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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Covid-19 roundup: CDC ad­vi­sors find like­ly link be­tween mR­NA vac­cines and rare cas­es of heart in­flam­ma­tion; NIH launch­es new vac­cine study in preg­nant vol­un­teers 

The FDA will update the fact sheets for the Pfizer/BioNTech and Moderna Covid-19 vaccines, after the CDC advisory group ACIP found that rare cases of heart inflammation in adolescents and young adults are likely linked to the shots, Reuters reported.

According to the CDC’s website, there have been more than a thousand reports of heart inflammation following mRNA vaccination since April. These cases are rare, according to the agency, given the hundreds of millions of doses administered. Most have been mild, and individuals often recover on their own or with minimal treatment, several public health figures said in a joint statement.