In a stun­ner, Mer­ck leaps ahead of ri­vals with com­bo Keytru­da/chemo at­tack on lung can­cer

Mer­ck’s im­muno-on­col­o­gy team has be­come ex­pert at press­ing an ear­ly ad­van­tage.

The Keytru­da com­pa­ny, which re­cent­ly trounced Bris­tol-My­ers in their ri­val­ry on lung can­cer, has now filed an ear­ly and stun­ning ap­pli­ca­tion to mar­ket a com­bi­na­tion of Keytru­da and chemo for first-line lung can­cer. And the move has the po­ten­tial to carve out a short­cut that will al­low them to cut ahead of a strug­gling As­traZeneca and a po­tent Roche.

Mer­ck’s stock $MRK spiked close to 5% on the news of its lat­est ad­vance in the field as an­a­lysts pon­dered the im­pli­ca­tions in a field with block­buster po­ten­tial. Check­points alone treat on­ly a por­tion of all can­cer pa­tients, and a front­line com­bo could cap­ture the li­on’s share of the mar­ket.

The FDA ac­cept­ed the sup­ple­men­tal ap­pli­ca­tion and agreed to give the ap­pli­ca­tion a speedy re­view, of­fer­ing a de­ci­sion by May 10. And giv­en the agency’s go-go record on rush­ing ahead on promis­ing I/O ther­a­pies, Mer­ck may be on the verge of mak­ing an even ear­li­er break­through with its first com­bo ap­proach.

As­traZeneca ear­li­er re­tooled its im­muno-on­col­o­gy ef­fort for dur­val­um­ab, its all-im­por­tant check­point pro­gram, as it lagged be­hind the fron­trun­ners in the field. It’s now lin­ing up for the fourth or pos­si­bly fifth new ap­proval for a check­point, as it looks to en­ter a crowd­ed mar­ket in­volv­ing some of the most ag­gres­sive play­ers in the in­dus­try. And af­ter mul­ti­ple set­backs over the past year, the UK gi­ant can ill af­ford to con­tin­ue get­ting beat in I/O if it ever ex­pects to de­liv­er on am­bi­tious fore­casts of rev­enue growth.

As­traZeneca’s stock dropped 1% on the news.

Mer­ck’s play here is not with­out risk. Sea­mus Fer­nan­dez at Leerink not­ed:

MRK’s an­nounce­ment of the ac­cep­tance of an sBLA fil­ing for Keytru­da (pem­brolizum­ab) + chemother­a­py in first-line (1L) non-squa­mous non-small cell lung can­cer (NSCLC) re­gard­less of PD-L1 sta­tus comes as a sig­nif­i­cant sur­prise, po­ten­tial­ly es­tab­lish­ing Keytru­da as the first IO agent to be used broad­ly in non-squa­mous NSCLC re­gard­less of PDL1 sta­tus. FDA’s will­ing­ness to ac­cept the fil­ing based on such a small study (with no ev­i­dence of a sur­vival ben­e­fit in the da­ta pre­sent­ed at ES­MO) sug­gests to us that the agency may have vis­i­bil­i­ty in­to the like­li­hood of suc­cess on the PFS end­point in the on­go­ing Phase 3 Keynote-189 tri­al. If this com­bo re­ceives ac­cel­er­at­ed ap­proval by its PDU­FA date of 5/10/17, it like­ly would give MRK an­oth­er leg-up in the 1L NSCLC race over AZN (OP) and BMY’s (OP) IO+IO com­bos and RHH­BY’s (NR) IO+chemo com­bo. While we con­tin­ue to be­lieve that IO+IO com­bos will even­tu­al­ly pro­duce more durable re­spons­es (par­tic­u­lar­ly in pa­tients with high­er lev­els of PD-L1 ex­pres­sion), an ear­ly and broad ac­cel­er­at­ed ap­proval for this IO+chemo com­bo could fur­ther es­tab­lish Keytru­da as the PD-1 of choice in the 1L set­ting – at least un­til oth­er agents are ap­proved in this set­ting.

Roger Dansey, Mer­ck

Mer­ck has mount­ed hun­dreds of stud­ies around its Keytru­da fran­chise, of­ten part­ner­ing on po­ten­tial com­bos as the team mar­ries an im­mune sys­tem at­tack with com­ple­men­tary ther­a­pies.

Bris­tol-My­ers has al­so been la­bor­ing long and hard with Op­di­vo. But it’s ear­ly lead in the field was bad­ly dam­aged in 2016 as an over­ly am­bi­tious at­tempt to grab proof of ef­fi­ca­cy as a stand­alone lung can­cer drug end­ed in dis­as­ter.

Dr. Roger Dansey, se­nior vice pres­i­dent and ther­a­peu­tic area head, on­col­o­gy late-stage de­vel­op­ment, Mer­ck Re­search Lab­o­ra­to­ries, has this to say:

“Keytru­da in com­bi­na­tion with chemother­a­py has shown promise ver­sus chemother­a­py alone in the first-line treat­ment of non-squa­mous metasta­t­ic non-small cell lung can­cer, re­gard­less of PD-L1 lev­els. If ap­proved, this could be the first reg­i­men com­bin­ing chemother­a­py with an im­muno-on­col­o­gy agent for pa­tients with ad­vanced non-small cell lung can­cer.”

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.