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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.