In­cyte antes up $200M — promis­es bil­lions more — to launch a bis­pe­cif­ic de­vel­op­ment deal with Merus

Reid Hu­ber, In­cyte

In­cyte is em­brac­ing Dutch biotech Merus and its bis­pe­cif­ic an­ti­body tech, agree­ing to buy in­to a new dis­cov­ery and de­vel­op­ment col­lab­o­ra­tion that starts with $200 mil­lion in an up­front and eq­ui­ty pay­ment and has the po­ten­tial to earn bil­lions more if it ma­tures in­to a co-com­mer­cial­iza­tion arrange­ment.

Al­ready backed by a trio of Big Phar­ma play­ers — J&J, Pfiz­er and No­var­tis — Merus has gained close at­ten­tion for its own bis­pe­cif­ic plat­form and a lead drug dubbed MCLA-128, which has pro­duced some in­trigu­ing da­ta in a Phase I/II tri­al. Merus has been promis­ing to re­lease in­ter­im Phase II da­ta on 128 by the end of this year. And while the da­ta has yet to ar­rive pub­licly, an ob­vi­ous ques­tion for now is whether In­cyte has al­ready seen more ma­ture da­ta that helped per­suade it to pull the trig­ger on this deal.

Merus is keep­ing rights to its two clin­i­cal-stage ef­forts, along with MCLA-158, which is near the clin­ic.

In­cyte $IN­CY and Merus will start work on the pre­clin­i­cal side, with In­cyte pay­ing $120 mil­lion up­front and adding $80 mil­lion for an eq­ui­ty stake in the Dutch biotech. Tack­ling up to 11 pre­clin­i­cal pro­grams, the two have al­ready de­cid­ed to split com­mer­cial­iza­tion for one on­go­ing ef­fort, with Merus keep­ing US rights. Merus al­so has buy-in rights to oth­er prod­ucts with an eye to split­ting or shar­ing US prof­its.

The mile­stones on each range up to $350 mil­lion, for a to­tal of $2.8 bil­lion. Typ­i­cal­ly, though, these col­lab­o­ra­tions rarely ring the bell for achiev­ing the full set of mile­stones.

In­vestors, though, cheered on the news by dri­ving a big ral­ly, with shares on Nas­daq $MRUS rock­et­ing up 53%. Merus went pub­lic in May, rais­ing about $50 mil­lion.

Still, the part­ner­ship starts strong and is an im­pres­sive achieve­ment for the com­pa­ny.

“By virtue of a unique abil­i­ty to si­mul­ta­ne­ous­ly en­gage mul­ti­ple pro­tein tar­gets, we be­lieve bis­pe­cif­ic an­ti­bod­ies have the po­ten­tial to play an im­por­tant role in the fu­ture of bio­ther­a­peu­tics,” said Reid Hu­ber, PhD, In­cyte’s Chief Sci­en­tif­ic Of­fi­cer. “This col­lab­o­ra­tion with Merus ex­pands our large mol­e­cule dis­cov­ery ca­pa­bil­i­ties in­to an in­no­va­tion-rich area of re­search, cre­at­ing ad­di­tion­al op­por­tu­ni­ties for us to de­liv­er on our com­mit­ment to im­prov­ing and ex­tend­ing the lives of pa­tients with can­cer and oth­er se­ri­ous dis­eases.”

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Lat­est Mass­Bio re­port shows just how much bio­phar­ma's biggest sec­tor boomed in 2020

It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.

The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Amid back of­fice con­sol­i­da­tion, Gilead ax­es 179 jobs in Cal­i­for­nia

Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.

Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.

Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.