Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thurs­day evening that Christi Shaw has giv­en up her top post as the head of the Bio-Med­i­cines group at Eli Lil­ly for the helm at CAR-T pi­o­neer Kite. New Gilead CEO Daniel O’Day, a Roche vet­er­an, had made find­ing a Kite CEO a top pri­or­i­ty on his ar­rival at Gilead. And he went right for a head­lin­er.

O’Day was clear­ly ex­cit­ed about the coup.

Geor­gios Ke­falas for AP

Click on the im­age to see the full-sized ver­sion

“We con­duct­ed an ex­ten­sive search for a new leader at Kite and we be­lieve that Christi’s unique set of skills will al­low us to con­tin­ue to build on our lead­er­ship po­si­tion in cell ther­a­py,” he said in a pre­pared state­ment. “Christi’s vast ex­pe­ri­ence across com­plex ther­a­peu­tic ar­eas, and par­tic­u­lar­ly in on­col­o­gy, will serve Kite very well. She is clear­ly a leader who will bring teams and in­di­vid­u­als to­geth­er and I am con­fi­dent she will build up­on the en­tre­pre­neur­ial spir­it at Kite as we seek to help more peo­ple with can­cer around the world.”

Kite was the num­ber two com­pa­ny — be­hind No­var­tis — to in­tro­duce per­son­al­ized cell ther­a­pies to can­cer pa­tients. But it quick­ly leapfrogged to the front af­ter es­tab­lish­ing a more re­li­able man­u­fac­tur­ing process — a key piece of the puz­zle in terms of build­ing that mar­ket.

More re­cent­ly, though, the fo­cus in R&D has turned to off-the-shelf ver­sions of CAR-T, where the lead­ers like Arie Bellde­grun have be­gun seek­ing out new ther­a­pies that don’t have to use adapt­ed cells from pa­tients.

Shaw brings a rare per­son­al ap­proach to drug de­vel­op­ment. A vet­er­an phar­ma ex­ec, she left a big job run­ning No­var­tis’ US busi­ness to help care for her ail­ing sis­ter. She talked about that a few months ago dur­ing our pan­el con­ver­sa­tion on drug pric­ing and the rel­a­tive val­ue of new ther­a­peu­tics, putting the is­sue in a hu­man con­text.

If we want to take, like my sis­ter, rare dis­ease, mul­ti­ple myelo­ma. Thank God we in­vest­ed be­cause she was on sev­en dif­fer­ent med­i­cines. She had a great qual­i­ty of life for three out of four years, while she would’ve on­ly got­ten sev­en months be­fore. Now, that may not mean a lot to every­body un­til it’s your own sis­ter, un­til it’s your own pa­tient, your own child, your moth­er.

That makes her a po­tent spokesper­son for cell ther­a­pies at a time that seg­ment of on­col­o­gy is still find­ing its feet on the mar­ket.

Bellde­grun, the CEO who guid­ed Kite to its land­mark suc­cess, of­fered a thumbs up from Eu­rope.

“I had  re­cent­ly the plea­sure to meet with Christi and dis­cuss with her the unique op­por­tu­ni­ty to be­come the first CEO of a stand-alone com­pa­ny with­in Gilead. With Christi’s im­pres­sive track record and with her great lead­er­ship skills I have no doubt that she will ex­cel in keep­ing Kite as the pre­miere force in the rapid­ly grow­ing space of en­gi­neered cell ther­a­py and in ex­pand­ing its reach glob­al­ly.”

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.