Bristol Myers Squibb's facility in Devens, MA

Bris­tol My­ers scales up cell ther­a­py pro­duc­tion with liso-cel nod in hand and an­oth­er ap­proval maybe on the way

Af­ter a long-await­ed ap­proval for its CD19 tar­get­ing CAR-T liso-cel, Bris­tol My­ers Squibb is gear­ing up for the loom­ing re­view of an­oth­er cell ther­a­py in its pipeline, ide-cel. Tak­ing not one but two CAR-Ts to mar­ket — and po­ten­tial­ly more — means Bris­tol will have to step on the gas to get its man­u­fac­tur­ing in or­der.

Look­ing to ad­dress that po­ten­tial road­block, Bris­tol will add a 244,000 square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its De­vens, MA site as it looks to grow its pro­duc­tion ca­pac­i­ty around liso-cel and, po­ten­tial­ly, ide-cel in the com­ing weeks, the drug­mak­er said Tues­day.

The 89-acre De­vens site in the Boston area will hold the fourth in-house cell ther­a­py man­u­fac­tur­ing site for Bris­tol, along­side fa­cil­i­ties in Both­ell, WA; and War­ren and Sum­mit, NJ. Bris­tol al­so counts con­tract part­ners in the EU and Japan as part of its cell ther­a­py net­work.

The site will pro­duce both clin­i­cal- and com­mer­cial-stage ther­a­pies, and Bris­tol ex­pects to hire “sev­er­al hun­dred em­ploy­ees over the next few years” to scale up the site, ac­cord­ing to a re­lease.

The fi­nan­cial terms of the ex­pan­sion were not dis­closed, and a Bris­tol spokes­woman did not com­ment by press time.

The ex­pan­sion comes at an op­por­tune time for Bris­tol as it looks to take CD19 tar­get­ed liso-cel, mar­ket­ed as Breyanzi and ap­proved ear­li­er this month, to mar­ket. The ther­a­py had a cir­cuitous road to its FDA nod, in­clud­ing a se­ries of man­u­fac­tur­ing sna­fus at a Lon­za Hous­ton con­tract site that led to a Form 483 in De­cem­ber and may have tor­pe­doed a $9 CVR from Bris­tol’s Cel­gene buy­out tied, in part, to liso-cel’s ap­proval by the end of 2020.

Samit Hi­rawat

Mean­while, Bris­tol is gear­ing back up for the FDA’s re­view next month of ide-cel, a BC­MA CAR-T. Just weeks out from a po­ten­tial de­ci­sion, Bris­tol an­nounced two weeks ago that it was pulling an­oth­er CAR-T can­di­date in the pipeline, or­va-cel, out of de­vel­op­ment and writ­ing off $470 mil­lion from its books.

Samit Hi­rawat, head of drug de­vel­op­ment, ex­plained in an an­a­lyst call this month that the de­ci­sion was all about tak­ing the best med­i­cines for­ward — es­pe­cial­ly in a land­scape as crowd­ed as BC­MA, where an au­tol­o­gous CAR-T doesn’t just have to face di­rect ri­vals like Leg­end’s J&J-part­nered cil­ta-cel but al­so an­gle for space among off-the-shelf cell ther­a­pies, bis­pecifics, an­ti­body-drug con­ju­gates and more.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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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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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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Ab­b­Vie of­floads UK site for $119M in sale to Chi­nese cell and gene ther­a­py play­er Phar­maron

With its Allergan buyout now long in the books, AbbVie has been taking a hard look at its suddenly expansive global ops to find space for a deal. Now, working with a Chinese cell and gene therapy player hungry for more elbow room abroad, AbbVie has taken one UK facility off its books.

AbbVie has offloaded its Liverpool manufacturing site as part of a $118.7 million sale to Chinese cell and gene therapy player Pharmaron, which is pitching the purchase as the next step in its global expansion plans, the companies said last week.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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