Gear­ing up new part­ner­ships, Boehringer gets an op­tion to buy a new play­er in on­colyt­ic virus­es in $230M deal

Boehringer In­gel­heim is ac­tive­ly join­ing the hunt for the next big on­colyt­ic virus pro­gram in the hot and hap­pen­ing can­cer field.

Dr. Michel Pairet, Mem­ber of the Board of Man­ag­ing Di­rec­tors

Af­ter back­ing a small start­up round for Vi­raTher­a­peu­tics a lit­tle more than a year ago, the phar­ma com­pa­ny has come back with a $230 mil­lion pack­age deal to part­ner on their work — grab­bing an op­tion in the process to buy the com­pa­ny. And the phar­ma gi­ant says the part­ner­ship is a sign of more deals to come as it gears up new pacts.

The com­pa­nies didn’t spell out the terms, but dis­cov­ery-stage col­lab­o­ra­tions like this are usu­al­ly heav­i­ly back end­ed.

The Aus­tri­an biotech is fo­cused on VSV-GP, a chimeric virus de­rived from the Vesic­u­lar Stom­ati­tis Virus which has been stud­ied in the lab by Dorothee von Laer at the Med­ical Uni­ver­si­ty of Inns­bruck.

Vi­raTher­a­peu­tics has been in­volved in pre­clin­i­cal test­ing up to now, con­cen­trat­ing on mouse stud­ies to track this drug’s abil­i­ty to be used sys­tem­i­cal­ly in re­peat ap­pli­ca­tions. Boehringer clear­ly must have been im­pressed by the lab work so far, though ac­tu­al clin­i­cal tri­als won’t get un­der­way un­til next year.

Am­gen was the first to make it to the mar­ket with a pi­o­neer­ing on­colyt­ic virus called Im­ly­g­ic (T-Vec), which it bagged in a bil­lion-dol­lar deal to ac­quire BioVex. That drug has had a slow launch since its ap­proval, though, and a grow­ing line­up of biotech com­pa­nies have set out to beat it.

Im­ly­g­ic is in­ject­ed di­rect­ly in­to tu­mors. Like PsiOxus, Vi­raTher­a­peu­tics be­lieves that an on­colyt­ic virus that is de­liv­ered sys­tem­i­cal­ly can have a much bet­ter shot at get­ting in­to can­cer cells, where they can mul­ti­ple and then de­stroy their tar­get. Von Laer al­so says their drug can spur an im­mune sys­tem at­tack on can­cer, and the com­pa­ny is look­ing at at­tach­ing ther­a­peu­tic genes and anti­gens that can dri­ve a bet­ter out­come.

In this fren­zied deal-mak­ing en­vi­ron­ment, next-gen on­colyt­ic virus­es have proved a hot com­mod­i­ty, dri­ving a va­ri­ety of star­tups. Philip Ast­ley-Sparke, who helmed BioVex be­fore Am­gen bought it up for T-Vec, co-found­ed Replimune, an­oth­er next-gen on­colyt­ic virus play­er. Mitchell Fin­er, the for­mer CSO at blue­bird bio, took the helm at the up­start On­corus, which just raised a $57 mil­lion ven­ture round and is us­ing a her­pes sim­plex virus for their work on glioblas­toma. And Duke Uni­ver­si­ty’s Dr. Matthias Gromeier has ge­net­i­cal­ly en­gi­neered his virus to keep it fo­cused on can­cer, and away from healthy tis­sues. Mean­while Cana­da’s On­colyt­ics Biotech and the Pink Army Co­op­er­a­tive—a very un­usu­al, open source col­lec­tive com­mand­ed by Am­gen vet An­drew Hes­sel—are al­so in play.

Dr. Michel Pairet, a mem­ber of Boehringer In­gel­heim’s Board of Man­ag­ing Di­rec­tors, had this to say:

“On­colyt­ic virus­es are among the most promis­ing new ther­a­py ap­proach­es in can­cer re­search and the tech­nol­o­gy de­vel­oped by Vi­raTher­a­peu­tics may of­fer sig­nif­i­cant ad­van­tages com­pared to oth­ers cur­rent­ly un­der de­vel­op­ment. The new col­lab­o­ra­tion is an ex­am­ple of Boehringer In­gel­heim’s in­creas­ing fo­cus on part­ner­ing and fur­ther com­ple­ments the com­pa­ny’s grow­ing im­mune-on­col­o­gy pipeline that in­cludes among oth­ers, a ther­a­peu­tic can­cer vac­cine and next gen­er­a­tion check­point in­hibitors.”

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.