Genen­tech vet Myr­tle Pot­ter takes a lead­ing role in Vivek Ra­maswamy's fast-mov­ing Vant ops

The tal­ent mag­net that is Vivek Ra­maswamy’s Roivant Sci­ences has at­tract­ed a biotech vet­er­an to over­see op­er­a­tions of the ever-grow­ing Vant king­dom.

Myr­tle Pot­ter, a for­mer pres­i­dent and COO of Genen­tech, has been named Vant op­er­at­ing chair. The role grants her an au­to­mat­ic board mem­ber­ship at each of Roivant’s 12 biotech sub­sidiaries, where she is ex­pect­ed to as­sist the (of­ten high-pro­file) CEOs and “en­sure op­er­a­tional ex­cel­lence.”

Pot­ter had a sto­ried run in Big Phar­ma that be­gan with 14 years at Mer­ck, help­ing cre­ate the busi­ness that would lat­er be­come As­traZeneca. She lat­er moved to Bris­tol-My­ers Squibb, even­tu­al­ly helm­ing its car­dio­vas­cu­lar and meta­bol­ic busi­ness and over­see­ing sev­er­al cru­cial drug launch­es — a skill she con­tin­ued to hone at Genen­tech, where un­der her watch block­buster drugs like Avastin and Xo­lair came to be known.

She fol­lowed that up by found­ing a con­sult­ing firm in 2005, ad­vis­ing a range of phar­ma, biotech, med­ical de­vice and me­dia com­pa­nies as well as VCs and in­vest­ment bankers.

Her ap­point­ment was tout­ed at Roivant’s in­au­gur­al R&D day, co­in­cid­ing with a burst of an­nounce­ments in­tend­ed to high­light the com­pa­ny’s en­thu­si­asm for its pipeline — un­de­terred even af­ter the spec­tac­u­lar fail­ure of Ax­o­vant’s first for­ay in­to Alzheimer’s cast shad­ows on founder Ra­maswamy’s abil­i­ty to bring ac­tu­al drugs to the mar­ket.

Here are the up­dates we found most in­ter­est­ing:

  • Genevant, the RNA-fo­cused joint ven­ture formed on Ar­bu­tus’ de­liv­ery tech, has inked a deal to de­vel­op and com­mer­cial­ize five to ten ther­a­peu­tic pro­grams with Ger­man biotech uni­corn BioN­Tech. Five of these will be rare dis­ease ther­a­pies, to be de­vel­oped us­ing a com­bi­na­tion of Genevant’s lipid nanopar­ti­cle plat­form and BioN­Tech’s mR­NA drug dis­cov­ery plat­form. The oth­er half of the agree­ment cov­ers a li­cense to use Genevant’s tech in five of BioN­Tech’s on­col­o­gy pro­grams — a field that the com­pa­ny is best known in, with some of its per­son­al­ized can­cer vac­cines al­ready part­nered with Genen­tech. If all goes ac­cord­ing to plan, the duo will have some­thing for the clin­ic by 2020.
  • Bet­ting on the neona­tal Fc re­cep­tor (FcRn) tar­get in IgG-me­di­at­ed au­toim­mune dis­eases, Roivant is found­ing yet an­oth­er sub­sidiary called Im­muno­vant to de­vel­op what it’s call­ing RVT-1401, a mon­o­clon­al an­ti­body it in-li­censed from HanAll.
  • En­zy­vant has sub­mit­ted a bi­o­log­ics li­cense ap­pli­ca­tion — its first — for RVT-802, which treats an ex­treme­ly rare dis­ease called Di­Ge­orge Anom­aly, a fa­tal con­di­tion char­ac­ter­ized by an in­abil­i­ty to fight off in­fec­tions.

Ra­maswamy has be­come one of the most en­vied and de­spised ex­ec­u­tives in biotech. Love him or hate him, he’s raised more than $2 bil­lion for this com­pa­ny and its sub­sidiaries. Af­ter the lead pro­gram for Alzheimer’s blew up in dis­grace, the col­lec­tive still has 30 drugs in clin­i­cal de­vel­op­ment com­pared to 13 a years ago. The group, which al­so re­cent­ly re­or­ga­nized with lay­offs, now has 672 em­ploy­ees com­pared 262 a year ago; 12 vants now ver­sus 5 at this point in 2017.

Im­age: Myr­tle Pot­ter (via YouTube)

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.

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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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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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.