Mer­ck goes in deep­er with Keytru­da/Lyn­parza com­bo; PureTech un­veils stem cell ther­a­py start­up

→ Mer­ck is open­ing up a new wing of its Keytru­da pipeline, de­vot­ing it to a slate of new Phase III com­bi­na­tion stud­ies with Lyn­parza in treat­ing prostate can­cer. Re­searchers spot­ted an­ti-tu­mor ac­tiv­i­ty in 3 co­horts, send­ing them the sig­nal they were look­ing for to pile on piv­otal stud­ies in search of a new mar­ket. “These promis­ing da­ta pre­sent­ed at AS­CO GU cou­pled with the sig­nif­i­cant un­met med­ical need in pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer, pro­pelled us to ini­ti­ate three new Phase 3 tri­als to fur­ther eval­u­ate these KEYTRU­DA com­bi­na­tion reg­i­mens,” not­ed Mer­ck’s Roy Baynes.

PureTech Health is help­ing chart a path for Sid­dhartha Mukher­jee to bring some of his re­search from Co­lum­bia Uni­ver­si­ty to the clin­ic with a new start­up. De­but­ing with a $42 mil­lion round led by 5AM Ven­tures and RA Cap­i­tal Man­age­ment, Vor Bio­phar­ma is look­ing to treat hema­to­log­i­cal ma­lig­nan­cies with hematopoi­et­ic stem cell ther­a­pies, start­ing with acute myeloid leukemia. 5AM man­ag­ing part­ner Kush Par­mar is tak­ing the ex­ec­u­tive chair­man role while Joshua Resnick of RA Cap­i­tal al­so joins the board. Oth­er in­vestors in­clude John­son & John­son In­no­va­tion – JJDC, No­var­tis In­sti­tutes for Bio­Med­ical Re­search and Os­age Uni­ver­si­ty Part­ners.

Tesaro‘s PARP drug Ze­ju­la, which in 2017 saw its la­bel ex­pand­ed by the FDA, has shown ear­ly promise in a mid-stage study in cer­tain metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer pa­tients. J&J $JNJ and Tesaro – which is now a part of GSK $GSK  – agreed to col­lab­o­rate on test­ing the drug, known chem­i­cal­ly as ni­ra­parib, in 2016. Pre­lim­i­nary da­ta from the 120-pa­tient study showed 40% of pa­tients with path­way de­fects – BR­CA1 or BR­CA2 – who re­ceived treat­ment with ni­ra­parib demon­strat­ed an ob­jec­tive re­sponse rate as mea­sured by a de­creased tu­mor size in soft tis­sue. 

→ It’s on. Sarep­ta $SRPT to­day said that the FDA has ac­cept­ed its NDA for golodirsen (SRP-4053) as it hunts an­oth­er ac­cel­er­at­ed ap­proval for a new drug to treat Duchenne mus­cu­lar dy­s­tro­phy. The agency set the PDU­FA date at Au­gust 19.

→ A gener­ic ver­sion of Cel­gene’s best-sell­ing can­cer drug Revlim­id will soon be avail­able around the world. Alvo­gen an­nounced that it has launched the gener­ic in Ro­ma­nia, Croa­t­ia, Bul­gar­ia and the Baltic states, with a glob­al roll­out to fol­low.

→ TCR2 Ther­a­peu­tics has priced its IPO at $15 a share. The Cam­bridge, MA-based TCR biotech raised $75 mil­lion from the of­fer­ing, pric­ing at the mid­point of the range it set for it­self. The stock will be­gin trad­ing to­day as $TCRR.

→ Ver­tex $VRTX says it came up with pos­i­tive da­ta from their Phase III study of teza­caftor in com­bi­na­tion with iva­caftor, hit­ting the pri­ma­ry end­point of ab­solute change in lung clear­ance in­dex (LCI2.5) through 8 weeks of treat­ment. Re­searchers say that there was “a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in LCI2.5 among pa­tients treat­ed” with the com­bo. An ap­pli­ca­tion is due in H2.

→ Cal­adrius Bio­sciences says its Phase IIa study us­ing a Treg strat­e­gy for au­toim­mune dis­eases failed. Re­searchers test­ed CLBS03 in new­ly di­ag­nosed Type 1 di­a­betes pa­tients, hop­ing that the well-known ef­fect that Tregs have in blunt­ing an im­mune sys­tem at­tack would work for this dis­ease. Its shares $CLBS were down 15% in mid-morn­ing trad­ing.

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.

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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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.