Al­lied with Penn, Tmu­ni­ty’s cell ther­a­py pi­o­neers bag $100M mega-round to back a break­through quest on CAR-T, CRISPR

No­var­tis vet Us­man “Oz” Azam and Penn re­searcher Carl June are two of the ul­ti­mate in­sid­ers in the CAR-T rev­o­lu­tion. They each played promi­nent roles in ad­vanc­ing No­var­tis’ break­through ther­a­py Kym­ri­ah to an his­toric first-ever ap­proval. They are now al­lied in an at­tempt to do it all much, much bet­ter with next-gen tech which just at­tract­ed a $100 mil­lion mega-round from an un­con­ven­tion­al group of glob­al glo­biotech in­vestors.

And af­ter stay­ing qui­et for more than a year, they’re al­ready in the clin­ic with two open pro­grams, play­ing a key role co-fund­ing a cut­ting-edge cell ther­a­py study at Penn us­ing CRISPR to mod­i­fy im­mune cells.

Azam, you may re­call, head­ed up No­var­tis’ cell and gene ther­a­py unit be­fore its spec­tac­u­lar breakup a year and a half ago, as the phar­ma gi­ant man­aged the un­like­ly task of slash­ing its costs while main­tain­ing the lead on get­ting the first CAR-T ther­a­py ap­proved. As the re­struc­tur­ing went in place in the sum­mer of 2016, Azam left and soon af­ter jumped to the Penn spin­out, re­main­ing re­lent­less­ly un­der the radar — un­til to­day.

So what, giv­en the bil­lions of dol­lars be­ing in­vest­ed in I/O, makes Tmu­ni­ty dif­fer­ent from the rest of the grow­ing crowd?

Azam quick­ly ze­roes in on June and the net­work of sci­en­tists at Penn en­list­ed in the ex­clu­sive col­lab­o­ra­tion deal they have to work to­geth­er.

It’s the “biotech-like struc­ture that Carl found­ed, that can trans­late these ther­a­pies through the reg­u­la­to­ry hur­dles and in­to clin­i­cal tri­al set­tings” that make one key dif­fer­ence, he says.

Azam of­fered that Tmu­ni­ty along with the Park­er In­sti­tute for Can­cer Im­munother­a­py are fund­ing a new­ly opened — and close­ly watched — tri­al at the Uni­ver­si­ty of Penn­syl­va­nia us­ing CRISPR gene edit­ing tech to mod­i­fy can­cer cells. And he adds there’s al­so a clin­i­cal tri­al un­der­way in prostate can­cer they’re back­ing as well, with more pro­grams in the pipeline out of Penn.

I asked Azam if there was one key thing he had learned about the field at No­var­tis. His re­ply:

“The big learn­ing I had was link­ing and bring­ing to­geth­er trans­la­tion­al med­i­cine and man­u­fac­tur­ing as soon as pos­si­ble.”

Jiang Zhang

The jour­ney from proof-of-con­cept to com­mer­cial­iza­tion was just 7 years, he adds. “That’s pret­ty breath­tak­ing.” And do­ing it re­quired a quick leap from ear­ly clin­i­cal de­vel­op­ment in trans­la­tion­al med­i­cine and “em­brac­ing man­u­fac­tur­ing and tech­ni­cal com­pe­ten­cies ear­ly on. That’s been the biggest chal­lenge for the field. Not just aca­d­e­m­ic set­ting suc­cess, but mak­ing prod­ucts.”

The in­vestors in­clude:

— Gilead, the new own­er of CAR-T play­er Kite, which has vowed to stay in the fore­front of new tech in the space.

— The Park­er In­sti­tute, the non­prof­it re­search group backed by Face­Book bil­lion­aire Sean Park­er, out to spark new brush­fires of in­no­va­tion.

— Ping An Ven­tures, the ven­ture arm of the Glob­al For­tune 500 Chi­nese in­sur­ance out­fit, which al­so backed Shang­hai-based In­novent Bi­o­log­ics.

— And Be The Match Bio­Ther­a­pies, with the seed round in­vestors at the Uni­ver­si­ty of Penn­syl­va­nia and Lil­ly Asia Ven­tures.

“We were al­so at­tract­ed to the glob­al po­ten­tial of the pipeline, es­pe­cial­ly the T cell ther­a­pies in on­col­o­gy in Chi­na, as well as the scope be­yond on­col­o­gy in­to au­toim­mune and in­fec­tious dis­eases, as we be­gin to ex­pand our in­vest­ment port­fo­lio,” said Jiang Zhang, man­ag­ing part­ner of Ping An Ven­tures.

Michael Polan­sky

I asked the Park­er In­sti­tute why they de­cid­ed to help bankroll the com­pa­ny, and got a re­sponse from Michael Polan­sky, pres­i­dent of the Park­er Group and mem­ber of the Park­er In­sti­tute for Can­cer Im­munother­a­py Board of Di­rec­tors:

As you know Carl June at the Uni­ver­si­ty of Penn­syl­va­nia is such a gi­ant in the field of cell ther­a­py and CAR-T, such a pi­o­neer, which is why we want­ed to bring him on as a di­rec­tor at the Park­er In­sti­tute. His lead­er­ship and in­sight in­to the field of cell ther­a­py are in­valu­able.

With him as sci­en­tif­ic founder of Tmu­ni­ty, that gave us a lot of con­fi­dence that the tech­nol­o­gy and the sci­ence will be top tier. And from what we’ve seen there’s no ques­tion that they have a sol­id plan for de­vel­op­ing the next wave of suc­cess­ful cell and gene ther­a­pies, re­al­ly trans­lat­ing those the dis­cov­er­ies so they can be de­vel­oped in­to ther­a­pies at an ac­cel­er­at­ed pace to help more can­cer pa­tients faster.

So far, the biotech has made all of two an­nounce­ments, start­ing with Azam’s ar­rival and end­ing with Mike Chris­tiano’s move to the BD side of the busi­ness af­ter play­ing a sim­i­lar role in No­var­tis.

Now that the A round is in, Azam says he can start re­cruit­ing, build­ing up the small team as they con­tin­ue to work with top in­ves­ti­ga­tors at Penn on the re­search, tech­nol­o­gy and clin­i­cal tri­als.

“It’s a great space to be in now,” he says, “and will be for decades to come.”

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.