Covid-19 roundup: Pfiz­er, BioN­Tech start US hu­man tri­al; World lead­ers (not in­clud­ing the US) pledge $8 bil­lion in vac­cine, treat­ment re­search

Last week, part­ners Pfiz­er and BioN­Tech joined the elite group of CanSi­no, Mod­er­na and Ox­ford who have be­gun hu­man tri­als of their ex­per­i­men­tal Covid-19 vac­cine. On Tues­day, the US-Ger­man part­ners kicked off dos­ing in the Unit­ed States.

The team, which kicked off dos­ing in Ger­many in late April, said the first US par­tic­i­pants had been giv­en a vac­cine from the BNT162 pro­gram in a Phase I/II tri­al. The vac­cine pro­gram in­cludes four ex­per­i­men­tal vac­cines — each with com­bi­na­tion of mR­NA for­mat and tar­get anti­gen — the de­sign of the tri­al will al­low for the eval­u­a­tion of the var­i­ous can­di­dates si­mul­ta­ne­ous­ly so that the safest and po­ten­tial­ly most ef­fi­ca­cious can­di­date can be iden­ti­fied.

“The short, less than four-month time­frame in which we’ve been able to move from pre-clin­i­cal stud­ies to hu­man test­ing is ex­tra­or­di­nary…” said Pfiz­er chief Al­bert Bourla in a state­ment.

The Phase I/II study is set to en­roll up to 360 healthy sub­jects in­to two age co­horts (18-55 and 65-85 years of age) — the sub­jects im­mu­nized in the first por­tion of the study will be healthy adults 18-55 years of age. Old­er adults will on­ly be im­mu­nized with a giv­en dose lev­el of a vac­cine can­di­date, once test­ing in younger adults of­fers ini­tial ev­i­dence of safe­ty and im­muno­genic­i­ty.

From the man­u­fac­tur­ing side, the part­ners are scal­ing up pro­duc­tion. Mil­lions of vac­cine dos­es should be avail­able in 2020, and those num­bers should grow to hun­dreds of mil­lions by next year, the com­pa­nies said.

World lead­ers, bar­ring the US, pledge $8 bil­lion in vac­cine, treat­ment re­search — re­port

Last month, Pres­i­dent Don­ald Trump said he would stop fund­ing the WHO, tak­ing is­sue with the way the or­ga­ni­za­tion has been tack­ling the pan­dem­ic. Now, the Unit­ed States is steer­ing clear of a glob­al ef­fort to sup­port vac­cine and treat­ment de­vel­op­ment.

On Mon­day, world lead­ers vowed to raise $8 bil­lion to kick­start the ef­fort, to build on ef­forts by the World Bank, the Bill and Melin­da Gates Foun­da­tion and wealthy in­di­vid­u­als, Reuters re­port­ed. The event was or­ga­nized by the Eu­ro­pean Union and non-EU coun­tries Britain, Nor­way and Sau­di Ara­bia, and in­clud­ed the par­tic­i­pa­tion of Japan, Cana­da, South Africa and Chi­na, among oth­ers.

A se­nior US ad­min­is­tra­tion of­fi­cial de­clined to tell the wire ser­vice specif­i­cal­ly why the Unit­ed States was not par­tic­i­pat­ing.

The suc­cess­ful de­vel­op­ment of a vac­cine is on­ly the first step — easy ac­cess glob­al­ly will be the next big hur­dle. EU of­fi­cials said that the fund­ing will not strip the re­cip­i­ent phar­ma­ceu­ti­cal com­pa­nies of in­tel­lec­tu­al prop­er­ty on any vac­cine or treat­ment, but com­pa­nies will be ex­pect­ed to com­mit to mak­ing them avail­able at af­ford­able prices.

Many lead­ers stressed that any vac­cine must be made avail­able to every­one. Cana­di­an Prime Min­is­ter Justin Trudeau said it should not just be for rich coun­tries.

