Franz-Werner Haas, CureVac CEO (Thomas Kienzle/AFP via Getty Images)

Covid-19 roundup: Cure­Vac backs out of man­u­fac­tur­ing con­tracts as de­mand dwin­dles; De­spite PhII/III flop, biotech keeps look­ing for sil­ver lin­ing

Cure­Vac ter­mi­nat­ed con­tracts with two com­pa­nies who had signed on to help the Ger­man drug mak­er man­u­fac­ture its mR­NA Covid-19 vac­cine in Eu­rope, as po­ten­tial de­mand for its shot has dwin­dled.

Con­tracts with Wack­er for the man­u­fac­tur­ing of mR­NA drug sub­stance and Celonic for the man­u­fac­tur­ing and for­mu­la­tion of the mR­NA drug sub­stance for the drug, dubbed CVn­CoV, are no more. The com­pa­ny has held on to ex­ist­ing agree­ments with Rentschler Bio­phar­ma and No­var­tis for mR­NA pro­duc­tion, and said that those will not be af­fect­ed.

The com­pa­ny at­trib­uted the de­ci­sion to what it called “the re­duced short-term peak de­mand for vac­cines fol­low­ing the first wave of the pan­dem­ic vac­ci­na­tion ef­forts,” in com­bi­na­tion with change in de­mand for its can­di­date.

The an­nounce­ment comes a few months af­ter the com­pa­ny failed a piv­otal Covid-19 vac­cine tri­al, when it was on­ly 48% ef­fec­tive. The com­pa­ny chalked up the fail­ure to vari­ants, specif­i­cal­ly the Lamb­da vari­ant out of Pe­ru, al­though that ar­gu­ment found lit­tle trac­tion with ex­perts.

The com­pa­ny has said it’s still com­mit­ted to seek­ing reg­u­la­to­ry ap­proval with the EMA. Mean­while, vac­ci­na­tion rates in Eu­rope have risen to the high­est in the world, sur­pass­ing the Unit­ed States.

“The de­vel­op­ment from a very high, short-term pan­dem­ic de­mand to broad­er avail­abil­i­ty of vac­cines has led us to re-eval­u­ate our im­me­di­ate man­u­fac­tur­ing ca­pac­i­ty re­quire­ments in or­der to align the ca­pac­i­ty with ac­tu­al com­mer­cial and clin­i­cal ca­pac­i­ty needs for CVn­CoV,” COO Malte Gre­une said in a press re­lease. “We would like to thank both our man­u­fac­tur­ing part­ners for their ded­i­ca­tion and ef­fort in achiev­ing our com­mon goal to com­bat the pan­dem­ic with this key tech­nol­o­gy.”

Fi­nan­cial terms sur­round­ing the can­cel­la­tion weren’t dis­closed, per an agree­ment be­tween both sides, the press re­lease said. — Josh Sul­li­van

An­oth­er ther­a­py fails to help se­vere pa­tients — but biotech isn’t giv­ing up

More than a year af­ter the pan­dem­ic sent a horde of biotechs in­to a fren­zied cam­paign to re­pur­pose their drugs for Covid-19, the search is still prov­ing elu­sive.

Red­Hill Bio­phar­ma’s opa­ganib is the lat­est can­di­date to dis­ap­point, as it failed to meet the pri­ma­ry end­point — the pro­por­tion of pa­tients breath­ing room air with­out oxy­gen sup­port by Day 14 — of a Phase II/III study for se­vere pa­tients.

All 475 pa­tients in the tri­al were hos­pi­tal­ized with se­vere Covid-19 pneu­mo­nia. They were giv­en ei­ther opa­ganib or place­bo on top of stan­dard of care.

But Red­Hill isn’t throw­ing in the tow­el just yet. Point­ing to the drug’s “strong an­tivi­ral mech­a­nism and ef­fect against vari­ants” ob­served in a pre­vi­ous Phase II study, ex­ecs say re­searchers are still an­a­lyz­ing the da­ta to see if they can find sil­ver lin­ings such as sub­group ben­e­fits. Be­sides, they say, the drug ap­pears to have good tol­er­a­bil­i­ty with bal­anced ad­verse events in the drug and place­bo arms.

“While we are dis­ap­point­ed with the da­ta not reach­ing sta­tis­ti­cal sig­nif­i­cance, we do see a trend that needs to be in­ves­ti­gat­ed that opa­ganib may pro­vide ben­e­fit to pa­tients ear­li­er in the course of the dis­ease,” said CEO Dror Ben Ash­er.

