Covid-19 roundup: Ger­many pours near­ly $450M in­to BioN­Tech; As­traZeneca still has­n't re­sumed its vac­cine tri­al in the US

Pfiz­er CEO Al­bert Bourla has made a point since the pan­dem­ic’s ear­ly days of re­ject­ing US as­sis­tance for their Covid-19 vac­cine, sep­a­rat­ing them from the rest of the big play­ers and cast­ing the old phar­ma gi­ant as a dy­nam­ic com­pa­ny that could move bet­ter and faster alone.

Al­bert Bourla

The sto­ry, though, for their Ger­man biotech part­ner BioN­Tech — the com­pa­ny whose mR­NA tech­nol­o­gy is ac­tu­al­ly be­hind their vac­cine — is a lit­tle dif­fer­ent. In June, the Eu­ro­pean In­vest­ment Bank gave BioN­Tech €100 mil­lion debt fi­nanc­ing to sup­port man­u­fac­tur­ing and de­vel­op­ment.

And to­day, Berlin hand­ed them a €375 mil­lion — near­ly $450 mil­lion — grant to sup­port late-stage de­vel­op­ment of the vac­cine. The con­tract, anal­o­gous in both size and scope to some of the con­tracts hand­ed out by Op­er­a­tion Warp Speed, will help BioN­Tech run the Ger­man arm of their piv­otal Phase II/III tri­al and up­scale man­u­fac­tur­ing in Ger­many, al­though no de­tails were dis­closed on how many dos­es it might cov­er.

For Ger­many, the grant rep­re­sents an­oth­er at­tempt to keep some of the vac­cines pro­duced by Ger­man com­pa­nies with­in Ger­man bor­ders. It is an ex­ten­sion of a larg­er tus­sle be­tween coun­tries over ac­cess to the first Covid-19 vac­cines and a tug-of-war over Ger­man com­pa­nies in par­tic­u­lar. The coun­try’s size­able bio­phar­ma sec­tor in­cludes mul­ti­ple home-grown com­pa­nies built on mR­NA — a tech­nol­o­gy that has proved vi­tal in the world’s re­sponse to Covid-19.

In June, Cure­Vac, the oth­er ma­jor mR­NA play­er, re­ceived a €300 mil­lion grant from Ger­many in a move ex­plic­it­ly tied to keep­ing the com­pa­ny and sup­ply of its vac­cines with­in the coun­try. Ear­li­er re­port­ing, con­firmed by the Ger­man Health Min­istry but de­nied by Cure­Vac, sug­gest­ed that the Trump ad­min­is­tra­tion had tried to lure the com­pa­ny to the US.

With their piv­otal tri­al al­ready near­ing 30,000 par­tic­i­pants, Pfiz­er and BioN­Tech are cur­rent­ly fron­trun­ners to be the first vac­cine to grab au­tho­riza­tion. Bourla has re­peat­ed­ly said they ex­pect to know if the vac­cine works by the end of Oc­to­ber — a time­line that oth­er pub­lic health of­fi­cials have said is pos­si­ble but un­like­ly. — Ja­son Mast

As­traZeneca still hasn’t re­sumed its vac­cine tri­al in the US

Nine days af­ter As­traZeneca’s Covid-19 vac­cine tri­al screeched to a halt to probe a po­ten­tial­ly se­ri­ous side ef­fect, the biotech still hasn’t got­ten the FDA green light to re­sume dos­ing in the US.

Dos­ing won’t con­tin­ue un­til US in­ves­ti­ga­tors fin­ish re­view­ing the case, ac­cord­ing to a Reuters re­port. The pa­tient in Britain re­port­ed­ly ex­pe­ri­enced in­flam­ma­tion of the spinal cord.

Pas­cal So­ri­ot As­traZeneca

As­traZeneca has al­ready restart­ed a tri­al of the Ox­ford vac­cine in Britain, ac­cord­ing to Reuters. CEO Pas­cal So­ri­ot re­mains con­fi­dent the vac­cine will still ar­rive this year. The com­pa­ny had struck deals to sup­ply the UK with dos­es as ear­ly as Sep­tem­ber.

“If the re­view of the safe­ty com­mit­tee al­lows us to restart the tri­al, I still think we are on track for hav­ing a set of da­ta that we would sub­mit be­fore the end of the year, and then of course af­ter this it de­pends on how fast the reg­u­la­tor will re­view and give ap­proval,” So­ri­ot told a Tor­toise Me­dia con­fer­ence last week. “So we can still have a vac­cine by the end of this year or maybe ear­ly next year, but by the end of this year it’s still fea­si­ble.”

