The top win­ners and losers on AS­CO ab­stract night: Loxo, Blue­print, Jounce, Mer­ck KGaA and more

Let the joust­ing be­gin.

The big ab­stract drop ahead of AS­CO — the an­nu­al Olympics of can­cer R&D — pro­vid­ed some ear­ly, quick snap­shots that helped dri­ve stocks up or down, or sim­ply pro­vid­ed a chance to tout some po­ten­tial in a hot­ly con­test­ed field.

As more and more bio­phar­ma mon­ey has been in­vest­ed in the on­col­o­gy field in re­cent years, AS­CO has been at­tract­ing a big­ger range of en­trants, and ab­stract night will help de­ter­mine who comes out on top dur­ing the melee ahead. I’ve picked out a few of the most no­tice­able ab­stracts, which you can see be­low.

Loxo takes an­oth­er round in its bruis­ing, toe-to-toe fight with Blue­print

Josh Bilenker

Loxo On­col­o­gy $LOXO was the big win­ner Wednes­day night as in­vestors be­gan to pick through a pile of AS­CO ab­stracts to see what gems could be culled from the num­bers.

The biotech’s stock soared 18% overnight as in­vestors spot­light­ed a 69% over­all re­sponse rate among 32 evalu­able RET-fu­sion pos­i­tive pa­tients tak­ing LOXO-292. Loxo’s claim to fame is that it de­vel­ops can­cer drugs that tar­get small, ge­net­i­cal­ly de­fined pa­tient groups with an ag­nos­tic ap­proach to tu­mor types. Reg­u­la­tors at the FDA have been en­thu­si­as­tic about this emerg­ing field, which bodes well for Loxo. And they backed that en­thu­si­asm up with da­ta demon­strat­ing a 65% re­sponse rate in NSCLC and 83% for pap­il­lary thy­roid can­cer. 84% (27/32) of the pa­tients had ra­di­ograph­ic tu­mor re­duc­tion rang­ing from 19% to 67%.

That’s good, but it may well get bet­ter. Loxo CEO Josh Bilenker has flagged that since the Jan­u­ary cut­off date for the ab­stract the da­ta are even bet­ter now, which we’ll see at AS­CO. Loxo helped stoke the en­thu­si­asm with a note high­light­ing that LOXO-292 has been se­lect­ed for best of show at AS­CO, which will keep the com­pa­ny in the spot­light.

Can­cer R&D, though, is the ul­ti­mate blood sport in biotech. And when some­thing goes up, it’s of­ten at the ex­pense of a ri­val. In this case, that’s Blue­print Med­i­cines — again — which has al­ready felt the sting of a neg­a­tive com­par­i­son with Loxo.

Blue­print Med­i­cines $BPMC has been ad­vanc­ing BLU-667, which has been at­tract­ing warm re­views by an­a­lysts — un­less they start com­par­ing it to the ri­val. That side-by-side com­par­i­son knocked their stock back at AACR, and it did it again last night as the num­bers once again fa­vored Loxo. Shares are down about 8% in pre-mar­ket trad­ing Thurs­day.

No­var­tis vs Gilead/Kite: Is Kym­ri­ah bet­ter and safer than Yescar­ta?

Few ri­val­ries have been as in­tense as the show­down be­tween these two pi­o­neers in the CAR-T field. No­var­tis’ Kym­ri­ah $NVS still has to over­come a nag­ging is­sue with one-time man­u­fac­tur­ing is­sues, but Gilead’s Yescar­ta $GILD is now be­ing com­pared with its ri­val, and at first blush may have some ex­plain­ing to do. 

A group in Bei­jing ran a small com­par­i­son study of the two types of CAR-Ts — which use the 4-1BB and CD28 co-stim­u­la­to­ry sig­nal­ing do­mains — for CD19-pos­i­tive B-cell acute lym­phoblas­tic leukemia and found that the Kym­ri­ah/4-1BB ap­proach ap­pears to have a dis­tinct set of ad­van­tages. 

In that 4-1BB arm there was a 100% over­all ob­jec­tive re­sponse rate, com­pared to 89% in the CD28 arm. In ad­di­tion, and more im­por­tant­ly, all 5 of the pa­tients suf­fer­ing from se­ri­ous Grade 3 or 4 cy­tokine re­lease syn­drome were in the CD28/Yescar­ta group. This ar­gu­ment has a long way to run, and Gilead won’t con­cede an inch of the race. But the com­par­isons have just be­gun.

On Mon­day, Gilead con­tact­ed us to of­fer this state­ment:

It is im­por­tant to note that Yescar­ta was not eval­u­at­ed in this study. The ab­stract dis­cuss­es da­ta from a study eval­u­at­ing oth­er CAR T prod­ucts us­ing 4-1BB and CD28 co-stim­u­la­to­ry sig­nal­ing do­mains, re­spec­tive­ly. Im­por­tant­ly, Yescar­ta is en­gi­neered us­ing Kite’s man­u­fac­tur­ing process. The CD28 CAR T eval­u­at­ed in this tri­al was not man­u­fac­tured by Kite and there have been no head-to-head stud­ies of Yescar­ta com­pared to ti­s­agen­le­cleu­cel.

Ever­core ISI an­a­lyst Umer Raf­fat this morn­ing called the re­sults of this study provoca­tive, but wants to see the de­tails. So do I.

