Covid-19 roundup: J&J gives deep­est look yet at vac­cine; As­traZeneca shies away from dis­cussing vac­cine com­mer­cial op­por­tu­ni­ty

J&J has giv­en its deep­est look yet in­to its coro­n­avirus vac­cine can­di­date.

The NJ phar­ma and Op­er­a­tion Warp Speed mem­ber pub­lished the pre­clin­i­cal re­sults for their vac­cine in Na­ture Thurs­day morn­ing, show­ing that a sin­gle dose pro­vid­ed “com­plete or near-com­plete pro­tec­tion” from SARS-CoV-2 in rhe­sus macaques. The re­sults bol­stered a Phase I tri­al that is al­ready un­der­way, hav­ing launched in Bel­gium and the US.

Al­though it’s dif­fi­cult to say how the pre­clin­i­cal re­sults will trans­late in­to hu­mans, the study is no­table be­cause it sug­gests that J&J’s vac­cine might be able to pro­vide pro­tec­tion af­ter just a sin­gle dose. The most ad­vanced vac­cine ef­forts out­side of Chi­na — from Mod­er­na, As­traZeneca, and Pfiz­er — all re­quire two dos­es, mak­ing them more dif­fi­cult to ad­min­is­ter and cut­ting the po­ten­tial sup­ply in half.

J&J us­es an ade­n­ovirus vec­tor to de­liv­er a gene for a coro­n­avirus anti­gen in­to cells, trig­ger­ing an im­mune re­sponse. They cre­at­ed sev­en can­di­dates with slight­ly dif­fer­ent anti­gens and test­ed them in 52 dif­fer­ent mon­keys, in­oc­u­lat­ing them and then chal­leng­ing them 6 weeks lat­er with the virus. The can­di­date they will ul­ti­mate­ly bring in the clin­ic ful­ly pro­tect­ed 5 of 6 mon­keys from in­fec­tion. The 6th mon­key had low vi­ral lev­els.

J&J has tak­en that vac­cine in­to Phase I, where they are test­ing both a sin­gle dose and mul­ti­ple dos­es. They hope to be­gin Phase III in Sep­tem­ber. They’ve re­ceived $456 mil­lion from BAR­DA for re­search and de­vel­op­ment, and have pledged to sell their vac­cine at cost while the pan­dem­ic is still rag­ing. — Ja­son Mast

Might Sin­ga­pore have the best Covid-19 an­ti­body?

A young com­pa­ny that was one of the first to bring a Covid-19 an­ti­body in­to the clin­ic is prepar­ing to move in­to Phase III, as its plat­form gets its first val­i­da­tion in the New Eng­land Jour­nal of Med­i­cine. 

Ty­chan, a small biotech set up and backed by the Sin­ga­pore gov­ern­ment dur­ing the 2014-2016 West African Ebo­la cri­sis to re­spond quick­ly to emerg­ing in­fec­tions, pub­lished in NE­JM a mon­o­clon­al an­ti­body they de­vel­oped for yel­low fever virus, show­ing it was safe and neu­tral­ized the virus in pa­tients ex­posed to the in­ac­ti­vat­ed vac­cine in a Phase Ib tri­al.

There were no ma­jor yel­low fever out­breaks in Brazil this year, so the com­pa­ny did not launch the an­ti­body as they thought they might. Still, as sci­en­tif­ic founder Ram Sasisekha­ran said, the an­ti­body could be used if an emerg­ing out­break in Africa wors­ens. And the re­sults help val­i­date their ap­proach for Covid-19.

Like sev­er­al big­ger name com­pa­nies, Ty­chan de­vel­oped an an­ti­body that can bind to and neu­tral­ize SARS-CoV-2 and which can hope­ful­ly in­oc­u­late healthy peo­ple for a lim­it­ed pe­ri­od of time and treat pa­tients with ear­ly-stage or even late-stage dis­ease. They start­ed a Phase I on June 10, 9 days af­ter Eli Lil­ly start­ed the first Covid-19 an­ti­body tri­al in the world. They have since com­plet­ed dos­ing, Sasisekha­ran said.

“There [have been] no ad­verse events,” he told End­points News, not­ing that they test­ed high dos­es.”The mol­e­cule looks very safe.”

