EASL Roundup: Bris­tol-My­ers and NGM post a pos­i­tive look at PhII NASH da­ta; Gen­fit de­tails PhI­II de­lay

Over the week­end some of the prospec­tive play­ers in the NASH field had a chance to roll out new da­ta on their con­tenders for the field at the an­nu­al EASL meet­ing. We were treat­ed to some in­trigu­ing ear­ly- and mid-stage da­ta on liv­er fat lev­els that could be im­por­tant fur­ther down the R&D road. And a top late-stage play­er spot­light­ed a de­lay that could set it be­hind ri­vals in the field.

Bill Berkrot at Reuters did a great deep dive on NASH, a big mar­ket dis­ease that could be worth tens of bil­lions of dol­lars every year. NASH and fat­ty liv­er dis­ease are the hall­mark of an in­creas­ing­ly obese, seden­tary glob­al pop­u­la­tion. Ul­ti­mate­ly, the dis­ease could lead to liv­er trans­plants, though there is a lot left to be learned about dis­ease pro­gres­sion and risk.

The top com­pa­nies in the field now in­clude Gilead and Al­ler­gan with No­var­tis, Mer­ck, Bris­tol-My­ers and J&J all an­gling in. France’s Gen­fit is al­so a key play­er.

Here’s a look at the top head­lines from EASL in Am­s­ter­dam:

Bris­tol-My­ers drug flush­es liv­er fat in Phase II

Bris­tol-My­ers Squibb led the group over the week­end with its Phase II da­ta out on BMS-986036, hu­man fi­brob­last growth fac­tor 21. Both 10 mg and 20 mg week­ly dos­es knocked down liv­er fat by 6.8% and 5.2% com­pared to on­ly 1.3% in the place­bo arm. And they tracked the changes through imag­ing tech­nol­o­gy.

Bris­tol-My­ers has been work­ing on bio­mark­ers that can al­so track the im­pact of a drug, look­ing for ways to get around the liv­er biop­sies — ex­pen­sive and de­mand­ing on pa­tients — that have been used for de­fin­i­tive in­sight.

“We are en­cour­aged by the im­prove­ments these da­ta showed across mul­ti­ple as­pects of NASH, and that pa­tients could be ef­fec­tive­ly eval­u­at­ed through imag­ing rather than through in­va­sive liv­er biop­sy,” said Mike Burgess, head of Car­dio­vas­cu­lar, Fi­bro­sis and Im­muno­science De­vel­op­ment, Bris­tol-My­ers Squibb.

NGM Bio Phase II hits pri­ma­ry NASH end­point

Stephen Har­ri­son

NGM Bio turned out in Am­s­ter­dam to boast about the im­pact of NGM282 in an­oth­er Phase II tri­al. In­ves­ti­ga­tors said that they test­ed 3 and 6 mg sub­cu­ta­neous dos­es over 12 weeks in 82 NASH pa­tients with ear­ly-stage fi­bro­sis. They came up with 9.7% and 11.9% re­duc­tions in liv­er fat.

About a third of the pa­tients hit a nor­mal lev­el of liv­er fat, while 4 out of 5 achieved the pri­ma­ry end­point in fat re­duc­tion. Re­searchers al­so saw some im­prove­ments in bio­mark­ers of liv­er func­tion, lipid me­tab­o­lism and fi­bro­sis, though this drug would have a far way to go to nail down sol­id ef­fi­ca­cy da­ta.

“NGM282 is the first agent I’ve test­ed that holds the po­ten­tial to com­plete­ly re­verse steato­sis in as short as 12 weeks of ther­a­py,” said Stephen Har­ri­son, Med­ical Di­rec­tor at Pin­na­cle Clin­i­cal Re­search and Vis­it­ing Pro­fes­sor of He­pa­tol­ogy at the Rad­cliffe De­part­ment of Med­i­cine at Uni­ver­si­ty of Ox­ford, UK.

NGM struck a big $450 mil­lion deal with Mer­ck in 2015 that is help­ing pay the bills while it ad­vances its own pipeline.

Gen­fit ex­plains a sig­nif­i­cant de­lay for PhI­II NASH study

Paris-based Gen­fit has run in­to some hur­dles in re­cruit­ing pa­tients for its close­ly watched RE­SOLVE-IT Phase III, which will de­lay its time­line by up to six months. The biotech says that the de­lay is part­ly due to the chal­lenge of re­cruit­ing pa­tients at a time ex­per­i­men­tal drugs in the clin­ic are pro­lif­er­at­ing. But it says the big ob­sta­cle is its own “de­sire to en­sure en­roll­ment qual­i­ty so as to pro­duce the most sta­tis­ti­cal­ly ro­bust clin­i­cal tri­al by en­sur­ing that pa­tient strat­i­fi­ca­tion ra­tios re­main as close as pos­si­ble to the med­ical re­al­i­ty.”

Gen­fit out­lined the slow­down in its Q1 up­date.

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.