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.