Covid-19 roundup: EMA ups Pfiz­er, Mod­er­na vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties amid short­age

As vac­cine short­ages have caused coun­tries to scram­ble, sup­ply chain short­ages and even law­suits, the EMA has ap­proved an in­crease man­u­fac­tur­ing at Eu­ro­pean fa­cil­i­ties for both Pfiz­er-BioN­Tech and Mod­er­na’s Covid-19 vac­cines.

An in­crease in batch size at Pfiz­er’s Pu­urs, Bel­gium plant was ap­proved, in an ef­fort to suc­cess­ful­ly and safe­ly ramp up pro­duc­tion to in­crease the num­ber of dos­es avail­able. BioN­Tech CEO Ugur Sahin told Bloomberg TV last month that Pfiz­er and BioN­Tech could in­crease man­u­fac­tur­ing ca­pac­i­ty to pro­duce 3 bil­lion dos­es next year, and could cre­ate 2 bil­lion by 2021’s end. CFO Sierk Po­et­ting has al­so said that con­struct­ing new pro­duc­tion sites to keep up with de­mand is pos­si­ble.

A new man­u­fac­tur­ing line was al­so ap­proved for Mod­er­na’s site in Rovi, Spain. The line will in­crease fill-fin­ish ca­pa­bil­i­ties to keep up with a scale-up process ap­proved at Lon­za’s Visp man­u­fac­tur­ing site ap­proved in March, ac­cord­ing to a re­lease.

Pfiz­er/BioN­Tech, Mod­er­na vac­cines clear more vari­ant tests

Even as drug­mak­ers race to de­vel­op new ver­sions of Covid-19 vac­cines tai­lored to emerg­ing SARS-CoV-2 vari­ants, Pfiz­er/BioN­Tech and Mod­er­na’s orig­i­nal jabs con­tin­ue to look good enough for these new virus strains.

In the lat­est ex­am­ple, the mR­NA vac­cines have cleared pre­lim­i­nary tests against the New York vari­ant, or B.1.526, ac­cord­ing to two preprints post­ed Thurs­day. While sci­en­tists found a re­duc­tion of neu­tral­iza­tion titers in vac­cine-elicit­ed an­ti­bod­ies when pre­sent­ed with pseudovirus­es that have mu­tat­ed spike pro­teins, they note that the an­ti­bod­ies are still enough to neu­tral­ize the vari­ants.

The new re­sults add to ear­li­er ev­i­dence sug­gest­ing that the vac­cines are ef­fec­tive against the South African and UK vari­ants.

The take­away? Get vac­ci­nat­ed, with mon­i­tor­ing vari­ants and how they af­fect vac­cine and an­ti­body ef­fi­ca­cy.

“The find­ings sug­gest that cur­rent vac­cines and ther­a­peu­tic mon­o­clon­al an­ti­bod­ies will re­main pro­tec­tive against the B.1.526 vari­ants,” read a study from the NYU Gross­man School of Med­i­cine and NYU Lan­gone Vac­cine Cen­ter, re­fer­ring to Pfiz­er/BioN­Tech and Mod­er­na’s vac­cines as well as Re­gen­eron’s an­ti­body cock­tail.

Com­pared to the wild type spike pro­tein, vac­cine-elicit­ed an­ti­bod­ies still neu­tral­ized a pseudovirus with a E484K mu­tat­ed spike pro­tein but sport­ed “a mod­est 3.5-fold de­crease in titer,” they added.

The oth­er study, con­duct­ed by a coali­tion in New York, Boston and Cal­i­for­nia, not­ed that a “B.1.526 pseudovirus had a sta­tis­ti­cal­ly sig­nif­i­cant re­duced neu­tral­iza­tion titer com­pared to the D614G con­trol: for vac­ci­nee plas­ma, 4.5-fold re­duced (p = 0.00005).”

“We’re not see­ing big dif­fer­ences,” Michel Nussen­zweig, an im­mu­nol­o­gist at Rock­e­feller Uni­ver­si­ty in New York who was in­volved in that sec­ond study, told the New York Times.

EU seals sup­ply deal for 1.8B Pfiz­er/BioN­Tech dos­es while snub­bing J&J, As­traZeneca — re­port

The EU has re­port­ed­ly sealed its third con­tract with Pfiz­er and BioN­Tech, clinch­ing the sup­ply of 1.8 bil­lion dos­es over the next cou­ple of years while de­clin­ing to take up the ex­tra 300 mil­lion dos­es it’s pre­vi­ous­ly re­served from As­traZeneca and J&J.

