Ken Takeshita (Kite)

Kite de­vel­op­ment head Ken Takeshi­ta jumps to Dai­ichi Sankyo amid on­col­o­gy push

Months af­ter lead­ing Kite Phar­ma to a land­mark OK and es­tab­lish­ing the first-ever com­mer­cial CAR-T port­fo­lio, glob­al de­vel­op­ment head Ken Takeshi­ta vague­ly an­nounced he was leav­ing the helm for an­oth­er op­por­tu­ni­ty. Now we know what he’s been up to.

Ju­nichi Ko­ga

Takeshi­ta is jump­ing over to Dai­ichi Sankyo on April 1, where he’ll lead the com­pa­ny’s push to be­come an es­tab­lished on­col­o­gy play­er as glob­al head of R&D. He’s fill­ing the shoes of Ju­nichi Ko­ga, who’s re­tir­ing af­ter 12 years at the com­pa­ny.

“We are thrilled to wel­come Ken in­to the Dai­ichi Sankyo fam­i­ly to lead glob­al R&D in our con­tin­ued trans­for­ma­tion in­to a glob­al on­col­o­gy leader and to pur­sue world-class sci­ence and tech­nol­o­gy,” CEO Sunao Man­abe said in a state­ment. “Ken brings re­mark­able depth and breadth of ex­pe­ri­ence to our or­ga­ni­za­tion – from first-hand pa­tient care to over­see­ing more than 20 reg­is­tra­tional tri­als lead­ing to many reg­u­la­to­ry ap­provals.”

Takeshi­ta spent the last two years at Kite, steer­ing the com­pa­ny to an ap­proval for Tecar­tus in re­lapsed or re­frac­to­ry man­tle cell lym­phoma back in Ju­ly. He’s pass­ing the torch to Take­da vet Frank Neu­mann, just as the FDA is set to make a de­ci­sion on Kite’s sup­ple­men­tal BLA for three-year-old Yescar­ta in fol­lic­u­lar lym­phoma (FL) and mar­gin­al zone lym­phoma (MZL).

Man­abe has laid out big plans to so­lid­i­fy Dai­ichi Sankyo’s place in the can­cer space by 2025, with the main fo­cus on their bil­lion-dol­lar ADC En­her­tu. The As­traZeneca-part­nered drug, which was al­ready ap­proved in the US for third-line metasta­t­ic breast can­cer pa­tients, snagged a sec­ond ap­proval in gas­tric can­cer last month.

“DS-8201 (En­her­tu) and our ADC tech­nol­o­gy are cur­rent­ly vis­i­ble, but they are on­ly the tip of the ice­berg when it comes to Dai­ichi Sankyo’s R&D ca­pa­bil­i­ties with sci­ence and tech­nol­o­gy run­ning through­out them,” Man­abe wrote in the com­pa­ny’s 2019 val­ue re­port. The CEO named gene ther­a­py, next-gen AD­Cs and bis­pe­cif­ic an­ti­bod­ies as po­ten­tial ar­eas of growth.

Dai­ichi jumped in­to the gene ther­a­py space less than a year ago, when it dropped $200 mil­lion to ac­cess Ul­tragenyx’s man­u­fac­tur­ing tech­nol­o­gy. For $125 mil­lion in cash and a $75 mil­lion eq­ui­ty in­vest­ment, Dai­ichi Sankyo bought a non-ex­clu­sive li­cense to the IP around two plat­forms with which it plans to de­vel­op AAV-based gene ther­a­py prod­ucts.

“We are cur­rent­ly do­ing dis­cov­ery re­search for gene ther­a­py drugs us­ing AAV vec­tors as one of our fo­cused modal­i­ties to­ward sus­tained growth be­yond achieve­ment of our 2025 vi­sion,” Masayu­ki Yabu­ta, Dai­ichi Sankyo’s head of bi­o­log­ics, said at the time.

Takeshi­ta is tak­ing over from Ko­ga, who took the job amid an R&D shake­up back in 2019. A cou­ple of years pri­or, Dai­ichi Sankyo shut­tered a cou­ple of large re­search groups in In­dia and Japan, lay­ing off hun­dreds of staffers and re­dis­trib­ut­ing their work.

“I have watched Dai­ichi Sankyo build and grow with ad­mi­ra­tion,” Takeshi­ta said. “I am hon­ored to join the Dai­ichi Sankyo R&D or­ga­ni­za­tion to seek to ex­tend and im­prove lives of pa­tients and elim­i­nate can­cer al­to­geth­er.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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