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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Covid-19 roundup: Eu­rope to seek clar­i­fi­ca­tion on Pfiz­er/BioN­Tech de­lays; J&J pre­dicts 100M dos­es for US by April

With reports over slowed distribution of the Pfizer/BioNTech vaccine and threats of lawsuits dangling, the European Commission is planning to ask the company for a clarification over delivery timelines.

A spokesman for the EU’s executive branch made the comments early Friday, according to a Reuters report. Pfizer and the Commission had earlier said that there would be no more slowdowns next week as it continues to alter a manufacturing site in Belgium to ramp up production.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.