Jounce shares plunge on the lat­est da­ta cut for JTX-2011

Eliz­a­beth Tre­hu

The biggest los­er overnight was Jounce Ther­a­peu­tics $JNCE, which took a nasty hit af­ter post­ing their up­date on their lead ther­a­py — JTX-2011. As a monother­a­py, 1 out of 7 pa­tients with gas­tric can­cer re­spond­ed, com­pared to 2 out of 19 who got the com­bo with Op­di­vo — an 11% re­sponse rate. The rate wasn’t much bet­ter in triple-neg­a­tive breast can­cer. 

In a re­lease, re­searchers hit the theme that these were heav­i­ly pre­treat­ed pa­tients, but on­look­ers were in a can­tan­ker­ous mood and didn’t like the un­der­whelm­ing num­bers. Shares plunged 26% and Wells Far­go down­grad­ed the stock.

Cel­gene struck a ma­jor deal to col­lab­o­rate with Jounce on this drug, and that wasn’t ig­nored this morn­ing.

“The pre­lim­i­nary da­ta from pa­tients across mul­ti­ple sol­id tu­mor types en­rolled in the ICON­IC tri­al show that JTX-2011 is well-tol­er­at­ed alone and in com­bi­na­tion with nivolum­ab and has demon­strat­ed ev­i­dence of bi­o­log­ic ac­tiv­i­ty and tu­mor re­duc­tions in heav­i­ly pre-treat­ed pa­tients who have failed all avail­able ther­a­pies. In ad­di­tion, a po­ten­tial sur­ro­gate bio­mark­er of re­sponse has been iden­ti­fied that may help to guide JTX-2011 de­vel­op­ment,” said Eliz­a­beth Tre­hu, chief med­ical of­fi­cer of Jounce Ther­a­peu­tics.

Nek­tar sees a big ero­sion in re­sponse rates for close­ly-watched I/O star NK­TR-214

Nek­tar $NK­TR scored one of the biggest deals in bio­phar­ma so far this year when Bris­tol-My­ers came in with a $3.6 bil­lion deal to part­ner on NK­TR-214. That part­ner­ship was an­nounced in the wake of the first glimpse of how ef­fec­tive a pair­ing of their drug could be with Op­di­vo, with 63% of a small group of ad­vanced melanoma pa­tients re­spond­ing to first-line ther­a­py. But in Nek­tar’s up­date this week re­searchers note that the re­sponse rate in the bas­ket study showed a re­duced melanoma im­pact, with a 52% re­sponse rate.

Re­nal cell car­ci­no­ma al­so dropped, falling to 54%, down from 71% re­port­ed in the com­pa­ny’s Q4 call in ear­ly March.

That’s by no means the kiss of death. Re­sponse rates tend to de­cline over time. But an­a­lysts will be watch­ing these num­bers close­ly to see just how far they drop for a drug that is now front and cen­ter in the late-stage on­col­o­gy pipeline. The stock is down 3% in pre-mar­ket trad­ing, with the ju­ry still out on this promis­ing ther­a­py.

Mer­ck KGaA plans to shine a light on its can­cer pipeline at AS­CO — with Pfiz­er jump­ing in

Mer­ck KGaA will be back at AS­CO look­ing to earn some re­spect for its can­cer drug pipeline. So far the bulk of the at­ten­tion has gone to Baven­cio, its PD-L1 check­point in­hibitor part­nered with Pfiz­er, which is fight­ing an up­hill bat­tle to gain mar­ket share against the lead­ers in the field. But the Ger­man Mer­ck has a pipeline in on­col­o­gy, and they will do their best to high­light their chances on a range of ther­a­pies in Chica­go.

Its c-Met re­cep­tor ty­ro­sine ki­nase in­hibitor tepo­tinib has earned some ku­dos from Bern­stein. And re­searchers post­ed da­ta on 15 pa­tients with ad­vanced non-small cell lung can­cer har­bor­ing MET ex­on 14 skip­ping mu­ta­tions, with 60% demon­strat­ing a con­firmed par­tial re­sponse. An­a­lysts be­lieve this drug could hit $650 mil­lion in sales by 2030 — not a block­buster but a sol­id suc­cess, which the com­pa­ny bad­ly needs af­ter a long drought in clin­i­cal de­vel­op­ment suc­cess­es.

On the com­bo front, where all the PD-1/PD-L1 play­ers are fo­cus­ing on in a va­ri­ety of ways, Mer­ck KGaA tout­ed their M7824, a TGF-ß trap/an­ti-PD-L1 bi-func­tion­al im­munother­a­py fu­sion pro­tein. High PD-L1 ex­press­ing pa­tients ex­hib­it­ed an ORR of 71.4%.

The next big step on Baven­cio lies in com­bo ther­a­pies, and there Mer­ck KGaA says it gained some ear­ly-stage ev­i­dence to back up a com­bi­na­tion of the check­point with lor­la­tinib in non-small cell lung can­cer — a key com­pet­i­tive front for these play­ers. And their com­bo came out way ahead in the JAVELIN Lung 101 study, which com­pared their check­point with Xalko­ri (crizo­tinib) and the lor­la­tinib match-up. Lor­la­tinib — a drug Pfiz­er has high hopes for — came out way ahead. From the ab­stract:

The con­firmed ob­jec­tive re­sponse rate with A+C in ALK− pts was 16.7% (95% CI, 2.1-48.4; par­tial re­sponse [PR] in 2 pts), and with A+L in ALK+ pts was 46.4% (95% CI, 27.5-66.1; PR in 12 pts; com­plete re­sponse in 1 pt).


Im­age: Poster ses­sion at AS­CO 2017. AS­CO

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.