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.

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.