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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

Iron­wood kicks de­layed-re­lease Linzess for­mu­la­tion to the curb af­ter tri­al fail­ure

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.