This isn’t the first time the tri­al has been held up. As­traZeneca ac­knowl­edged that the tri­al hit a brief road­block in Ju­ly af­ter a dif­fer­ent pa­tient re­port­ed neu­ro­log­i­cal symp­toms. That case, how­ev­er, was tied to un­di­ag­nosed mul­ti­ple scle­ro­sis.

This time, the po­ten­tial­ly se­ri­ous ad­verse event oc­curred in a 10,000-per­son tri­al. Ex­perts say the in­ci­dence may have been co­in­ci­den­tal, giv­en the large size of the study. The con­di­tion is rare, but there has been spec­u­la­tion ty­ing it to oth­er vac­cines. Guil­lain-Barre syn­drome, an­oth­er in­flam­ma­to­ry con­di­tion, was con­nect­ed to the 1976 Swine Flu vac­cine.

Ear­li­er this month, As­traZeneca be­gan dos­ing 30,000 sub­jects for its fi­nal round of US vac­cine test­ing. The vol­un­teers are sched­uled to get 2 dos­es 4 weeks apart. Plus, As­traZeneca beefed up on­go­ing tri­als with an­oth­er 20,000 peo­ple in the UK, Brazil and South Africa.

So­ri­ot has said that though the com­pa­ny is mov­ing fast, it will ad­here to safe­ty and ef­fi­ca­cy stan­dards. Ex­perts have said the hold-up shows the sys­tem of checks and bal­ances is work­ing. — Nicole De­Feud­is 

Chi­nese CDC says vac­cine could come as ear­ly as No­vem­ber

Chi­nese CDC chief biosafe­ty ex­pert Guizhen Wu said vac­cines be­ing de­vel­oped in the coun­try could be ready for gen­er­al use in No­vem­ber or De­cem­ber, ac­cord­ing to a Reuters re­port.

Wu didn’t spec­i­fy which of Chi­na’s four vac­cines in late-stage clin­i­cal tri­als would be ready. But she added that she hasn’t ex­pe­ri­enced any ab­nor­mal side ef­fects since tak­ing a vac­cine in April.

Sinopharm and Sino­vac are work­ing on three vac­cines un­der the state’s emer­gency use pro­gram. Sino­vac’s can­di­date Coro­n­aVac was au­tho­rized for emer­gency use in Ju­ly, and of­fered to some med­ical pro­fes­sion­als and bor­der of­fi­cers, a Chi­nese of­fi­cial said in an in­ter­view with state me­dia.

CanSi­no’s can­di­date be­came the first vac­cine ap­proved for lim­it­ed use in hu­mans in June, when Chi­na’s gov­ern­ment be­gan al­low­ing the mil­i­tary to take it. It was al­so Chi­na’s first vac­cine to en­ter hu­man test­ing. The biotech re­cent­ly dropped plans for a Phase I/II study in Cana­da, af­ter dos­es of the vac­cine got stuck in cus­toms. There’s been spec­u­la­tion that po­lit­i­cal ten­sion caused the hold-up. — Nicole De­Feud­is 

Kiadis gets $9.5 mil­lion to ad­vance po­ten­tial Covid-19 treat­ment

Am­s­ter­dam-based Kiadis Phar­ma bagged $9.5 mil­lion in fund­ing from the Ad­vanced Re­gen­er­a­tive Man­u­fac­tur­ing In­sti­tute’s (AR­MI) Bio­FabUSA pro­gram and the US DoD to de­vel­op its po­ten­tial Covid-19 treat­ment.

Arthur Lahr

The mon­ey will fund re­search of its can­di­date, K-NK-ID101, a new com­pa­ny-spon­sored Phase I/IIa clin­i­cal tri­al, and the ex­pan­sion of GMP man­u­fac­tur­ing. Kiadis will work with the AR­MI pro­gram to es­tab­lish large-scale man­u­fac­tur­ing ca­pac­i­ty for K-NK cell ther­a­py in the US.

The com­pa­ny be­lieves NK (nat­ur­al killer) cells can con­trol Covid-19, which has been cor­re­lat­ed with the short­age and ex­haus­tion of NK cells. The cells are able to work to­geth­er with an­ti­bod­ies, im­munoglob­u­lins and vac­cines, ac­cord­ing to the com­pa­ny.

“K-NK cells could po­ten­tial­ly of­fer a uni­ver­sal pan­dem­ic pre­pared­ness plat­form, for COVID-19 and fu­ture pan­demics. Over time, K-NK cells could be de­vel­oped to pro­tect im­muno­com­pro­mised and high-risk pa­tients against mul­ti­ple sea­son­al res­pi­ra­to­ry in­fec­tions, in­clud­ing in­fluen­za and RSV, ei­ther alone or in com­bi­na­tion with vac­cines and an­ti­bod­ies,” CEO Arthur Lahr said in a state­ment. — Nicole De­Feud­is 

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

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.

#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.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.