Covid-19 roundup: Pfiz­er hus­tling up mil­lions of dos­es of vac­cine — de­tails $748M BioN­Tech deal; CDC tweaks stance on con­tro­ver­sial malar­ia drugs

Pfiz­er and BioN­Tech are ready to out­line the de­tails of their am­bi­tious al­liance on a Covid-19 mR­NA vac­cine for the world.

Their plan now is to start hu­man tri­als in a mat­ter of days, while ramp­ing up man­u­fac­tur­ing for a glob­al mar­ket well ahead of the first read­out. And the Ger­man mR­NA com­pa­ny — large­ly owned by the bil­lion­aire Stru­eng­mann broth­ers — is get­ting a big up­front to go with the col­lab­o­ra­tion.

The phar­ma gi­ant is pro­vid­ing the biotech $185 mil­lion in cash, in­clud­ing an eq­ui­ty in­vest­ment of $113 mil­lion. Then there’s $563 mil­lion in mile­stones. They plan to joint­ly com­mer­cial­ize the vac­cine around the plan­et, with Fo­s­un tak­ing Chi­na per their sep­a­rate pact with BioN­Tech.

The clin­i­cal tri­al sup­plies of the vac­cine will be pro­vid­ed by BioN­Tech’s ex­ist­ing man­u­fac­tur­ing fa­cil­i­ty, leav­ing the part­ners to start im­me­di­ate­ly build­ing out enough man­u­fac­tur­ing ca­pac­i­ty to pro­vide “mil­lions” of dos­es be­fore the end of this year and “hun­dreds of mil­lions” by next year. All of that in­vest­ment is “at risk” — a bet that their jab can end the out­break.

Pfiz­er, mean­while, is al­so be­gin­ning test­ing soon on a new Covid-19 drug for mild to mod­er­ate cas­es. The com­pa­ny tells the Wall Street Jour­nal that the ther­a­py has the po­ten­tial to stop the virus from repli­cat­ing. And they al­so plan to study their rheuma­toid arthri­tis drug Xel­janz against the virus, part of a mul­ti-prong ef­fort to com­bat Covid-19.

First up, though, is mR­NA.

A group of mR­NA com­pa­nies are tak­ing a shot at pro­duc­ing new vac­cines in record time. That group in­cludes BioN­Tech, Cure­Vac and Mod­er­na in the US. Their tech­nol­o­gy, while yet to pro­duce an ap­proved prod­uct, holds the promise of swift iden­ti­fi­ca­tion of the anti­gens need­ed to come up with an ef­fec­tive way to spur im­mune re­sis­tance to the coro­n­avirus.

If it works, it will rev­o­lu­tion­ize pan­dem­ic pre­pared­ness ef­forts. The whole world is watch­ing what hap­pens next. — John Car­roll

CDC tweaks guid­ance on con­tro­ver­sial coro­n­avirus meds — re­port

The Eu­ro­pean Med­i­cines Agency has cau­tioned against us­ing the pair of malar­ia drugs — chloro­quine and hy­drox­y­chloro­quine — out­side of clin­i­cal tri­als or na­tion­al emer­gency use pro­grams for coro­n­avirus pa­tients, cit­ing the po­ten­tial for se­ri­ous side-ef­fects at high dos­es or when used in com­bi­na­tion with oth­er drugs.

Mean­while, in the mid­dle of March, Pres­i­dent Trump re­port­ed­ly per­son­al­ly pressed fed­er­al health of­fi­cials to make the malar­ia drugs avail­able to treat the new coro­n­avirus. Soon af­ter, the FDA cit­ed lim­it­ed in-vit­ro and anec­do­tal clin­i­cal da­ta to en­dorse the emer­gency use of the two ther­a­pies to treat malar­ia and lu­pus among oth­er dis­or­ders for Covid-19 when clin­i­cal tri­als are not avail­able, or par­tic­i­pa­tion is not fea­si­ble.

