An ac­quis­i­tive Cel­gene looks ready to pop a new mul­ti­ple myelo­ma deal

Is Cel­gene $CELG about to un­veil a new deal BC­MA-tar­get­ing deal? A sharp-eyed Bri­an Abra­hams at Jef­feries spot­ted a no­tice post­ed at the FTC cit­ing Cel­gene as the “ac­quir­ing par­ty” for En­gMab, a Swiss biotech work­ing on bis­pe­cif­ic an­ti­bod­ies that are co­va­lent to BC­MA — a hot tar­get for Cel­gene — and CD3.

A Cel­gene spokesper­son says there’s no deal — yet.

“A deal has not com­plet­ed,” the spokesper­son said in an email to me. “We can­not com­ment any fur­ther at this time.”

Abra­hams has been pay­ing close at­ten­tion to the low-pro­file biotech, ear­li­er ob­serv­ing the work it’s do­ing with T cell re­cruit­ing tech in-li­censed from Roche.

This is a sweet spot for Cel­gene, which last year re­worked its deal with blue­bird bio to go af­ter B-cell mat­u­ra­tion anti­gen, a tar­get ex­pressed on mul­ti­ple myelo­ma cells.

A deal with En­gMab wouldn’t be too sur­pris­ing. Cel­gene has one of the busiest busi­ness de­vel­op­ment teams in the biotech busi­ness, ink­ing a steady stream of deals with part­ners work­ing on re­lat­ed ther­a­peu­tics and tech­nolo­gies. And mul­ti­ple myelo­ma is its flag­ship dis­ease, with Revlim­id and Po­m­a­lyst both ap­proved for the dis­ease. The com­pa­ny has a glob­al frame­work, ready to go wher­ev­er nec­es­sary to bag what it wants.

Here’s what Abra­hams had to say:

At ASH’15 we had the opp­ty to speak with En­gMab and view their posters, and learned they are de­vel­op­ing sev­er­al Abs to tar­get BC­MA. Our un­der­stand­ing is that their mol­e­cules are for­mat­ted as asym­met­ric IgG bis­pecifics (bi­va­lent to BC­MA and mono­va­lent to CD3) uti­liz­ing tech­nol­o­gy li­censed from Roche to min­i­mize mi­s­pair­ing. The Abs al­so have an en­gi­neered Fc re­gion to re­duce non-spe­cif­ic in­ter­ac­tions and risk of in­fu­sion re­ac­tions from I.V. or S.C. ad­min­is­tra­tion. En­gMab men­tioned their Ab has a PK sim­i­lar to tra­di­tion­al Abs (half life of up to 2 wks) and we be­lieve may be more prac­ti­cal rel­a­tive to CAR-Ts since it is off-the-shelf. We con­tin­ue to see BC­MA as a promis­ing tar­get in MM, giv­en the tar­get is es­ti­mat­ed to be present in 60-70% of myelo­ma cas­es, is pri­mar­i­ly ex­pressed by plas­ma cells, and does not ap­pear to be heav­i­ly in­volved in oth­er B cells process­es. In ad­di­tion to CELG-BLUE’s bb2121 and NCI’s BC­MA pro­gram, which are both in the clin­ic and de­scribed in a Jef­feries ASH’15 note here, GSK has a BC­MA-tar­get­ed ADC (GSK2857916) and AMGN has a bis­pe­cif­ic (AMG420) al­so in ph.I tri­als. JUNO and the Cal­i­for­nia In­sti­tute of Bio­med­ical Re­search al­so ap­par­ent­ly have pre­clin­i­cal BC­MA pro­grams.

Abra­hams is al­so en­thu­si­as­tic about one of the biotech’s drugs.

In an ASH poster (#117) En­gMab screened pri­ma­ry hu­man MM cells from 726 pts and ob­served BC­MA ex­pressed on the plas­ma cells in a ma­jor­i­ty of pts. Ad­di­tion­al­ly, in in vit­ro as­says they demon­strat­ed EM801 was po­tent and showed dose-de­pen­dent killing of the pri­ma­ry MM cells. Some po­ten­tial off-tar­get cel­lu­lar tox­i­c­i­ty was ob­served in the cell cul­tures, but we are un­clear on the im­pli­ca­tions. EM801 was al­so test­ed in a xenograft mod­el and showed sub­stan­tial tu­mor re­duc­tion com­pared to con­trol groups. The ASH da­ta al­so sup­port­ed MOA show­ing that CD4 and CD8 T cell ac­ti­va­tion was in­creased along with in­creased se­cre­tion of IFN-gam­ma, granzyme B, and per­forin in­di­cat­ing cell-me­di­at­ed killing. Our un­der­stand­ing is that a dif­fer­ent an­ti­body with high­er po­ten­cy with ‘801 was planned to be tak­en for­ward; time­lines and sta­tus of clin­i­cal en­try have not been dis­closed.

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.

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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.

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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.

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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.

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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.

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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.

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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.