“Those who in­vent it, of course, will be fair­ly paid, but ac­cess will be giv­en to peo­ple across the globe by the or­ga­ni­za­tion we choose,” French Pres­i­dent Em­manuel Macron said, ac­cord­ing to the Reuters re­port.

The is­sue of how a vac­cine will be dis­trib­uted across the globe, if proved safe and ef­fec­tive, is para­mount. In a Wall Street Jour­nal opin­ion piece late last month en­ti­tled “Amer­i­ca needs to win the coro­n­avirus vac­cine race,” for­mer FDA chief Scott Got­tlieb warned that “while friend­ly na­tions will try to share a suc­cess­ful prod­uct — to a point — the US can’t re­ly on vac­cines from Chi­na or even Eu­rope be­ing avail­able in Amer­i­ca quick­ly.”

Last week, Bloomberg re­port­ed that the Trump ad­min­is­tra­tion is work­ing on ex­e­cut­ing a multi­bil­lion-dol­lar plan “Op­er­a­tion Warp Speed” to as­sure that 300 mil­lion dos­es (of any po­ten­tial vac­cine) — which should cov­er near­ly the en­tire US pop­u­la­tion — are avail­able by Jan­u­ary, the ear­li­est time­line chart­ed by vac­cine de­vel­op­ers. Al­though the de­tails are sparse, the plan brings phar­ma­ceu­ti­cal com­pa­nies, gov­ern­ment agen­cies and the mil­i­tary to co­or­di­nate test­ing of ex­per­i­men­tal vac­cines and in­volves large in­vest­ments in man­u­fac­tur­ing.

The vac­cine part­ner­ship be­tween Ox­ford, As­traZeneca and Vac­citech — which aims to make 100 mil­lion dos­es by the end of 2020 — in­cludes pro­vi­sions to dis­trib­ute the vac­cine to low and medi­um-in­come coun­tries, al­though the de­tails are sparse.

Sep­a­rate­ly, the Serum In­sti­tute of In­dia that has al­so part­nered with Ox­ford sci­en­tists to mass-pro­duce their vac­cine (with plans to pro­duce up to 60 mil­lion dos­es this year) told Reuters that their first pri­or­i­ty is In­dia and its pop­u­la­tion of 1.3 bil­lion. A ma­jor­i­ty of the vac­cine, at least ini­tial­ly, would have to go to our coun­try­men be­fore it goes abroad,” Serum CEO Adar Poon­awal­la said.

Gilead’s promis­ing Covid-19 an­tivi­ral remde­sivir gets Bangladeshi pro­duc­er — re­port

The com­pa­ny, which has pre­vi­ous­ly pledged to do­nate its ex­ist­ing sup­ply of 1.5 mil­lion in­di­vid­ual dos­es of remde­sivir for use in pa­tients in clin­i­cal tri­als and on a com­pas­sion­ate use ba­sis, has re­port­ed­ly found a new sup­pli­er in the form of one of Bangladesh’s largest drug­mak­ers, Bex­im­co Phar­ma­ceu­ti­cals.

The an­tivi­ral, which failed to pass muster as an Ebo­la ther­a­py, quick­ly rose to promi­nence as a po­ten­tial Covid-19 drug af­ter in­duc­ing a sta­tis­ti­cal­ly sig­nif­i­cant im­pact in help­ing hos­pi­tal­ized Covid-19 pa­tients re­cov­er faster in a ran­dom­ized, place­bo-con­trolled study — the gold-stan­dard for ben­e­fit-risk cal­cu­la­tions. Al­though more da­ta are in­com­ing, the drug was grant­ed emer­gency use au­tho­riza­tion by the FDA on Fri­day.

Apart from the $50 mil­lion the com­pa­ny has al­ready in­vest­ed in de­vel­op­ing the drug, an­oth­er $1 bil­lion is ex­pect­ed to be spent, as Gilead ramps up fur­ther de­vel­op­ment and man­u­fac­tur­ing of remde­sivir in an­tic­i­pa­tion of reg­u­la­to­ry ap­provals, ex­ec­u­tives said in a re­cent con­fer­ence call.