Now, the CDC has walked in­to the con­tro­ver­sy. Ac­cord­ing to a re­port by Reuters, the agency hasti­ly re­moved from its web­site atyp­i­cal guid­ance in­form­ing doc­tors on how to pre­scribe hy­drox­y­chloro­quine and chloro­quine. Ini­tial­ly, the CDC web­page, ti­tled In­for­ma­tion for Clin­i­cians on Ther­a­peu­tic Op­tions for Pa­tients with COVID-19, said: “Al­though op­ti­mal dos­ing and du­ra­tion of hy­drox­y­chloro­quine for treat­ment of COVID-19 are un­known, some U.S. clin­i­cians have re­port­ed anec­do­tal­ly” sev­er­al ways to pre­scribe the drugs to treat Covid-19.

A few tiny tri­als out of France and Chi­na have so far yield­ed in­con­clu­sive ev­i­dence on the use of the drugs in pa­tients with Covid-19. The stud­ies and the da­ta that em­anat­ed from them is not peer-re­viewed.

“Why would CDC be pub­lish­ing anec­dotes?” asked Lynn Gold­man, dean of the Milken In­sti­tute School of Pub­lic Health at George Wash­ing­ton Uni­ver­si­ty, in con­ver­sa­tion with the wire agency.

On Wednes­day, the CDC web­site read: “There are no drugs or oth­er ther­a­peu­tics ap­proved by the US Food and Drug Ad­min­is­tra­tion to pre­vent or treat COVID-19.” The trun­cat­ed guid­ance al­so said “hy­drox­y­chloro­quine and chloro­quine are un­der in­ves­ti­ga­tion in clin­i­cal tri­als” for use in coro­n­avirus pa­tients.

Trump has been tout­ing the pair of drugs as Covid-19 treat­ments for weeks now, de­spite cau­tion from his own sci­en­tif­ic ad­vi­sors, in­clud­ing in­fec­tious dis­ease ex­pert and NI­AID chief An­tho­ny Fau­ci who has in­sist­ed that there is no strong sci­en­tif­ic proof back­ing their ef­fi­ca­cy against Covid-19.

Cowen an­a­lyst Yaron Wer­ber, in a note on Wednes­day, sug­gest­ed that giv­en the ex­ist­ing (lim­it­ed) da­ta on hy­drox­y­chloro­quine (HCQ), the po­ten­tial for its use will like­ly be as a pro­phy­lac­tic agent.

“(B)ased on all avail­able da­ta, HCQ is un­like­ly to sig­nif­i­cant­ly im­prove clin­i­cal out­comes for hos­pi­tal­ized pa­tients with COVID-19…we would like­ly al­ready be aware if HCQ was hav­ing a ro­bust ef­fect giv­en its wide use through­out Chi­na, Italy and the U.S. thus far,” he wrote. “The role for HCQ in post-ex­po­sure pro­phy­lax­is ap­pears more promis­ing with many clin­i­cal tri­als cur­rent­ly in­ves­ti­gat­ing this con­cept. The drug has shown ef­fec­tive­ness in vi­ral clear­ance in vit­ro and may pro­vide ben­e­fit if vi­ral repli­ca­tion is im­paired in the very ear­ly stages of ill­ness, be­fore the sys­temic in­flam­ma­to­ry cas­cade takes hold.” — Na­tal­ie Grover

Boston hos­pi­tals as­sem­ble a small Covid-19 study in the front lines of the Covid-19 war

A flu an­tivi­ral from Japan that was rushed in­to use in Chi­na to help fight the first out­break of Covid-19 will now be fea­tured in a small US study — right in one of the cen­tral fronts of the out­break.

Brigham and Women’s Hos­pi­tal, Mass­a­chu­setts Gen­er­al Hos­pi­tal and the Uni­ver­si­ty of Mass­a­chu­setts Med­ical School have be­gun col­lab­o­rat­ing on a Phase II study of favipi­ravir that will re­cruit 50 pa­tients suf­fer­ing from coro­n­avirus, ac­cord­ing to its man­u­fac­tur­er, Fu­ji­film.

This small tri­al comes a lit­tle more than a week af­ter Fu­ji­film launched a more am­bi­tious Phase III in Japan.

Favipi­ravir — sold as Avi­gan in Japan since its ini­tial ap­proval in 2014 — at­tract­ed a lot of at­ten­tion in Chi­na dur­ing the peak of its fight against the new virus. The Chi­nese adopt­ed it af­ter a pair of small stud­ies. And it’s helped shed some ad­di­tion­al lus­ter on Gilead’s remde­sivir, which many be­lieve will work bet­ter us­ing the same mech­a­nism of ac­tion.

