Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has ze­roed in on a Covid-19 vac­cine can­di­date that it hopes to be­gin test­ing in hu­mans by Sep­tem­ber this year — with the ex­tra­or­di­nary goal of get­ting it ready for emer­gency use in ear­ly 2021. And to­geth­er with BAR­DA, it’s com­mit­ting $1 bil­lion to make it hap­pen.

That kind of ac­cel­er­at­ed time­line would fall on the fast side of NI­AID di­rec­tor An­tho­ny Fau­ci’s well-pub­li­cized pre­dic­tion that it would be an­oth­er 12 to 18 months be­fore a vac­cine can be avail­able for pub­lic use. A Phase I tri­al of Mod­er­na’s mR­NA vac­cine be­gan two weeks ago, and both the biotech and fel­low mR­NA play­er Cure­Vac have dis­cussed sim­i­lar, if not even faster, time­lines for emer­gency use among health­care work­ers.

The J&J can­di­date (as well as two oth­er back­ups) was cre­at­ed on an ade­n­ovirus vec­tor-based plat­form in a col­lab­o­ra­tion be­tween its Janssen unit and re­searchers at Har­vard’s Beth Is­rael Dea­coness Med­ical Cen­ter. They be­gan work­ing with mul­ti­ple con­structs back in Jan­u­ary, the com­pa­ny added, se­lect­ing the ones pro­duc­ing the largest im­mune re­sponse in pre­clin­i­cal ex­per­i­ments. Ini­tial safe­ty and ef­fi­ca­cy da­ta are avail­able by the end of the year.

Ac­cord­ing to the web­site, the tech­nol­o­gy used here has been de­ployed dur­ing the Ebo­la epi­dem­ic.

With pro­duc­tion to be­gin im­mi­nent­ly, the com­pa­ny is al­so scal­ing up its glob­al man­u­fac­tur­ing ca­pac­i­ty so that it will even­tu­al­ly be able to sup­ply 1 bil­lion dos­es of the coro­n­avirus vac­cine, which will be af­ford­able and avail­able “on a not-for-prof­it ba­sis for emer­gency pan­dem­ic use.”

Of­fi­cials have long ap­pealed for Big Phar­ma to lend their mus­cles to the fran­tic vac­cine race. Even though Mod­er­na has be­gun work to cre­ate mil­lions of dos­es, de­mand around the world will like­ly be high­er by mul­ti­ple fac­tors.

In ad­di­tion to a pro­phy­lac­tic, J&J said it’s al­so ex­pand­ing its part­ner­ship with BAR­DA, or Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty, on its an­tivi­ral work. Sci­en­tists in Bel­gium are help­ing screen its and oth­ers’ com­pound li­braries. Undis­closed ad­di­tion­al fund­ing has been poured in­to this project.

FDA au­tho­rizes emer­gency use of con­tro­ver­sial (hy­droxy)chloro­quine — do­na­tions from No­var­tis, Bay­er flood in

The FDA has en­dowed chloro­quine and hy­drox­y­chloro­quine — the pair of malar­ia drugs in the spot­light thanks large­ly to Pres­i­dent Trump’s feel­ing about it — with its first emer­gency use au­tho­riza­tion for a Covid-19 treat­ment, paving the way for hos­pi­tals to pre­scribe the mil­lion dos­es of the med­i­cines that have been do­nat­ed to the na­tion­al stock­pile.

The OK comes ahead of any piv­otal da­ta on the drugs’ ef­fi­ca­cy and safe­ty for Covid-19 pa­tients, some­thing that FDA chief Stephen Hahn has in­sist­ed would be re­quired for any drug ap­proved to fight Covid-19.

On the same day CEO Vas Narasimhan told Swiss news­pa­per Son­ntagsZeitung that hy­drox­y­chloro­quine sul­fate is No­var­tis’ biggest hope against the coro­n­avirus, the phar­ma gi­ant’s gener­ics unit, San­doz, has do­nat­ed 30 mil­lion dos­es of it to the HHS. Ger­many’s Bay­er con­tributed 1 mil­lion dos­es of chloro­quine phos­phate.

BAR­DA, the HHS de­part­ment tasked with pre­pared­ness and re­sponse, sub­mit­ted the EUA re­quest. The FDA not­ed that this au­tho­riza­tion is in­tend­ed to ben­e­fit adult and teen pa­tients who are hos­pi­tal­ized and can’t par­tic­i­pate in the hand­ful of clin­i­cal tri­als un­der­way in the US.

