Kite grabs a stem cell bi­ol­o­gy ‘break­through’ in race for off-the-shelf T cell ther­a­pies

Look­ing for an edge in the race to de­vel­op block­buster off-the-shelf cell ther­a­pies to fight can­cer, Kite Ther­a­peu­tics has grabbed a li­cense for new T cell tech from UCLA that the biotech be­lieves can play a break­through role in the field of al­lo­gene­ic drugs.

Kite’s rep in R&D has been based on the first gen­er­a­tion of CAR-T drugs that ex­tracts cells from pa­tients and then cus­tomizes them with chimeric anti­gen re­cep­tors. Once in­fused back in­to pa­tients, they’re de­signed to track down and elim­i­nate can­cer cells. And Kite has one of the most ad­vanced pro­grams now in a piv­otal study.

But be­hind the first-gen drugs, Cel­lec­tis and oth­ers have been work­ing on al­lo­gene­ic ther­a­pies, adapt­ing a stock­pile of cells to do the same work with­out the ex­pen­sive per­son­al­iza­tion process.

The hunt for that new, more ef­fi­cient cell ther­a­py led Kite to the lab of Gay M. Crooks at  UCLA. Ac­cord­ing to Kite, the plat­form us­es stem cell bi­ol­o­gy to cu­rate an ide­al se­lec­tion of T cells which can then be ge­net­i­cal­ly en­gi­neered to make ef­fec­tive can­cer ther­a­pies.

The first CAR-Ts from Juno, Kite and No­var­tis are all en­ter­ing the last leg of clin­i­cal de­vel­op­ment. But as re­cent deaths in Juno’s JCAR015 study demon­strat­ed, there are still se­ri­ous safe­ty is­sues to con­sid­er as well as lim­i­ta­tions in terms of the type of can­cers that can be treat­ed and the ex­tent of the pa­tients who will ben­e­fit.

“This ATO sys­tem rep­re­sents a sig­nif­i­cant break­through in stem cell bi­ol­o­gy that will dri­ve our long-term strat­e­gy to de­vel­op best-in-class al­lo­gene­ic T-cell ther­a­pies,” said David Chang, M.D., Ph.D., Kite’s R&D chief. “This plat­form pro­vides a re­new­able source of T-cells and can be fur­ther ex­ploit­ed with gene en­gi­neer­ing, in­clud­ing chimeric anti­gen re­cep­tors, T-cell re­cep­tors and oth­er gene mod­i­fi­ca­tions of in­ter­est, to gen­er­ate po­tent T-cell prod­ucts that have the po­ten­tial to be re­sis­tant to re­jec­tion and to bear no risk of graft-ver­sus-host dis­ease.”

There’s no word on terms, but all the lead­ers in this field have been will­ing to pay top dol­lar for new tech.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.

Green-light­ed in Japan, FDA quick­ly spurns Dai­ichi Sanky­o's flawed ap­pli­ca­tion for AML drug

Three days af­ter win­ning Japan­ese ap­proval for its acute myeloid leukemia drug quizar­tinib, Dai­ichi Sankyo is be­ing forced to en­dure an em­bar­rass­ing re­jec­tion at the hands of the FDA.

US reg­u­la­tors wast­ed no time in bat­ting back quizar­tinib af­ter first high­light­ing the messy da­ta in its ap­pli­ca­tion in an in­ter­nal re­view, that in turn per­suad­ed a large ma­jor­i­ty of out­side ex­perts to rec­om­mend a re­jec­tion for the drug, which tar­gets FLT3-ITD–pos­i­tive AML cas­es.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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HIV, pneu­mo­coc­cal — and what? Mer­ck­'s un­ex­pect­ed pipeline high­light ex­cites a lit­tle biotech

In an R&D update dominated by oncology — mostly Keytruda, followed by Lynparza and Lenvima — Merck chose to highlight a program in sensory pathology, an HIV drug, and a group of pneumococcal vaccines. And that has made at least one biotech very happy.

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