Cel­gene part­ners on Phase 0 can­cer drug stud­ies; FDA lifts clin­i­cal hold on Xen­cor's bis­pe­cif­ic

→  Cel­gene is ty­ing up with Seat­tle-based Presage Bio­sciences to test its ear­ly-stage can­cer drugs on pa­tients in Phase 0 stud­ies. In Phase 0, pa­tients are giv­en mi­cro­dos­es of a drug to test pa­tient re­spons­es. It’s one way to help in­crease the odds of suc­cess, and help over­come the in­her­ent lim­i­ta­tions of an­i­mal stud­ies.

Hide­ho Oka­da

Tmu­ni­ty and the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co will en­ter a li­cens­ing and re­search col­lab­o­ra­tion to ad­vance TCR ther­a­pies for cur­rent­ly in­cur­able pe­di­atric can­cers with high mor­tal­i­ty rates. The com­pa­ny says that ini­tial re­search will fo­cus on dif­fuse in­trin­sic pon­tine glioma (DIPG), a rare and high­ly ag­gres­sive brain stem tu­mor, which af­fects around 300 chil­dren in the US each year. Hide­ho Oka­da, a pro­fes­sor of neu­ro­log­i­cal surgery at UCSF who de­vised the TCR at the cen­ter of the pact, will work with Tmu­ni­ty through IND-en­abling stud­ies.

“This col­lab­o­ra­tion with UCSF em­bod­ies our com­mit­ment to ad­vance nov­el T cell ther­a­pies in­to the clin­ic faster. Sad­ly, chil­dren who are di­ag­nosed with DIPG cur­rent­ly have very few ther­a­peu­tic op­tions and there has been lit­tle progress in im­prov­ing treat­ments and over­all sur­vival rates for DIPG over the last few decades,” said CEO Us­man “Oz” Azam, adding that their new ther­a­py is al­so a po­ten­tial break­through for oth­er gliomas.

→ More than two months af­ter the FDA or­dered a par­tial hold on a Phase I study of Xen­cor’s CD123 x CD3 bis­pe­cif­ic, XmAb14045, the biotech says it can now re­sume re­cruit­ment of pa­tients. Reg­u­la­tors lift­ed the hold, ap­par­ent­ly sat­is­fied with an amend­ed pro­to­col that now fea­tures guid­ance on the mon­i­tor­ing and clin­i­cal man­age­ment of cy­tokine re­lease syn­drome — which caused one of the two deaths that in­ves­ti­ga­tors tracked in the study. The oth­er pa­tient died from acute pul­monary ede­ma.

→ Swiss biotech AMAL Ther­a­peu­tics is test­ing its can­cer vac­cine with Boehringer In­gel­heim’s PD-1, BI754091, in a Phase Ib tri­al that will re­cruit Mi­crosatel­lite Sta­ble (MSS) pa­tients with stage IV col­orec­tal can­cer. The idea is to see how ATP128 — which com­pris­es a cell pen­e­trat­ing pep­tide for anti­gen de­liv­ery, a TLR pep­tide ag­o­nist and a mul­ti­ple anti­genic do­main — per­forms both as a sin­gle agent and in com­bo. Boehringer is pro­vid­ing its drug for joint own­er­ship of the re­sults.

→ Sin­ga­pore’s tech­nol­o­gy agency has en­ticed a Hong Kong-based phar­ma­ceu­ti­cal group called Ap­to­rum to es­tab­lish a ven­ture fund catered to health care star­tups in Sin­ga­pore. To­geth­er, they will raise $90 mil­lion to fund up to 20 star­tups, some of which have al­ready been iden­ti­fied as com­pa­nies work­ing on 2D and 3D mag­net­ic res­o­nance imag­ing and sur­gi­cal ro­bot­ics. Ae­neas Cap­i­tal, which is al­so con­trolled by Ap­to­rum co-founder Ian Huen, will al­so chip in. 

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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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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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.