Short­age of mon­keys slowed down Eli Lil­ly's Covid-19 an­ti­body part­ner. And it's a prob­lem for every­one

It may not be sur­pris­ing that Shang­hai Jun­shi Bio­sciences has pushed back some clin­i­cal tri­als to pri­or­i­tize its Eli Lil­ly-part­nered Covid-19 an­ti­body. But what ex­act­ly was suck­ing up their time is al­most cer­tain to raise some eye­brows: The com­pa­ny spent months find­ing enough mon­keys on which to test the ex­per­i­men­tal drug.

Jun­shi’s plight high­lights a se­ri­ous, if oft-un­der­looked, chal­lenge that’s be­set the whole bio­med­ical re­search en­ter­prise. Test­ing a mol­e­cule on non-hu­man pri­mates is of­ten a cru­cial fi­nal step be­fore it can be moved in­to the clin­ic, but a con­flu­ence of fac­tors have re­sult­ed in a short­age in both the US and Eu­rope just as drug­mak­ers were scram­bling to put their ex­per­i­men­tal pro­grams through tri­als at record speed.

Jun­shi COO Feng Hui told in­vestors on a call on Fri­day that the short­age was acute be­tween Feb­ru­ary and June, when the biotech was com­pet­ing with oth­er com­pa­nies and in­sti­tutes.

But the is­sue re­mains un­re­solved. Just days ago, the Eu­ro­pean An­i­mal Re­search As­so­ci­a­tion brought at­ten­tion to a “grow­ing short­age of pur­pose-bred macaque mon­key” used in Covid-19 and oth­er vi­tal re­search.

One of the main bot­tle­necks is how Chi­na, a main source of mon­keys for med­ical re­search, has banned the ex­port from breed­ing fa­cil­i­ties since the be­gin­ning of 2020 cit­ing con­cerns about the spread of the coro­n­avirus.

“The on­go­ing em­bar­go is now be­gin­ning to have se­ri­ous con­se­quences for re­search in Eu­rope and the rest of the world,” the group wrote in a state­ment. Kirk Leech, the ex­ec­u­tive di­rec­tor, added: “Mon­keys play a crit­i­cal role in the de­vel­op­ment of vac­cines, such as those for Covid-19, and ur­gent in­ter­na­tion­al co-op­er­a­tion is need­ed to lift the ban.”

In a let­ter urg­ing the WHO to in­ter­vene, EARA ar­gued that “while the sus­pen­sion was pru­dent at the time it has be­come clear that an­i­mals ex­port­ed from Chi­na pos­sess a very low risk of trans­mit­ting any com­mu­ni­ca­ble dis­ease.” Re­search mon­keys, they added, are al­so sub­ject to strict rules in han­dling and trans­porta­tion, in­clud­ing quar­an­tine and per­son­al pro­tec­tive equip­ment re­quire­ments.

Still, those fac­ing the chal­lenge are not op­ti­mistic that the prob­lem will be solved soon. As the At­lantic re­port­ed in Au­gust, Bio­qual — which has done pri­mate re­search for Mod­er­na’s vac­cine and sev­er­al oth­er Covid-19 play­ers — said while it was ini­tial­ly able to reuse some an­i­mals from non-dis­ease stud­ies, the sup­ply had been used up.

New macaques al­so cost $10,000, dou­ble the orig­i­nal price.

“This may just be the be­gin­ning,” R. Kei­th Reeves, a vi­rol­o­gist at Har­vard work­ing on HIV, told the At­lantic. “And I think that we’re all prepar­ing for there to be sig­nif­i­cant de­lays.”

For its part, Jun­shi has pro­ceed­ed in­to hu­man tri­als of its an­ti­body. Re­sults from a re­cent study test­ing it in com­bi­na­tion with bam­lanivimab, the an­ti­body de­vel­oped by Eli Lil­ly and Ab­Cellera, im­pressed an­a­lysts and paved the way for an emer­gency use au­tho­riza­tion re­quest. The FDA has grant­ed an EUA for bam­lanivimab.

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

So­cial: AP Im­ages

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Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

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Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

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The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Elizabeth Warren (Michael Brochstein/Sipa USA)(Sipa via AP Images)

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Two top Senate Finance committee senators on Thursday called for a hearing to examine the questions and challenges for Medicare arising from the FDA’s recent approval of Biogen’s Aduhelm, the controversial new drug approved to treat Alzheimer’s disease.

In a letter to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), subcommittee chair Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) hinted at making policy changes to enable Medicare to more directly connect prescription drug pricing to clinical effectiveness. They raised questions about the “dramatic implications for our health care system” from the approval, which they said “stretch well beyond the scope of FDA’s jurisdiction.”

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