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 

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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