With mul­ti­ple re­pur­posed Covid-19 treat­ments al­ready in the clin­ic (and one that flunked out), Ab­b­Vie is plac­ing its next bet on some­thing new: an ex­per­i­men­tal an­ti­body it spent the last sev­er­al months de­vel­op­ing with Har­bour Bio­Med, the Nether­lands’ Utrecht Uni­ver­si­ty and Eras­mus Med­ical Cen­ter.

Ab­b­Vie joined the an­ti­body hunt back in June, with its sights set on Har­bour’s 47D11. The Illi­nois-based phar­ma is now putting down a one-time li­cense fee for world­wide de­vel­op­ment and com­mer­cial­iza­tion rights to the an­ti­body, which it says shows promise in not on­ly SARS-CoV-2, but al­so re­lat­ed mu­ta­tions of the virus and SARS-CoV-1. It dosed the first pa­tient in a 24-per­son Phase I tri­al just last week.

Har­bour and Utrecht are keep­ing qui­et about the terms of the li­cens­ing deal, ex­cept to note that they’ll re­ceive cer­tain mile­stone pay­ments and tiered roy­al­ties on net sales. Eras­mus wasn’t in­volved in the deal.

47D11 was dis­cov­ered last year us­ing the Har­bour Mice plat­form, and was orig­i­nal­ly in de­vel­op­ment for SARS-CoV-1. Then the pan­dem­ic struck, and Har­bour CEO Jing­song Wang said the com­pa­nies re­al­ized its po­ten­tial for SARS-CoV-2. It tar­gets a con­served re­gion of the SARS-CoV-2 spike pro­tein, and Wang said there’s a pos­si­bil­i­ty it could be used to treat oth­er coro­n­avirus­es as well.

“Of course, we’ll need fur­ther val­i­da­tion,” he added.

The study will test the an­ti­body in three dif­fer­ent dos­es at test sites across the US, with safe­ty as the pri­ma­ry end­point. Har­bour said they ex­pect the tri­al to wrap up around May.

Al­though Ab­b­Vie didn’t have much pri­or ex­pe­ri­ence in de­vel­op­ing an­ti­bod­ies for virus­es, much of their oth­er work cen­ters on an­ti­bod­ies, like the TNF-block­ing an­ti­body Hu­mi­ra.

Ab­b­Vie’s ceni­crivi­roc — which has shown to be un­der­whelm­ing as a NASH treat­ment — was se­lect­ed by the NIH in Oc­to­ber for a new AC­TIV-1 Im­mune Mod­u­la­tors adap­tive study, in an ef­fort to find new ways to stave off the cy­tokine storms that kill some pa­tients. Its IL-23 drug with Boehringer In­gel­heim was al­so cho­sen for an NIH study for Covid-19.

An­oth­er of the com­pa­ny’s ef­forts to fight the pan­dem­ic proved un­suc­cess­ful back in June, when UK RE­COV­ERY tri­al in­ves­ti­ga­tors con­clud­ed that the HIV an­tivi­ral Kale­tra was in­ef­fec­tive against Covid-19. For 1,596 pa­tients giv­en the drug, the 28-day mor­tal­i­ty rate was 22.1%, com­pared to 21.3% for the 3,376 who re­ceived stan­dard care.

Go­ing forth, AB­BV-47D11 may al­so be test­ed as a pre­ven­ta­tive ther­a­py. “That is some­thing that is be­ing re­viewed and dis­cussed in­ter­nal­ly at this point,” Har­bour chief strat­e­gy of­fi­cer and head of US op­er­a­tions At­ul Desh­pande said.

“We’re re­al­ly ex­cit­ed to con­tribute to the on­go­ing pan­dem­ic in face of all the chal­lenges that all of us glob­al­ly are fac­ing,” Wang said.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.