Just how much would no-deal Brex­it harm bio­med­ical sci­ence? Re­searchers speak out

As Con­ser­v­a­tive Par­ty lead­ers face off in a bid to be­come the UK’s next Prime Min­is­ter, sci­en­tists from a range of spe­cial­ties — from can­cer to cli­mate — are sound­ing loud­er alarms about the threats of a loom­ing no-deal Brex­it for their re­search work.

Pamela Kearns Birm­ing­ham

Cit­ing an analy­sis by the Uni­ver­si­ty Col­lege Lon­don of the lat­est EU re­search fund­ing da­ta, the Guardian re­port­ed that UCL and eight oth­er Rus­sell Group uni­ver­si­ties ran on­ly 20 big Eu­ro­pean re­search col­lab­o­ra­tions in 2018, a steep drop from around 50 in 2016. And in­di­vid­ual re­searchers are feel­ing the cloud of un­cer­tain­ty snuff­ing out prospects.

While the British gov­ern­ment un­der There­sa May had out­lined a co­op­er­a­tive frame­work to nur­ture sci­ence and in­no­va­tion, it all be­came moot when she failed mul­ti­ple at­tempts to get the deal she ne­go­ti­at­ed with the EU through the Par­lia­ment. That murky fu­ture has dri­ven po­ten­tial col­lab­o­ra­tors away, Pamela Kearns, di­rec­tor of Can­cer Re­search UK’s na­tion­al clin­i­cal tri­als unit, told the news­pa­per.

“In one re­cent dis­cus­sion about a fund­ing bid with very long­stand­ing Eu­ro­pean part­ners, it was de­cid­ed they wouldn’t have a UK part­ner on the project as it would be too great a risk,” Kearns, who cur­rent­ly over­sees 16 tri­als across 21 Eu­ro­pean coun­tries, said.

She is al­so wor­ried that UK sci­en­tists will lose ac­cess to Hori­zon Eu­rope, a €100 bil­lion (£89.9 bil­lion) fund­ing pro­gram that fea­tures can­cer as one of its key mis­sions, if it crash­es out of the EU on Oc­to­ber 31 with­out a deal.

Her con­cerns echo those of many oth­ers, in­clud­ing No­bel Prize-win­ning cell bi­ol­o­gist Paul Nurse, who com­pared the fund to the Cham­pi­on’s League. Drop­ping out of it, the Fran­cis Crick di­rec­tor warned, would rep­re­sent a ma­jor blow to UK sci­ence.

Paul Work­man ICR

Paul Work­man of the In­sti­tute of Can­cer Re­search al­so chimed in:

I am con­cerned that it could very well be­come much more dif­fi­cult for UK sci­en­tists to work with their col­leagues in Eu­rope if they can no longer join Eu­ro­pean con­sor­tia or ac­cess EU in­for­ma­tion re­sources that al­low sci­en­tists to find po­ten­tial col­lab­o­ra­tors in fu­ture. In­deed I al­ready hear many sto­ries where our UK sci­en­tists are be­ing dis­cour­aged from join­ing Eu­ro­pean ini­tia­tives – just based on the un­cer­tain­ty.

At the very least, Work­man added, the gov­ern­ment should reaf­firm its com­mit­ment to R&D and work to en­sure a stream of pub­lic and pri­vate in­vest­ments in the long term.

Days ago, 11 groups — in­clud­ing the CRUK, the Acad­e­my of Med­ical Sci­ences and the As­so­ci­a­tion of Med­ical Re­search Char­i­ties — made the same call to the PM hope­fuls, Boris John­son and Je­re­my Hunt:

The next Prime Min­is­ter must set out a long-term plan for re­search and in­no­va­tion in­vest­ment up to 2030. This should build on the Gov­ern­ment tar­get to boost over­all R&D in­vest­ment ini­tial­ly to 2.4% of GDP by 2027 – and the longer-term aim of 3% of GDP. But words and tar­gets will not be enough, the UK needs a co­her­ent long-term plan to build our po­si­tion as the glob­al hub for new world-lead­ing tech­nolo­gies, to draw on our strengths across mul­ti­ple dis­ci­plines, to at­tract tal­ent from around the world and to pro­mote British en­tre­pre­neur­ship.

The 160,000 To­ries tasked with se­lect­ing the coun­try’s next leader will be­gin vot­ing next week, with re­sults ex­pect­ed on Ju­ly 23.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.