J&J taps in­to BAR­DA well a third time to speed up its PhI­II Covid-19 vac­cine tri­al

BAR­DA is pour­ing $454 mil­lion more in­to John­son & John­son’s Covid-19 vac­cine ef­forts, as the phar­ma huffs and puffs to catch up with fast-mov­ing fron­trun­ners Pfiz­er/BioN­Tech and Mod­er­na.

Janssen, the J&J sub­sidiary de­vel­op­ing the vac­cine can­di­date, has al­ready re­ceived over $1.4 bil­lion from the HHS de­part­ment. Un­der the ex­pand­ed agree­ment, BAR­DA will kick in an­oth­er $454 mil­lion to sup­port the com­pa­ny’s 60,000-per­son Phase III tri­al, and J&J will com­mit an­oth­er $604 mil­lion.

The com­pa­ny pre­vi­ous­ly aimed to read out da­ta this year, but J&J head of glob­al R&D Math­ai Mam­men told Bloomberg last week that the lofty goal is now “a bit of a stretch.” On­ly a few thou­sand pa­tients have en­rolled in the tri­al, which is par­tial­ly due to a brief pause af­ter one par­tic­i­pant de­vel­oped an un­ex­plained ill­ness, he said. The tri­al re­sumed late last month, af­ter the com­pa­ny an­nounced that no clear cause was iden­ti­fied. They said there’s “no ev­i­dence that the vac­cine caused the event.”

Slow en­roll­ment puts the can­di­date, JNJ-78436735, far be­hind Pfiz­er and Mod­er­na, which have both read out re­sults from their first Phase III in­ter­im analy­ses. Pfiz­er said its BioN­Tech-part­nered can­di­date proved to be more than 90% ef­fec­tive, and Mod­er­na an­nounced to­day that its own can­di­date ap­pears to be 94.5% ef­fec­tive. Both can­di­dates should pro­duce the nec­es­sary safe­ty da­ta to ap­ply for emer­gency au­tho­riza­tion this month.

But J&J isn’t out of the game just yet. While Pfiz­er and Mod­er­na rush two-dose can­di­dates to ap­proval, J&J was the first com­pa­ny to en­ter Phase III with a sin­gle-dose reg­i­men. A sin­gle-dose can­di­date could ease man­u­fac­tur­ing and dis­tri­b­u­tion, which has be­come some­thing of a headache for oth­ers in the race.

Last week, J&J part­nered with Unit­ed­Health to ac­cel­er­ate en­roll­ment. It plans on us­ing the health care com­pa­ny’s trove of da­ta to help iden­ti­fy new tri­al sites and achieve a more di­verse par­tic­i­pant pop­u­la­tion. “Be­ing in front of that, you re­al­ly want surges to hap­pen af­ter you vac­ci­nate peo­ple so you have the fastest read on whether or not things are work­ing,” Unit­ed­Health CSO Ken Ehlert told Bloomberg. The com­pa­nies hope their col­lab­o­ra­tion can slash the Phase III tri­al time in half.

“We great­ly val­ue the on­go­ing con­fi­dence and sup­port of our in­ves­ti­ga­tion­al COVID-19 vac­cine can­di­date de­vel­op­ment pro­gram,” J&J CSO and ex­ec­u­tive com­mit­tee vice chair­man Paul Stof­fels said about the new BAR­DA agree­ment. “Com­bined with our own sig­nif­i­cant in­vest­ment, this agree­ment has en­abled our vi­tal re­search and de­vel­op­ment and un­der­scores the im­por­tance of pub­lic-pri­vate part­ner­ships to tack­le the world­wide COVID-19 pan­dem­ic.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Pascal Soriot (Getty)

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Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

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Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.