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.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Siddhartha Mukherjee, AP Images

Sid Mukher­jee's Vor taps a CAR-T de­vel­op­ment part­ner to strap to its at­tempt at bet­ter stem cell trans­plants

In the buzzy world of oncology, few names shine brighter than Columbia oncologist and bestselling author Siddhartha Mukherjee, whose Vor Biopharma is looking to rewrite the rules of stem cell transplants. If his team’s tech works as planned, it would also rewrite the rules on how CAR-Ts can be deployed in blood cancer — and now it’s partnering up with a little-known biotech to test that hypothesis.