Ty­chan is now prepar­ing to launch Phase III tri­als in Au­gust, a place that would put them in line with Eli Lil­ly and Re­gen­eron, the oth­er ma­jor an­ti­body com­pa­ny that has al­ready hit the clin­ic.

Ty­chan makes their an­ti­bod­ies dif­fer­ent­ly than most com­pa­nies. Rather than ex­tract an­ti­body-pro­duc­ing B cells from the blood of pa­tients who sur­vived the virus or from ge­net­i­cal­ly mod­i­fied mice and then tweak­ing the an­ti­bod­ies those B cells pro­duce, Ty­chan draws from in­ter­nal and pub­lic data­bas­es of dif­fer­ent an­ti­body se­quences to stitch to­geth­er one they think has the best prop­er­ties. That might mean en­gi­neer­ing their an­ti­body by com­bin­ing a head of one an­ti­body and a tail of an­oth­er, while tweak­ing both. (An FAB and an FC, for our im­mu­nol­o­gist read­ers, among oth­er parts).

“We’ve al­ways looked at them as Lego pieces,” Sasisekha­ran said. “Our ap­proach is more like an as­sem­bly, we as­sem­ble dif­fer­ent com­po­nents that come from dif­fer­ent sources.”

If the an­ti­body proves suc­cess­ful in Phase III, Sasisekha­ran said they have enough man­u­fac­tur­ing ca­pac­i­ty to sup­ply an­ti­bod­ies both in Sin­ga­pore and abroad. — Ja­son Mast 

In­ovio touts non-pub­lished an­i­mal da­ta 

In­ovio is tout­ing its own an­i­mal da­ta for its Covid-19 vac­cine, al­though those da­ta have yet to be peer-re­viewed. In a pre-print post­ed to BioRx­iv،the com­pa­ny said that its DNA vac­cine INO-4800 pro­tect­ed rhe­sus macaques from be­ing in­fect­ed by a SARS-CoV-2 virus for 13 weeks af­ter vac­ci­na­tion. It al­so showed an­ti­body and T cell re­spons­es for 13 months.

Al­though one of the first com­pa­nies to an­nounce a Covid-19 vac­cine pro­gram and one of the first to get fund­ing from the coali­tion of epi­dem­ic pre­pared­ness to do so, the biotech has in­creas­ing­ly found it­self on the fringes of the fight. The vac­cine’s de­vel­op­ment has been stalled in part by a dis­pute with the CD­MO li­censed to man­u­fac­ture its vac­cines. And, al­though In­ovio said in June that it had been “se­lect­ed for the U.S. Gov­ern­ment’s Op­er­a­tion Warp Speed” – one of a cou­ple small biotechs to make the claim, along­side Vaxart and Patrick Soon-Sh­iong’s Nan­tk­west –  they did not clar­i­fy un­til to­day’s re­lease that they had on­ly been se­lect­ed for the an­i­mal chal­lenge stud­ies, which nu­mer­ous com­pa­nies have re­ceived aid for.

In­ovio’s stock was up 11%, or $2.23 on the news. They be­gan the year at $2.98 per share. — Ja­son Mast

As­traZeneca shies away from dis­cussing vac­cine com­mer­cial op­por­tu­ni­ty

Pas­cal So­ri­ot isn’t think­ing about the prof­its an ap­proved Covid-19 vac­cine can bring As­traZeneca now — and he won’t be for quite some time.

“The num­ber 1 thing we’ve learned about this virus is that it is in­cred­i­bly un­pre­dictable,” he told re­porters on a me­dia call. ”So it’s re­al­ly hard to un­der­stand — in fact I would say at this stage im­pos­si­ble to an­swer your ques­tion about po­ten­tial long-term com­mer­cial op­por­tu­ni­ty. […] Give us a few more months and then maybe we can talk about it.”

It’s been three months since the phar­ma gi­ant took on the re­spon­si­bil­i­ty to de­vel­op as well as lin­ing up man­u­fac­tur­ing and dis­tri­b­u­tion for the ade­n­ovirus-based vac­cine in­vent­ed by Ox­ford Uni­ver­si­ty. Along­side J&J, As­traZeneca is among the on­ly fron­trun­ning vac­cine de­vel­op­ers to have pledged to sup­ply its prod­uct at no prof­it.

