Covid-19 roundup: North Ko­rea at­tempt­ed to steal Pfiz­er vac­cine tech; WHO OKs As­traZeneca shot de­spite South Africa woes

Pfiz­er was re­cent­ly sub­ject to a cy­ber­at­tack from North Ko­rea, South Ko­re­an of­fi­cials said Tues­day, as the reclu­sive na­tion sought Covid-19 vac­cine tech­nol­o­gy.

It wasn’t im­me­di­ate­ly clear when the at­tack oc­curred or whether it was suc­cess­ful, and a Pfiz­er rep wasn’t able to com­ment, the Wash­ing­ton Post re­port­ed. But news of the hack­ing at­tempt came de­spite North Ko­re­an leader Kim Jong Un in­sist­ing that his coun­try has not been af­fect­ed by the pan­dem­ic.

Ha Tae-ke­ung, a South Ko­re­an op­po­si­tion law­mak­er and mem­ber of the gov­ern­ment’s in­tel­li­gence com­mit­tee, dis­closed the at­tack and added that the coun­try had ob­served a 32% in­crease in North Ko­re­an cy­ber­at­tacks over the last year.

This is not the first time North Ko­rea has been ac­cused of try­ing to steal in­for­ma­tion on coro­n­avirus vac­cines and treat­ments. Back in No­vem­ber, Mi­crosoft said both North Ko­rea and Rus­sia tried to dig­i­tal­ly ran­sack phar­ma­ceu­ti­cal com­pa­nies and vac­cine re­searchers, though the at­tempts were most­ly un­suc­cess­ful. South Ko­rea had al­so pre­vi­ous­ly thwart­ed a North Ko­re­an hack­ing at­tempt in­to lo­cal phar­ma com­pa­nies last year.

North Ko­rea has al­so turned to cy­ber­at­tacks more fre­quent­ly dur­ing the pan­dem­ic as a way to fund its econ­o­my. Last week, the UN re­port­ed ev­i­dence “strong­ly” point­ed to­ward the coun­try con­duct­ing a $281 mil­lion theft in Sep­tem­ber.

Though it makes claims to the con­trary, North Ko­rea has re­quest­ed vac­cines through CO­V­AX and is slat­ed to re­ceive 2 mil­lion dos­es of the As­traZeneca/Ox­ford shot, the pro­gram re­port­ed ear­li­er this month.

As­traZeneca shot ap­proved by WHO as South Africa woes con­tin­ue

The WHO ap­proved a new Covid-19 vac­cine for emer­gency use Mon­day — and it’s the As­traZeneca/Ox­ford Uni­ver­si­ty shot.

With the OK, the vac­cine is now able to be dis­trib­uted to low­er-in­come na­tions with­out their own reg­u­la­to­ry bod­ies at a much more rapid pace, NBC News re­port­ed. The As­traZeneca shot makes up the vast ma­jor­i­ty of CO­V­AX vac­cines, with more than 330 mil­lion dos­es slat­ed to be doled out start­ing in late Feb­ru­ary.

“We now have all the pieces in place for the rapid dis­tri­b­u­tion of vac­cines. But we still need to scale up pro­duc­tion,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said at a news brief­ing.

The vac­cine has been hailed as a cheap­er al­ter­na­tive to its mR­NA ri­vals from Pfiz­er/BioN­Tech and Mod­er­na. But it’s not all ros­es for the shot as re­ports have emerged that it is not very ef­fec­tive at pre­vent­ing mild and mod­er­ate Covid-19 cas­es stem­ming from the virus vari­ant that first emerged in South Africa.

There has been much back and forth be­tween As­traZeneca and South Africa in the last cou­ple of weeks, with the coun­try paus­ing its roll­out of the com­pa­ny’s shots. South Africa has since been seek­ing to sell, swap or re­turn 1 mil­lion dos­es af­ter they proved on­ly 21.9% ef­fec­tive against mild or mod­er­ate cas­es in a Phase I/II tri­al, the Eco­nom­ic Times re­port­ed, and start­ed in­oc­u­lat­ing med­ical work­ers with J&J’s one-shot vac­cine in a Phase II­Ib tri­al in­stead.

Ear­ly Tues­day morn­ing, a South African news­pa­per al­so said the coun­try would be shar­ing the As­traZeneca vac­cine with oth­er coun­tries in the African Union.

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

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.

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.

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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‘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.