No­var­tis CEO Vas Narasimhan is rais­ing the bar on sec­ond-gen can­cer drug stud­ies

No­var­tis $NVS has been no­tice­ably ab­sent from the cen­ter ring of PD-1/L1 re­search, qui­et­ly ad­vanc­ing its own check­point as an in-house as­set to match up with a grow­ing pipeline of can­cer ther­a­pies. But that doesn’t mean that new­ly pro­mot­ed CEO Vas Narasimhan hasn’t been think­ing a lot about the phar­ma gi­ant’s de­vel­op­ment strat­e­gy or what it has to do to po­si­tion it­self as the in­dus­try faces read­outs on a tsuna­mi of more than 1,000 com­bi­na­tion stud­ies now in the clin­ic.

In a con­ver­sa­tion with an­a­lysts for the Q1 re­view, Narasimhan made these com­ments on I/O:

I think there is of course very im­pres­sive da­ta and cer­tain­ly from the PD-1 from one of our com­peti­tors (that’s a ref­er­ence to Mer­ck’s Keytru­da/chemo com­bo), which I think is trans­for­ma­tive for pa­tients in lung can­cer. So, it’s a great thing in gen­er­al for so­ci­ety and for pa­tients. 

And then he moved on to sec­ond-gen­er­a­tion on­col­o­gy as­sets and I/O, where the CEO sees a ris­ing set of stan­dards on what it’s go­ing to take to demon­strate a suc­cess.

We eval­u­ate our sec­ond-gen­er­a­tion as­sets now at a high­er bar. We…in­creas­ing­ly want to en­sure that we have ap­pro­pri­ate con­trol arms so that we can see whether or not the com­bi­na­tion is hav­ing an im­pact on top of the PD-1 mono.

And I think one of the things we’re al­so putting a very heavy lens on: 

Do we have sin­gle-agent ac­tiv­i­ty? Be­cause I think sin­gle agent ac­tiv­i­ty will in­crease the like­li­hood that whether in com­bi­na­tion or not we might have a med­i­cine that’s go­ing to mat­ter. We eval­u­ate and have a high­er bar on what we progress. 

The nice thing for us in on­col­o­gy is we have a broad set of plat­forms. We are a leader in tar­get­ed ther­a­py. You see that in Mekin­ist and Tafin­lar as well as a leader in non­ma­lig­nant hema­tol­ogy as you see with Pro­mac­ta, Revolade, Ex­jade and Jakavi. So, we have that strong po­si­tion.

Sec­ond, we are a leader in CAR-T. We have Kym­ri­ah we have a broad port­fo­lio of CAR-Ts com­ing be­hind that. So, we have that as a plat­form. We have im­muno-on­col­o­gy, we have the 20 or so as­sets that are in the clin­ic eval­u­at­ing them, but we’ll take a stronger look at them. And then we brought in ra­dionu­clide ther­a­py (Lu­tathera), trans­for­ma­tive in neu­roen­docrine tu­mors. We’ll see how it un­folds in prostate can­cer, al­so look­ing at gas­tric can­cers. So, we are strate­gi­cal­ly try­ing to take a broad po­si­tion. 

We’re not over­ex­posed to I/O per se. And it’s not a bi­na­ry event for us whether I/O pans out for the com­pa­ny.


Im­age: Vas Narasimhan. NO­VAR­TIS

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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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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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.