Stéphane Bancel, Getty

Mod­er­na tur­bocharges its sup­ply chain, up­ping com­mit­ment to 3B dos­es per year for a fu­ture where boost­ers are like­ly

With both As­traZeneca and J&J fac­ing ma­jor hur­dles in their glob­al Covid-19 vac­cine roll­outs, the bur­den has fall­en on Mod­er­na and Pfiz­er/BioN­Tech to step up their games in terms of pro­duc­tion. Now, look­ing at a fu­ture in which boost­ers and vari­ant vac­cines will like­ly be need­ed, Mod­er­na is adding ar­mor to its sup­ply chain.

Mod­er­na is now plan­ning to pro­duce up to 3 bil­lion dos­es in 2022, dou­bling ca­pac­i­ty at con­tract sites in Switzer­land and Spain run by Lon­za and Rovi, re­spec­tive­ly, and in­creas­ing drug sub­stance man­u­fac­tur­ing by 50% at its US fa­cil­i­ties. The ex­pan­sions will al­so al­low Mod­er­na to now pro­duce be­tween 800 mil­lion and 1 bil­lion dos­es in 2021, the com­pa­ny said.

The ac­tu­al num­ber of dos­es will de­pend on the man­u­fac­tur­ing split be­tween 100-mi­cro­gram vac­cine dos­es and po­ten­tial­ly low­er-dose boost­ers and pe­di­atric vac­cines, the com­pa­ny said. The fi­nan­cial terms of the ex­pan­sion weren’t dis­closed, but Mod­er­na said it is fund­ing the move out of pock­et.

“We said ‘what can we do for the world?’ and we ba­si­cal­ly went back to our board and said ‘we need to do mas­sive in­vest­ment,'” Ban­cel told End­points News. “We need to aim to in­crease our ca­pac­i­ty for next year so that we can make sure we can vac­ci­nate and boost every­body.”

While com­peti­tors Pfiz­er, As­traZeneca, Sanofi and J&J have all reached agree­ments with Co­v­ax, the glob­al ini­tia­tive aimed at eq­ui­table ac­cess to COVID-19, Mod­er­na has not. Ban­cel would not dis­cuss the terms of a po­ten­tial deal with the coali­tion Wednes­day, on­ly say­ing that his com­pa­ny is “very ac­tive” in the fi­nal dis­cus­sions.

De­spite the pa­per agree­ments with oth­er com­pa­nies, Co­v­ax has fall­en well short of its goals,  dis­trib­ut­ing just over 40 mil­lion dos­es to date.

On top of fin­ished dos­es, Mod­er­na will al­so stock­pile a “safe­ty stock”  of raw ma­te­ri­als and fin­ished drug sub­stance used in the vac­cine as a means of avoid­ing raw sup­ply short­ages. That’s been a run­ning is­sue for Mod­er­na, re­cent­ly lead­ing it cut the num­ber of dos­es it planned to send to Cana­da by April in half. It’s al­so trou­bled oth­er vac­cine mak­ers, in­clud­ing No­vavax and In­dia’s Serum In­sti­tute.

To­day, the team at Mod­er­na is set to get CEOs of the com­pa­nies that sup­ply raw ma­te­ri­als on the phone, and lay out just what their ex­pec­ta­tions are for the next year, Ban­cel said. The cur­rent short­ages could not have been pre­dict­ed, but if this boost in man­u­fac­tur­ing is to be suc­cess­ful, Ban­cel said it is vi­tal to pre­vent the next one.

“We’re still tight on raw ma­te­ri­als, be­cause a lot of peo­ple around the world are us­ing them,” Ban­cel said.

Aid­ing its am­bi­tious dis­tri­b­u­tion plan is new da­ta un­veiled to­day show­ing the vac­cine can be vi­able with a three-month re­frig­er­at­ed shelf life. That could be a big deal since Mod­er­na’s shot is on­ly ap­proved for re­frig­er­a­tion of up to one month and sev­en months in a stan­dard freez­er. The ex­tend­ed shelf life could be cru­cial for de­liv­er­ing and ad­min­is­ter­ing the vac­cine suc­cess­ful­ly to small­er lo­ca­tions with­in coun­tries in which re­frig­er­a­tion is sparse and freez­ers are a rar­i­ty.

As it looks to ex­pand its part­ner­ship with two of its pri­ma­ry con­tract man­u­fac­tur­ers, Mod­er­na has al­so added some pro­duc­tion heft in re­cent months. French drug­mak­er Sanofi en­tered an agree­ment ear­li­er this week with Mod­er­na to help man­u­fac­ture 200 mil­lion dos­es of the com­pa­ny’s Covid-19 vac­cine at its Ridge­field, NJ site. That will be­gin in Sep­tem­ber.

New Jer­sey CD­MO Catal­ent an­nounced on April 6 that it was up­ping pro­duc­tion ca­pac­i­ty of the vac­cine in its Bloom­ing­ton, IN bi­o­log­ics fa­cil­i­ty through its new high-speed vial fill­ing line. Those dos­es are ex­pect­ed to be ready in May.

“We said look, we have a cer­tain re­spon­si­bil­i­ty as a com­pa­ny and we will in­vest ag­gres­sive­ly … so that next year we can have a big im­pact,” Ban­cel said. “If you think about it, look at the pop­u­la­tion of the plan­et, you see that 70% of peo­ple want the vac­cine, which is what we’re see­ing in polls across the world, and if we can make 3 bil­lion vac­cines, that will be, for a com­pa­ny that just launched its first prod­uct a few months ago, ex­tra­or­di­nary.”

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.

Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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