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 

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.