Scoop: Cel­gene tar­gets a cure for myelo­ma/lym­phoma with $600M En­gMab buy­out

Cel­gene Ex­ec­u­tive Chair­man Bob Hug­in

Cel­gene has com­plet­ed a deal to ac­quire the Swiss biotech En­gMab for $600 mil­lion, adding a new BC­MA-tar­get­ing mul­ti­ple myelo­ma pro­gram to the pipeline, End­points News has learned. And it’s putting the new tech to work with its on­go­ing ef­forts on CAR-T and CD-3 an­ti­bod­ies with an eye on find­ing a cure for myelo­ma and lym­phoma.

A Cel­gene spokesper­son con­firmed the deal to me in a state­ment Fri­day morn­ing, say­ing that “we are ac­quir­ing En­gmab for $600 mil­lion.”

“B-cell mat­u­ra­tion anti­gen (BC­MA) is high­ly and se­lec­tive­ly ex­pressed on the sur­face of ma­lig­nant plas­ma cells in MM and tar­get of high val­ue for im­mune based ther­a­pies such as re-en­gi­neered au­tol­o­gous T-CAR-T and the re-di­rec­tion of CD4+ and CD8+ T lym­pho­cytes via an­ti-CD3 bi-spe­cif­ic an­ti­bod­ies,” he said. Cel­gene added:

Through this ac­qui­si­tion, Cel­gene is now unique­ly po­si­tioned to pur­sue BC­MA de­vel­op­ment op­por­tu­ni­ties us­ing both CAR-T and CD-3- redi­rect­ed killing plat­forms. Both ap­proach­es and as­sets pro­vide the op­por­tu­ni­ty for best in class as­sets.

We see both this and the Blue­bird BC­MA plat­form as high­ly com­ple­men­tary with the po­ten­tial to be cu­ra­tive.  In ad­di­tion to mono-ther­a­py in Myelo­ma pa­tients, both plat­forms pro­vide the op­por­tu­ni­ty for ra­tio­nal com­bi­na­tion ther­a­pies with CELMods and Check­point in­hibitors in or­der to fur­ther im­prove treat­ment ef­fi­ca­cy, as well as clin­i­cal de­vel­op­ment in oth­er BC­MA ex­press­ing B-cell ma­lig­nan­cies such as lym­phoma.

B-cell mat­u­ra­tion anti­gen, a tar­get com­mon­ly ex­pressed on mul­ti­ple myelo­ma cells, is a hot fo­cus at Cel­gene. The big biotech re­struc­tured its deal with blue­bird bio $blue last year to go af­ter BC­MA.

Jef­feries’ Bri­an Abra­hams high­light­ed signs of a pend­ing deal a cou­ple of weeks ago, not­ing that En­gMab has been work­ing on sev­er­al T cell-re­cruit­ing an­ti­bod­ies that ze­ro in on BC­MA.

Ac­cord­ing to En­gMab’s web site, the biotech has been la­bor­ing on T-cell bis­pe­cif­ic an­ti­bod­ies, which are de­signed to bring im­mune cells in­to con­tact with a tar­get on can­cer cells, a forcible head butt that should de­stroy the can­cer cell. And its in­ves­ti­ga­tors showed up at ASH late last year to talk up their work on mul­ti­ple myelo­ma.

Cel­gene is the leader in the mul­ti­ple myelo­ma mar­ket, dom­i­nat­ing the field with Revlim­id and Po­m­a­lyst while J&J and Bris­tol-My­ers Squibb have jumped in with Darza­lex and Em­plic­i­ti. And it has good rea­son to go af­ter BC­MA, a tar­get that is present at an es­ti­mat­ed 60% to 70% of all mul­ti­ple myelo­ma cas­es.

This is the lat­est in a long string of high-pro­file M&A and li­cens­ing deals for Cel­gene, which has been in­vest­ing heav­i­ly in its pipeline un­der ex­ec­u­tive chair­man Bob Hug­in. Hug­in will like­ly find him­self back in the spot­light to­day, as an­a­lysts won­der whether the com­pa­ny is pay­ing too much for its pro­grams. But Hug­in has al­ways said that there’s no re­al way to say if you’ve paid too much or too lit­tle. The drugs that work are al­ways ac­quired for a small price. The ones that don’t work are al­ways too ex­pen­sive.

Share­hold­ers seem to be lov­ing it to­day, bid­ding up Cel­gene’s shares by 2% in the ear­ly af­ter­noon.

Cel­gene is far from alone in the field. In a note out this morn­ing, Abra­hams cites the blue­bird pro­gram along with an ef­fort by the NCI, both in the clin­ic. “GSK has a BC­MA-tar­get­ed ADC (GSK2857916) and AMGN has a bis­pe­cif­ic (AMG420) al­so in ph.I tri­als,” the an­a­lyst adds. “JUNO and the Cal­i­for­nia In­sti­tute of Bio­med­ical Re­search al­so ap­par­ent­ly have (a) pre­clin­i­cal BC­MA pro­gram.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

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She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

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This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Jonathan Lim, Erasca CEO (ARCH Venture Partners)

Eras­ca delves fur­ther in­to RAS/MAPK with No­var­tis drug, prices $100M of­fer­ing

After receiving feedback on pivotal studies from European regulators, but not yet the FDA, Novartis is out-licensing a pan-RAF inhibitor going after tumors excited by the RAS/MAPK pathway.

To get the exclusive worldwide license to the asset, Erasca is paying the Swiss Big Pharma $20 million upfront in cash and $80 million worth of shares. Erasca CEO Jonathan Lim told analysts Friday morning that the process was “competitive,” implying his biotech was far from the only one attempting to snag the drug from Novartis, which is going through a reorganization and a fine-tuning to its pipeline.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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