Based on a sup­ply agree­ment with the Nether­lands, Ger­many, France and Italy, SVB Leerink an­a­lyst Ge­of­frey Porges has cal­cu­lat­ed the price to be $3 to $4 a dose — a fig­ure echoed by Pam Cheng, the VP of op­er­a­tions and IT who’s tasked with pro­cure­ment.

“So from a COGS per­spec­tive we are able to man­u­fac­ture such a vac­cine at a few dol­lars per dose,” she said. “Now ob­vi­ous­ly the ex­act cost is de­pen­dent on the sup­ply chain, but we’re look­ing in gen­er­al a few dol­lars a dose. So that’s very good news.”

That sug­gests a treat­ment course cost­ing un­der $10 even if it’s a two-dose reg­i­men, which is be­ing tak­en in­to Phase III.

Pfiz­er, mean­while, has con­firmed that it’s charg­ing $39 for its own two-dose course of its BioN­Tech-part­nered mR­NA vac­cine, al­low­ing it­self to make a prof­it. Mod­er­na is re­port­ed­ly look­ing to go high­er with a price tag go­ing in­to the $50 to $60 range.

As the un­of­fi­cial Oc­to­ber dead­line for an emer­gency ap­proval looms, vac­cine mak­ers have found them­selves un­der con­flict­ing pres­sure from politi­cians ar­gu­ing for “fair pric­ing” to en­sure ac­cess and an­a­lysts press­ing why com­pa­nies shouldn’t make mon­ey for help­ing solve a glob­al health­care cri­sis.

As­traZeneca has sug­gest­ed that it would charge a dif­fer­ent price once the pan­dem­ic is over. But when asked how they would de­ter­mine when that is, the CEO left it up to “a va­ri­ety of in­put.”

“The re­al­i­ty is that if our vac­cine or sev­er­al vac­cines work, there should not be a pan­dem­ic any­more,” So­ri­ot said. “If there is still a pan­dem­ic, it means the vac­cines are not work­ing.”

The pri­or­i­ty, he em­pha­sized, is work­ing with the net­work of more than 20 con­tract man­u­fac­tur­ers to en­sure they can de­liv­er the 2 bil­lion dos­es they have pledged to dis­trib­ute glob­al­ly on time. Ox­ford’s tech­nol­o­gy al­so gives them an edge; as it stands, the vac­cine can­di­date can be stored in “nor­mal cold chain” at 2 to 8 de­grees Cel­sius.

From So­ri­ot:

Peo­ple tend to fo­cus these days on­ly on safe­ty and ef­fi­ca­cy. But if you have a vac­cine that works and is safe, but is ex­pen­sive to make or you can­not scale it up, or you have to keep it un­der -60 or -20 de­grees — I mean imag­ine how prac­ti­cal it is to dis­trib­ute these in Latin Amer­i­ca, Africa etc. So if you want the vac­cine to have bril­liant im­pact to make a dent on this pan­dem­ic, it has to be safe and ef­fec­tive. You have to be able to scale it up in bil­lions of dos­es which is a mas­sive ef­fort, it has to be at a rea­son­able price, as cheap as pos­si­ble, you have to dis­trib­ute to every­body, and it has to be easy to keep at nor­mal fridge tem­per­a­ture … that’s what this team hopes to de­liv­er.

Am­ber Tong

FDA could au­tho­rize con­va­les­cent plas­ma with­in a week

An­ti­body-rich plas­ma from re­cov­ered Covid-19 pa­tients has seen some suc­cess in treat­ing oth­ers with the most se­vere symp­toms, but now the FDA is get­ting clos­er to ap­prov­ing its emer­gency use in mild cas­es.

A de­ci­sion could come as soon as next week, ac­cord­ing to a re­port in the Wall Street Jour­nal. Thus far, on­ly remde­sivir has re­ceived the reg­u­la­to­ry green light for emer­gency au­tho­riza­tion.

Doc­tors and hos­pi­tals have al­ready treat­ed Covid-19 pa­tients with con­va­les­cent plas­ma due to a lack of proven drugs, most­ly un­der com­pas­sion­ate use and as part of stud­ies. An ex­pand­ed ac­cess study at the Mayo Clin­ic in Rochester, MN, has seen more than 48,000 pa­tients treat­ed with plas­ma in­fu­sions.

