Ma­gen­ta's R&D head hits the ex­it just weeks af­ter read­ing out mid-stage da­ta for lead ther­a­py, eye­ing clin­ic for an­oth­er

Cam­bridge, MA-based Ma­gen­ta Ther­a­peu­tics has had a most­ly qui­et few years as it steers its stem cell trans­plant hope­fuls through ear­ly-stage hu­man tri­als. For the past three years, that ear­ly clin­i­cal work was head­ed up by Pfiz­er vet­er­an John Davis — but now, Davis is tak­ing off right as the biotech’s lead drug preps for a late-stage test.

John Davis

Davis, Ma­gen­ta’s CMO and head of R&D, will leave the com­pa­ny as a full-time em­ploy­ee no lat­er than Ju­ly 30 for “fam­i­ly rea­sons,” leav­ing the biotech on the hunt for its next clin­i­cal lead, ac­cord­ing to an SEC fil­ing.

Davis joined up with Ma­gen­ta in Feb­ru­ary 2018, com­ing aboard pedi­greed with past work as head of ear­ly clin­i­cal de­vel­op­ment at Pfiz­er and for­mer­ly glob­al area head of im­munol­o­gy at Bax­al­ta. Davis al­so led ear­ly clin­i­cal work at Genen­tech in the in­flam­ma­tion and CV/me­tab­o­lism group.

Af­ter the brief tran­si­tion pe­ri­od, Davis will re­main on Ma­gen­ta’s sci­en­tif­ic ad­vi­so­ry board, help­ing steer the com­pa­ny’s stem cell trans­plant and gene ther­a­py ef­forts, Ma­gen­ta said. The biotech not­ed in the fil­ing that “Davis’ de­par­ture was not re­lat­ed to any dis­agree­ments with the Com­pa­ny on any mat­ter re­lat­ing to its op­er­a­tions, poli­cies, prac­tices or any is­sues re­gard­ing fi­nan­cial dis­clo­sures, ac­count­ing or le­gal mat­ters.”

As part of the de­par­ture, Ma­gen­ta ex­pects to cut a deal with Davis pay­ing him dur­ing the tran­si­tion, ac­cord­ing to the fil­ing, with all the usu­al con­fi­den­tial­i­ty and non-so­lic­i­ta­tion hand­shakes at­tached.

It’s un­for­tu­nate tim­ing for Ma­gen­ta, which just wrapped a Phase II mul­ti­ple myelo­ma study on one of its lead ther­a­pies, CX­CR2 ag­o­nist MG­TA-145, along­side bone mar­row stim­u­lant pler­ix­afor for stem cell col­lec­tion and mo­bi­liza­tion pri­or to con­di­tion­ing. Pre­lim­i­nary find­ings from that study re­leased this month showed 10 out of 10 pa­tients dosed with the com­bo met the pri­ma­ry end­point for stem cell mo­bi­liza­tion and col­lec­tion, and all six trans­plant­ed pa­tients suc­cess­ful­ly en­graft­ed as of the da­ta cut­off date, Ma­gen­ta said.

The mul­ti­ple myelo­ma study for au­tol­o­gous stem cells is a part­ner­ship with Stan­ford Uni­ver­si­ty, and fol­low-up re­sults are ex­pect­ed at AS­CO next month.

Mean­while, the biotech al­so out­lined plans this month to bring an­oth­er pro­gram in­to the clin­ic af­ter dis­cus­sions with the FDA. That ther­a­py, MG­TA-117, will be test­ed as a con­di­tion­ing reg­i­ment for trans­plants in pa­tients with re­lapsed/re­frac­to­ry AML and MDS.

Con­di­tion­ing is the phase of stem cell trans­plants in which pa­tients’ bone mar­row and some­times im­mune cells are re­moved to make way for the trans­plant. Ma­gen­ta thinks MG­TA-117, if proven suc­cess­ful, could even­tu­al­ly re­place high-in­ten­si­ty chemother­a­py, which is the stan­dard of care in con­di­tion­ing pa­tients for a trans­plant.

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.

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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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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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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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.