Stéphane Bancel, Getty

Covid-19 roundup: Mod­er­na inks fill-fin­ish pact with Sam­sung Bi­o­log­ics; So­ri­ot dis­cuss­es vac­cine woes, says shot 'has a fu­ture' — re­port

As Mod­er­na has ramped up its man­u­fac­tur­ing ca­pa­bil­i­ties and looks to dis­trib­ute its vac­cine dos­es to coun­tries in dire need, the com­pa­ny has inked a deal with South Ko­re­an CD­MO Sam­sung Bi­o­log­ics for fill-fin­ish du­ties.

Sam­sung’s pro­duc­tion line in In­cheon will sup­port the pro­duc­tion of 100s of mil­lions of dos­es, good for dis­tri­b­u­tion at the start of Q3. Ko­rea has se­cured 40 mil­lion dos­es of the vac­cine.

Mod­er­na an­nounced Fri­day that its vac­cine was ap­proved by the Japan­ese and South Ko­re­an gov­ern­ments. Dis­tri­b­u­tion will hap­pen in Japan im­me­di­ate­ly, with the help of Take­da, as a part of a 3-way agree­ment. No­vavax will help man­u­fac­ture the jab in Japan.

Sam­sung’s stock rose as much as 5.2% af­ter the con­tract was an­nounced.

The move comes as vac­cine mak­ers make the push to get dos­es to Asia. Last week, Ger­many’s BioN­Tech, which col­lab­o­rat­ed with Pfiz­er on its vac­cine, an­nounced that the com­pa­ny will set roots down with an Asia re­gion­al head­quar­ters in Sin­ga­pore as the de­mand for mR­NA vac­cines has sky­rock­et­ed.

In late April, Mod­er­na an­nounced its plans to tur­bocharge its sup­ply chain and up its glob­al com­mit­ment 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.

That move was in­spired, ac­cord­ing to CEO Stéphane Ban­cel in a pre­vi­ous in­ter­view with End­points News, to pro­vide dos­es and boost­ers to coun­tries in need.

“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. “We need to aim to in­crease our ca­pac­i­ty for next year so that we can make sure we can vac­ci­nate and boost every­body.” — Josh Sul­li­van

Pas­cal So­ri­ot says As­traZeneca vac­cine ‘has a fu­ture’ in new in­ter­view

As­traZeneca has had its share of speed bumps re­gard­ing de­vel­op­ment for its Covid-19 vac­cine, and CEO Pas­cal So­ri­ot dished on some of the set­backs and opined on the shot’s fu­ture in a new in­ter­view with the Fi­nan­cial Times.

Among the high­lights? So­ri­ot be­lieves the com­pa­ny’s vac­cine “has a fu­ture” giv­en the sheer num­ber of coun­tries around the world that are sign­ing up for de­liv­er­ies. He al­so dis­cussed the dis­par­i­ty be­tween the vac­cine’s roll­out in the UK com­pared to the rest of Eu­rope, and re­ferred to the much-ma­ligned US Phase III da­ta re­lease as an “own goal.”

The com­ments were his first since the Eu­ro­pean Com­mis­sion said it would pur­sue le­gal ac­tion against the com­pa­ny over a short­fall in vac­cine de­liv­er­ies.

“I’m a Eu­ro­pean so I love Eu­rope, don’t get me wrong,” he told FT. “But at the end of the day Eu­rope is part of the world, it’s not the whole world. And there are many coun­tries around the world who ac­tu­al­ly want this vac­cine, so this vac­cine has a fu­ture.”

One of the rea­sons be­hind many of the EU coun­tries’ frus­tra­tions had been the UK’s pri­or­i­ty ac­cess to the vac­cine. So­ri­ot re­it­er­at­ed that the coun­try had been grant­ed such ac­cess as part of the agree­ment it signed with Ox­ford Uni­ver­si­ty be­fore the Big Phar­ma part­nered to help man­u­fac­ture and dis­trib­ute the shot.

He praised the UK’s de­ci­sion to ap­point some­one from the in­dus­try to run the coun­try’s vac­cine roll­out in Kate Bing­ham, a ven­ture cap­i­tal­ist. But he stopped short of crit­i­ciz­ing the EU di­rect­ly over whether it should have tak­en a sim­i­lar tac­tic.

Among As­traZeneca’s high-pro­file stum­bles came back in March, when the com­pa­ny re­port­ed its Phase III in­ter­im re­sults. Af­ter the com­pa­ny paint­ed a good pic­ture in a press re­lease, the NIH pub­lished an ex­tra­or­di­nary state­ment say­ing the com­pa­ny may have in­clud­ed out­dat­ed da­ta in its re­sults.

NI­AID chief An­tho­ny Fau­ci had called the move an “un­forced er­ror” at the time, and So­ri­ot ap­peared to agree with his “own goal” com­ment. Ac­cord­ing to So­ri­ot’s ac­count­ing of the or­deal, re­searchers were rush­ing to get out the da­ta and sim­u­lat­ed what the fi­nal re­sults would look like while for­get­ting to in­form the DSMB.

“It is not typ­i­cal­ly nec­es­sary but out of po­lite­ness and out of good prac­tice, they should have told them,” So­ri­ot said. “Peo­ple have worked so hard, they were tired, they were rush­ing.” — Max Gel­man

No­vavax to ex­plore dual flu-Covid-19 vac­cine with SK bio­sciences

No­vavax, SK Bio­science and the Ko­re­an min­istry of health have signed an agree­ment to ex­plore the de­vel­op­ment of No­vavax’s Covid-19 vac­cine.

The deal was an­nounced in a cer­e­mo­ny host­ed by South Ko­re­an Pres­i­dent Moon Jae-in. It ex­pands on a deal that was in­tend­ed to pro­vide broad ac­cess to NVX-CoV2373 glob­al­ly. As a part of the agree­ment, SK and No­vavax will ex­plore vac­cines that com­bat Covid-19 vari­ants and the pos­si­bil­i­ty of a vac­cine that would fight both Covid-19 and the flu.

NVX-CoV2373 is in 2 piv­otal Phase III tri­als: 1 in the UK that demon­strat­ed 96.4% ef­fi­ca­cy against the orig­i­nal virus strain and 86.3% ef­fi­ca­cy against the vari­ants, and a US/Mex­i­co PRE­VENT-19 tri­al.

SK Bio­science be­gan the sub­mis­sion process for the vac­cine to the South Ko­re­an gov­ern­ment in April.

First pa­tients in Pfiz­er 20vP­nC tri­al have been jabbed 

The first of 600 adults that will re­ceive a dose of the Pfiz­er-BioN­Tech 20-va­lent pneu­mo­coc­cal con­ju­gate vac­cine have re­ceived their jab, Pfiz­er an­nounced Mon­day.

The tri­al is ex­plor­ing the co-ad­min­is­tra­tion of 20vP­nC with a boost­er dose of the Pfiz­er-BioN­Tech vac­cine that’s been ap­proved by the FDA. It will de­scribe safe­ty when the vac­cines are co-ad­min­is­tered, and fol­low up 6 months af­ter vac­ci­na­tion, the com­pa­ny said.

The pa­tients will be a part of 1 of 3 groups. The first group will re­ceive the 20vP­nC vac­cine plus the Pfiz­er-BioN­Tech boost­er. The sec­ond will re­ceive 20vP­nC and a place­bo, and the third will re­ceive the Pfiz­er-BioN­Tech jab and a boost­er.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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