Bex­im­co plans to price the drug at be­tween 5000 and 6000 takas per vial ($59-$71/per vial), Bex­im­co’s Chief Op­er­at­ing Of­fi­cer Rab­bur Reza told Reuters, adding a pa­tient might need any­where be­tween 5 and 11 vials.

“We will on­ly know ex­act­ly how much a pa­tient needs once stud­ies are com­plete,” Reza said, not­ing that pro­duc­tion would be­gin this month, ini­tial­ly for do­mes­tic use.

Mod­els pre­dict Amer­i­can dai­ly death rate to hit 3,000 by June 

As part of the Unit­ed States get ready to ease back in­to nor­mal­i­ty, the Uni­ver­si­ty of Wash­ing­ton’s In­sti­tute for Health Mod­el­ing and Eval­u­a­tion says the coro­n­avirus pan­dem­ic will claim near­ly 135,000 Amer­i­can lives by Au­gust, in part due to states eas­ing their so­cial dis­tanc­ing re­stric­tions.

Source: IHME, 2020

Click on the im­age to see the full-sized ver­sion

The pro­jec­tion is grim for the com­ing weeks. IHME pre­dicts that there will be as many as 3,000 deaths per day in by June 1, with a sharp peak hit­ting around mid-May — well ahead of the cur­rent pace of about 1,500 dai­ly deaths.

An­oth­er draft re­port pro­ject­ed Covid-19 cas­es will surge to about 200,000 per day by June 1, with 3,000 deaths ex­pect­ed per day, the Wash­ing­ton Post re­port­ed. The White House and the CDC dis­avowed the re­port, al­though the slides do car­ry the CDC’s lo­go, the Post said, adding that the cre­ator of the mod­el said the num­bers are un­fin­ished pro­jec­tions shown to the CDC as a work in progress.

SEC in­ves­ti­ga­tion trig­gers sus­pen­sion of Mol­e­culin Biotech’s stock

Every few years, a pub­lic health cri­sis (think Ebo­la, Zi­ka) spurred by a rogue pathogen trig­gers a small-biotech ral­ly, as drug­mak­ers emerge from the wood­work with am­bi­tious plans to treat the mount­ing out­break. In most cas­es, that en­thu­si­asm nev­er quite de­liv­ers.

With Covid-19 hav­ing rav­aged much of the globe, the ever op­por­tune biotech is al­ways around the cor­ner.

On Mon­day, Texas can­cer-fo­cused biotech Mol­e­culin said its shares had been placed in a tem­po­rary trad­ing halt fol­low­ing no­ti­fi­ca­tion from the SEC.

The small com­pa­ny, which has a mar­ket cap of about $65 mil­lion, has been mak­ing state­ments in a smat­ter­ing of reg­u­la­to­ry fil­ings and press re­leas­es since March 19 sug­gest­ing its ex­per­i­men­tal drug, WP1122, was a po­ten­tial can­di­date for use in Covid-19 and that it could ex­pe­dite the reg­u­la­to­ry ap­proval of the treat­ment. Be­tween March 18 and May 1st (when the trad­ing sus­pen­sion came in­to ef­fect), the val­ue of the com­pa­ny’s stock has more than dou­bled to $1.o7.

The sus­pen­sion will ter­mi­nate at 11:59 p.m. ET on May 15th, 2020. Mol­e­culin said it be­lieves it will be able to demon­strate the ac­cu­ra­cy and ad­e­qua­cy of its pub­lic dis­clo­sures.

Milken In­sti­tute track­er iden­ti­fies loads more Covid-19 treat­ment and vac­cine can­di­dates in de­vel­op­ment

In ear­ly March, the think tank had tracked 55 treat­ments and 38 vac­cine can­di­dates. Fast for­ward to May 4, those num­bers have jumped to more than 111 vac­cines and 197 treat­ments in the pipeline to treat and pre­vent Covid-19.

Of this bur­geon­ing group, nine vac­cines and more than 50 treat­ments cur­rent­ly are in clin­i­cal tri­als.

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

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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