Albert Bourla, AP

Covid-19 roundup: EC strikes deals with Pfiz­er, Mod­er­na for an­oth­er 350 mil­lion vac­cine dos­es; UK ethics body OKs chal­lenge tri­al

The Eu­ro­pean Com­mis­sion has inked deals with Mod­er­na and Pfiz­er for a to­tal of 350 mil­lion more vac­cine dos­es, to be de­liv­ered through­out 2021.

It’s un­clear how much the EC is pay­ing for any of the dos­es. Mod­er­na has promised to de­liv­er 150 mil­lion more dos­es in Q3 and Q4, bring­ing the biotech’s to­tal com­mit­ment up to 310 mil­lion dos­es in 2021. As part of the new agree­ment, the EU al­so holds the op­tion to buy an­oth­er 150 mil­lion dos­es for de­liv­ery in 2022.

“Mod­er­na is com­mit­ted to work­ing re­lent­less­ly to bring to mar­ket vac­cine boosts with the rel­e­vant vari­ants to ad­dress this glob­al pan­dem­ic,” CEO Stéphane Ban­cel said in a state­ment.

The EC al­so struck a deal for 200 mil­lion more dos­es of Pfiz­er and BioN­Tech’s vac­cine, even as com­plaints about dis­tri­b­u­tion lags sur­face across the bloc.

The ad­di­tion­al dos­es will bring the EU’s to­tal sup­ply up to 500 mil­lion dos­es of the vac­cine, which is mar­ket­ed as Comir­naty in Eu­rope — a com­bi­na­tion of the terms Covid-19, mR­NA, com­mu­ni­ty and im­mu­ni­ty. The EU holds the op­tion to re­quest an­oth­er 100 mil­lion more dos­es down the road.

The 200 mil­lion dos­es will be de­liv­ered in 2021, with an es­ti­mat­ed 75 mil­lion com­ing in Q2. It’s un­clear how much the EC paid for the ad­di­tion­al dos­es.

“With this new agree­ment with the Eu­ro­pean Com­mis­sion, we now ex­pect to de­liv­er enough dos­es to vac­ci­nate at least 250 mil­lion Eu­ro­peans be­fore the end of the year,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

The an­nounce­ment comes less than a week af­ter Pres­i­dent Joe Biden said his ad­min­is­tra­tion has pur­chased an­oth­er 100 mil­lion dos­es from Pfiz­er, bring­ing its com­mit­ment up to 300 mil­lion dos­es. The US gov­ern­ment al­so pur­chased an­oth­er 100 mil­lion dos­es of Mod­er­na’s vac­cine, which are sched­uled to ar­rive by the end of Ju­ly.

Mul­ti­ple coun­tries in the EU have is­sued com­plaints about the dis­tri­b­u­tion of Pfiz­er/BioN­Tech vac­cines, in­clud­ing Italy, which threat­ened le­gal ac­tion more than once. Af­ter their vac­cine sup­ply was cut, the Ital­ian gov­ern­ment sent a for­mal let­ter of no­tice to Pfiz­er back in Jan­u­ary, urg­ing them to com­ply with con­trac­tu­al com­mit­ments for vac­cine de­liv­ery, ac­cord­ing to Reuters. Ger­many’s Ham­burg has al­so com­plained of small­er ship­ments — and said they’re hav­ing trou­ble ex­tract­ing a full six dos­es from vials.

Swe­den, on the oth­er hand, said it would refuse to pay Pfiz­er and BioN­Tech un­til they clar­i­fied with the EU how many charge­able dos­es are in a vial. The coun­try said it was charged for six dos­es per vial in­stead of five as they ini­tial­ly agreed, and the sixth dose is im­pos­si­ble to ex­tract with­out a spe­cial sy­ringe. Pfiz­er and BioN­Tech of­fi­cial­ly changed their la­bel in late Jan­u­ary to ac­count for a sixth dose in each vial.

Sev­er­al oth­er biotechs are jump­ing in to as­sist Pfiz­er and BioN­Tech with de­vel­op­ment, in­clud­ing Mer­ck KGaA, which says it can ac­cel­er­ate its sup­ply of cus­tom lipids to BioN­Tech. No­var­tis has al­so agreed to lend a hand with de­vel­op­ment, and Sanofi has of­fered the use of its Frank­furt plant to pro­duce more than 100 mil­lion dos­es. — Nicole De­Feud­is 

UK ethics body ap­proves chal­lenge tri­al

Covid-19 chal­lenge tri­als are one step clos­er to ar­riv­ing.

