Bay­er, Ori­on prostate can­cer drug de­lays spread of dis­ease in PhI­II, but can it make a mark in a crowd­ed mar­ket?

Bay­er and Fin­land’s Ori­on (ORN­BV: $FH) on Wednes­day said their prostate can­cer drug, daro­lu­tamide, met the main goal in a late-stage tri­al, lift­ing Ori­on’s shares up in Helsin­ki by near­ly 10%. But the two drug­mak­ers may be late to the par­ty, with oth­er such an­dro­gen re­cep­tor (AR) in­hibitors such as Pfiz­er’s $PFE Xtan­di as well as J&J’s $JNJ new­er Er­lea­da al­ready on the mar­ket.

The tri­al test­ed daro­lu­tamide against a place­bo in more than 1,500 pa­tients with non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (nm­CR­PC) that were al­ready on stan­dard-of-care an­dro­gen de­pri­va­tion ther­a­py, and were at risk of the dis­ease spread­ing.  Da­ta showed the drug met the pri­ma­ry end­point of metas­ta­sis-free sur­vival, as it thwart­ed the can­cer from spread­ing over the course of the study. De­tailed re­sults will be pre­sent­ed at an up­com­ing sci­en­tif­ic meet­ing, the com­pa­nies said.

The Ger­man drug­mak­er agreed to de­vel­op daro­lu­tamide with Ori­on in 2014, the same year the Phase III ARAMIS tri­al com­menced.

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high lev­el AR func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

AR in­hibitors are a class of drugs de­signed to block the growth of can­cer cells by bind­ing to the an­dro­gen re­cep­tor and in­hibit­ing its func­tion. How­ev­er, oth­er biotechs such as Arv­inas $ARVN are hop­ing to go one step fur­ther to help pa­tients that progress de­spite AR in­hibitor ther­a­py by de­vel­op­ing drugs to de­grade the AR, po­ten­tial­ly re­sult­ing in more pro­found an­ti-can­cer ef­fects and dif­fer­en­tial bi­ol­o­gy, ver­sus in­hi­bi­tion.

Bay­er, which al­ready sells Xofi­go for metasta­t­ic prostate can­cer, said it plans to dis­cuss ARAMIS da­ta with health reg­u­la­tors re­gard­ing mar­ket­ing au­tho­riza­tion. The drug has al­ready se­cured fast-track sta­tus with FDA as a treat­ment for nm­CR­PC. If ap­proved, Ori­on will be in charge of man­u­fac­tur­ing and Bay­er will have the right to sell the drug glob­al­ly, al­though Ori­on has the op­tion of co-pro­mot­ing the prod­uct in Eu­rope. Up­on the first sale in the Unit­ed States, Ori­on is el­i­gi­ble to re­ceive €45 mil­lion; the num­bers are €20 mil­lion in Eu­rope and €8 mil­lion in Japan.

An­oth­er tri­al eval­u­at­ing daro­lu­tamide in pa­tients with metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC) is on­go­ing, and is ex­pect­ed to be com­plet­ed in 2022.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

Sanofi’s big week in­cludes a promis­ing PhI­II for an or­phan dis­ease drug, with plans for a pitch to the FDA

The biopharma R&D food chain is paying off with a plan at Sanofi to pitch regulators on a new drug for an orphan disease called cold agglutinin disease.

The pharma giant ushered out a statement Tuesday morning — after it spelled out plans to radically restructure the company, abandoning cardio and diabetes research altogether — saying that their C1s inhibitor sutimlimab had cleared the pivotal study.