Seat­tle Ge­net­ics grabs Im­munomedics’ tu­mor drug in $2B deal, shoot­ing for a quick OK

Clay Sie­gall, Seat­tle Ge­net­ics

You can count Seat­tle Ge­net­ics as the new flag car­ri­er for Im­munomedics’ sol­id tu­mor drug IM­MU-132. The biotech is pay­ing $300 mil­lion to claim glob­al rights on the drug, com­mit­ting up to $1.7 bil­lion more in mile­stones.

That mile­stone mon­ey should get rolling soon. Seat­tle Ge­net­ics will now take the lead on a Phase III study for metasta­t­ic triple neg­a­tive breast can­cer. And once the BLA is filed, it’s ob­lig­at­ed to pay over the first of its mile­stone mon­ey as Seat­tle Ge­net­ics looks to vault to an ap­proval as ear­ly as late 2017.

“In just over three years, we have brought IM­MU-132 through clin­i­cal de­vel­op­ments in mul­ti­ple in­di­ca­tions, and have ad­vanced the TNBC in­di­ca­tion to a po­ten­tial ac­cel­er­at­ed ap­proval and launch by late 2017 or ear­ly 2018, which could make IM­MU-132 avail­able to pa­tients deal­ing with a high­ly ma­lig­nant form of breast can­cer,” not­ed Mor­ris Plains, NJ-based Im­munomedics CEO Cyn­thia L. Sul­li­van.

Seat­tle Ge­net­ics $SGEN in­vestors drove the stock down 6%, while Im­munomedics $IM­MU saw their shares rise on­ly 7%.

IM­MU-132 (sac­i­tuzum­ab govite­can) fits square­ly in Seat­tle Ge­net­ics’ com­fort zone. It is an armed an­ti­body that con­tains SN-38, the ac­tive metabo­lite of irinote­can, de­signed for pre­cise de­liv­ery to avoid off-tar­get tox­i­c­i­ty.

The deal — with a $250 mil­lion in an up­front and an ad­di­tion­al $50 mil­lion for ad­di­tion­al ex-US rights — falls just days af­ter Sul­li­van and her crew tout­ed the lat­est up­date on the drug and its plans to seek an ac­cel­er­at­ed ap­proval. At a re­cent re­view, the com­pa­ny said:

(P)atients ex­pe­ri­enced two com­plete and 23 par­tial re­spons­es, while an ad­di­tion­al three pa­tients with ini­tial par­tial re­spons­es are await­ing con­fir­ma­tion. Over­all, 81% of pa­tients treat­ed with IM­MU-132 showed tu­mor shrink­age from base­line mea­sure­ments. The clin­i­cal ben­e­fit rate (com­plete and par­tial re­mis­sions, and pa­tients with sta­ble dis­ease) at six months or lat­er com­put­ed to 44%. The me­di­an du­ra­tion of re­sponse for those with ob­jec­tive re­spons­es was al­most 11 months. It was em­pha­sized that these are in­ter­im re­sults, since 20 pa­tients are con­tin­u­ing treat­ment; a fi­nal out­come must await analy­sis of all pa­tients en­rolled.

An­a­lysts though, have fret­ted about this drug in the re­cent past, in­clud­ing wor­ries about the man­u­fac­tur­ing process, which Seat­tle Ge­net­ics is like­ly to tack­le quick­ly.

Af­ter TNBC, Seat­tle Ge­net­ics plans to go af­ter new in­di­ca­tions as it fol­lows up on Phase II stud­ies in urothe­lial can­cer, small-cell lung can­cer and non-small-cell lung can­cer. And Seat­tle Ge­net­ics CEO Clay Sie­gall says the late-stage tu­mor drug will fit neat­ly in its pipeline of an­ti­body drug con­ju­gates. He said:

This pro­gram would com­ple­ment our rich pipeline of late- and ear­ly-stage pro­grams, po­ten­tial­ly al­low­ing us to bring a new ther­a­py for triple-neg­a­tive breast can­cer to pa­tients in need. We have suc­cess­ful­ly demon­strat­ed our ex­per­tise in the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion of AD­Cs in on­col­o­gy, and we look for­ward to work­ing with Im­munomedics to ad­vance this pro­gram.

In ad­di­tion to the cash and mile­stones, Seat­tle Ge­net­ics is al­so buy­ing in­to Im­munomedics, pay­ing $14.7 mil­lion for shares at a slight pre­mi­um and re­serv­ing the right to buy more lat­er at the same price. Seat­tle Ge­net­ics has the right to make up to a $57 mil­lion eq­ui­ty in­vest­ment for up to a 9.9% stake in Im­munomedics.

Right af­ter the deal was an­nounced, Im­munomedics said it would post­pone its an­nu­al meet­ing as its in­vestors took time to ab­sorb the im­pli­ca­tions of the pact.

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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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.

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→ 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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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.