BAR­DA re­cent­ly fund­ed a tri­al across sev­er­al uni­ver­si­ties, in­clud­ing the Uni­ver­si­ty of Pitts­burgh, the Uni­ver­si­ty of Michi­gan, the Uni­ver­si­ty of South Car­oli­na, and Stan­ford to study the ef­fec­tive­ness of out­pa­tient con­va­les­cent plas­ma treat­ments.

The tri­al, dubbed C3PO, will treat 600 pa­tients with mild symp­toms across 50 hos­pi­tals. Ide­al­ly, these pa­tients will be con­sid­ered high-risk: old­er than 50, with heart dis­ease, lung dis­ease or di­a­betes, or be im­muno­com­pro­mised.

Par­tic­i­pants will be giv­en ei­ther the plas­ma or a saline IV so­lu­tion in the emer­gency room and doc­tors will check up on them with a phone call every oth­er day. The study should have re­sults by the time the flu sea­son rolls around in Sep­tem­ber.

Re­searchers from Johns Hop­kins Uni­ver­si­ty pub­lished a “how-to” guide for Covid-19 plas­ma trans­fu­sions back in April, as the ther­a­py hasn’t been wide­ly used in the US in decades. Though con­va­les­cent plas­ma has been used to treat H1N1 and SARS in past out­breaks, the pro­ce­dure con­tin­ues to leave hos­pi­tals with many ques­tions about its safe­ty and ef­fi­ca­cy.

The pa­per sug­gest­ed a SARS tri­al in Hong Kong in­di­cates pa­tients who re­ceive con­va­les­cent plas­ma treat­ments with­in 14 days of con­tract­ing the virus re­cov­er faster than those giv­en the plas­ma lat­er. Much re­mains un­known about the treat­ments, how­ev­er, in­clud­ing which an­ti­bod­ies best pro­tect against the virus. — Max Gel­man

EU gets a hold of 30,000 remde­sivir treat­ments de­spite US buy­ing up sup­ply

De­spite the Unit­ed States buy­ing al­most the en­tire glob­al sup­ply of remde­sivir, the Eu­ro­pean Union has man­aged to get in on the ac­tion.

The EU com­mis­sion is pay­ing about $74 mil­lion for 30,000 treat­ments of the drug to help ad­dress needs of Covid-19 pa­tients in the short term, Reuters re­port­ed Wednes­day. That’s a rel­a­tive­ly lim­it­ed amount, giv­en that the US gov­ern­ment last month pur­chased enough dos­es — more than 500,000 — to make up for Gilead’s en­tire pro­duc­tion through Sep­tem­ber.

Sold un­der the brand name Vek­lury, the treat­ments will be avail­able be­gin­ning in ear­ly Au­gust. The an­tivi­ral is the on­ly drug au­tho­rized in the EU to treat se­vere cas­es of Covid-19.

When sell­ing to gov­ern­ments, Gilead $GILD set a price of $2,340 per pa­tient for a five-day course of remde­sivir in late June. That pric­ing ap­pears to match up with the price the EU paid Wednes­day. The bloc is al­ready plan­ning an ad­di­tion­al pur­chase for Oc­to­ber should a sec­ond wave hit Eu­ro­pean cities.

So far, remde­sivir has proved to be one of on­ly two treat­ments ef­fec­tive at treat­ing Covid-19 symp­toms, in ad­di­tion to a gener­ic steroid called dex­am­etha­sone. An ob­ser­va­tion­al study ear­li­er this month in­di­cat­ed that pa­tients with se­vere symp­toms tak­ing remde­sivir had a 62 per­cent bet­ter chance at sur­viv­ing than those not on the drug.

Gilead is ex­pect­ed to re­port its sec­ond quar­ter earn­ings Thurs­day evening, and its stock price is al­ready up al­most 12 per­cent, peak­ing as high as $84. The com­pa­ny’s first quar­ter sales reached $5.5 bil­lion and an­a­lysts ex­pect sales north of $5 bil­lion for the sec­ond quar­ter, ac­cord­ing to Bar­ron’s. — Max Gel­man

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

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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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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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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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.