Based up­on lim­it­ed in-vit­ro and anec­do­tal clin­i­cal da­ta in case se­ries, chloro­quine phos­phate and hy­drox­y­chloro­quine sul­fate are cur­rent­ly rec­om­mend­ed for treat­ment of hos­pi­tal­ized COVID-19 pa­tients in sev­er­al coun­tries, and a num­ber of na­tion­al guide­lines re­port in­cor­po­rat­ing rec­om­men­da­tions re­gard­ing use of chloro­quine phos­phate or hy­drox­y­chloro­quine sul­fate in the set­ting of COVID-19. […]

Based on the to­tal­i­ty of sci­en­tif­ic ev­i­dence avail­able to FDA, it is rea­son­able to be­lieve that chloro­quine phos­phate and hy­drox­y­chloro­quine sul­fate may be ef­fec­tive in treat­ing COVID-19, and that, when used un­der the con­di­tions de­scribed in this au­tho­riza­tion, the known and po­ten­tial ben­e­fits of chloro­quine phos­phate and hy­drox­y­chloro­quine­sul­fate when used to treat COVID-19 out­weigh the known and po­ten­tial risks of such­prod­ucts.

“The safe­ty pro­file of these drugs has on­ly been stud­ied for FDA ap­proved in­di­ca­tions, not COVID-19,” the agency added, re­fer­ring to malar­ia, lu­pus and rheuma­toid arthri­tis.

Oth­ers have al­so ques­tioned the ef­fi­ca­cy of the drugs, pok­ing holes in the study re­sults be­ing of­fered up as proof that they might work.

While the EUA cov­ers on­ly FDA-ap­proved hy­drox­y­chloro­quine sul­fate, reg­u­la­tors are al­so open­ing up to chloro­quine phos­phate that has not got­ten the OK in the US for any in­di­ca­tions.

The sug­gest­ed dose for chloro­quine phos­phate is 1 gram on day 1 fol­lowed by 500 mg for 4 to 7 days. As for hy­drox­y­chloro­quine sul­fate, the sug­gest­ed dose is 800 mg to start and then 400 mg on sub­se­quent days.

Mod­er­na paus­es rare, in­fec­tious dis­ease tri­als amid ex­pect­ed tri­al de­lays

The Covid-19 pan­dem­ic is hit­ting every biotech play­er with prod­ucts in clin­i­cal tri­als — in­clud­ing those press­ing full-speed ahead with ef­forts to bat­tle it. Mod­er­na dis­closed that it’s paus­ing en­roll­ment for a num­ber of stud­ies in rare and in­fec­tious dis­eases, and cau­tioned that even the tri­als that re­main open will run in­to de­lays.

Pro­grams af­fect­ed in­clude mR­NA-1653 for hu­man metap­neu­movirus and parain­fluen­za virus 3 in­fec­tions, mR­NA-3704 for methyl­malonic acidemia and mR­NA-3927 for pro­pi­onic acidemia. En­roll­ment to the chikun­gun­ya virus an­ti­body tri­al, which pro­vid­ed Mod­er­na with some of its ear­li­est hu­man da­ta, has been halt­ed by the site.

Three on­col­o­gy stud­ies will go on, though the biotech ac­knowl­edged de­lays in en­roll­ment. Even for two ful­ly en­rolled stud­ies — a Phase II in CMV and Phase I for Zi­ka — some par­tic­i­pants will not be able to re­ceive their next vac­cine dose on time.

Like many fel­low biotechs, Mod­er­na in­sti­tut­ed a re­mote work plan as ear­ly as March 12, while hav­ing lab and man­u­fac­tur­ing per­son­nel con­tin­ue to come in on al­tered poli­cies.

Vir en­lists Gen­er­a­tion Bio and its gene ther­a­py plat­form as a new arm of an­ti­body pro­gram

Just days af­ter nom­i­nat­ing lead an­ti­body can­di­dates for test­ing with­in months, George Scan­gos has a new idea for what his team at Vir can do to fight and pro­tect against SARS-CoV-2. The biotech is em­bark­ing on re­search to see if Gen­er­a­tion Bio’s gene ther­a­py tech can be used to de­liv­er in­struc­tions for mak­ing neu­tral­iz­ing an­ti­bod­ies with­in the body and keep­ing them there for years.

The hope is that this ap­proach can pro­vide broad and longer-last­ing pro­tec­tion for pop­u­la­tion-wide pre­ven­tion and treat­ment.

The plat­form that Gen­er­a­tion Bio of­fers — com­pris­ing close-end­ed DNA, cell-tar­get­ed lipid nanopar­ti­cle de­liv­ery and a scal­able cap­sid-free man­u­fac­tur­ing process — al­so promis­es to sup­ple­ment Vir’s own man­u­fac­tur­ing ca­pa­bil­i­ties for an­ti­bod­ies, Scan­gos said.

