Chris Christie has recovered after testing positive for Covid-19 (AP Images)

Covid-19 roundup: Can Ab­b­Vie’s dis­ap­point­ing NASH drug ceni­crivi­roc find suc­cess fight­ing cy­tokine storms?; Trump al­ly Chris Christie says he re­ceived Lil­ly's an­ti­body cock­tail

Af­ter get­ting passed down the line to Ab­b­Vie through a cou­ple of biotech buy­outs, the phar­ma gi­ant is now in line to see if their drug ceni­crivi­roc can score a suc­cess in the glob­al war against Covid-19.

The NIH has se­lect­ed this drug — which has proven un­der­whelm­ing as a NASH-tar­get­ed ther­a­py — as one of 3 it will test in a new adap­tive study dubbed AC­TIV-1 Im­mune Mod­u­la­tors, which is look­ing for new ways to fight off the cy­tokine storms that kill some pa­tients.

The oth­er 2 drugs se­lect­ed from among 130 can­di­dates are the high pro­file im­mune mod­u­la­tors Rem­i­cade and Oren­cia. So far re­pur­pos­ing ex­ist­ing drugs for the virus has of­ten proved frus­trat­ing­ly dis­ap­point­ing. But no­body’s aban­doned that ap­proach yet. Armed with BAR­DA cash, in­ves­ti­ga­tors at the NIH say these 3 have pro­files in­di­cat­ing their po­ten­tial in com­bat­ing one of the most threat­en­ing as­pects of Covid-19. There’s al­so enough drug avail­able to add an ex­tra study.

All pa­tients en­rolled in the study will get remde­sivir, now un­der a cloud af­ter a new WHO study con­clud­ed it pro­vides no ev­i­dent ben­e­fit to pa­tients, as well as con­va­les­cent plas­ma and dex­am­etha­sone — if the doc­tors in­volved be­lieve it will help.

Why ceni­crivi­roc?

The late-stage drug has pro­vid­ed un­der­whelm­ing ev­i­dence of ef­fi­ca­cy in NASH — like most every­thing else thrown against NASH — af­ter Brent Saun­ders picked it up at Al­ler­gan in the $1.7 bil­lion To­bi­ra buy­out. Ab­b­Vie in­her­it­ed the pro­gram with the rest of the Al­ler­gan pipeline fol­low­ing its own buy­out.

The drug is a dual-re­cep­tor an­tag­o­nist, tar­get­ing CCR2 and CCR5, which pro­vides a ra­tio­nale that it can help the worst off pa­tients ad­mit­ted to the hos­pi­tal.

This isn’t the on­ly adap­tive tri­al ex­am­in­ing how this drug per­forms against Covid-19. It was al­so tapped along­side Ote­zla and Fi­razyr for I-SPY COVID back in Au­gust, where re­searchers are look­ing for ways to fight acute res­pi­ra­to­ry dis­tress syn­drome.

An­oth­er pos­si­ble rem­e­dy for cy­tokine storm has been pre­sent­ed by the an­ti-GM-CSF class of drugs, where Hu­mani­gen and GSK, among oth­ers, are test­ing drugs that have po­ten­tial specif­i­cal­ly to fight back against the most se­vere im­mune re­ac­tions. For Hu­mani­gen, the pan­dem­ic has of­fered a vir­tu­al re­birth for the com­pa­ny, af­ter watch­ing its shares trade OTC for some time.

Hu­mani­gen’s drug lenzilum­ab was cho­sen for an­oth­er NIH study on Covid-19 ear­li­er, which al­so added the IL-23 drug Skyrizi (risankizum­ab) from Ab­b­Vie and Boehringer In­gel­heim. — John Car­roll

Chi­na push­es ex­per­i­men­tal vac­cines out­side tri­als

Sino­vac and Chi­na Na­tion­al Biotec Group may not be test­ing their Covid-19 vac­cines, but the com­pa­nies are al­ready ex­pand­ing its reach to the Chi­nese pop­u­la­tion through emer­gency use pro­vi­sions.

As well as spawn­ing a light­ning-speed vac­cine de­vel­op­ment pro­gram, the pan­dem­ic has trig­gered an un­prece­dent­ed vac­ci­na­tion cam­paign in Chi­na, where at least 350,000 peo­ple are re­port­ed to have re­ceived an in­oc­u­la­tion out­side of clin­i­cal tri­als. Since the vac­cines re­main un­proven, ex­perts have cau­tioned that it could pro­vide a false sense of se­cu­ri­ty or worse, lead­ing to surges in side ef­fects that are not prop­er­ly mon­i­tored.

Ji­ax­ing, a city lo­cat­ed just south of Shang­hai with a pop­u­la­tion of over 3 mil­lion, is of­fer­ing Sino­vac’s ex­per­i­men­tal vac­cine to high-risk groups and res­i­dents who have “emer­gency needs.” The price, lo­cal me­dia re­port­ed, is RMB$200 ($29.87) per shot for a two-dose reg­i­men.

Chi­na Na­tion­al Biotec Group, on the oth­er hand, is of­fer­ing its jabs (it’s de­vel­op­ing two) for free to stu­dents who are study­ing abroad — much as it gave ac­cess to over­seas work­ers of state-owned en­ter­pris­es and med­ical work­ers with­in the coun­try.

