Covid-19 roundup: As­traZeneca touts boost­er as ef­fec­tive against Omi­cron; Africa CDC re­port­ed­ly in talks to buy Paxlovid

Though it still hasn’t re­ceived FDA au­tho­riza­tion for its Covid-19 vac­cine, As­traZeneca is chart­ing a course for boost­er shots.

On Thurs­day, the British-Swedish phar­ma com­pa­ny re­vealed new in­for­ma­tion for its Vaxzevria shot, say­ing a boost­er dose sig­nif­i­cant­ly raised an­ti­body lev­els against Omi­cron and oth­er vari­ants, in­clud­ing Delta, re­gard­less of whether an in­di­vid­u­als’ orig­i­nal vac­cine se­ries was As­traZeneca, an mR­NA shot or Sino­vac. As­traZeneca says it plans to sub­mit the da­ta to reg­u­la­to­ry bod­ies world­wide.

“These im­por­tant stud­ies show that a third dose of Vaxzevria af­ter two ini­tial dos­es of the same vac­cine, or af­ter mR­NA or in­ac­ti­vat­ed vac­cines, strong­ly boosts im­mu­ni­ty against COVID-19,” chief in­ves­ti­ga­tor and Ox­ford pro­fes­sor An­drew Pol­lard said in a state­ment. “The Ox­ford-As­traZeneca vac­cine is suit­able as an op­tion to en­hance im­mu­ni­ty in the pop­u­la­tion for coun­tries con­sid­er­ing boost­er pro­grams.”

As­traZeneca did not in­clude spe­cif­ic da­ta in its up­date, but it was the com­pa­ny’s first state­ment on how its Covid-19 vac­cine per­forms as a boost­er. As­traZeneca al­so point­ed to oth­er stud­ies that show its boost­er reg­i­men “in­duced sig­nif­i­cant­ly high­er im­mune re­spons­es” against Delta and the orig­i­nal strain than two-dose mR­NA or vi­ral vec­tor jabs.

Though As­traZeneca’s shot has been ap­proved in the UK and EU, it re­mains un­ap­proved and unau­tho­rized in the US. Af­ter be­ing beat­en to the mar­ket by Pfiz­er, Mod­er­na and J&J in the US, As­traZeneca said it would stop seek­ing an EUA from the FDA and in­stead go af­ter full ap­proval.

That goal hasn’t yet been reached, and it re­mains to be seen whether As­traZeneca can find a piece of the Amer­i­can mar­ket for its boost­er shots as well. The CDC has rub­ber-stamped the “mix and match” ap­proach for boost­er shots, how­ev­er, al­low­ing in­di­vid­u­als to re­ceive any boost­er re­gard­less of orig­i­nal vac­cine se­ries.

Africa CDC in talks to buy Paxlovid pills — re­port

The Africa CDC is re­port­ed­ly in dis­cus­sions with Pfiz­er to ac­quire ship­ments of its an­tivi­ral Covid-19 pill.

Paxlovid has shown to be 89% ef­fec­tive at re­duc­ing the risk of hos­pi­tal­iza­tion or death from Covid-19, Pfiz­er said pre­vi­ous­ly, and re­tains most of its ef­fi­ca­cy against the Omi­cron vari­ant. Gov­ern­ments around the world have scram­bled to buy up sup­plies, and now the Africa CDC is in the race as well, ac­cord­ing to a Reuters re­port.

“We are in re­al­ly close dis­cus­sions with Pfiz­er to see what can be done to make the drugs avail­able on the con­ti­nent and ac­ces­si­ble on the con­ti­nent, that is, the Paxlovid drugs,” Africa CDC di­rec­tor John Nken­ga­song told Reuters.

The Pfiz­er pill is one of two FDA-au­tho­rized an­tivi­rals to fight Covid-19, the oth­er be­ing Mer­ck’s mol­nupi­ravir. Fig­ures re­leased from Mer­ck, how­ev­er, are much low­er than Paxlovid, with an orig­i­nal 50% ef­fi­ca­cy rate falling to 30% in some cas­es and draw­ing con­cerns from an FDA ad­comm last month.

Much like last year with the vac­cine race, rich coun­tries have snapped up most avail­able Paxlovid sup­ply. The US con­tract for 10 mil­lion dos­es puts the price at $530 per five-day Paxlovid reg­i­men, a price that al­most cer­tain­ly re­mains out of reach for many poor na­tions.

Pfiz­er is work­ing with oth­er man­u­fac­tur­ers to pro­duce gener­ic ver­sions of Paxlovid for low- and mid­dle-in­come coun­tries, but it re­mains to be seen whether it will prove an ef­fec­tive strat­e­gy. Vac­cine up­take in Africa re­mains low, as on­ly 10% of Africans are ful­ly vac­ci­nat­ed, Nken­ga­song said.

Vir, Glax­o­SmithK­line seek EUA amend­ment for in­jectable an­ti­body

Vir and Glax­o­SmithK­line’s mon­o­clon­al an­ti­body re­mains the on­ly au­tho­rized treat­ment to re­duce the risk of hos­pi­tal­iza­tion and death against Omi­cron, and Thurs­day the pair re­quest­ed the FDA ex­pand its EUA.

The com­pa­nies are seek­ing an EUA amend­ment to in­clude in­tra­mus­cu­lar ad­min­is­tra­tion of the an­ti­body in ad­di­tion to the in­tra­venous method al­ready au­tho­rized, they said in a state­ment Thurs­day. Ac­cord­ing to a Phase III study, the in­jectable ver­sion proved non-in­fe­ri­or to the IV ver­sion and of­fered “sim­i­lar ef­fi­ca­cy” in mild-to-mod­er­ate, ear­ly Covid-19 cas­es.

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

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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.