As first Omicron case in US crops up, researchers wonder: which antibodies, vaccines will hold up?

As Covid-19 drug and vac­cine de­vel­op­ers race to fig­ure out which of their prod­ucts might be ham­pered by the new vari­ant, the CDC on Wednes­day af­ter­noon an­nounced the first con­firmed case of the Omi­cron vari­ant (B.1.1.529) in the US, found in San Fran­cis­co.

The uniden­ti­fied in­di­vid­ual was a trav­el­er who re­turned from South Africa on Nov. 22, 2021, was ful­ly vac­ci­nat­ed, and had mild symp­toms that the CDC de­scribed as im­prov­ing. All close con­tacts have been con­tact­ed and have test­ed neg­a­tive, the cen­ters said.

Mean­while, due to cer­tain mu­ta­tions in this vari­ant, drug­mak­ers from Re­gen­eron to Glax­o­SmithK­line to Mod­er­na and BioN­Tech are eval­u­at­ing how their mAb treat­ments and vac­cines may lose some ef­fi­ca­cy.

‘The Pres­i­dent’s med­ical team con­tin­ues to be­lieve that ex­ist­ing vac­cines will pro­vide some lev­el of pro­tec­tion against se­vere ill­ness from Omi­cron, and in­di­vid­u­als who have got­ten boost­ers have even stronger pro­tec­tion,’ White House Covid-19 re­sponse co­or­di­na­tor Jeff Zients said in a state­ment.

The FDA will like­ly be track­ing how the mAbs will fare, too. Back in March, the FDA re­vised the fact sheets for health­care providers on the sus­cep­ti­bil­i­ty of five SARS-CoV-2 vari­ants to each of the mAb ther­a­pies that were avail­able at the time, not­ing how Re­gen­eron seemed to fare bet­ter than Lil­ly with cer­tain vari­ants.

But Re­gen­eron said in a state­ment this week that Omi­cron is dif­fer­ent: ‘Pri­or in vit­ro analy­ses and struc­tur­al mod­el­ing re­gard­ing the in­di­vid­ual mu­ta­tions present in the Omi­cron vari­ant in­di­cate that there may be re­duced neu­tral­iza­tion ac­tiv­i­ty of both vac­cine-in­duced and mon­o­clon­al an­ti­body con­veyed im­mu­ni­ty, in­clud­ing the cur­rent RE­GEN-COV an­ti­bod­ies.’

But GSK was more op­ti­mistic about its mAb with Vir, which the com­pa­nies said was ‘de­lib­er­ate­ly de­signed with a mu­tat­ing virus in mind.’ A GSK spokesper­son told End­points News via email: ‘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.’

Eli Lil­ly and the oth­er drug­mak­ers said they’re await­ing fur­ther test re­sults, and the CDC al­so re­minds every­one that the emer­gence of Omi­cron is a good rea­son to get vac­ci­nat­ed.

‘The re­cent emer­gence of the Omi­cron vari­ant (B.1.1.529) fur­ther em­pha­sizes the im­por­tance of vac­ci­na­tion, boost­ers, and gen­er­al pre­ven­tion strate­gies need­ed to pro­tect against COVID-19. Every­one 5 and old­er should get vac­ci­nat­ed boost­ers are rec­om­mend­ed for every­one 18 years and old­er,’ CDC said.

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

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Philip Dormitzer, new GSK global head of vaccines R&D

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

GSK ‘Target the Future’ Ad Campaign

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its ‘Think Tank’ challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off ‘Shark Tank’ TV show-style finish next year.

The innovation contest kicks off GSK’s bigger ‘Target the Future’ unbranded campaign to advance innovation and awareness in multiple myeloma.

‘We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,’ Christine Roth, senior VP and global head of oncology at GSK, said.

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Lan Huang, BeyondSpring CEO

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the ‘great majority’ of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines ‘fair access.’
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