Af­ter a long, hard slog to the clin­ic, stem cell play­er Vi­a­Cyte fu­els up with $105M for its next big at­tack on di­a­betes

Over the 14 years since 3 com­pa­nies merged to­geth­er to cre­ate the stem cell play­er we now call Vi­a­Cyte in San Diego, the biotech has been op­er­at­ing on a steady stream of cash from the Cal­i­for­nia In­sti­tute of Re­gen­er­a­tive Med­i­cine as well as the non-prof­it JDRF or­ga­ni­za­tion. 

But with one stem cell prod­uct in the clin­ic and a next-gen prod­uct about to go back in­to hu­man test­ing af­ter a re­vamp — plus a new­ly formed col­lab­o­ra­tion with the gene edit­ing spe­cial­ists at CRISPR Ther­a­peu­tics — CEO Paul Laikind is ready to dou­ble down on a strate­gic bet that the crew at Vi­a­Cyte can make some ma­jor clin­i­cal progress over the next 2 to 3 years.

Paul Laikind, Vi­a­Cyte

To­day Laikind is un­veil­ing an $80 mil­lion ven­ture round, the first in years, that brings to­geth­er a set of new in­vestors — Bain Cap­i­tal Life Sci­ences and joined by TPG and RA Cap­i­tal Man­age­ment —who are join­ing Sander­ling and some in­di­vid­ual back­ers on the next leg of the jour­ney. To­geth­er with the $15 mil­lion CRISPR paid them to forge their tie-up and an­oth­er $10 mil­lion from part­ners at WL Gore and As­so­ci­ates, Laikind’s team now has $105 mil­lion to fund this next leg of prod­uct de­vel­op­ment.

“With this new fund­ing we’re re­al­ly open­ing the gate, say­ing ‘lets get this done,’” says the CEO.

“We stuck to our guns of what we want to ac­com­plish here,” adds Laikind. “It’s tak­en 7-8 years to de­vel­op the tech­nol­o­gy for dif­fer­en­ti­at­ing the cells in a reg­u­la­to­ry-com­pli­ant way.” 

Pe­ter Kolchin­sky

Laikind has been woo­ing RA’s Pe­ter Kolchin­sky for some time now. And Kolchin­sky and Bain’s Adam Kop­pel have a long­stand­ing re­la­tion­ship forg­ing deals to­geth­er, which helped get this syn­di­cate to gel.

Like a lot of the stem cell sur­vivors in Cal­i­for­nia, Vi­a­Cyte has seen the burst of glo­ry and hype suc­ceed­ed by the bleak­ness of the marathon run that stem cell R&D has proven to be — just like many oth­er new tech­nolo­gies in biotech. And it’s man­aged to keep plug­ging away at it to get to the re­newed era of op­ti­mism that has been lift­ing the sur­vivor’s prospects over the last cou­ple of years.

Adam Kop­pel

The lead prod­uct at Vi­a­Cyte is called PEC-Di­rect, de­signed to fer­ry pan­cre­at­ic prog­en­i­tor cells from stem cells that can se­crete in­sulin. It’s prob­lem­at­ic, though, trig­ger­ing the kind of im­mune re­sponse that re­quires im­muno­sup­pres­sion — which nec­es­sar­i­ly lim­its its us­es to 10% of high-risk Type 1 di­a­betes pa­tients will­ing to put up with the risks.

PEC-En­cap is an en­cap­su­lat­ed prod­uct that us­es Gore-tex like ma­te­r­i­al to de­liv­er the same pan­cre­at­ic prog­en­i­tor cells with­out spark­ing the for­eign body re­sponse that spurs the body to coat their de­vice with cells. And this can be used with­out im­mune sup­pres­sion, which would sig­nif­i­cant­ly ex­pand the mar­ket for Vi­a­Cyte.

CRISPR Ther­a­peu­tics $CR­SP, one of the lead­ers in CRISPR/Cas9 gene edit­ing with a big in­ter­est in re­gen­er­a­tive med­i­cine, is step­ping in to use their im­mune-eva­sive tech to cre­ate a new line of off-the-shelf cells that can do the job with­out kick­ing in the re­jec­tion re­sponse.

There are 55 staffers at the biotech, which the CEO says will grow now that he has his big fi­nanc­ing pack­age com­plet­ed. Vi­a­Cyte does its own man­u­fac­tur­ing work, and that team will need to ex­pand along with a spe­cial group ded­i­cat­ed to the part­ner­ship with CRISPR.

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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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.

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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.