Lady Eliza Manningham-Buller. Imperial College London

Well­come Trust joins warn­ing for no-deal Brex­it, calls on Boris John­son to cast R&D vi­sion

Boris John­son may have pledged to con­tin­ue build­ing on Britain’s “enor­mous strengths” in life sci­ence as he blazes a path to­ward Brex­it, but one of the coun­try’s top fun­ders of bio­med­ical re­search is de­mand­ing more.

In a let­ter to the UK’s new Prime Min­is­ter, Well­come Trust warned that “the fi­nal months of 2019 could be a tip­ping point for UK sci­ence” and leav­ing the EU with­out a deal is a threat to the thriv­ing sec­tor. La­dy Eliza Man­ning­ham-Buller, who chairs the char­i­ty, urged John­son to make a sig­nif­i­cant state­ment on sci­ence to lay out his vi­sion in the face of glob­al health emer­gen­cies and the loom­ing loss of ac­cess to col­lab­o­ra­tion with Eu­ro­pean peers.

But David Grainger of Medicxi, a Lon­don-based VC firm known for its as­set-cen­tric plays around Eu­rope, dis­missed Well­come Trust’s let­ter as “more scare­mon­ger­ing” and as­sert­ed “UK as a place to do sci­ence will be un­af­fect­ed” by Brex­it.

One of John­son’s key promis­es to the par­ty mem­bers who elect­ed him was that he will ex­e­cute the UK’s de­par­ture from the EU by Oc­to­ber 31, come what may.

The con­cerns are hard­ly new. While John­son was still vy­ing for the lead­er­ship role against fel­low Con­ser­v­a­tive Par­ty MP Je­re­my Hunt, re­searcher or­ga­ni­za­tions in­clud­ing Can­cer Re­search UK have sound­ed sim­i­lar alarms. The un­cer­tain­ty around the fu­ture re­la­tion­ship be­tween the UK and oth­er coun­tries in Eu­rope has al­ready jeop­ar­dized re­searchers’ par­tic­i­pa­tion in con­ti­nen­tal re­search pacts, they said.

Man­ning­ham-Buller echoes that “some dam­age has al­ready been done, with loss of re­searchers, and in­flu­ence.” And like Pamela Kearns of CRUK, she raised con­cerns about se­cur­ing mem­ber­ship in Hori­zon Eu­rope, a €100 bil­lion (£89.9 bil­lion) fund­ing pro­gram that fea­tures can­cer as one of its key mis­sions.

“While sci­ence pro­motes glob­al col­lab­o­ra­tion, the bar­ri­ers to suc­cess need to be min­i­mized, in­clud­ing with Eu­rope where our clos­est and most ex­ten­sive sci­ence re­la­tion­ships are,” the let­ter read. “That means ne­go­ti­at­ing as­so­ci­at­ed coun­try sta­tus in the EU’s ‘Hori­zon Eu­rope’ re­search pro­gramme, even if we in­tend to cre­ate our own sys­tems in the years ahead.”

It is up to John­son’s gov­ern­ment to seize the op­por­tu­ni­ty and “spend the sort of mon­ey our com­peti­tors are do­ing” — such as Ger­many — Man­ning­ham-Buller told the BBC.

“The key to this will be to en­sure that in­creased pub­lic in­vest­ment leads to an even greater pri­vate sec­tor con­tri­bu­tion to­wards the de­vel­op­ment and use of new tech­nolo­gies, in­clud­ing through pa­tient cap­i­tal,” she wrote in her let­ter.

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.