Covid-19 roundup: Paul Hud­son says US will have first dibs on Sanofi vac­cine; Gilead se­lects 5 gener­ic man­u­fac­tur­ing part­ners for remde­sivir

If Sanofi can suc­cess­ful­ly de­liv­er a Covid-19 vac­cine, the US will get first ac­cess to it, CEO Paul Hud­son told Bloomberg News.

That’s be­cause the US, through its bio­med­ical de­fense agency BAR­DA, has in­vest­ed in the tech­nol­o­gy, back­ing the com­pa­ny’s Pro­tein Sci­ences sub­sidiary with a $30 mil­lion grant for its re­com­bi­nant Covid-19 vac­cine ef­fort. Since its found­ing in 2005, BAR­DA has heav­i­ly fund­ed both Sanofi — a French com­pa­ny — and Pro­tein Sci­ences, which was an in­de­pen­dent biotech un­til 2017.

“The U.S. gov­ern­ment has the right to the largest pre-or­der be­cause it’s in­vest­ed in tak­ing the risk,” Hud­son told Bloomberg. The US ex­pects “that if we’ve helped you man­u­fac­ture the dos­es at risk, we ex­pect to get the dos­es first.”

Hud­son’s com­ments are the lat­est glimpse at a sim­mer­ing bat­tle over who will get a vac­cine once it’s ap­proved. That bat­tle has par­tic­u­lar­ly cen­tered on the US and the Trump ad­min­is­tra­tion, which has es­chewed in­ter­na­tion­al co­op­er­a­tion — in­clud­ing an $8 bil­lion fund raised ear­li­er this month — in fa­vor of an in­ter­nal and thus far vague­ly de­fined ef­fort to get Amer­i­cans in­oc­u­lat­ed first. BAR­DA is fund­ing some of the world’s lead­ing Covid-19 vac­cine ef­forts, back­ing not on­ly Sanofi, but al­so putting around $1 bil­lion be­hind J&J and Mod­er­na’s ef­forts.

The de­bate be­gan in earnest in March, when Reuters and a lead­ing Ger­man news­pa­per re­port­ed that the Trump ad­min­is­tra­tion tried to lure Ger­man mR­NA vac­cine com­pa­ny Cure­Vac to the Unit­ed States. Ger­man sci­en­tists and of­fi­cials re­spond­ed with dis­may and ac­ri­mo­ny, con­demn­ing ef­forts for any coun­try to se­cure ex­clu­sive ac­cess to a vac­cine. The EU sub­se­quent­ly gave Cure­Vac an $89 mil­lion grant, in part to ex­pand man­u­fac­tur­ing on the con­ti­nent.

Since then, oth­er coun­tries have tried to se­cure ear­ly ac­cess. As­traZeneca said the UK will re­ceive first ac­cess to the Ox­ford vac­cine they have agreed to man­u­fac­ture.

Hud­son’s com­ments are par­tic­u­lar­ly sur­pris­ing be­cause Sanofi is a French com­pa­ny, and it’s un­clear how French of­fi­cials will re­spond. Hud­son said he has tried to en­cour­age Eu­rope to back vac­cine ef­forts in the way the US and Chi­nese gov­ern­ments have, but to lit­tle avail.

“I’ve been cam­paign­ing in Eu­rope to say the U.S. will get vac­cines first,” Hud­son said.  “That’s how it will be be­cause they’ve in­vest­ed to try and pro­tect their pop­u­la­tion, to restart their econ­o­my.”

Part­ner­ing with GSK, Sanofi has said they can pro­duce 600 mil­lion dos­es of their ex­per­i­men­tal vac­cine per year but are aim­ing for more. — Ja­son Mast

Gilead se­lects 5 gener­ic man­u­fac­tur­ers for remde­sivir

Gilead has sealed deals with five gener­ic man­u­fac­tur­ers in In­dia and Pak­istan to pro­duce remde­sivir for 127 coun­tries — most­ly low- and low­er-mid­dle in­come coun­tries but al­so a hand­ful of up­per mid­dle and high-in­come coun­tries where health­care ac­cess is an is­sue.

Soon af­ter the US-based com­pa­ny un­veiled piv­otal da­ta sug­gest­ing its an­tivi­ral could help hos­pi­tal­ized Covid-19 pa­tients re­cov­er faster, which prompt­ed the FDA to is­sue an emer­gency use au­tho­riza­tion, ex­ecs had laid out plans to ramp up mass pro­duc­tion around the world through vol­un­tary li­cens­es com­plete with tech trans­fers.

The five part­ners ini­tial­ly cho­sen are Cipla, Fer­oz­sons Lab­o­ra­to­ries, Het­ero Labs, Ju­bi­lant Life­sciences and My­lan. They are free to set their own prices for the drugs in the coun­tries where the li­cens­es are ef­fec­tive.

In a state­ment, Gilead added:

The li­cens­es are roy­al­ty-free un­til the World Health Or­ga­ni­za­tion de­clares the end of the Pub­lic Health Emer­gency of In­ter­na­tion­al Con­cern re­gard­ing COVID-19, or un­til a phar­ma­ceu­ti­cal prod­uct oth­er than remde­sivir or a vac­cine is ap­proved to treat or pre­vent COVID-19, whichev­er is ear­li­er.

