Scoop: No­var­tis dis­bands its pi­o­neer­ing cell and gene ther­a­py unit

No­var­tis is dis­solv­ing its high-pro­file cell and gene ther­a­py unit op­er­at­ing un­der the guid­ing hand of Us­man “Oz” Azam, End­points has learned.

Us­man “Oz” Azam

Azam has is­sued a note to the 400 staffers in the group, which was ob­tained by End­points, that says:

“The risk of em­bark­ing on a new ad­ven­ture in un­chart­ed ter­ri­to­ry is that things don’t al­ways work out as en­vi­sioned. To­day, I have the un­for­tu­nate task of an­nounc­ing that we are dis­solv­ing the Cell and Gene Ther­a­pies Unit.”

No­var­tis con­firmed that the 400-mem­ber group is be­ing dis­band­ed, with most be­ing “re­de­ployed” to new po­si­tions while 120 could be left with­out a job.

That move is a stun­ner for many in the CAR-T field, es­pe­cial­ly af­ter all the hoopla at No­var­tis around its work.

Azam and his team have played point for one of No­var­tis’s biggest pipeline moves, jump­ing in ear­ly on CAR-T ther­a­pies that reengi­neer a pa­tient’s T cells in­to at­tack ve­hi­cles point­ed at can­cer cells. Work­ing through a part­ner­ship at the Uni­ver­si­ty of Penn­syl­va­nia, the group has ad­vanced one of the lead­ing CAR-T ther­a­pies now in the pipeline, as it races against Kite $KITE and Juno $JUNO to be in the first wave of new drugs to hit the mar­ket.

The field has been mov­ing fast, but not al­ways for­ward. Juno ex­pe­ri­enced a brief in­ter­rup­tion for its lead pro­gram when the FDA im­posed a clin­i­cal hold for a few days that ul­ti­mate­ly de­railed its de­vel­op­ment sched­ule and de­layed any ap­pli­ca­tion un­til 2018. That leaves Kite and No­var­tis rac­ing to the FDA, with Kite plan­ning a sub­mis­sion lat­er this year.

At one point, No­var­tis CEO Joe Jimenez told re­porters that he had made out a blank check for its CAR-T work, de­ter­mined to pay what was nec­es­sary to get these drugs to the mar­ket as fast as pos­si­ble. In a re­cent let­ter to share­hold­ers, Jimenez high­light­ed the CAR-T work as a key part of its strat­e­gy for its on­col­o­gy R&D ef­fort. But in the midst of a heat­ed Phase III ri­val­ry, the phar­ma gi­ant be­lieves that an iso­lat­ed unit no longer makes sense. And that is like­ly to add to the im­pres­sion that No­var­tis is falling be­hind.

The news hit Kite and Juno as well, though. Shares of Juno dropped 5% Wednes­day morn­ing, with Kite down 4%.

In re­sponse to a query from End­points, a spokesper­son for No­var­tis is­sued the fol­low­ing state­ment:

“We have made the de­ci­sion to re-in­te­grate ac­tiv­i­ties con­duct­ed by the Cell & Gene Ther­a­pies Unit in­to the larg­er No­var­tis or­ga­ni­za­tion, as part of a nat­ur­al evo­lu­tion of our in­ter­nal or­ga­ni­za­tion­al de­sign. An iso­lat­ed Unit worked well un­der our pri­or Phar­ma Di­vi­sion struc­ture, but with a new in­te­grat­ed de­vel­op­ment mod­el, we can ef­fi­cient­ly ad­vance our work on CART as part of our fo­cus in im­muno-on­col­o­gy by rein­te­grat­ing the func­tions.

This or­ga­ni­za­tion­al change will not im­pact the plan to file CTL019 in pe­di­atric r/r ALL with the US FDA in ear­ly 2017 and with EMA lat­er in 2017.

Most as­so­ciates who were pre­vi­ous­ly ded­i­cat­ed to cell & gene ther­a­pies will now be re­de­ployed to ar­eas where they will share their knowl­edge and im­prove ex­e­cu­tion of nov­el ther­a­peu­tics in the im­munother­a­py space to bet­ter de­liv­er on our mis­sion to im­prove and ex­tend peo­ple’s lives.

These or­ga­ni­za­tion­al changes will im­pact ap­prox­i­mate­ly 120 po­si­tions across sev­er­al dif­fer­ent No­var­tis af­fil­i­ates.  No­var­tis is com­mit­ted to as­sist­ing in the place­ment of im­pact­ed as­so­ciates wher­ev­er ap­pro­pri­ate in­ter­nal op­por­tu­ni­ties may ex­ist and in treat­ing dis­placed as­so­ciates fair­ly and with dig­ni­ty.”

In a fol­lowup, No­var­tis added that the move to dis­solve the unit will not af­fect its col­lab­o­ra­tion with Penn.

No­var­tis and Penn have an ex­clu­sive glob­al col­lab­o­ra­tion to re­search, de­vel­op and com­mer­cial­ize CAR T cell ther­a­pies for the in­ves­ti­ga­tion­al treat­ment of can­cers. We con­tin­ue to work with Penn un­der the terms of our agree­ment and look for­ward to ad­vanc­ing CART ther­a­pies.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.