Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

De­spite Ugur Sahin’s calls for calm over the Omi­cron vari­ant — mak­ing a much more mea­sured ap­peal than Mod­er­na CEO Stéphane Ban­cel — the BioN­Tech chief is al­ready pre­dict­ing the po­ten­tial need for new Covid-19 vac­cines.

In com­ments made at a con­fer­ence host­ed Fri­day morn­ing by Reuters, Sahin said that even though vac­ci­nat­ed in­di­vid­u­als would like­ly still be pro­tect­ed from se­vere dis­ease, Omi­cron could see greater num­bers of break­through in­fec­tions than oth­er vari­ants. The mu­ta­tions mean Covid shots will prob­a­bly be­come nec­es­sary every year, sim­i­lar to the flu.

“I be­lieve in prin­ci­ple at a cer­tain time point we will need a new vac­cine against this new vari­ant. The ques­tion is how ur­gent it needs to be avail­able,” Sahin said at the con­fer­ence, which was al­so re­port­ed on by Reuters.

He added that even though emerg­ing da­ta sig­nal Omi­cron is high­ly in­fec­tious, the ques­tion still re­mains whether or not it caus­es se­vere dis­ease at a high­er rate.

“It is not clear whether this vari­ant pro­duces more se­vere dis­ease,” Sahin said.

Sahin’s Fri­day com­ments come a cou­ple of days af­ter he said vac­cine-in­duced T cell re­spons­es would al­most cer­tain­ly re­main strong against Omi­cron, telling peo­ple “Don’t freak out” just yet over the vari­ant. In com­ments to the Wall Street Jour­nal, the CEO said those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against hos­pi­tal­iza­tion and death.

The re­marks con­trast­ed sharply with Ban­cel, who one day pri­or had said,“This is not go­ing to be good” in an in­ter­view with the Fi­nan­cial Times. Ban­cel pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness, but stressed he didn’t know how steep the drop might be.

UK reg­u­la­tors ful­ly ap­prove Vir/Glax­o­SmithK­line an­ti­body treat­ment

As the UK con­tin­ues try­ing to chart a path through a sig­nif­i­cant Covid-19 surge, the coun­try’s reg­u­la­tor ful­ly ap­proved an­oth­er tool to fight the virus.

The MHRA gave a full OK to the Vir/Glax­o­SmithK­line mon­o­clon­al an­ti­body on Fri­day, be­com­ing the sec­ond mAb treat­ment to get an ap­proval in the coun­try for use in mild-to-mod­er­ate cas­es where the pa­tient is at risk to de­vel­op se­vere Covid-19. The UK had pre­vi­ous­ly ap­proved the mon­o­clon­al an­ti­body de­vel­oped by Roche and Re­gen­eron.

“This is yet an­oth­er ther­a­peu­tic that has been shown to be ef­fec­tive at pro­tect­ing those most vul­ner­a­ble to COVID-19, and sig­nals an­oth­er sig­nif­i­cant step for­ward in our fight against this dev­as­tat­ing dis­ease,” MHRA chief June Raine said of the Vir/GSK treat­ment in a state­ment.

Reg­u­la­tors cit­ed a study show­ing a sin­gle treat­ment of the an­ti­body re­duced the risk of hos­pi­tal­iza­tion and death by 79% in pa­tients vul­ner­a­ble to se­vere Covid-19. The treat­ment had pre­vi­ous­ly won a con­di­tion­al au­tho­riza­tion in in­di­vid­u­als with mild or mod­er­ate cas­es and at least one co­mor­bid­i­ty.

The agency al­so not­ed it’s not yet known whether the Omi­cron vari­ant will have any im­pact on the drug’s ef­fec­tive­ness. Ear­li­er this week, how­ev­er, a GSK spokesper­son told End­points News it’s op­ti­mistic the an­ti­body will hold up against the new mu­ta­tion.

“Based on the se­quence of the Omi­cron vari­ant, we be­lieve sotro­vimab is like­ly to main­tain ac­tiv­i­ty and po­ten­cy against this vari­ant, and we are work­ing to con­firm this in the lab as a mat­ter of ur­gency,” the spokesper­son said, us­ing the treat­ment’s chem­i­cal name.

Al­so on Fri­day, the MHRA re­newed its au­tho­riza­tion for the Pfiz­er/BioN­Tech vac­cine, ex­act­ly one year to the day af­ter it be­came the first agency to al­low the shot’s use.

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.