#AS­CO17: In­cyte gets a boost from a se­ries of pos­i­tive da­ta snap­shots for its epaca­do­stat/Keytru­da com­bo

Hervé Hop­penot, In­cyte CEO

Wednes­day evening brought with it the da­ta dump on ab­stracts for the up­com­ing an­nu­al AS­CO con­fab in Chica­go in ear­ly June, and the big pre­lim­i­nary win­ner — not a big sur­prise — was In­cyte, with a slate of new da­ta points un­der­scor­ing the po­ten­tial of its lead­ing, late-stage IDO1 drug epaca­do­stat in com­bi­na­tion with Mer­ck’s Keytru­da.

In­cyte shares $IN­CY swelled 9.5% in af­ter-mar­ket trad­ing as in­vestors got a glimpse of things to come, with a 30%-plus re­sponse rate for a full slate of com­bi­na­tion stud­ies that are now push­ing in­to Phase III de­vel­op­ment.

Boiled down to the es­sen­tials:

  • The non-small cell lung can­cer group record­ed a 35% over­all re­sponse rate, with 14 of 40 pa­tients ex­pe­ri­enc­ing a par­tial re­sponse. As a mono ther­a­py, Keytru­da scored a re­sponse rate of 18% to 20%.
  • In head and neck can­cer the re­sponse rate was 34%, 34% (2 CR, 8 PR) among 36 pa­tients. #6010
  • The pre­lim­i­nary over­all re­sponse rate for urothe­lial can­cer was 35% — 13 of 37 pa­tients, all par­tial re­spons­es. #4503
  • For kid­ney can­cer the ORR was 30 per­cent, with a sin­gle com­plete re­sponse and 8 par­tials among 30 pa­tients. #4515

The rea­son why these da­ta points are im­por­tant is that they re­flect a dis­tinct in­crease in the per­cent of pa­tients who re­spond­ed, com­pared to Keytru­da alone, point­ing to its po­si­tion­ing as a next wave leader for com­bo ther­a­pies. There are hun­dreds of tri­als un­der­way now test­ing a slew of these com­bi­na­tions and this is one of the most promi­nent in the bunch.

In­cyte and Mer­ck $MRK re­cent­ly signed off on an in­de­pen­dent deal to com­bine their ther­a­pies in Phase III. But In­cyte, which is de­vel­op­ing its own check­point in­hibitor, is ag­nos­tic about who it part­ners with right now in Phase III. It’s al­so signed up for a late-stage se­ries with Bris­tol-My­ers Squib $BMY, which is strug­gling to catch back up to Mer­ck as the phar­ma ri­val surges ahead in lung can­cer.

Mer­ck, mean­while, has more than just In­cyte to thanks for an­oth­er good day on the im­muno-on­col­o­gy front. Leerink’s Sea­mus Fer­nan­dez not­ed:

For MRK, the most mean­ing­ful da­ta com­ing out of the AS­CO ab­stracts are 1) the sol­id over­all sur­vival trend emerg­ing from the Ph2 Keynote-021G co­hort of Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py in non-squa­mous non-small cell lung can­cer (NSCLC) and 2) the strong re­sponse rates seen in the ECHO-202 tri­al of Keytru­da + IN­CY’s (OP) epaca­do­stat (IDO in­hibitor) in sev­er­al tu­mor types (LINK). We ex­pect MRK shares to be high­er on the sur­vival trend in KN-021G.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.

As an­oth­er an­tibi­otics biotech sinks in­to a cri­sis, warn­ings of a sec­tor ‘col­lapse’

Another antibiotics company is scrambling to survive today, forcing the company’s founding CEO to exit in a reorganization that eliminates its research capabilities as the survivors look to improve on minuscule sales of their newly approved treatment. And the news — on top of an alarming series of failures — spurred at least one figure in the field to warn of a looming collapse of the antimicrobial resistance research field.

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'We kept at it': Jef­frey Blue­stone plots late-stage come­back af­ter teplizum­ab shown to de­lay type 1 di­a­betes

Late-stage da­ta pre­sent­ed at the Amer­i­can Di­a­betes As­so­ci­a­tion an­nu­al meet­ing in 2010 pushed Eli Lil­ly to put a crimp on teplizum­ab as the phar­ma gi­ant found it un­able to re­set the clock on new­ly di­ag­nosed type 1 di­a­betes. At the same con­fer­ence but in dif­fer­ent hands nine years lat­er, the drug is mak­ing a crit­i­cal come­back by scor­ing suc­cess in an­oth­er niche: de­lay­ing the on­set of the dis­ease.

In a Phase II tri­al with 76 high-risk in­di­vid­u­als — rel­a­tives of pa­tients with type 1 di­a­betes who have di­a­betes-re­lat­ed au­toan­ti­bod­ies in their bod­ies — teplizum­ab al­most dou­bled the me­di­an time of di­ag­no­sis com­pared to place­bo (48.4 months ver­sus 24.4 months). The haz­ard ra­tio for di­ag­no­sis was 0.41 (p=0.006).

Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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