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

Pascal Soriot (Getty)

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Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

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Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

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Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Robert Clarke (Kinaset)

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Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

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In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.