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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.