Covid-19 roundup: Cure­Vac ex­pands cache to $1.3B as coro­n­avirus race heats up; Russ­ian sci­en­tists pub­lish ear­ly da­ta to back up vac­cine

The mon­ey just keeps on pour­ing in for Cure­Vac.

Fol­low­ing a se­ries of high-pro­file deals and an IPO raise to­tal­ing near­ly $1 bil­lion in re­cent weeks, the biotech an­nounced an­oth­er cash in­jec­tion Fri­day, net­ting about $300 mil­lion (€252 mil­lion) from the Ger­man gov­ern­ment to sup­port its mR­NA Covid-19 vac­cine can­di­date. In ad­di­tion to de­vel­op­ing the vac­cine, the mon­ey will be used to rapid­ly ramp up pro­duc­tion.

The fund­ing was grant­ed af­ter Cure­Vac ap­plied to a Ger­man gov­ern­ment pro­gram to ac­cel­er­ate vac­cine R&D back in Ju­ly. Pay­ments are con­tin­gent on reach­ing pre­de­fined mile­stones, with an ex­pect­ed fund­ing of up to €103 mil­lion in 2020 and up to €149 mil­lion in 2021.

“Giv­en the sig­nif­i­cant costs re­lat­ed to the de­vel­op­ment of a safe and ef­fec­tive vac­cine, as well as to the ex­ten­sion of the man­u­fac­tur­ing ca­pac­i­ty, we be­lieve that this grant can sub­stan­tial­ly sup­port our ef­forts to pro­duce and de­vel­op a safe and ef­fec­tive vac­cine in high vol­ume as quick­ly as pos­si­ble,” CEO Franz-Wern­er Haas said in a state­ment.

Cure­Vac stock $CVAC jumped slight­ly at the news, up around 4% in ear­ly Fri­day trad­ing.

Fri­day’s an­nounce­ment is the lat­est in a long string of big fundrais­ing from the com­pa­ny, which for years was pri­vate­ly front­ed by Ger­man bil­lion­aire Di­et­mar Hopp. Its most re­cent round, pri­or to go­ing pub­lic a few weeks ago, brought in a whop­ping $640 mil­lion from main in­vestors GSK and Ger­many in late Ju­ly.

That was soon fol­lowed by the IPO, which raised $213 mil­lion, and an ad­di­tion­al share pur­chase by Hopp for $118 mil­lion. Af­ter rais­ing near­ly $1 bil­lion in the span of three weeks, and now with this new Ger­man grant in hand, Cure­Vac is now val­ued at around $10 bil­lion.

The news al­so came short­ly af­ter Hopp com­ment­ed ear­li­er Fri­day about his de­sire for Cure­Vac to pro­duce 100 mil­lion dos­es of its vac­cine can­di­date by the end of the year, ac­cord­ing to Reuters. Though the vac­cine is ex­pect­ed to gain reg­u­la­to­ry ap­proval by next spring or sum­mer, a lim­it­ed au­tho­riza­tion could come through for those with high-risk jobs.

Cure­Vac’s mR­NA vac­cine ri­vals, Mod­er­na and BioN­Tech, are al­so like­ly to beat the biotech to mar­ket, Hopp said, and it ranks 12th in End­points News’ Covid-19 vac­cine race track­er.

“We can’t win this race,” Hopp said. “But we want to win the race to pro­duce the best vac­cine and here we have good chances.”

Cure­Vac is just one of sev­er­al com­pa­nies re­search­ing how mes­sen­ger RNA can be ap­plied to po­ten­tial Covid-19 vac­cines. Though the tech­nol­o­gy has nev­er been ap­proved for vac­cine use be­fore, in­vestors are fun­nel­ing bil­lions of dol­lars on the hopes of a break­through, open­ing the door to a whole new pipeline of drugs across the in­dus­try. — Max Gel­man

Rus­sia’s reg­is­tered vac­cine shows promis­ing re­sults in ear­ly tri­al, sci­en­tists re­port

Al­most a month af­ter Rus­sia reg­is­tered the world’s first Covid-19 vac­cine, the whole world is fi­nal­ly get­ting a glimpse of some ear­ly hu­man da­ta.

The study, pub­lished in the Lancet, gives all the pos­i­tive signs: Among 76 vol­un­teers in two Phase I/II stud­ies, the vac­cine — dubbed Sput­nik V — ap­peared safe, and neu­tral­iz­ing an­ti­bod­ies were de­tect­ed in all par­tic­i­pants. T cell re­spons­es were al­so there, with pro­lif­er­a­tion of both CD4+ and CD8+ types.

“Sim­i­lar to these stud­ies be­fore it, Lo­gunov and col­leagues’ stud­ies are en­cour­ag­ing but small,” con­clud­ed an ac­com­pa­ny­ing ed­i­to­r­i­al. “The im­muno­genic­i­ty bodes well, al­though noth­ing can be in­ferred on im­muno­genic­i­ty in old­er age groups, and clin­i­cal ef­fi­ca­cy for any COVID-19 vac­cine has not yet been shown.”

None of the stud­ies, so far, have been deemed suf­fi­cient to sup­port vac­cine li­cen­sure, and Rus­sia’s sur­prise an­nounce­ment had stirred up dis­be­lief and mock­ery in the US, where of­fi­cials have re­port­ed­ly turned down Rus­sia’s of­fer to col­lab­o­rate on the vac­cine, say­ing “There’s no way in hell the US tries this on mon­keys, let alone peo­ple.”