Coun­tries like the US, Chi­na, South Ko­rea and Japan — where remde­sivir has al­ready been ap­proved — are not in­clud­ed from the deal. Gilead is ex­pect­ed to team up with “lead­ing chem­i­cal and phar­ma­ceu­ti­cal man­u­fac­tur­ing com­pa­nies” for most parts of Asia and Eu­rope. — Am­ber Tong

Chi­na’s lead­ing Covid-19 vac­cine man­u­fac­tur­er makes move in Cana­da

CanSi­no Bi­o­log­ics, the Chi­nese biotech that’s emerged at the head of a glob­al race for a Covid-19 vac­cine, will soon be bring­ing its ex­per­i­men­tal in­oc­u­la­tion to North Amer­i­ca.

CanSi­no and Cana­da’s Na­tion­al Re­search Coun­cil have agreed to col­lab­o­rate on a Phase I/II tri­al in the coun­try, with the goal of ramp­ing quick­ly in­to an ac­cel­er­at­ed Phase III study that can prove ef­fi­ca­cy. The agency said the deal in­cludes bio­pro­cess­ing and that the NRC would help scale up pro­duc­tion, al­though it was un­clear to what lev­el.

Al­though Mod­er­na, work­ing with the NIH, was the first to put their vac­cine in­to hu­mans, CanSi­no quick­ly emerged as the most clin­i­cal­ly ad­vanced ef­fort. Work­ing with the med­ical sci­ence arm of the Chi­nese mil­i­tary and with a tech­nol­o­gy that’s al­ready yield­ed a Chi­nese-ap­proved Ebo­la vac­cine, they were able to gain swift au­tho­riza­tion for a Phase II tri­al. Mod­er­na and a group at Ox­ford have both since joined them at that in­ter­me­di­ate ef­fi­ca­cy stage.

CanSi­no’s his­to­ry with the Cana­di­an re­search coun­cil goes back to 2013, the NRC said, when CanSi­no li­censed from the agency the cell lines it used to cre­ate its Ebo­la vac­cine and is now us­ing for Covid-19. Their ap­proach in­volves us­ing an ade­n­ovirus vec­tor to de­liv­er a gene for a coro­n­avirus anti­gen in­to hu­man cells. J&J and Ox­ford, along with a hand­ful of oth­er small­er ef­forts, both use a sim­i­lar tech­nol­o­gy. — Ja­son Mast

430 vac­cine and drugs aimed at Covid-19? Is that a mas­sive re­sponse or chaos?

The lat­est tal­ly and analy­sis by BIO, the biotech trade group, has tracked 430 unique com­pounds in de­vel­op­ment ei­ther to pro­tect against or treat Covid-19. US-based com­pa­nies are lead­ing the cam­paign with 207 pro­grams in var­i­ous stages of hu­man test­ing, they not­ed.

Chi­na lays claim to 31 pro­grams in de­vel­op­ment while the UK is home to 16 po­ten­tial weapons to fight the coro­n­avirus.

Break­ing down the to­tal num­ber in­to an­tivi­rals, treat­ments and vac­cines, BIO found while more than half of the an­tivi­rals and es­sen­tial­ly all vac­cines were new for the coro­n­avirus, as many as 63% of treat­ments were redi­rect­ed and an­oth­er 31% were re­pur­posed. — Am­ber Tong

Source: BIO

Click on the im­age to see the full-sized ver­sion

FDA looks to re­sume on-site in­spec­tions

As the White House pon­ders steps to re­open the coun­try, the FDA said it is col­lab­o­rat­ing with the CDC to “de­vel­op a process that would gov­ern how and where to re­turn to on-site fa­cil­i­ty sur­veil­lance in­spec­tions.”

The agency de­cid­ed in ear­ly March — one day be­fore the WHO would de­clare the Covid-19 out­break a pan­dem­ic — to post­pone most for­eign in­spec­tions. A week lat­er, it stopped vis­it­ing do­mes­tic fa­cil­i­ties too.

With the ex­cep­tion of “mis­sion crit­i­cal in­spec­tions,” reg­u­la­tors have been turn­ing to al­ter­na­tive tools for sur­veil­lance.

“Al­though in­spec­tions are crit­i­cal, they are one part of a ro­bust and mul­ti-pronged ap­proach to over­see­ing the safe­ty and qual­i­ty of FDA reg­u­lat­ed prod­ucts,” FDA com­mis­sion­er Stephen Hahn said in a state­ment. “Based on decades of ex­pe­ri­ence with our di­verse reg­u­lat­ed in­dus­tries, we be­lieve most FDA-reg­u­lat­ed firms un­der­stand and ap­pre­ci­ate their re­spon­si­bil­i­ty to en­sure the safe­ty of the prod­ucts they man­u­fac­ture or pro­duce. We con­sid­er these firms to be our part­ners in pub­lic health.” — Am­ber Tong

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

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.