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 

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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