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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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