Bris­tol-My­ers takes a stake in Taris Bio­med­ical; Zai Lab, Five Prime strike a deal to de­vel­op tu­mor im­munother­a­py in Chi­na

Bris­tol-My­ers Squibb has tak­en a stake in Taris Bio­med­ical as part of their new col­lab­o­ra­tion on a Phase Ib study of a com­bo ap­proach for mus­cle in­va­sive blad­der can­cer for pa­tients who are sched­uled for rad­i­cal cys­tec­to­my. They’ll be com­bin­ing Op­di­vo with TAR-200, which con­trols re­lease of a ther­a­py in the blad­der.

Five Prime {FPRX} and Zai Lab have struck a $44 mil­lion deal to bring FPA144, the South San Fran­cis­co biotech’s tar­get­ed im­munother­a­py for tu­mors, to gas­tric and gas­tro-esophageal junc­tion can­cer pa­tients in Chi­na. Shang­hai-based Zai Lab $ZLAB paid $5 mil­lion up­front for de­vel­op­ment and com­mer­cial­iza­tion rights, and promised $39 in mile­stones. The part­ners plan to jump in­to Phase III (in com­bi­na­tion with chemother­a­py) in the sec­ond half of 2018, with Zai Lab re­spon­si­ble for the Greater Chi­na por­tion of the glob­al study. “Chi­na ac­counts for more than 40% of new gas­tric can­cer cas­es glob­al­ly, so it is crit­i­cal to align strate­gi­cal­ly with a strong col­lab­o­ra­tor with the in­fra­struc­ture, re­la­tion­ships and re­sources to help us ad­vance FPA144 glob­al de­vel­op­ment ex­pe­di­tious­ly,” said Aron Knicker­bock­er, cur­rent COO and in­com­ing CEO, in a state­ment. Per the li­cens­ing agree­ment, both sides are al­so el­i­gi­ble to re­ceive roy­al­ties on sales on each oth­er’s turfs, with Five Prime com­mand­ing a high­er per­cent­age.

→ Keep­ing with ear­li­er promis­es, Loxo On­col­o­gy $LOXO has be­gun sub­mit­ting a rolling NDA for its lead drug larotrec­tinib for un­re­sectable or metasta­t­ic sol­id tu­mors. In­stead of fo­cus­ing on the anato­my, larotrec­tinib goes af­ter a fam­i­ly of sig­nal­ing pro­teins called tropomyosin re­cep­tor ki­nas­es (TRK). That ap­proach has earned the in­hibitor des­ig­na­tions for break­through ther­a­py, rare pe­di­atric dis­ease and or­phan drug from the FDA. The com­pa­ny plans to wrap things up in ear­ly 2018. Bay­er will be watch­ing (and like­ly help­ing with) this process close­ly, as it is in­vest­ing at least $400 mil­lion for this drug and is bank­ing on its reg­u­la­to­ry suc­cess both in the US and over­seas.

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

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Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.

With EMA re­view in progress, No­var­tis un­veils more pos­i­tive da­ta on asth­ma ther­a­py

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.

The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.