Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

'Don't freak out': Ugur Sahin takes a dif­fer­ent tone on Omi­cron than his mR­NA coun­ter­part — re­ports

Where­as some pub­lic health of­fi­cials and bio­phar­ma lead­ers — in­clud­ing Mod­er­na CEO Stéphane Ban­cel — are sound­ing the alarm over the new Omi­cron coro­n­avirus vari­ant, BioN­Tech chief Ugur Sahin is press­ing a more cau­tious ap­proach.

In in­ter­views Tues­day with the Wall Street Jour­nal and Reuters, Sahin cau­tioned that lit­tle is yet known of the vari­ant’s abil­i­ty to cause se­vere Covid-19, and T cell re­spons­es among the vac­ci­nat­ed would like­ly re­main strong. Though the biotech is still con­duct­ing lab tests to de­ter­mine whether an­ti­body pro­tec­tion will be di­min­ished, Sahin isn’t press­ing the pan­ic but­ton.

“Our mes­sage is: Don’t freak out, the plan re­mains the same: Speed up the ad­min­is­tra­tion of a third boost­er shot,” Sahin told WSJ on Tues­day.

The com­ments stand in stark con­trast to an in­ter­view Ban­cel gave to the Fi­nan­cial Times ear­li­er this week, in which he pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness against Omi­cron. Ban­cel hedged, not­ing he didn’t know how steep the drop would be, but stressed that “all the sci­en­tists I’ve talked to … are like, ‘This is not go­ing to be good.’”

Omi­cron has shak­en glob­al mar­kets since South African sci­en­tists first de­tect­ed the vari­ant last week, and coun­tries around the world are is­su­ing new trav­el bans in the hopes of stem­ming the tide. The vari­ant has been par­tic­u­lar­ly no­table for its high num­ber of mu­ta­tions, lead­ing to fears it may be more con­ta­gious than the Al­pha or Delta strains and in­fect vac­ci­nat­ed peo­ple more eas­i­ly.

But Sahin told WSJ he thinks those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against se­vere dis­ease re­sult­ing in hos­pi­tal­iza­tion or death. The CEO high­light­ed that the shot pro­duced by BioN­Tech and Pfiz­er has large­ly low­ered se­vere dis­ease risk from oth­er vari­ants and said most Delta break­through in­fec­tions are mild.

He said the same would like­ly hold true for Omi­cron, as T cells con­tin­ue to of­fer pro­tec­tion even if the virus evades an­ti­bod­ies. The re­duc­tion in an­ti­body pro­tec­tion against Omi­cron is yet to be de­ter­mined, he told Reuters, but he is ex­pect­ing some loss against mild and mod­er­ate dis­ease.

Even so, Sahin is stay­ing calm.

“To my mind there’s no rea­son to be par­tic­u­lar­ly wor­ried. The on­ly thing that wor­ries me at the mo­ment is the fact that there are peo­ple that have not been vac­ci­nat­ed at all,” Sahin told Reuters.

While re­searchers await an­swers on on­go­ing lab tests, the virus and emerg­ing vari­ants aren’t go­ing away any time soon. The pan­dem­ic has al­ready cre­at­ed a boon for Pfiz­er and Mod­er­na, with the for­mer al­so de­vel­op­ing an an­tivi­ral pill it says is 89% ef­fec­tive in re­duc­ing se­vere dis­ease in in­fect­ed in­di­vid­u­als.

Pfiz­er al­so like­ly has a leg up on Mer­ck, an­oth­er com­pa­ny work­ing on an oral treat­ment. In an ad­comm yes­ter­day, ad­vis­ers nar­row­ly vot­ed to rec­om­mend au­tho­riz­ing the Mer­ck pill de­spite ques­tions about ef­fi­ca­cy and con­cerns over us­ing the ther­a­py in preg­nant women.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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