Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfiz­er and BioN­Tech an­nounced Tues­day that they’ve ini­ti­at­ed a clin­i­cal study to eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty of an Omi­cron-tar­get­ed vac­cine can­di­date in healthy adults 18 through 55 years of age, al­though it re­mains un­clear when, if ever, that vac­cine might be nec­es­sary.

Draw­ing on some of the par­tic­i­pants from the com­pa­nies’ Phase III boost­er study, the tri­al will en­roll up to 1,420 par­tic­i­pants and eval­u­ate three groups of healthy adults up to the age of 55, in­clud­ing one group who re­ceived 2 dos­es of the Pfiz­er vac­cine and will get one shot of the Omi­cron-spe­cif­ic boost­er, one group that re­ceived three dos­es of the Pfiz­er vac­cine and will get one of the Omi­cron-based vac­cines, and then a third group re­ceiv­ing three dos­es of the Omi­cron-based vac­cine.

“While cur­rent re­search and re­al-world da­ta show that boost­ers con­tin­ue to pro­vide a high lev­el of pro­tec­tion against se­vere dis­ease and hos­pi­tal­iza­tion with Omi­cron, we rec­og­nize the need to be pre­pared in the event this pro­tec­tion wanes over time and to po­ten­tial­ly help ad­dress Omi­cron and new vari­ants in the fu­ture,” Kathrin Jansen, head of vac­cine R&D at Pfiz­er, said in a state­ment.

The com­pa­nies said they ex­pect to pro­duce 4 bil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine this year, and that ca­pac­i­ty is not ex­pect­ed to change if an Omi­cron-adapt­ed vac­cine is re­quired.

Britain looks to en­roll thou­sands more in mol­nupi­ravir tri­al to see if Mer­ck’s pill works

The UK gov­ern­ment said on Tues­day it needs to re­cruit 6,000 more peo­ple in­to a tri­al for Mer­ck’s Covid-19 pill mol­nupi­ravir be­fore it can be dis­trib­uted more wide­ly.

First ap­proved by Britain’s drug reg­u­la­tor in No­vem­ber, the UK launched a na­tion­al study to es­tab­lish the best way to use the drug.

Ac­cord­ing to Reuters, the UK health min­istry said that while more than 4,500 tri­al par­tic­i­pants had signed up for the tri­al, dubbed Panoram­ic, thou­sands more were need­ed to gath­er the da­ta need­ed.

Eu­ro­pean and Cana­di­an reg­u­la­tors of­fer a peek in­to Mod­er­na’s vac­cine da­ta

The Eu­ro­pean Med­i­cines Agency and Health Cana­da took the proac­tive step to­ward more trans­paren­cy around Covid-19 vac­cines on Tues­day, with the re­lease of da­ta on Mod­er­na’s vac­cine.

The EMA pre­vi­ous­ly re­leased da­ta on the Covid vac­cines from Pfiz­er/BioN­Tech, J&J, As­traZeneca, and Gilead’s Covid treat­ment remde­sivir.

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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