GSK poach­es new drug de­vel­op­ment chief Chris Cor­si­co from Boehringer, di­vid­ing R&D in­to two groups

Chris Cor­si­co

Glax­o­SmithK­line is con­tin­u­ing its makeover in the ex­ec­u­tive team that runs its R&D group.

The phar­ma gi­ant tells me that Chris Cor­si­co, who had been chief med­ical of­fi­cer at the pri­vate Ger­man out­fit Boehringer In­gel­heim, is step­ping over to GSK as the head of drug de­vel­op­ment, putting him in a new, top po­si­tion for ham­mer­ing out the clin­i­cal plans that the phar­ma gi­ant is putting in­to place un­der R&D chief Hal Bar­ron. 

“We have cre­at­ed two dis­tinct re­search and de­vel­op­ment or­ga­ni­za­tions – Chris will lead all of de­vel­op­ment,” says the GSK spokesper­son. Cor­si­co, she added, will be based in GSK’s big R&D group in Steve­nage in the UK, with plans to trav­el reg­u­lar­ly to its oth­er arm in Philadel­phia. He’ll be re­port­ing to Bar­ron, who is keep­ing a base of­fice in the Bay Area.

The oth­er group is re­search, un­der John Lep­ore, which “will iden­ti­fy and pros­e­cute nov­el im­munol­o­gy and ge­net­i­cal­ly-val­i­dat­ed tar­gets with the use of in­no­v­a­tive tech­nolo­gies – both ours and through part­ner­ships.” And my con­tact at GSK fol­lowed up on Wednes­day to note that on­col­o­gy — new­ly re-emer­gent at Glaxo af­ter the big as­set swap with No­var­tis — re­mains a sep­a­rate unit of its own un­der the di­rect con­trol of Ax­el Hoos. It’s based in the Philadel­phia re­gion.

Boehringer an­nounced about a week ago that Cor­si­co was leav­ing BI af­ter a 20-year stint at the com­pa­ny. Over the past few years, that kind of move has usu­al­ly flagged a jump to a biotech start­up, but Cor­si­co clear­ly has some­thing dif­fer­ent in mind.

Boehringer has been a busy play­er in drug de­vel­op­ment, re­cent­ly buy­ing a col­lab­o­ra­tor it’s been work­ing with on on­colyt­ics virus re­search for on­col­o­gy. They have a num­ber of late-stage can­cer drugs in the clin­ic, where GSK — and Genen­tech vet Bar­ron — are like­ly to be­come more ac­tive. An al­liance with Eli Lil­ly al­so put them in front of some ma­jor di­a­betes projects over the years.

Em­ma Walm­s­ley

Boehringer’s plans for R&D haven’t all gone smooth­ly, though. Back in 2016, the com­pa­ny hand­ed back rights to Han­mi’s can­cer drug ol­mu­tinib, choos­ing to ini­tial­ly stay qui­et about pa­tient deaths that sparked a con­tro­ver­sy in South Ko­rea.

Af­ter build­ing an­tic­i­pa­tion for more than a year that new CEO Em­ma Walm­s­ley was mak­ing over the lead­er­ship team at GSK in or­der to be­come far more am­bi­tious with its drug de­vel­op­ment work — prep work that in­clud­ed hun­dreds of lay­offs with an ex­press in­ter­est in in­vest­ing more in new drugs — the phar­ma gi­ant’s ini­tial roll­out of its new strate­gic ap­proach to R&D left a lot to be de­sired. GSK in­vest­ed $300 mil­lion in 23andMe and talked up its in­ter­est in ge­net­ics, fol­low­ing a dis­cov­ery trail that’s been blazed by many oth­ers be­fore it.

In the mean­time, the com­pa­ny has de­vel­oped a rep for the weak­est late-stage pipeline in the in­dus­try, with a dire need to do some­thing dra­mat­ic to in­spire in­vestors. In big phar­ma­land, it’s the late-stage pipeline that de­fines R&D. And Walm­s­ley was named CEO two years ago, with lit­tle new to show for it.

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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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.

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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