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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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