, SVP and head of vac­cine R&D at Pfiz­er, said in a state­ment.

There are cur­rent­ly two main types of pneu­mo­coc­cal vac­cine: pneu­mo­coc­cal con­ju­gate vac­cines (PCV) and pneu­mo­coc­cal poly­sac­cha­ride vac­cines (PPSV). Both con­tain poly­sac­cha­rides tak­en from serotypes of S. pneu­mo­ni­ae bac­te­ria, which cause pa­tients’ im­mune sys­tems to de­vel­op an­ti­bod­ies that will lat­er rec­og­nize that poly­sac­cha­ride.

Mer­ck came out with its 23-va­lent PPSV, Pneu­movax 23, back in 1983. How­ev­er, PPSVs have been shown to have poor per­for­mance in younger chil­dren. As a so­lu­tion, drug­mak­ers have de­vel­oped “con­ju­gat­ed” vac­cines, in which the poly­sac­cha­rides are at­tached to a car­ri­er pro­tein.

Pfiz­er got a 7-va­lent con­ju­gate vac­cine ap­proved in 2000, fol­lowed by its 13-va­lent megablock­buster Pre­vnar 13 in 2010. Pre­vnar 20 cov­ers all 13 strains that Pre­vnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F. The ad­di­tion­al sev­en strains ac­count for about 40% of all pneu­mo­coc­cal dis­ease cas­es and deaths in the US, ac­cord­ing to Pfiz­er.

Pre­vnar 13 raked in $5.8 bil­lion in 2020 and was once the world’s best-sell­ing vac­cine in pre-Covid times. The fol­low-on won’t bring in the $26 bil­lion that Pfiz­er’s Covid-19 vac­cine is ex­pect­ed to in 2021, but Prophe­cy Mar­ket In­sights ex­pects the glob­al pneu­mo­coc­cal vac­cine mar­ket to grow from $8.1 bil­lion in 2020 to $13.5 bil­lion by 2030.

The vac­cine was fast tracked by the FDA back in 2017, then giv­en pri­or­i­ty re­view in 2018. The FDA’s de­ci­sion was based on Phase I and II da­ta, as well as three Phase III tri­als that en­rolled a to­tal of 6,000 adults.

Pfiz­er un­veiled da­ta from one of those stud­ies — a piv­otal Phase III that en­rolled 902 adults with no his­to­ry of pneu­mo­coc­cal vac­ci­na­tion — back in Oc­to­ber at ID­Week. The study com­pared Pre­vnar 20’s per­for­mance to Pre­vnar 13 and Pneu­movax 23. All 20 serotypes in­duced “ro­bust re­spons­es” across three age co­horts (18 to 49, 50 to 59, and 60 or old­er), ac­cord­ing to Pfiz­er.

In the fo­cus group of adults 60 and old­er, Pre­vnar 20’s re­sponse was non-in­fe­ri­or to all serotypes in com­mon with Pre­vnar 13, and six of the sev­en new serotypes in com­mon with Pneu­movax 23 one month af­ter vac­ci­na­tion. Serotype 8 just bare­ly missed the non-in­fe­ri­or­i­ty low­er bound cri­te­ria, but showed im­mune re­spons­es in oth­er pa­ra­me­ters, the com­pa­ny said. Im­mune re­spons­es to Pre­vnar 20 in the two younger age co­horts were non-in­fe­ri­or to the same vac­cine’s re­spons­es in adults 60 to 64 years old.

Pfiz­er al­so read out da­ta from in­fant tri­als (en­rolling ba­bies 42 to 98 days old), which showed a con­sis­tent safe­ty pro­file com­pared to Pre­vnar 13 and im­mune re­sponse to all 20 serotypes one month af­ter the third dose. Boost­er re­spons­es were record­ed for all serotypes a month af­ter the fourth dose.

Mer­ck isn’t throw­ing in the tow­el just yet. Last month — even as it looked like Pre­vnar 20 might beat it to mar­ket — the Ke­nil­worth, NJ-based phar­ma read out topline re­sults from two Phase III pe­di­atric stud­ies, and said it’s on track to sub­mit a sup­ple­men­tary BLA by the end of the year.

V114 cov­ers the 13 serotypes cov­ered by Pre­vnar 13, plus an ad­di­tion­al two: 22F and 33F.

Roy Baynes

“Re­sults from these stud­ies sup­port the po­ten­tial of V114 to con­fer im­muno­genic­i­ty for PCV13 serotypes in in­fants who have pre­vi­ous­ly re­ceived one or mul­ti­ple dos­es of PCV13, and for the 15 serotypes in V114 in chil­dren in a catch-up set­ting,” Mer­ck Re­search Labs CMO Roy Baynes said.

As Mer­ck and Pfiz­er duke it out, a 24-va­lent can­di­date is in the mak­ing that hopes to top­ple them both. Vax­cyte, for­mer­ly known as SutroVax, is in ear­ly de­vel­op­ment with VAX-24 and ex­pects to file an IND in the first half of 2022. The com­pa­ny pulled in $249 mil­lion in an IPO last June, and says a Phase I/II read­out would fol­low be­tween late 2022 and ear­ly 2023.

On Jan. 11 — the same day the FDA ac­cept­ed a BLA for V114 — Mer­ck filed a law­suit chal­leng­ing three of Pfiz­er’s patents re­lat­ing to its pneu­mo­coc­cal con­ju­gate com­po­si­tions. The com­pa­ny has asked a judge to rule that V114 “does not and will not in­fringe any valid claim of these three patents.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantial reforms to the advisory committee process at the agency.

Short on examples of the adcomms she was referring to, Cavazzoni said at a BIO event aired on Monday that some recent committees show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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