Reuters cit­ed se­nior of­fi­cials in re­port­ing both moves. Amid long­stand­ing ten­sion with As­traZeneca and in­ves­ti­ga­tions on the safe­ty of J&J’s vac­cine, the Eu­ro­pean bloc has open­ly put its faith in the mR­NA vac­cine, with EC pres­i­dent Ur­su­la von der Leyen of­fer­ing a pub­lic shoutout to Pfiz­er-BioN­Tech and prais­ing the two com­pa­nies as a “re­li­able part­ner” that de­liv­ers on its com­mit­ments.

So far, the EU has or­dered 300 mil­lion from As­traZeneca and 200 mil­lion dos­es from J&J, with the op­tions to pur­chase an ad­di­tion­al 100 mil­lion and 200 mil­lion, re­spec­tive­ly.

“There is no need to ex­er­cise the op­tions” for those ex­tra dos­es, an of­fi­cial di­rect­ly in­volved in talks with vac­cine mak­ers told Reuters.

Here’s what a PhI­II tri­al for a sec­ond-gen Covid-19 vac­cine looks like 

French vac­cine mak­er Val­ne­va has of­fi­cial­ly made the leap to Phase III with its Covid-19 vac­cine can­di­date. But it may look a bit un­fa­mil­iar.

In­stead of en­rolling tens of thou­sands of vol­un­teers and giv­ing half of them place­bos to tease out the pro­tec­tive ef­fect of its vac­cine, Val­ne­va’s piv­otal tri­al will in­volve around 4,000 par­tic­i­pants. They will re­ceive ei­ther two shots of ei­ther VLA2001 or Vaxzevria, As­traZeneca and Ox­ford’s con­di­tion­al­ly ap­proved vac­cine. In­ves­ti­ga­tors will then com­pare the im­mune re­spons­es (i.e. an­ti­body titers) elicit­ed by each of the jabs, with an eye to su­pe­ri­or­i­ty.

While Val­ne­va sug­gest­ed that the tri­al re­sults, if pos­i­tive, would sup­port reg­u­la­to­ry ap­proval in the UK, they wouldn’t be enough for an emer­gency use au­tho­riza­tion in the US based on cur­rent FDA re­quire­ments. As­traZeneca’s shot isn’t cur­rent­ly cleared for use in the US.

No­tably, Val­ne­va is go­ing with a 4-week reg­i­men. As­traZeneca has sug­gest­ed that its ade­n­ovirus-based vac­cine is more ef­fec­tive when giv­en 12 weeks apart.

Thomas Lin­gel­bach

The on­ly Eu­ro­pean play­er to test an in­ac­ti­vat­ed vac­cine — a pop­u­lar ap­proach in Chi­na — Val­ne­va has struck a sup­ply deal with the UK, where the tri­al will take place, and is man­u­fac­tur­ing its shots in Scot­land.

“We be­lieve that VLA2001 has an im­por­tant role to play in­clud­ing boost­ers or po­ten­tial mod­i­fi­ca­tions to the vac­cine to ad­dress vari­ants,” CEO Thomas Lin­gel­bach said in a state­ment. “While Cov-Com­pare is pro­gress­ing we are plan­ning to con­duct ad­di­tion­al, com­ple­men­tary tri­als.”

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Covid-19 roundup: High­er an­ti­body counts seen in spaced-out vac­cine in­ter­vals — study; Roche CEO com­pares IP waiv­er to East Ger­man 'ex­per­i­ments'

Near the outset of the UK’s vaccination campaign, the British government outlined plans to space out shots in larger intervals in order to get more people their first shot. Now, a study has come out saying the approach can drive a higher antibody response — at least in older populations.

In a study with 175 people older than 80, the antibody response was 3.5 times higher in individuals who received their second Pfizer/BioNTech shot 12 weeks after their first, compared to those who followed the typical three-week period. Antibody levels were measured about two to three weeks after the follow-up jabs.

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Brazil­ian Covid vari­ant in Illi­nois leads to a pause in ship­ments of Lil­ly’s mAb com­bo

The US is pausing shipments of Eli Lilly’s Covid-19 treatment combo (bamlanivimab and etesevimab) to Illinois because of the increased frequency of the coronavirus variant that originated in Brazil, known also as the P.1 variant.

The FDA is now recommending that health care providers in Illinois instead use Regeneron’s monoclonal antibody combo therapy of casirivimab with imdevimab, which it said is likely to retain activity against the P.1 variant, until further notice.