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.

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.