More than 168,000 peo­ple had signed up for the pro­gram on­line and over 91,000 are be­ing con­sid­ered, AP re­port­ed, cit­ing a no­tice on CN­BG’s web­site that’s since been re­moved.

In com­par­i­son, its Phase III tri­als are en­rolling a to­tal of 40,000 vol­un­teers across the Unit­ed Arab Emi­rates, Bahrain, Pe­ru and Mo­roc­co. Sino­vac, which is con­duct­ing tri­als in Brazil and In­done­sia, among oth­ers, is en­rolling sim­i­lar num­bers. — Am­ber Tong

Trump al­ly Chris Christie says he re­ceived Lil­ly’s an­ti­body cock­tail

When he was hos­pi­tal­ized for Covid-19, Pres­i­dent Don­ald Trump said he asked for Re­gen­eron’s ex­per­i­men­tal an­ti­body cock­tail — and re­ceived it. And now one of his long­time al­lies re­vealed he’s re­ceived a ri­val an­ti­body treat­ment from Eli Lil­ly.

Chris Christie, the for­mer gov­er­nor of New Jer­sey, was be­lieved to have been in­fect­ed at the Rose Gar­den cer­e­mo­ny that An­tho­ny Fau­ci has called a su­per-spread­er event. Hav­ing re­cov­ered from the in­fec­tion — af­ter 7 days in in­ten­sive care — he thanked his doc­tors and “the man­u­fac­tur­ers of Remde­sivir and the Eli Lil­ly mon­o­clon­al an­ti-body cock­tail for giv­ing me ac­cess to their ex­tra­or­di­nary treat­ments.”

Trump, who was al­so giv­en remde­sivir, had since lav­ished praise on both Re­gen­eron’s and Eli Lil­ly’s drugs, promis­ing to au­tho­rize them quick­ly and make them avail­able for free to the Amer­i­can pub­lic.

Both Trump and Christie had se­cured ac­cess through com­pas­sion­ate use re­quests, some­thing bio­phar­ma com­pa­nies don’t typ­i­cal­ly like and are not oblig­ed to com­ply.

As the drugs are still be­ing test­ed in clin­i­cal tri­als and not yet wide­ly avail­able — Re­gen­eron has 50,000 dos­es cur­rent­ly while Lil­ly ex­pects to have 100,000 some time in Oc­to­ber — bioethi­cists and watch­dogs have ques­tioned the ethics be­hind giv­ing Trump spe­cial ac­cess.

“When it’s the pres­i­dent of the Unit­ed States, of course, that gets — ob­vi­ous­ly — gets our at­ten­tion,” Re­gen­eron CEO Len Schleifer had told Katie Thomas at the New York Times.

With Christie, how­ev­er, the stakes ap­pear dif­fer­ent. It is not im­me­di­ate­ly clear what stan­dards Lil­ly ap­plied in grant­i­ng his re­quest.

Lil­ly’s pro­gram is un­der a cloud of un­cer­tain­ty af­ter the NIH halt­ed a tri­al test­ing its an­ti­body, which was co-de­vel­oped with Ab­Cellera, over a safe­ty con­cern — while FDA in­spec­tors took is­sue with qual­i­ty con­trol at a man­u­fac­tur­ing plant. — Am­ber Tong

First au­tho­rized vac­cines may be met with re­luc­tant Amer­i­cans, poll sug­gests

About 70% of reg­is­tered vot­ers sur­veyed said they would take a Covid-19 vac­cine, al­though many want to wait un­til it has been avail­able for a while to see if there are ma­jor prob­lems or side ef­fects, a new Wall Street Jour­nal/NBC News poll shows.

The sur­vey found that 20% of re­spon­dents said they would take a vac­cine as soon as one be­comes avail­able, while about half the re­spon­dents want­ed to wait un­til they learned more in­for­ma­tion about the shot.

The lat­est re­sults echo ear­li­er sen­ti­ments amid a cam­paign to de­vel­op im­mu­niza­tions at un­prece­dent­ed speed and come af­ter ac­cu­sa­tions of politi­ciza­tion from all sides. Crit­ics have lam­bast­ed Pres­i­dent Don­ald Trump’s pub­lic promise to de­liv­er a vac­cine by Elec­tion Day and sound­ed alarm on the pres­sure he ap­pears to be push­ing on FDA com­mis­sion­er Stephen Hahn — while Trump has sug­gest­ed with­out ev­i­dence that there’s a “deep state” work­ing in­side the agency to de­lay a vac­cine au­tho­riza­tion. — Am­ber Tong

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

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Covid-19 roundup: As­traZeneca ships first CO­V­AX dos­es as Cana­da rec­om­mends against 65+ use; In­ovio, still stuck in PhI­II, to re­spond to FDA in May

AstraZeneca’s Covid-19 vaccine has had a bumpy ride, but the prominent drugmaker is ready to start supplying their shots to COVAX.

The first doses of the AstraZeneca/Oxford vaccine were shipped to Ghana and Cote D’Ivoire, AstraZeneca announced Tuesday, with more set to begin arriving this week in the Philippines, Indonesia, Fiji, Mongolia and Moldova. For many of these countries, these doses represent their first Covid-10 vaccines, AstraZeneca said.