No­var­tis’ CAR-T chief Azam is leav­ing, but phar­ma gi­ant de­nies any ‘re­treat’ is un­der­way


No­var­tis re­spond­ed to a re­port in End­points News this morn­ing which out­lines the com­pa­ny’s de­ci­sion to purge most of the ex­ec­u­tive team in­volved in its pi­o­neer­ing cell and gene ther­a­py unit. Ac­cord­ing to the com­pa­ny, the de­ci­sion to cut up to 120 staffers as it re­de­ployed most of the 400 staffers back in­to its on­col­o­gy di­vi­sion does not sig­ni­fy any kind of a “re­treat.”

No­var­tis is still on track to nab the first FDA OK for a CAR-T to treat pe­di­atric acute lym­phoblas­tic leukemia, as­serts a com­pa­ny state­ment. In ad­di­tion, the com­pa­ny said that Us­man “Oz” Azam, the glob­al chief for this unit, has de­cid­ed to leave the com­pa­ny, while oth­er team ex­ecs in­volved in the cut­back still have a chance to land new jobs at the phar­ma gi­ant.

Ear­li­er this week End­points broke the sto­ry that No­var­tis is dis­band­ing the unit, which had been charged with de­vel­op­ing No­var­tis’s CAR-T pipeline, backed with con­sid­er­able hoopla two years ago in a cov­er sto­ry on CEO Joe Jimenez in Forbes.

This morn­ing, we fol­lowed up with a new re­port af­ter gain­ing ac­cess to the full memo that Azam had writ­ten. In it, he not­ed:

Un­for­tu­nate­ly a num­ber of col­leagues will be im­pact­ed by this change as many po­si­tions are be­ing elim­i­nat­ed. Im­pact­ed US-based as­so­ciates are be­ing no­ti­fied in meet­ings to­day. As­so­ci­ates based in Basel will learn more about their in­di­vid­ual cir­cum­stances on Thurs­day. The ma­jor­i­ty of the CG­TU Lead­er­ship Team mem­bers, who are among the best I have worked with, are al­so im­pact­ed.

The com­pa­ny’s re­sponse, though, is not like­ly to change the grow­ing per­cep­tion that the com­pa­ny is pulling back from the field just as the first CAR-T drugs are be­ing prepped for the FDA. Kite is now the wide­ly rec­og­nized leader af­ter a re­cent set­back at Juno, with plans to hus­tle an ap­pli­ca­tion to the FDA lat­er this year. And a num­ber of oth­er com­pa­nies are in the hunt to fol­low up with new drugs of their own.

Here’s the full re­sponse:

No­var­tis is seek­ing to clar­i­fy mis­in­for­ma­tion in the lat­est End­points re­port on the re-in­te­gra­tion of the Cell & Gene Ther­a­pies Unit (CG­TU) in­to the broad­er No­var­tis or­ga­ni­za­tion.

Con­trary to your head­line that we are “re­treat­ing from CAR-T,” our com­mit­ment to CAR-T and CRISPR tech­nolo­gies re­mains strong.  As we have pre­vi­ous­ly stat­ed, CTL019 is on track to be filed with the FDA ear­ly next year and with the EMA lat­er in 2017.  In fact, we ex­pect CTL019 will be the first chimeric anti­gen re­cep­tor T-cell (CAR T) ther­a­py to be ap­proved for pe­di­atric acute lym­phoblas­tic leukemia.

Dr. Us­man Azam along with his lead­er­ship team helped to de­sign the en­tire re-in­te­gra­tion plan. Ac­tions like re-in­te­gra­tion in­to oth­er parts of busi­ness­es can cause re­dun­dan­cies in roles, e.g. HR, fi­nance, le­gal, and that is why some peo­ple will leave our or­ga­ni­za­tion.  Dr. Azam de­cid­ed that as part of the re-in­te­gra­tion he would like to use this tran­si­tion to look at new op­por­tu­ni­ties out­side of the com­pa­ny. The CG­TU lead­er­ship team, along with ap­prox­i­mate­ly 120 oth­er as­so­ciates who will be im­pact­ed, have the op­por­tu­ni­ty to stay at No­var­tis if there is a role that is avail­able or suit­able for them.  It is im­por­tant to note that most of the CG­TU em­ploy­ees will be re­de­ployed to oth­er parts of the com­pa­ny.

At No­var­tis, we are trans­form­ing the com­pa­ny to be more fo­cused with a less-com­plex, more ag­ile struc­ture. While the CG­TU struc­ture was crit­i­cal to ramp up our ca­pa­bil­i­ties in cer­tain ar­eas like man­u­fac­tur­ing, clin­i­cal tri­als and com­mer­cial­iza­tion for a com­plete­ly new way of treat­ing can­cer, now that the com­pa­ny has re-or­ga­nized un­der a new op­er­at­ing mod­el, the re-in­te­gra­tion of CG­TU is the log­i­cal next step in our evo­lu­tion.

The No­var­tis en­ter­prise has all of the ca­pa­bil­i­ties we need to ef­fi­cient­ly re-in­te­grate CG­TU in­to the broad­er or­ga­ni­za­tion: lead­er­ship in on­col­o­gy and hema­tol­ogy specif­i­cal­ly, a glob­al com­mer­cial and de­vel­op­ment foot­print, a strong en­ter­prise man­u­fac­tur­ing or­ga­ni­za­tion, as well as sup­port func­tions to en­able a suc­cess­ful tran­si­tion.

No­var­tis is proud that we have played a lead­er­ship role in ad­vanc­ing the sci­en­tif­ic con­cept of CAR-T to the point where this com­plex way of treat­ing can­cer can be­come a re­al­i­ty for pa­tients. We look for­ward to con­tin­u­ing to ad­vance the sci­ence and our ca­pa­bil­i­ties in this ex­cit­ing area of med­i­cine.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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