Peer Re­view: GSK re­cruits a star can­cer sci­en­tist to its board ahead of R&D re­or­ga­ni­za­tion

Lau­rie Glim­ch­er FRANCK FIFE/AFP/Get­ty

Glax­o­SmithK­line has just ap­point­ed Lau­rie Glim­ch­er — a pi­o­neer­ing sci­en­tist and a cham­pi­on for ad­vanc­ing women to se­nior po­si­tions in the bio­med­ical world — to its board. Up un­til just 7 days ago, she was al­so on the board of Bris­tol-My­ers Squibb, a trend­set­ter in the block­buster im­muno-on­col­o­gy world. And the move just may say some­thing about GSK CEO Em­ma Walm­s­ley’s ideas about the fu­ture of the com­pa­ny, which now re­port­ed­ly in­clude a plan to re­vamp the pipeline.

Glim­ch­er is the CEO of Dana-Far­ber, one of the most pres­ti­gious can­cer re­search cen­ters in the world. She is al­so a re­searcher who has de­vot­ed a con­sid­er­able amount of lab time to im­muno-on­col­o­gy, a sub­ject she helped cov­er dur­ing her 20 years on the board of Bris­tol-My­ers Squibb, a post which she abrupt­ly jumped out of a week ago with a note about her “re­tire­ment.”

GSK Chair­man Philip Hamp­ton spot­light­ed her “wealth of ex­per­tise in sci­en­tif­ic and med­ical in­no­va­tion” for her new board role as a sci­en­tif­ic and med­ical ex­pert.

GSK com­plet­ed a high-pro­file as­set swap with No­var­tis a few years ago, ex­chang­ing its ma­ture can­cer projects and com­mer­cial prod­ucts with No­var­tis in ex­change for vac­cines. Since then, it’s made lit­tle head­way in the late-stage pipeline out­side of vac­cines and HIV, through its ma­jor­i­ty-owned sub­sidiary Vi­iV. Af­ter the Phase III washout of a slate of ma­jor can­di­dates, GSK slashed its US R&D group in North Car­oli­na as it cut costs and re­grouped. Since then phar­ma R&D has be­come one of its least ex­cit­ing fields, with no big prod­ucts in the late-stage pipeline to ex­cite in­vestors.

Ac­cord­ing to a re­port from Reuters, Walm­s­ley is qui­et­ly plan­ning a re­vamp of the pipeline, look­ing to dump mar­gin­al projects and bring in new ones.

GSK, though, nev­er got out of on­col­o­gy. The phar­ma gi­ant re­tained a sig­nif­i­cant ear­ly-stage R&D group in can­cer, ex­e­cut­ing a part­ner­ship with the UK’s Adap­ti­m­mune. Any move to switch the spot­light back to on­col­o­gy would be a ma­jor change­up in the Big Phar­ma world. So you can ex­pect at least a few peo­ple to be pay­ing close at­ten­tion to this news.

David Meek­er

→ Ra­dius put out the word that it is mak­ing a change at the helm, with long­time CEO Bob Ward out and No­vo US pres­i­dent Jes­per Høi­land step­ping in to or­ches­trate the cam­paign for Ra­dius’ first mar­ket launch. The news ar­rived just af­ter Am­gen an­nounced that the FDA had for­mer­ly re­ject­ed its ri­val os­teo­poro­sis drug.

→ David Meek­er, the for­mer chief of Sanofi-Gen­zyme, has an­oth­er chair­man’s role to fill. This time he’s tak­ing the lead board chair at Tre­vi Ther­a­peu­tics, which just raised a $50 mil­lion C round.  Meek­er was named chair­man of Rhythm in April, fol­low­ing up with a board ap­point­ment at San Fran­cis­co-based MyoKar­dia.

→ My­ovant Sci­ences CEO Lynn Seely has been build­ing out her team. This week she named Matthew Lang as gen­er­al coun­sel and cor­po­rate sec­re­tary; Juan Cami­lo Ar­jona Fer­reira, has joined as chief med­ical of­fi­cer; Tere­sa Per­ney, PhD, has joined as se­nior vice pres­i­dent of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance; and An­dria Lan­gen­berg, has joined as head of drug safe­ty and phar­ma­covig­i­lance.

→ Sin­ga­pore-based Tes­sa Ther­a­peu­tics, an on­col­o­gy-fo­cused biotech which re­cent­ly part­nered with the Park­er In­sti­tute, an­nounced the ap­point­ment of Jen­nifer But­ler as chief com­mer­cial of­fi­cer. She’s in charge of build­ing the com­pa­ny’s US op­er­a­tions.

→ Lon­don-based Au­to­lus has been adding to the T-cell team this week. Its new ex­ecs are Christo­pher Vann, chief op­er­at­ing of­fi­cer; Matthias Alder, chief busi­ness of­fi­cer; Muham­mad Al-Ha­jj, SVP of trans­la­tion­al sci­ence and Nush­mia Khokar, VP of clin­i­cal de­vel­op­ment.

→ Austin-based Ae­glea Bio­Ther­a­peu­tics $AGLE says that David Lowe re­signed as the com­pa­ny’s pres­i­dent, chief ex­ec­u­tive of­fi­cer and di­rec­tor, ef­fec­tive im­me­di­ate­ly. An­tho­ny Quinn, has been ap­point­ed to serve as in­ter­im chief ex­ec­u­tive of­fi­cer while the com­pa­ny con­ducts a com­pre­hen­sive search for a per­ma­nent chief ex­ec­u­tive of­fi­cer.

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. 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.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

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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