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.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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