As far as the da­ta we’ve seen so far, though, it’s all still a crap­shoot.

The drug in­hibits RNA poly­merase nec­es­sary for in­fluen­za virus repli­ca­tion, which could be use­ful in the Covid-19 war. The ju­ry, though, is still very much out over how ef­fec­tive it may be or whether it can be more than a mar­gin­al treat­ment against a fast-spread­ing virus. — John Car­roll

Biotechs broad­en the spec­trum of an­ti-in­flam­ma­to­ry drugs thrown against Covid-19

With the FDA sig­nalling a will­ing­ness to wave a broad spec­trum of Covid-19 ther­a­pies in­to the clin­ic, two biotechs are pitch­ing in their pipeline stars to tame the in­flam­ma­tion of­ten re­spon­si­ble for dev­as­tat­ing pa­tients.

Bio­haven has the green light to be­gin test­ing in­tranasal vazegepant — its CGRP re­cep­tor an­tag­o­nist de­signed for acute mi­graines — in pul­monary com­pli­ca­tions of the vi­ral in­fec­tion. “This pan­dem­ic is a call to ac­tion for our en­tire in­dus­try,” CEO Vlad Coric said, and Bio­haven with re­searchers at Thomas Jef­fer­son Uni­ver­si­ty to de­vel­op the pro­to­col.

Sim­i­lar­ly, San Diego-based Cal­ciMed­ica has per­mis­sion to study whether its small mol­e­cule drug — which in­hibits cal­ci­um re­lease-ac­ti­vat­ed cal­ci­um (CRAC) chan­nels — can keep pa­tients with se­vere pneu­mo­nia from go­ing on ven­ti­la­tors.

Once they pro­vid­ed da­ta from their Phase II pan­cre­ati­tis tri­al in­volv­ing pa­tients with sys­temic in­flam­ma­tion and hy­pox­ia, as well as an­i­mal da­ta sug­gest­ing CM4620-IE has pro­tec­tive ef­fects on lung in­jury, the FDA ap­proved their IND in less than 10 days, CMO Su­dar­shan Heb­bar told End­points News.

The tri­al will start small with plans to re­cruit 60 pa­tients be­tween Re­gions Hos­pi­tal in St. Paul, Min­neso­ta and Hen­ry Ford Hos­pi­tal in De­troit. Pa­tients will be ran­dom­ized to re­ceive drug or place­bo in a 2:1 ra­tio. — Am­ber Tong

Ra­maswamy’s Data­vant kicks off ef­fort to cre­ate a da­ta repos­i­to­ry for US coro­n­avirus pa­tients

For­get Zoom, health care and soft­ware com­pa­nies are re­port­ed­ly look­ing to col­late da­ta from coro­n­avirus-in­fect­ed pa­tients to study dis­ease trans­mis­sion, iden­ti­fy the most vul­ner­a­ble groups of the pop­u­la­tion and eval­u­ate how ef­fec­tive in­ves­ti­ga­tion­al drugs are.

Vivek Ra­maswamy’s Data­vant — which ag­gre­gates and an­a­lyzes re­al-world med­ical da­ta from a suite of sources to as­sist bio­phar­ma com­pa­nies, providers and pay­ers — be­gan to spear­head one such ef­fort in March, ac­cord­ing to the Wall Street Jour­nal, which cit­ed a per­son fa­mil­iar with the mat­ter.

Health care tech com­pa­nies — Allscripts Health­care So­lu­tions and Change Health­care — have com­mit­ted to do­nat­ing da­ta for the ef­fort, while health in­sur­ance com­pa­ny An­them has been ap­proached to con­tribute med­ical claims da­ta, the re­port said.

Data­vant, which calls the big CRO Parex­el a part­ner, aims to in­clude da­ta about every Covid-19 pos­i­tive pa­tient (ex­clud­ing names or iden­ti­fy­ing de­tails) draw­ing on in­for­ma­tion that em­anates from hos­pi­tals, phar­ma­cies and health in­sur­ers. The reg­istry is be­ing po­si­tioned as a free re­source for gov­ern­ment and aca­d­e­m­ic re­searchers, the WSJ re­port­ed.

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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