Pfiz­er chips in on $26M raise for rheuma­toid arthri­tis col­lab­o­ra­tor; Han­soh li­cens­es an an­ti-fun­gal for a mys­te­ri­ous in­fec­tion

Two weeks af­ter Pfiz­er jumped in­to an R&D part­ner­ship with Im­cyse, the Bel­gian biotech re­ports that the phar­ma gi­ant has helped con­tribute to a new, $26 mil­lion add-on raise to their B round.

Im­cyse re­ports Wednes­day morn­ing that the added cash will go to help fund its work on a pipeline of im­munother­a­pies. Biogeno­sis, Epimede, LSP, Noshaq, So­ciété Ré­gionale d’In­vestisse­ment de Wal­lonie (SRIW), So­ciété Fédérale de Par­tic­i­pa­tions et d’In­vestisse­ment (SF­PI) and KU Leu­ven all par­tic­i­pat­ed.

Pfiz­er signed up for a col­lab­o­ra­tion in ear­ly Feb­ru­ary cov­er­ing rheuma­toid arthri­tis, a move that led it to take an un­spec­i­fied eq­ui­ty stake in the com­pa­ny.

“Our aim is to be a ma­jor play­er in ac­tive spe­cif­ic im­munother­a­py,” says CEO De­nis Bedoret in a pre­pared state­ment. “In this pur­suit, we have tak­en our lead Imo­tope can­di­date in­to Phase II for type 1 di­a­betes and have four oth­er pro­grams run­ning in mul­ti­ple scle­ro­sis, neu­romyelitis op­ti­ca spec­trum dis­or­ders, celi­ac dis­ease and rheuma­toid arthri­tis.” — John Car­roll

Han­soh li­cens­es an an­ti-fun­gal for a mys­te­ri­ous in­fec­tion

Chi­nese phar­ma pow­er­house Han­soh has a new part­ner, team­ing with the New Jer­sey biotech Scynex­is to de­vel­op a drug that has re­cent­ly gained at­ten­tion for its po­ten­tial to treat drug re­sis­tant and dif­fi­cult-to-treat in­fec­tions, in­clud­ing a par­tic­u­lar form of fun­gus.

Han­soh will pay Scynex­is $10 mil­lion up­front, $112 mil­lion in po­ten­tial mile­stones and dou­ble-dig­it roy­al­ties to li­cense ibrex­a­fungerp, a broad-spec­trum an­ti­fun­gal, for Chi­na and neigh­bor­ing re­gions. It would not be a ma­jor deal for most biotechs, but it rep­re­sents a sig­nif­i­cant in­vest­ment for com­pa­nies in the in­fec­tious dis­ease space, who have his­tor­i­cal­ly strug­gled. (Un­less you fo­cus on virus­es; virus com­pa­nies are do­ing just fine right now.)

Scynex­is de­vel­oped ibrex­a­fungerp most promi­nent­ly for vagi­nal in­fec­tions, but it gained world­wide at­ten­tion in 2019 for its po­ten­tial to treat Can­di­da Au­ris, a dead­ly fun­gus that mys­te­ri­ous­ly cropped out in a hand­ful of pa­tients in dis­parate lo­ca­tions across the globe. Some sci­en­tists now sus­pect cli­mate change is the cul­prit.  — Ja­son Mast

Lil­ly presents full tirzepatide PhI­II da­ta

Eli Lil­ly re­vealed full da­ta from its tirzepatide Type 2 di­a­betes study, da­ta it hopes can prove to be win­ners in front of the FDA.

The pro­gram sig­nif­i­cant­ly re­duced A1C and body weight from base­line in adults with type 2 di­a­betes, Lil­ly an­nounced Thurs­day morn­ing. In the topline re­sults of two Phase III tri­als, tirzepatide met all pri­ma­ry and sec­ondary end­points.

One of the tri­als com­pared the can­di­date to titrat­ed in­sulin degludec over 52 weeks, while the oth­er pit­ted it against place­bo on top of titrat­ed in­sulin glargine through 40 weeks.

In the first tri­al, the high­est dose of tirzepatide (15 mg) re­duced A1C by 2.37% and body weight by 12.9 kg (13.9%), while it re­duced A1C by 2.59% and body weight by 10.9 kg (11.6%) in the sec­ond. The place­bo tri­al al­so saw 62.4% of par­tic­i­pants achieve an A1C of less than 5.7%, the lev­el seen in peo­ple with­out di­a­betes.

The com­pound it­self is a once-week­ly dual glu­cose-de­pen­dent in­sulinotrop­ic polypep­tide (GIP) and GLP-1 re­cep­tor ag­o­nist. — Max Gel­man

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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Gala­pa­gos posts a safe­ty win for fil­go­tinib, but is it too lit­tle, too late?; Bio-Techne inks $320M mol­e­c­u­lar di­ag­nos­tics buy­out

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

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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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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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.

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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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.