Bris­tol-My­ers of­fers a pos­i­tive snap­shot on ear­ly da­ta for an IDO1 ri­val to In­cyte

WASH­ING­TON, DC — While In­cyte and the founders of Flexus scrap in court over who owns the IDO1 tech­nol­o­gy that Bris­tol-My­ers Squibb $BMY bought in a $1.25 bil­lion deal a cou­ple of years ago, Bris­tol-My­ers is ready to start putting the ear­ly-stage da­ta from a com­bi­na­tion study with Op­di­vo on dis­play.

To­day at the SITC meet­ing, in­ves­ti­ga­tors say their on­go­ing Phase I/II study of the check­point drug Op­di­vo plus BMS-986205 pro­duced some vary­ing pos­i­tive re­sults for heav­i­ly pre-treat­ed blad­der (25 cas­es) and cer­vi­cal can­cer pa­tients (22 pa­tients).

Bot­tom line:

— In the blad­der can­cer co­hort, the ob­jec­tive re­sponse rate and dis­ease con­trol rate were 32% and 44%, re­spec­tive­ly.

— In the cer­vi­cal can­cer co­hort, the ORR was 14% and DCR was 64%.

PD-L1 ex­pres­sion mat­tered. Ze­ro­ing in on pa­tients who ex­press PD-L1 more than 1%, ORR was 46% and 25% in the blad­der and cer­vi­cal can­cer groups, re­spec­tive­ly, while for pa­tients who ex­press PD-L1 less than 1%, ORR was 22% in the blad­der can­cer co­hort with no re­spons­es ob­served in cer­vi­cal can­cer pa­tients.

In a court case filed in Delaware, In­cyte claimed that Jor­dan Frid­man, a sci­en­tist in its ranks, had sys­tem­at­i­cal­ly lift­ed its IDO1 se­crets be­fore mak­ing his way to Flexus, which sub­se­quent­ly ac­cept­ed a jaw-drop­ping buy­out of­fer from Bris­tol-My­ers. The law­suit filed against Flexus founders Ter­ry Rosen and Juan Jean seeks more than a bil­lion dol­lars in dam­ages.

In­cyte $IN­CY has the most ad­vanced IDO1 in the clin­ic — epaca­do­stat — and is clear­ly in­tent on de­fend­ing its IP turf. Bris­tol-My­ers, mean­while, is plac­ing a heavy em­pha­sis on mov­ing as fast as pos­si­ble on the IDO1 front as it push­es ahead with its big check­point ther­a­py and com­bos around it.

Bris­tol-My­ers IDO de­vel­op­ment lead Mark Rut­stein not­ed:

We are ur­gent­ly pur­su­ing trans­for­ma­tive re­search to bet­ter un­der­stand tu­mor eva­sion mech­a­nisms to help in­form po­ten­tial new treat­ment op­tions for pa­tients with ad­vanced can­cers. BMS-986205 has shown en­cour­ag­ing char­ac­ter­is­tics, in­clud­ing po­tent and se­lec­tive in­hi­bi­tion of IDO1, as well as phar­ma­co­ki­net­ic da­ta that sup­port once-dai­ly dos­ing. We look for­ward to ad­di­tion­al da­ta from this study.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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).

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.