Gilead for­ti­fies its pi­o­neer­ing cell ther­a­py sta­tus, ex­pand­ing in­to three new fa­cil­i­ties and team­ing with NCI

Af­ter the com­pa­ny’s $12 bil­lion buy­out of Kite last year, Gilead is wast­ing no time ce­ment­ing its sta­tus as a leader in cell ther­a­py. The com­pa­ny an­nounced plans Tues­day to beef up its op­er­a­tions with three new fa­cil­i­ties around the globe — and inked a re­search agree­ment that could con­nect the com­pa­ny with more cut­ting-edge work in the field.

John Mil­li­gan

Be­com­ing an overnight leader in adop­tive cell ther­a­py af­ter its pur­chase of Kite, Gilead is now pri­or­i­tiz­ing the R&D and man­u­fac­ture of these drugs. In the Nether­lands, Gilead has leased a 117,000 square-foot man­u­fac­tur­ing site in Hoofd­dorp, al­low­ing the com­pa­ny to make and de­liv­er cell ther­a­pies to peo­ple liv­ing with can­cer in Eu­rope. Among oth­er drugs, the fa­cil­i­ty will man­u­fac­ture the CAR-T axi­cab­ta­gene ciloleu­cel (which goes un­der the brand name Yescar­ta here in the US). The ther­a­py is cur­rent­ly un­der re­view by the Eu­ro­pean Med­i­cines Agency.

“This new Eu­ro­pean man­u­fac­tur­ing fa­cil­i­ty will en­able per­son­al­ized cell ther­a­pies to be man­u­fac­tured in clos­er ge­o­graph­ic prox­im­i­ty to the pa­tients who will re­ceive them, po­ten­tial­ly short­en­ing the turn­around time for peo­ple who ur­gent­ly need care,” said Gilead’s pres­i­dent and CEO John Mil­li­gan in a state­ment.

On top of the Nether­lands fa­cil­i­ty, Kite bought a new build­ing in San­ta Mon­i­ca — where it’s long been head­quar­tered — from Astel­las Phar­ma. That fa­cil­i­ty will be used for cell ther­a­py R&D and the ex­pan­sion of clin­i­cal man­u­fac­tur­ing ca­pa­bil­i­ties, the com­pa­ny said.

Alessan­dro Ri­va

On the oth­er side of the coast, Kite has leased a 26,000 square-foot build­ing in Gaithers­burg, Mary­land, which will serve as home base for a new re­search project with the Na­tion­al Can­cer In­sti­tute. You’ll note that NCI is home to Steve Rosen­berg, who’s pi­o­neered the de­vel­op­ment of im­munother­a­pies and gene ther­a­pies for ad­vanced can­cers. That Co­op­er­a­tive Re­search and De­vel­op­ment Agree­ment will fo­cus on de­vel­op­ing adop­tive cell ther­a­pies tar­get­ing pa­tient-spe­cif­ic tu­mor neoanti­gens.

“We are proud to be at the fore­front of ad­vanc­ing cell ther­a­py, which we be­lieve has the po­ten­tial to trans­form can­cer treat­ment,” said Alessan­dro Ri­va, Gilead’s head of cell ther­a­py and ex­ec­u­tive VP of on­col­o­gy ther­a­peu­tics, in a state­ment. “The ad­di­tion of these three new fa­cil­i­ties and the ex­pand­ed CRA­DA with our re­search col­lab­o­ra­tors at the NCI will help us bring cell ther­a­pies to more peo­ple with can­cer around the world.”

This is the lat­est in a se­ries of steps Gilead has tak­en to ramp up its ef­forts in next-gen cell ther­a­py. These three new fa­cil­i­ties — along with the new NCI re­search agree­ment — come just months af­ter Gilead agreed to ac­quire Cell De­sign Labs in a $567 mil­lion deal.

 

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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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.

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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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.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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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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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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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.