On the oth­er hand, Chi­na has opened up ac­cess to ex­per­i­men­tal jabs for cer­tain pop­u­la­tions such as mil­i­tary per­son­nel, med­ical work­ers and more re­cent­ly avi­a­tion staffers.

De­vel­oped by the Gama­leya Na­tion­al Re­search In­sti­tute of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy, the vac­cine com­pris­es two vec­tor com­po­nents, re­com­bi­nant ade­n­ovirus type 26 (rAd26) and re­com­bi­nant ade­n­ovirus type 5 (rAd5), car­ry­ing the gene for the SARS-CoV-2 full-length spike gly­co­pro­tein. Af­ter an ini­tial safe­ty test, in­ves­ti­ga­tors ad­min­is­tered rAd26 and rAd5 se­quen­tial­ly in a prime-boost reg­i­men.

In to­tal, 40 par­tic­i­pants were giv­en this reg­i­men, de­signed to al­le­vi­ate con­cerns about pre-ex­ist­ing im­mu­ni­ty to ade­n­ovirus­es. Some re­ceived the frozen for­mu­la­tion, while oth­ers got the lyophilized ver­sion — which Lancet re­view­ers Naor Bar-Zeev and Tom In­gles­by con­sid­ered a strength of the study.

Com­pared to the frozen for­mu­la­tion, the lyophilized (freeze-dried) could mean sta­bil­i­ty with­in ex­ist­ing cold chains with­out caus­ing the hur­dle that’s fac­ing play­ers like Pfiz­er and BioN­Tech.

An­oth­er strength, they not­ed, is a high stan­dard for mea­sur­ing neu­tral­iza­tion.

“With this (pub­li­ca­tion) we an­swer all of the ques­tions of the West that were dili­gent­ly asked over the past three weeks, frankly with the clear goal of tar­nish­ing the Russ­ian vac­cine,” Kir­ill Dmitriev, the head of the Russ­ian Di­rect In­vest­ment Fund (RDIF), told Reuters. The sov­er­eign wealth fund has backed the vac­cine can­di­date. “All of the box­es are checked,” he told Reuters. “Now… we will start ask­ing ques­tions of some of the West­ern vac­cines.”

But Bar-Zeev and In­gles­by al­so not­ed lim­i­ta­tions with the Russ­ian da­ta. In the frozen vac­cine por­tion of the tri­al, for in­stance, the group in­clud­ed young mil­i­tary per­son­nel who could be health­i­er than the gen­er­al pub­lic. Old­er adults are al­so ab­sent from the group, which was al­so over­whelm­ing­ly white.

“Clear­ly, much more re­mains to be learned from the phase 3 ran­domised tri­al planned to in­clude 40 000 civil­ian vol­un­teers and, hope­ful­ly, broad­ly in­clu­sive of groups at risk,” they wrote. — Am­ber Tong

No­vo look­ing at di­a­betes drugs to treat se­vere Covid-19 cas­es

No­vo Nordisk is in­ves­ti­gat­ing whether an ex­ist­ing drug class used to treat di­a­betes can pro­vide new treat­ment op­tions for se­vere cas­es of Covid-19.

Mads Krogs­gaard Thom­sen, the Dan­ish drug­mak­er’s CSO, told Bloomberg News in an in­ter­view Fri­day that GLP-1 drugs could prove ef­fec­tive in treat­ing Covid-19. Stud­ies have shown that in­di­vid­u­als af­flict­ed with di­a­betes, as well as those with obe­si­ty, of­ten show more se­ri­ous symp­toms from coro­n­avirus in­fec­tions.

“The ear­ly in­di­ca­tion is that the GLP-1 class is ac­tu­al­ly ben­e­fi­cial in Covid-19,” he told Bloomberg. “That’s not un­ex­pect­ed be­cause this is the class of agents that tar­get the risk fac­tors for bad Covid-19 out­comes.”

Thom­sen point­ed to new re­search sug­gest­ing that young peo­ple who con­tract Covid-19 are at risk of de­vel­op­ing type 1 di­a­betes, an au­toim­mune dis­or­der, as an­oth­er rea­son for the new fo­cus. Rather than a pa­tient’s own im­mune sys­tem at­tack­ing be­ta cells in the pan­creas, coro­n­avirus de­stroys the body’s in­sulin pro­duc­ers.

A small study out of France ear­li­er this week al­so il­lus­trat­ed the links be­tween Covid-19, weight and di­a­betes, es­ti­mat­ing that on­ly one out of 10 pa­tients who end up in in­ten­sive care are in a range of healthy weight.

No­vo is the biggest di­a­betes drug pro­duc­er in the world and has a slate of GLP-1 drugs on the mar­ket, such as Ozem­pic for type 2 di­a­betes and Sax­en­da for obe­si­ty. Ozem­pic raked in $1.64 bil­lion in glob­al 2019 sales, up from $264 mil­lion in 2018, and is ex­pect­ed to sur­pass $3 bil­lion in 2020. Sax­en­da is al­so on pace for a $1 bil­lion haul this year.

On the whole, the GLP-1 mar­ket to­taled $11.3 bil­lion last year. This in­clud­ed sales of block­busters Trulic­i­ty, from Eli Lil­ly, and By­dure­on, from As­traZeneca. — Max Gel­man

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

So­cial im­age: Franz-Wern­er Haas, Cure­Vac

Janet Woodcock (AP Images)

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