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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Hervé Hoppenot, Incyte CEO

In­cyte pays out $70M to get hands on Medicxi-backed vi­tili­go biotech

The M&A wheels keep on turning in biotech — and this time it’s Incyte that gets to do the dealmaking.

The Delaware biotech put out word on Monday morning that it will be shelling out $70 million in cash to acquire Villaris Therapeutics. Incyte will not only acquire Villaris, but also exclusive global rights for Villaris’s lead candidate auremolimab.

Auremolimab, currently in IND-enabling studies, is an anti-IL-15Rβ monoclonal antibody being investigated in vitiligo, with a possibility of other autoimmune and inflammatory indications. Villaris says it is targeting that pathway after a mouse study showed that doing so could be effective at reversing the disease.

Kelly Ganjei, AmplifyBio CEO

Am­pli­fy­Bio scoops up lab space and oth­er as­sets from PACT Phar­ma as cell ther­a­py biotech read­justs

The West Coast cell therapy biotech PACT Pharma was facing some challenges after several employees got the axe from the company and execs put the kibosh on its only clinical trial. Now, the company has sold some of its assets to an Ohio-based contract research organization.

AmplifyBio has acquired a 46,280 square-foot lab in South San Francisco, CA, with around 40 employees specializing in cell and gene therapy development and access to technology platforms that can be applied to “product characterization.”