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

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.