Scoop: Cel­gene tar­gets a cure for myelo­ma/lym­phoma with $600M En­gMab buy­out

Cel­gene Ex­ec­u­tive Chair­man Bob Hug­in

Cel­gene has com­plet­ed a deal to ac­quire the Swiss biotech En­gMab for $600 mil­lion, adding a new BC­MA-tar­get­ing mul­ti­ple myelo­ma pro­gram to the pipeline, End­points News has learned. And it’s putting the new tech to work with its on­go­ing ef­forts on CAR-T and CD-3 an­ti­bod­ies with an eye on find­ing a cure for myelo­ma and lym­phoma.

A Cel­gene spokesper­son con­firmed the deal to me in a state­ment Fri­day morn­ing, say­ing that “we are ac­quir­ing En­gmab for $600 mil­lion.”

“B-cell mat­u­ra­tion anti­gen (BC­MA) is high­ly and se­lec­tive­ly ex­pressed on the sur­face of ma­lig­nant plas­ma cells in MM and tar­get of high val­ue for im­mune based ther­a­pies such as re-en­gi­neered au­tol­o­gous T-CAR-T and the re-di­rec­tion of CD4+ and CD8+ T lym­pho­cytes via an­ti-CD3 bi-spe­cif­ic an­ti­bod­ies,” he said. Cel­gene added:

Through this ac­qui­si­tion, Cel­gene is now unique­ly po­si­tioned to pur­sue BC­MA de­vel­op­ment op­por­tu­ni­ties us­ing both CAR-T and CD-3- redi­rect­ed killing plat­forms. Both ap­proach­es and as­sets pro­vide the op­por­tu­ni­ty for best in class as­sets.

We see both this and the Blue­bird BC­MA plat­form as high­ly com­ple­men­tary with the po­ten­tial to be cu­ra­tive.  In ad­di­tion to mono-ther­a­py in Myelo­ma pa­tients, both plat­forms pro­vide the op­por­tu­ni­ty for ra­tio­nal com­bi­na­tion ther­a­pies with CELMods and Check­point in­hibitors in or­der to fur­ther im­prove treat­ment ef­fi­ca­cy, as well as clin­i­cal de­vel­op­ment in oth­er BC­MA ex­press­ing B-cell ma­lig­nan­cies such as lym­phoma.

B-cell mat­u­ra­tion anti­gen, a tar­get com­mon­ly ex­pressed on mul­ti­ple myelo­ma cells, is a hot fo­cus at Cel­gene. The big biotech re­struc­tured its deal with blue­bird bio $blue last year to go af­ter BC­MA.

Jef­feries’ Bri­an Abra­hams high­light­ed signs of a pend­ing deal a cou­ple of weeks ago, not­ing that En­gMab has been work­ing on sev­er­al T cell-re­cruit­ing an­ti­bod­ies that ze­ro in on BC­MA.

Ac­cord­ing to En­gMab’s web site, the biotech has been la­bor­ing on T-cell bis­pe­cif­ic an­ti­bod­ies, which are de­signed to bring im­mune cells in­to con­tact with a tar­get on can­cer cells, a forcible head butt that should de­stroy the can­cer cell. And its in­ves­ti­ga­tors showed up at ASH late last year to talk up their work on mul­ti­ple myelo­ma.

Cel­gene is the leader in the mul­ti­ple myelo­ma mar­ket, dom­i­nat­ing the field with Revlim­id and Po­m­a­lyst while J&J and Bris­tol-My­ers Squibb have jumped in with Darza­lex and Em­plic­i­ti. And it has good rea­son to go af­ter BC­MA, a tar­get that is present at an es­ti­mat­ed 60% to 70% of all mul­ti­ple myelo­ma cas­es.

This is the lat­est in a long string of high-pro­file M&A and li­cens­ing deals for Cel­gene, which has been in­vest­ing heav­i­ly in its pipeline un­der ex­ec­u­tive chair­man Bob Hug­in. Hug­in will like­ly find him­self back in the spot­light to­day, as an­a­lysts won­der whether the com­pa­ny is pay­ing too much for its pro­grams. But Hug­in has al­ways said that there’s no re­al way to say if you’ve paid too much or too lit­tle. The drugs that work are al­ways ac­quired for a small price. The ones that don’t work are al­ways too ex­pen­sive.

Share­hold­ers seem to be lov­ing it to­day, bid­ding up Cel­gene’s shares by 2% in the ear­ly af­ter­noon.

Cel­gene is far from alone in the field. In a note out this morn­ing, Abra­hams cites the blue­bird pro­gram along with an ef­fort by the NCI, both in the clin­ic. “GSK has a BC­MA-tar­get­ed ADC (GSK2857916) and AMGN has a bis­pe­cif­ic (AMG420) al­so in ph.I tri­als,” the an­a­lyst adds. “JUNO and the Cal­i­for­nia In­sti­tute of Bio­med­ical Re­search al­so ap­par­ent­ly have (a) pre­clin­i­cal BC­MA pro­gram.”

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

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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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.