Take­da re­ports sec­ond PhI­II win for sub­cu­ta­neous En­tyvio as reg­u­la­tors re­view ex­pand­ed use

Be­fore con­sum­mat­ing its $62 bil­lion buy­out of Shire, Take­da di­vest­ed SHP647 — which the rare dis­ease biotech was de­vel­op­ing for ul­cer­a­tive col­i­tis — so it can re­tain its block­buster drug En­tyvio. In do­ing so the Japan­ese phar­ma took the op­po­site ap­proach to Bris­tol-My­ers, which found it­self in a sim­i­lar predica­ment but chose to bet on its own in­ves­ti­ga­tion­al drug over Cel­gene’s Ote­zla — a top sell­er that’s just ex­pand­ed its la­bel.

Asit Parikh

That strat­e­gy seems to be pay­ing off for Take­da, which has re­port­ed pos­i­tive re­sults for a Phase III study test­ing the sub­cu­ta­neous for­mu­la­tion of the drug, al­so known as vedolizum­ab, as a main­te­nance ther­a­py.

Con­duct­ed over a year, the VIS­I­BLE-2 tri­al re­cruit­ed pa­tients with mod­er­ate­ly to se­vere­ly ac­tive Crohn’s dis­ease that is in­suf­fi­cient­ly con­trolled by cur­rent treat­ments — from cor­ti­cos­teroids and im­munomod­u­la­tors to tu­mor necro­sis fac­tor-al­pha (TN­Fα)-an­tag­o­nists. Re­searchers first dosed all 644 par­tic­i­pants with the in­tra­venous En­tyvio, then took those who achieved clin­i­cal re­sponse at week 6 and gave them sub­cu­ta­neous in­jec­tions of ei­ther drug or place­bo for an­oth­er 44 weeks.

A sta­tis­ti­cal­ly sig­nif­i­cant pro­por­tion of pa­tients on SC vedolizum­ab achieved clin­i­cal re­mis­sion over place­bo, Take­da said with break­ing out the num­bers, meet­ing the pri­ma­ry end­point of the tri­al.

It’s a cru­cial step in ex­pand­ing the dos­ing op­tions for En­tyvio, which blocks the bind­ing of α₄β₇ in­te­grin to in­testi­nal mu­cos­al ad­dressin cell ad­he­sion mol­e­cule 1 (MAd­CAM-1), there­by ame­lio­rat­ing the in­flam­ma­to­ry ef­fect of white blood cells on gut tis­sues. To be pre­sent­ed at lat­er con­fer­ences and sub­mit­ted to reg­u­la­tors, the da­ta add to re­sults from an ear­li­er tri­al con­firm­ing sim­i­lar ef­fects for ul­cer­a­tive col­i­tis, Asit Parikh, Take­da’s gas­troen­terol­o­gy head, said in a pre­pared state­ment.

Both the FDA and EMA have ac­cept­ed the ap­pli­ca­tions for sub­cu­ta­neous En­vy­tio for re­view.

En­tyvio gen­er­at­ed around $2.5 bil­lion in sales in the fis­cal year end­ing March 2019, ac­cord­ing to fil­ings. That’s a third more than the pre­vi­ous year, mark­ing it as a key growth prod­uct for the com­pa­ny.

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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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.

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.”

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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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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