Af­ter Ro­va-T bust, Ab­b­Vie plans new sol­id tu­mor as­sault, li­cens­ing next-gen CAR-T tech from Cal­i­br

Af­ter its dis­ap­point­ing Ro­va-T flop last month, Ab­b­Vie is shoring up its sol­id tu­mor bets with a fresh­ly inked re­search deal that should elic­it new strate­gies for tu­mor at­tack. This time, Ab­b­Vie is hop­ing to use po­ten­tial­ly safer, next-gen CAR-Ts that have been cook­ing in the labs of a San Diego re­search in­sti­tute for the past few years.

The phar­ma gi­ant is buy­ing an ex­clu­sive four-year li­cense to tech de­vel­oped at the Cal­i­for­nia In­sti­tute for Bio­med­ical Re­search — bet­ter known as Cal­i­br — to in­ter­ro­gate some of its own can­cer tar­gets, in­clud­ing sol­id tu­mors. Cal­i­br is bring­ing to the ta­ble a plat­form based on a “switch­able” CAR-T cell. I talked with Travis Young, Cal­i­br’s di­rec­tor of pro­tein sci­ences, last Fri­day to find out what that ac­tu­al­ly means. Young tells me it’s about re­duc­ing tox­i­c­i­ty and get­ting a more durable re­sponse from CAR-Ts, which are known to cause safe­ty is­sues.

Travis Young

“CAR-Ts are po­tent, and they can cause tox­i­c­i­ty in the clin­ic,” Young said. “This is about tun­abil­i­ty. We’re call­ing this a switch, but it’s re­al­ly more like a light dim­mer. We want to tune ac­tiv­i­ty and elim­i­nate can­cer cells with­out caus­ing that tox­i­c­i­ty.”

They do that by us­ing an­ti­body-based switch mol­e­cules to con­trol the ac­ti­va­tion and anti­gen speci­fici­ty of CAR-T cells. Young said it’s im­por­tant to note this ap­proach dif­fers from the in­creas­ing­ly pop­u­lar “kill switch” tac­tic, which has been tout­ed as a way to make CAR-Ts safer.

“Rather than killing off the cells in the case of an ad­verse event, this is more proac­tive,” Young said.

The part­ner­ship has both Cal­i­br and Ab­b­Vie do­ing pre­clin­i­cal work, while Ab­b­Vie alone will be re­spon­si­ble for clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion. Cal­i­br, of course, will get mile­stones and roy­al­ties if cer­tain tar­gets are met, but the duo was tight-lipped on fi­nan­cial de­tails of the deal.

The main fo­cus of the col­lab­o­ra­tion will be Ab­b­Vie’s can­cer tar­gets, but Cal­i­br is al­so work­ing on a liq­uid tu­mor pro­gram of its own that might come in­to play down the road. Young said the yet-named pro­gram is a CD19 tar­get­ed switch­able CAR-T ther­a­py, which the in­sti­tute plans to take in­to Phase I for lym­phoma in 2019. As part of the deal, Ab­b­Vie has the op­tion to li­cense that pro­gram (and oth­ers at Cal­i­br). That op­tion ex­pires in four years, how­ev­er.

You didn’t used to see re­search in­sti­tutes mov­ing pro­grams in­to the clin­ic, but its be­com­ing an in­creas­ing­ly pop­u­lar strat­e­gy for non-prof­it re­search cen­ters and uni­ver­si­ties. The idea is that it helps them cre­ate a source of rev­enue in­de­pen­dent from the fed­er­al gov­ern­ment and phil­an­thropy.

Matt Trem­blay

“We’re at the head of this new theme to take your as­sets — your IP orig­i­nat­ed at the in­sti­tute — and take them for­ward in­to clin­i­cal de­vel­op­ment,” Cal­i­br and Scripps Re­search COO Matt Trem­blay told me. 

This is some­thing I dis­cussed with Dave Gib­bons, who han­dles com­mer­cial li­cens­ing at the biotech-heavy cam­pus at UC San Diego, last year. By de-risk­ing pro­grams and de­vel­op­ing up to IND, “you’d have a tremen­dous­ly more valu­able as­set for li­cens­ing,” Gib­bons said.

Ab­b­Vie’s on­col­o­gy and clin­i­cal de­vel­op­ment ex­per­tise will be a boon to the re­source-slim Cal­i­br, but the phar­ma gi­ant was al­so in need of this deal. The com­pa­ny dis­ap­point­ed in­vestors in March when news that its Ro­va-T pro­gram post­ed poor mid-stage re­sults for third-line non-small cell lung can­cer. That was a re­al blow, con­sid­er­ing it was hoped to be a $5 bil­lion earn­er for the com­pa­ny.

Ge­of­frey Porges at Leerink post­ed a scathing as­sess­ment of Ab­b­Vie’s sit­u­a­tion short­ly af­ter the news.

“On­col­o­gy is the key growth busi­ness seg­ment for Ab­b­Vie af­ter the loss of ex­clu­siv­i­ty for Hu­mi­ra in 2023, and to­day’s re­sults and reg­u­la­to­ry de­ci­sion call in­to ques­tion the vi­a­bil­i­ty of the com­pa­ny’s cur­rent sol­id tu­mor strat­e­gy,” he wrote.

Per­haps Cal­i­br’s tech will give their sol­id tu­mor strat­e­gy more hope.

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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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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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.