Got­tlieb of­fers cri­te­ria for be­gin­ning to re­open econ­o­my

When can the US move on from the strict lock­down mea­sures cur­rent­ly in place? It won’t be by East­er; Trump has aban­doned his goal of re­open­ing the econ­o­my in two weeks, ex­tend­ing so­cial dis­tanc­ing guide­lines for an­oth­er month. But in lieu of a con­sen­sus on a con­crete time­frame, Scott Got­tlieb — the for­mer FDA com­mis­sion­er who’s been dubbed the “shad­ow coro­n­avirus czar” — and a few col­leagues have of­fered up a road map.

In a new re­port pub­lished by the Amer­i­can En­ter­prise In­sti­tute, Got­tlieb, writ­ing with two ex-FDA of­fi­cials and two Johns Hop­kins re­searchers, ar­gues that the na­tion­al re­sponse must be rolled out in four phas­es. The aim in Phase I is to slow the spread; Phase II will see a state-by-state re­open­ing, with some dis­tanc­ing mea­sures still in place; those can be lift­ed once im­mune pro­tec­tion in­clud­ing vac­cines and ther­a­peu­tics is es­tab­lished and the coun­try en­ters Phase III; and Phase IV is all about re­build­ing readi­ness for the next pan­dem­ic.

The US is in Phase I now, with com­mu­ni­ty trans­mis­sion ob­served in every state. A few con­di­tions must be met be­fore a state de­cides to re­open (and en­ter Phase II):

  • A sus­tained re­duc­tion in cas­es for at least 14 days,
  • Hos­pi­tals in the state are safe­ly able to treat all pa­tients re­quir­ing hos­pi­tal­iza­tion with­out re­sort­ing to cri­sis stan­dards of care,
  • The state is able to test all peo­ple with COVID-19 symp­toms, and
  • The state is able to con­duct ac­tive mon­i­tor­ing of con­firmed cas­es and their con­tacts.

Mask wear­ing, vol­un­tary iso­la­tion and quar­an­tine, mas­sive scal­ing of con­tact trac­ing, com­pre­hen­sive sur­veil­lance sys­tems, in­creased sup­ply of per­son­al pro­tec­tive equip­ment, a func­tion­al health­care sys­tem and in­creased di­ag­nos­tic ca­pac­i­ty would help us get there, the au­thors wrote.

If the US man­ages to stop the virus by adopt­ing a na­tion­wide shel­ter-in-place for the next eight to 10 weeks, UPenn health pol­i­cy ex­pert Ezekiel Emanuel be­lieves that the econ­o­my can be restart­ed in June — pro­vid­ed that a mass ed­u­ca­tion cam­paign and a Covid-19 cer­ti­fi­ca­tion sys­tem are al­so in place.

Out­break in New York claims the life of Jef­feries CFO Peg Broad­bent

As the state of New York marked the grim mile­stone of 1,000 deaths due to Covid-19, in­vest­ment bank Jef­feries mourned the death of Peg Broad­bent, its long­time CFO, on Sun­day morn­ing. Hav­ing served in the post since 2007, Broad­bent had helped build the firm up from less than half its cur­rent size, CEO Rich Han­dler and pres­i­dent Bri­an Fried­man wrote in a joint state­ment. “His de­cen­cy, calm­ness and dry wit were al­ways there, al­ways mak­ing things bet­ter.”

Teri Gen­dron, cur­rent­ly CFO of the par­ent group’s fi­nan­cial ser­vices arm, has been named his in­ter­im suc­ces­sor.

Ma­chines ap­proved to clean hos­pi­tal work­ers’ PPE amid fears of short­age

In an at­tempt to ad­dress hos­pi­tals’ ur­gent need for per­son­al pro­tec­tive equip­ment, the FDA has sanc­tioned a mask ster­il­iza­tion tech­nol­o­gy de­vel­oped by pri­vate non­prof­it Bat­telle. The Ohio-based group has de­signed its crit­i­cal care de­con­t­a­m­i­na­tion sys­tem to clean up to 80,000 pieces of PPE (from masks to gloves and gog­gles) at a time. It in­tends to send one ma­chine to New York City and one to Stony Brook, NY, with ad­di­tion­al ma­chines to be dis­patched to Wash­ing­ton.

Oth­er sto­ries

→ It’s been a hec­tic week for Gilead, which first halt­ed its com­pas­sion­ate use pro­gram for remde­sivir and then came un­der fire for ob­tain­ing or­phan drug sta­tus, which it swift­ly with­drew. So CEO Dan O’Day took some time to ex­plain the clin­i­cal path and new ex­pand­ed ac­cess pro­gram go­ing for­ward. (End­points link)

→ Con­tin­u­ing to tar­get pa­tients with se­vere cas­es of Covid-19, Sanofi and Re­gen­eron have cooked up a sec­ond piv­otal tri­al to test their Kevzara in 300 pa­tients. The the­o­ry is that by block­ing IL-6, the drug can tamp down a dan­ger­ous over­re­ac­tive im­mune re­sponse. (End­points link)

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

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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