8 stars: A look back at AS­CO spot­lights the top can­cer drugs to watch, and 1 to for­get

I’ve been mak­ing the trek to AS­CO for some years now, and I don’t re­call any oth­er week that ri­vals what I’ve just seen. There wasn’t just im­por­tant da­ta to re­port on, there was a lot of it.

CAR-T, with all of its splen­did ini­tial promise in liq­uid tu­mors, is reach­ing the first ma­jor com­mer­cial fin­ish line, with No­var­tis’ $NVS CTL019 out in front of Kite’s $KITE KTE-C19 by a nose. No­var­tis wait­ed to cap­ture the in­dus­try’s at­ten­tion at an­oth­er con­fer­ence mid-week with head-to-head da­ta, but you bet­ter be­lieve it fig­ured promi­nent­ly on my AS­CO in­ter­view sched­ule.

Juno $JUNO, knocked out of the first race, is mak­ing a strong come­back bid with JCAR017, which will like­ly fig­ure promi­nent­ly in the sec­ond wave ther­a­pies to get a close ex­am­i­na­tion in a piv­otal tri­al.

But what about BC­MA? Blue­bird $BLUE tru­ly wowed the field with da­ta from its close­ly-watched Cel­gene-part­nered pro­gram for bb2121 in treat­ing mul­ti­ple myelo­ma. But in this field the po­ten­tial for sur­prise un­der­lies every twist and turn of the im­muno-on­col­o­gy field. And so we find an ob­scure Chi­nese com­pa­ny called Nan­jing Leg­end — “great name, isn’t it?” said chief blue­bird Nick Leschly with a smile as we com­pared BC­MA da­ta — get­ting shoved in­to AS­CO’s mar­quee cir­cle with even bet­ter da­ta from a larg­er group.

So now we have a new drug to track.

I’ll ad­mit, Loxo ex­ecs have a weary­ing habit of tout­ing every tiny bit of new da­ta on pos­i­tive out­comes, but it $LOXO too is look­ing to make can­cer drug his­to­ry by go­ing af­ter a dual adult/pe­di­atric ap­proval based on a bio­mark­er, fol­low­ing close­ly on a ge­net­ic break­through by Mer­ck $MRK.

One sto­ry that didn’t get much trac­tion over­all, but should have, be­longed to Re­gen­eron $REGN and its Big Phar­ma part­ner Sanofi, which are mov­ing ahead with a next-gen PD-1 check­point, REGN2810. Re­gen­eron has one of the best an­ti­body de­vel­op­ment shops in the world. And if its re­searchers are right, they’ve gleaned new in­sights on the field that could have a pro­found af­fect on how these drugs are made and used. If you missed it, I’d en­cour­age you to go back for an­oth­er look.

In­cyte’s new up­dat­ed da­ta $IN­CY on epaca­dos­tat were al­so gone over with a fine tooth comb. There have been some re­cent jit­ters in the IDO1 field, but In­cyte re­mains out front as the big PD-(L)1 Phase III tri­als with Mer­ck and Bris­tol-My­ers Squibb get un­der­way.

There have been a few IDO jit­ters ev­i­dent, though, es­pe­cial­ly af­ter Roche’s team held their noses while dis­cussing their IDO1 da­ta for GDC-0919 (navox­i­mod), in-li­censed from NewLink for $150 mil­lion up front.

In­de­pen­dent can­cer drug in­vestor Brad Lon­car was on hand for the Roche pre­sen­ta­tion at AS­CO, and not­ed a de­tectable sound of skep­ti­cism.

A few days lat­er, Roche’s Genen­tech kicked it out of the pipeline. For NewLink $NLNK, which has ex­pe­ri­enced a string of pun­ish­ing set­backs, it was an­oth­er cau­tion­ary tale to re­mind ob­servers that not every­one is suc­ceed­ing in the boom­ing on­col­o­gy busi­ness. But the stand­outs mark po­ten­tial­ly new stan­dards of ther­a­py in on­col­o­gy. And the progress is gath­er­ing speed.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Watch out Bay­er, Roche is com­ing for you with a dis­count price ri­val to the tu­mor ag­nos­tic drug you got from Loxo

Just ahead of schedule the FDA has come through with a key approval for Genentech’s tumor agnostic entrectinib — now headed to the market as Rozlytrek.

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