Tout­ed as an oral, first-in-class sphin­go­sine ki­nase-2 (SK2) se­lec­tive in­hibitor, opa­ganib is de­signed to tar­get a key en­zyme in hu­man cells that virus­es are be­lieved to co-opt as they repli­cate.

The biotech is al­so test­ing RHB-107 (up­amo­stat) in non-hos­pi­tal­ized symp­to­matic Covid-19 pa­tients. — Am­ber Tong

12- to 15-year-olds now el­i­gi­ble for vac­cine in UK

With a re­duced dis­rup­tion of ed­u­ca­tion in mind, the British gov­ern­ment has giv­en the OK to ado­les­cents ages 12 to 15 to re­ceive the Covid-19 vac­cine, the coun­try’s health min­is­ter said in a state­ment.

Vac­ci­na­tions will be­gin in Eng­land next week, and Scot­land, Wales and North­ern Ire­land will set their own health pol­i­cy.

“I have ac­cept­ed the rec­om­men­da­tion from the Chief Med­ical Of­fi­cers to ex­pand vac­ci­na­tion to those aged 12 to 15 — pro­tect­ing young peo­ple from catch­ing COVID-19, re­duc­ing trans­mis­sion in schools and keep­ing pupils in the class­room,” health min­is­ter Sajid Javid said.

The Pfiz­er-BioN­Tech vac­cine will be of­fered, as im­muno­com­pro­mised chil­dren in that age group were al­ready el­i­gi­ble for that shot. — Josh Sul­li­van

On heels of man­u­fac­tur­ing agree­ment for mR­NA vac­cine, Prov­i­dence CEO trash­es gov­ern­ment 

On Tues­day, Prov­i­dence Ther­a­peu­tics an­nounced that it was team­ing with the high­ly scru­ti­nized Emer­gent Bioso­lu­tions to get help de­vel­op­ing its mR­NA Covid-19 vac­cine can­di­date. Just a day ear­li­er, its CEO went on tele­vi­sion and trashed the Cana­di­an gov­ern­ment for its role in do­mes­tic vac­cine pro­duc­tion.

CEO Brad Soren­son went on the Bloomberg News Net­work and called out Prime Min­is­ter Justin Trudeau and his ad­min­is­tra­tion, say­ing he’s done the “ab­solute min­i­mum”  to sup­port Cana­di­an biotech, in­clud­ing Prov­i­dence, while throw­ing mon­ey at for­eign com­pa­nies to get them to come to Cana­da.

“We could’ve been sup­ply­ing vac­cines to the world and we could’ve been adding to the so­lu­tion as op­posed to dri­ving up prices and adding to the prob­lem,” he said in an in­ter­view.

Last week, Re­silience an­nounced that it will start mak­ing mR­NA for Mod­er­na’s Covid-19 vac­cine at its new site in Cana­da. The com­pa­ny land­ed a $163 mil­lion con­tract from the gov­ern­ment of Cana­da, while Mod­er­na al­so struck a deal for its own plant in Au­gust, and Ab­Cellera got $125.6 mil­lion to help build its 130,000-square-foot fa­cil­i­ty to de­vel­op an­ti­bod­ies and of­fer pre­pared­ness for fu­ture pan­demics.

“In March of 2020, we were one month be­hind Mod­er­na,” he said. “Mod­er­na re­ceived a bil­lion dol­lars in sup­port from Warp Speed and you can see where they’re at now. Prov­i­dence re­ceived no sup­port from the Cana­di­an gov­ern­ment un­til al­most a year lat­er and even then, we re­ceived $10 mil­lion, which is nom­i­nal at best.” — Josh Sul­li­van

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

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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President Biden in the East Room of the White House (Evan Vucci/AP Images)

Opin­ion: How the con­fus­ing boost­er shot de­ba­cle aligns Biden with Trump's pan­dem­ic re­sponse

When President Joe Biden took office, many public health advocates heaved a sigh of relief, assuming the US was back to following the science during this once-in-a-lifetime pandemic, and gone were the days of an American president touting ineffective treatments to the world.

But this latest debacle around the Pfizer/BioNTech booster shot has now not only led to the retirements of two top FDA vaccine officials, both of whom would’ve been key resources as the US soon reviews Covid vaccines for children, but also to question marks around conflicting FDA and CDC opinions and lingering debates on who exactly should receive a boost first and who should be the one that makes that decision.