That $1.25B Bris­tol-My­ers IDO1 drug? In­cyte claims a for­mer staffer stole it

Ter­ry Rosen

When Bris­tol-My­ers Squibb agreed to pay up to a jaw-drop­ping $1.25 bil­lion to ac­quire the fledg­ling biotech Flexus back in ear­ly 2015 for the sole pur­pose of gain­ing con­trol of a pre­clin­i­cal IDO1 drug, the math seemed to de­fy every known stan­dard on overnight biotech wind­falls.

The 18-month-old biotech had just lined up a $38 mil­lion round from Klein­er Perkins, Cel­gene and The Col­umn Group. In a world where a 10X pay­off af­ter a few years is con­sid­ered a home run, Bris­tol-My­ers’ $800 mil­lion up­front, with $450 mil­lion in ear­ly-stage mile­stones, for a drug that had yet to go in­to hu­mans was done on a whole new lev­el.

“We had a da­ta set that sug­gest­ed it has the po­ten­tial to be best-in-class, with the abil­i­ty for a part­ner to com­bine it with many oth­er as­sets,” Flexus co-founder Ter­ry Rosen told me at the time. “If you look at any com­pa­ny work­ing in on­col­o­gy, it can po­ten­tial­ly in­crease the val­ue of a whole port­fo­lio of as­sets. It could be mul­ti­plica­tive and that cre­ates a big val­u­a­tion.”

What went large­ly (though not en­tire­ly) un­no­ticed at the time was that a fu­ri­ous In­cyte — the wide­ly rec­og­nized leader in IDO1 now in late-stage test­ing with one of the most close­ly-watched pro­grams in on­col­o­gy — quick­ly went to war over the deal.

The com­pa­ny claimed that Jor­dan Frid­man, a sci­en­tist in its ranks, had sys­tem­at­i­cal­ly lift­ed its IDO1 se­crets be­fore mak­ing his way to Flexus. In a law­suit filed against Rosen and Juan Jaen seek­ing more than a bil­lion dol­lars in dam­ages, In­cyte claimed that Frid­man had been de­mand­ing in­for­ma­tion on their IDO1 work in the three months he re­mained at In­cyte af­ter giv­ing no­tice.

Lat­er in 2014, ac­cord­ing to a law­suit In­cyte filed against Flexus, Frid­man “false­ly told In­cyte’s em­ploy­ees that Flexus did not have an IDO-1 in­hibitor project and that he was no longer work­ing on IDO-1 in­hibitors.” But then he al­leged­ly ad­mit­ted his in­volve­ment lat­er that year.

The News Jour­nal in Delaware cov­ered the case in a big fea­ture to­day, which is like­ly to re­fo­cus con­sid­er­able at­ten­tion on Bris­tol-My­ers’ IDO1 work on BMS-986205, which is now be­ing stud­ied in com­bi­na­tion with its big check­point in­hibitor Op­di­vo. Ac­cord­ing to the re­port, the case is head­ed to court next year.

Lawyers for Rosen and Jaen de­nied the claims and seem ready to fight it out in front of a judge.

In an ab­stract post­ed at AACR last April, Bris­tol-My­ers — which like its ri­vals is part­nered with In­cyte’s IDO1 epaca­do­stat — boast­ed about the clear po­ten­tial they were see­ing in their ear­ly-stage in-house pro­gram. Ac­cord­ing to their ab­stract:

Ev­i­dence of sub­stan­tial serum kyn re­duc­tion was ob­served at dos­es as low as 25 mg QD; in­hi­bi­tion at 100 and 200 mg QD ap­pears greater than that re­port­ed for oth­er in-class com­pounds. In ad­di­tion, we have pre­sent­ed the first ev­i­dence of in­tra­tu­moral kyn re­duc­tion by an IDO1 in­hibitor. These da­ta sug­gest the po­ten­tial of BMS-986205 as an IDO1 in­hibitor with su­pe­ri­or PD prop­er­ties and sup­port fur­ther eval­u­a­tion in com­bi­na­tion with ni­vo.

Ever­cor­eISI’s Umer Raf­fat just days ago put out a note say­ing that he thinks the Bris­tol-My­ers drug could be bet­ter than In­cyte’s — with one cru­cial dif­fer­ence. He wrote: “(R)ather than sim­ply pre­vent the en­zyme’s sub­strate from bind­ing, BMY’s in­hibitor wrecks the whole struc­ture of the ac­tive site, form­ing the ba­sis for a po­ten­tial­ly ir­re­versible in­hibitor.”

The Bris­tol-My­ers drug is now in three dif­fer­ent stud­ies, ac­cord­ing to the list­ings on clin­i­cal­tri­als.gov, in­clud­ing a Phase II rapid-fire set of com­bi­na­tion tests for non-small cell lung can­cer. And Phase I/II da­ta is due at the up­com­ing SITC con­fer­ence in ear­ly No­vem­ber.

Frid­man, who’s not a named par­ty in the law­suit, went on to join an­oth­er Klein­er Perkins start­up called FLX Bio as the CSO. A spokesper­son for the com­pa­ny, though, says he’s left the biotech.

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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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.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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