Genen­tech I/O chief Dan Chen heads to an up­start biotech look­ing to cre­ate a land­mark ad­vance on an­ti­bod­ies

One of the top sci­en­tif­ic lead­ers be­hind the emer­gence of PD-1/L1 check­point in­hibitors has left Genen­tech to take the chief med­ical of­fi­cer’s job at a low-pro­file biotech up­start look­ing to make an­ti­body his­to­ry.

Dan Chen, who led the de­vel­op­ment of Tecen­triq from start to post-mar­ket star­dom, has tak­en the CMO’s job at IgM Bio­sciences in Moun­tain View, CA.

I couldn’t find much about them. No ven­ture rounds or high-pro­file en­dorse­ments. But the web­site in­cludes some lofty claims about their goal to re­vamp the way an­ti­bod­ies are de­vel­oped, build­ing on a blue­print that can sig­nif­i­cant­ly in­crease the abil­i­ty of an an­ti­body to bind with mul­ti­ple do­mains us­ing a much more com­plex IgM struc­ture, rather than the Ig­Gs that dom­i­nate the in­dus­try.

Chen wasn’t just in charge of the Tecen­triq pro­gram, which Roche de­vout­ly be­lieves is a block­buster in the mak­ing, he al­so helped guide a se­ries of al­liances with key an­ti­body de­vel­op­ers around the world. That added ex­pe­ri­ence that could come in handy on his new job.

Chen is join­ing an­oth­er Genen­tech vet, Bruce Heyt, who serves as chief sci­en­tif­ic of­fi­cer at IgM.

Chen told me in an in­ter­view Thurs­day that when he first start­ed work­ing on Tecen­triq, he was a team of 1. And af­ter watch­ing the clin­i­cal de­vel­op­ment team alone ex­pand in­to the hun­dreds of staffers at Genen­tech over the years, he’s back at an N of 1, ready to start build­ing a new team.

Once again, he is look­ing to make some biotech his­to­ry.

These IgM projects he’s start­ed work on now are “hard to make, a lot more com­pli­cat­ed than IgG (with two bind­ing do­mains),” he says. “But af­ter 8 years they’ve solved the man­u­fac­tur­ing prob­lems.”

“IgMs are sort of like Vel­cro,” he ex­plains, ca­pa­ble of mak­ing mul­ti­ple weak do­mains in­to one strong bond — like Vel­cro. And the same tech plat­form has mul­ti­ple ap­pli­ca­tions as you work on ag­o­nists, what Chen calls “en­hanced su­per-ag­o­nists.”

Like a lot of top de­vel­op­ers in the hottest field in on­col­o­gy, Chen says he was treat­ed to a long line­up of queries about new jobs over the years. But he passed on all of them, un­til IgM Bio called.

His first re­sponse when he got a good look: “Wow, Genen­tech should have done this. They’re en­gi­neer­ing around a nat­u­ral­ly oc­cur­ring an­ti­body for­mat.” 

“The thing that re­al­ly hooked me was the longterm fu­ture,” says Chen. Af­ter all the work aimed at scour­ing the hu­man genome for the right tar­gets for dis­ease over the last 20 years, he adds, the time has come to shift fo­cus to us­ing “them in a more com­plex way than we ever have be­fore….With an IgM mol­e­cule, you have a lot more room to play.”

And it’s in no way lim­it­ed to im­muno-on­col­o­gy or on­col­o­gy in gen­er­al.

They built the com­pa­ny with pri­vate fi­nanc­ing, says the sci­en­tist, which al­lowed the tiny biotech to re­main in stealth mode un­til just a year or two ago as they pa­tient­ly worked out their plat­form tech­nol­o­gy.

Chen can cer­tain­ly dis­tin­guish one good an­ti­body ap­proach from an­oth­er. And William Strohl, who once led ear­ly de­vel­op­ment at J&J’s re­search group, is al­so join­ing the board, of­fer­ing an­oth­er mar­quee thumbs-up for what they’re try­ing to do.

Fred Schwarz­er, the CEO of IGM Bio­sciences, hit that theme hard in their state­ment to­day. He not­ed:

Dan is wide­ly re­gard­ed as a glob­al leader in im­muno-on­col­o­gy, and he over­saw some of the most im­por­tant R&D in on­col­o­gy over the last decade while at Genen­tech/Roche, mak­ing his de­ci­sion to join IGM a strong en­dorse­ment of the po­ten­tial of our tech­nol­o­gy and our emerg­ing pipeline. Bill is wide­ly re­gard­ed as a glob­al thought leader in an­ti­body en­gi­neer­ing and nov­el an­ti­body de­vel­op­ment, and we look for­ward to his con­tri­bu­tions as a mem­ber of our Board of Di­rec­tors.


Im­age: Daniel Chen speaks to Ira Mell­man, Genen­tech Vice Pres­i­dent of Can­cer Im­munol­o­gy. Roche

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II 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.

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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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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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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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

UP­DAT­ED: 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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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.