As­traZeneca ax­es an­oth­er R&D track on dur­val­um­ab af­ter once again falling be­hind ri­vals

As­traZeneca CEO Pas­cal So­ri­ot

It’s not easy be­ing fourth.

The R&D team at As­traZeneca had thought that its sin­gle-arm study for its Phase II tri­al of the PD-L1 check­point dur­val­um­ab might have of­fered a short­cut to an ap­proval for sec­ond-line head and neck can­cer. But Mer­ck eas­i­ly beat them to the mar­ket with Keytru­da for head and neck with a nod in Au­gust and now Bris­tol-My­ers is breath­ing down its neck in the hope that they can cat­a­pult ahead — which would be wel­come af­ter the em­bar­rass­ing lung can­cer de­ba­cle.

So now As­traZeneca says it is scrap­ping plans to file for an ear­ly ap­proval in the in­di­ca­tion, un­like­ly to find reg­u­la­tors in­ter­est­ed in speed­ing an OK. Da­ta are ex­pect­ed this quar­ter, but don’t look for any quick pub­lic dis­cus­sion of what in­ves­ti­ga­tors found. The da­ta will be for in­ter­nal dis­cus­sion on­ly, and in “due course,” ac­cord­ing to As­traZeneca’s Q3 wrap-up.

That leaves As­traZeneca play­ing catch-up with three com­bi­na­tion stud­ies in head and neck can­cer, adding the CT­LA-4 treat­ment treme­li­mum­ab with dur­val­um­ab. But the R&D team has run in­to a de­lay here as well af­ter the FDA opt­ed to drop a par­tial hold on the com­bos a cou­ple of weeks ago.

The par­tial hold was in­sti­tut­ed af­ter in­ves­ti­ga­tors tracked bleed­ing events in the Phase III pro­gram. But the com­pa­ny cau­tions that all oth­er stud­ies in oth­er can­cers are pro­ceed­ing as planned, not­ing that such bleed­ing events are not un­usu­al in head and neck can­cer.

That said, As­traZeneca can ill af­ford any de­lays in the de­vel­op­ment of dur­val­um­ab/treme­li­mum­ab now. The com­pa­ny al­ready de­layed its de­vel­op­ment time­line for the check­point in­hibitor to al­low for com­bi­na­tion stud­ies, which As­traZeneca is count­ing on to make a splash with a late ar­rival in the field.

Now its chief hope in the field lies in get­ting its com­bo ap­proach to reg­u­la­tors for first-line non-small cell lung can­cer, ahead of a com­bi­na­tion of Op­di­vo and Yer­voy from Bris­tol-My­ers. The first piv­otal late-stage da­ta are ex­pect­ed in H1 2017.

It’s been a rough year for As­traZeneca, which has suf­fered a string of set­backs in 2016. And it’s not get­ting any eas­i­er. Mer­ck, Bris­tol-My­ers and Roche all beat the com­pa­ny to the mar­ket with im­pres­sive check­points, and the Pfiz­er/Mer­ck KGaA team is al­so play­ing catch-up as well.

As­traZeneca al­so out­lined the lat­est round of pro­grams to get cut out of the pipeline to­day. The scrap heap list in­clud­ed inebi­lizum­ab, its an­ti-CD19 an­ti­body, for dif­fuse large B cell lym­phoma, ME­DI3617 — a se­lec­tive an­giopoi­etin-2 in­hibitor — for sol­id tu­mors and cedi­ranib for PSR ovar­i­an can­cer. Back in Sep­tem­ber As­traZeneca pulled its ap­pli­ca­tion at the EMA for cedi­ranib, say­ing that reg­u­la­tors had some dif­fer­ing opin­ions on the drug’s safe­ty/ben­e­fit ra­tio.

As­traZeneca CEO Pas­cal So­ri­ot prefers to sweep away set­backs in foot­notes, re­serv­ing the head­line treat­ment for new pipeline ad­vances. To­day, though, the im­pact of gener­ic com­pe­ti­tion con­tin­ued to sav­age the phar­ma gi­ant’s rev­enue num­bers, set­ting a bleak back­ground for So­ri­ot’s trade­mark R&D bull­ish­ness. The com­pa­ny has scored sig­nif­i­cant progress with two new can­cer drugs, Tagris­so and Lyn­parza, but the com­pa­ny is not mak­ing near­ly the progress it promised in­vestors when So­ri­ot fend­ed off a takeover at­tempt by Pfiz­er. As­traZeneca al­so post­ed $674 mil­lion in rev­enue from ex­ter­nal­iza­tion deals done on as­sets that have ei­ther failed to mea­sure up in the clin­ic or no longer fit the com­pa­ny’s com­mer­cial/R&D fo­cus, which leans heav­i­ly on dur­val­um­ab.

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 55,100+ 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 55,100+ 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 55,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

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 55,100+ 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.