Scoop: Juno re­cruits Sunil Agar­w­al as R&D chief, open­ing a Bay Area fa­cil­i­ty in re­search re­vamp

Hans Bish­op, CEO of Juno Ther­a­peu­tics Vic­tor J. Blue/Bloomberg via Get­ty Im­ages

A trou­bled Juno Ther­a­peu­tics $JUNO has re­cruit­ed ex-Genen­tech sci­en­tist Sunil Agar­w­al to head up a re­vamped R&D or­ga­ni­za­tion as the Seat­tle-based biotech sets out to es­tab­lish a San Fran­cis­co group to help rev up its work on the biotech’s lead­ing CAR-T ther­a­pies and get back on tar­get af­ter its lead pro­gram jumped the tracks, End­points News has learned.

Ac­cord­ing to an in­ter­nal memo ob­tained by End­points, Juno CEO Hans Bish­op alert­ed staff on Fri­day af­ter­noon that the com­pa­ny plans to an­nounce the new hire be­fore the mar­ket opens on Mon­day. A com­pa­ny spokesper­son con­firmed the an­nounce­ment late Sun­day.

Agar­w­al has been named pres­i­dent of R&D with CMO Mark Gilbert, CSO Hy Lev­it­sky and Liz Smith, head of reg­u­la­to­ry and qual­i­ty as­sur­ance, re­port­ing di­rect­ly to him. The new R&D chief will al­so lead the new San Fran­cis­co or­ga­ni­za­tion.

Mark Frohlich, EVP of de­vel­op­ment and port­fo­lio strat­e­gy, an­nounced sev­er­al weeks ago that he was leav­ing the com­pa­ny.

“With Sunil’s ap­point­ment,” Bish­op not­ed in his com­pa­ny memo, “we are bring­ing re­search and de­vel­op­ment to­geth­er as a sin­gle in­te­grat­ed or­ga­ni­za­tion un­der his lead­er­ship.”

Juno has been bad­ly shak­en by back-to-back in­ci­dents with its ini­tial lead pro­gram for JCAR015. The drug killed 5 pa­tients, with the last two deaths in 2016 — which came af­ter the FDA had lift­ed a clin­i­cal hold on the drug — forc­ing the com­pa­ny to slam the brakes on its de­vel­op­ment for the sec­ond time. Bish­op lat­er de­cid­ed to scrap the drug, push­ing the one-time CAR-T leader far be­hind sched­ule for its first FDA ap­pli­ca­tion.

Juno is now more than a year be­hind Kite Phar­ma­ceu­ti­cals and No­var­tis, which are in a neck-and-neck race to the agency’s fin­ish line with ri­val CAR-Ts.

In the memo, Bish­op writes that Agar­w­al will be tasked with cre­at­ing and ex­e­cut­ing a clear strat­e­gy with an aim at de­creas­ing “the time it takes to get new tech­nolo­gies and trans­la­tion­al in­sights in­to the clin­ic.”

Based on the very pos­i­tive clin­i­cal da­ta as­so­ci­at­ed with JCAR014, JCAR017 and BC­MA, Juno has de­cid­ed to ful­ly in­vest in JCAR017 and JCAR025 to de­vel­op them as quick­ly as pos­si­ble. Start­ing im­me­di­ate­ly and over the next few years, we will need to sig­nif­i­cant­ly ramp up our clin­i­cal de­vel­op­ment ca­pa­bil­i­ties to achieve the qual­i­ty and speed of ex­e­cu­tion to be a mar­ket leader in the CAR T space and to bring this (sic) in­no­v­a­tive prod­ucts to pa­tients. The com­pet­i­tive land­scape is al­so heat­ing up, so our pri­or­i­ti­za­tion and de­ci­sion mak­ing as­so­ci­at­ed with tri­al ex­e­cu­tion and pipeline pri­or­i­ti­za­tion will need to be en­hanced as well.

Sim­i­lar to our of­fices in Boston and Ger­many, the ad­di­tion of a Bay Area of­fice en­ables the com­pa­ny to con­tin­ue our growth tra­jec­to­ry and puts us in the best po­si­tion to con­tin­ue to hire world-class tal­ent.

Agar­w­al is an un­con­ven­tion­al pick as head of R&D at Juno. At Genen­tech he led work on in­fec­tious dis­eases, me­tab­o­lism, neu­ro­science and oph­thal­mol­o­gy, then joined Ul­tragenyx, a rare dis­ease play­er, for a brief stint. More re­cent­ly he’s worked at Sofinno­va, a high-pro­file ven­ture group.

Juno isn’t the on­ly play­er to re­vamp its CAR-T R&D group. Last sum­mer No­var­tis dis­solved its CAR-T group and laid off 120 staffers as it ab­sorbed the unit in its on­col­o­gy di­vi­sion. And just weeks ago a top No­var­tis team mem­ber fo­cused on CAR-T, Karen Walk­er, left to take a new job at Seat­tle Ge­net­ics.

To cre­ate these CAR-Ts, in­ves­ti­ga­tors ex­tract T cells from pa­tients and then reengi­neer them to specif­i­cal­ly tar­get can­cer cells. This ap­proach has pro­duced some com­pelling da­ta, par­tic­u­lar­ly for blood can­cers. And the race to de­vel­op a port­fo­lio of mar­ket­ed prod­ucts has at­tract­ed con­sid­er­able in­vestor in­ter­est, with a group of lead­ers land­ing bil­lions in new in­vest­ments.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Lat­est Mass­Bio re­port shows just how much bio­phar­ma's biggest sec­tor boomed in 2020

It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.

The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Amid back of­fice con­sol­i­da­tion, Gilead ax­es 179 jobs in Cal­i­for­nia

Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.

Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.

Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.