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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.

UP­DAT­ED: Gilead keeps push­ing trove of Trodelvy da­ta as it seeks to be­come new stan­dard of care in TNBC

Gilead is continuing to churn out results for its newly approved drug Trodelvy, and #ESMO21 is the latest stop on the data train.

The biopharma put out new quality of life data in second-line patients with metastatic triple-negative breast cancer, saying that a sub-analysis from their Phase III study showed significant and clinically meaningful improvements in health-related quality of life over standard of care.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.