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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection: