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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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'Bank of BAR­DA': In­ves­ti­ga­tion finds HHS raid­ed pan­dem­ic pre­pared­ness funds for decade be­fore Covid-19

Before 2020, few Americans had ever heard of the Biomedical Advanced Research and Development Authority, BARDA, or its far-flung mission to stave off future pandemics and bio-threats. Allegedly, that made it a pretty good target for others in HHS who needed to scavenge some extra cash.

Over the last decade, other HHS officials raided BARDA’s coffers and misappropriated millions of dollars that Congress had earmarked to fund vaccine research and prepare for public health emergencies like Covid-19, according to a new report from the US Office of Special Counsel, which investigated a whistleblower report.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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