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.


Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.