The UK gov­ern­ment has giv­en its stamp of ap­proval on what would be the world’s first Covid-19 hu­man chal­lenge tri­al, as the na­tion’s clin­i­cal tri­als ethics body gave the thumbs-up on Wednes­day. Britain will of­fi­cial­ly launch the tri­al with­in a month and has been prepar­ing for the stud­ies since last Oc­to­ber.

“While there has been very pos­i­tive progress in vac­cine de­vel­op­ment, we want to find the best and most ef­fec­tive vac­cines for use over the longer term,” UK busi­ness sec­re­tary Kwasi Kwarteng said in a state­ment. “These hu­man chal­lenge stud­ies will take place here in the UK and will help ac­cel­er­ate sci­en­tists’ knowl­edge of how coro­n­avirus af­fects peo­ple and could even­tu­al­ly fur­ther the rapid de­vel­op­ment of vac­cines.”

Re­searchers plan to re­cruit up to 90 young and healthy vol­un­teers aged 18 to 30 years old, who will be ex­posed to the virus in a con­trolled set­ting in an ef­fort to de­ter­mine the low­est pos­si­ble virus amount need­ed to cause in­fec­tion. Vac­cines could then be giv­en to a small num­ber of vol­un­teers be­fore be­ing ex­posed to the virus.

British of­fi­cials did not say which vac­cine might be used, on­ly those that have proven safe in clin­i­cal tri­als. So far, the UK has OK’ed three vac­cines for use: Pfiz­er/BioN­Tech’s vac­cine, Mod­er­na’s jab and As­traZeneca/Ox­ford’s shot.

In or­der to lim­it the risk to these in­di­vid­u­als, Britain plans to use the orig­i­nal strain of SARS-CoV-2 that first be­gan cir­cu­lat­ing in March, rather than any of the new virus vari­ants.

The study is be­ing run in col­lab­o­ra­tion with the UK gov­ern­ment’s Vac­cines Task­force, Im­pe­r­i­al Col­lege Lon­don, the Roy­al Free Lon­don NHS Foun­da­tion Trust and the com­pa­ny hVI­VO.

De­bate over the chal­lenge tri­als has been on­go­ing since the start of the pan­dem­ic. Pro­po­nents ar­gue that they aren’t any dif­fer­ent than wait­ing for vol­un­teers to get in­fect­ed in a large-scale piv­otal tri­al.

But crit­ics say test­ing the tri­als won’t be rep­re­sen­ta­tive of the most se­vere cas­es be­cause of the age of vol­un­teers, and ex­pos­ing them to the virus can still pose a risk. And un­like chal­lenge tri­als in oth­er dis­eases, there are few, if any, “res­cue ther­a­pies” avail­able should pa­tients fall se­ri­ous­ly ill. — Max Gel­man

Till­man Gern­gross en­ters PhI with new mon­o­clon­al an­ti­body can­di­date

An­oth­er mon­o­clon­al an­ti­body treat­ment — this one from the lab of leg­endary Till­man Gern­gross — has en­tered the clin­ic.

Till­man Gern­gross

Ada­gio Ther­a­peu­tics shared the news on Tues­day that it dosed the first pa­tient in a Phase I tri­al for its lead an­ti­body can­di­date, ADG20. That’s right on track with a plan Gern­gross laid out in Ju­ly, short­ly af­ter he raised $50 mil­lion to launch the biotech.

The CEO said that he was aim­ing for a drug that can be dosed twice a year with 90% ef­fi­ca­cy — enough to cre­ate and main­tain herd im­mu­ni­ty while hold­ing its own against any­thing else that may hit the mar­ket.

The Phase I tri­al will study ADG20’s safe­ty and tol­er­a­bil­i­ty, as well as phar­ma­co­ki­net­ics. Once safe­ty da­ta are eval­u­at­ed, Ada­gio plans on launch­ing glob­al piv­otal tri­als to as­sess its abil­i­ty to treat and pre­vent Covid-19 in­fec­tion.

“We are in the unique po­si­tion of hav­ing a mon­o­clon­al an­ti­body that binds to and pro­tects against com­mon cir­cu­lat­ing SARS-CoV-2 vari­ants as well as SARS-re­lat­ed virus­es with pan­dem­ic po­ten­tial,” Gern­gross said in a state­ment. “This broad­ly neu­tral­iz­ing ac­tiv­i­ty was in­ten­tion­al­ly de­signed in­to ADG20, as we an­tic­i­pat­ed the con­tin­ued emer­gence of re­sis­tance mu­ta­tions, and we took de­lib­er­ate steps to en­gi­neer ADG20 to max­i­mize its po­ten­tial to avoid vi­ral es­cape.” — Nicole De­Feud­is 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

As first Omi­cron case in US crops up, re­searchers won­der: Which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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