Mys­tery in­vestors back a new NASH ap­proach; GSK an­tibi­otics sale trig­gers lay­off fears

A mys­tery in­vestor is back­ing a new late-stage ef­fort to treat NASH, lead­ing an $80 mil­lion crossover round for Sagimet Bio­sciences.

The Se­ries F round was led by an “undis­closed pub­lic eq­ui­ty health­care in­vest­ment fund” and joined by Al­tium Cap­i­tal, HM Cap­i­tal, In­vus, and PFM Health Sci­ences, As­cle­tis, Klein­er Perkins, New En­ter­prise As­so­ci­ates, and Rock Springs Cap­i­tal. It comes on the heels of pos­i­tive mid-stage da­ta last June, when the com­pa­ny an­nounced a 61% re­sponse rate in 30 pa­tients and a me­di­an liv­er fat re­duc­tion of 28.2%.

A sec­ond undis­closed pub­lic health­care in­vest­ment fund al­so joined the round.

Sagimet, which was known as 3-V Bio­sciences un­til 2019, spe­cial­izes in FASN. The en­zyme is in­volved in lipid syn­the­sis; in­hibit­ing it, in the­o­ry, could re­duce fat pro­duc­tion and al­le­vi­ate dis­eases such as NASH and even can­cer. The com­pa­ny will use the cap­i­tal to help launch a Phase IIb tri­al.  — Ja­son Mast

Em­ploy­ees at GSK plant fear lay­offs af­ter No­var­tis sale

Glax­o­SmithK­line’s de­ci­sion to sell its gener­ics an­tibi­otics busi­ness to No­var­tis’s San­doz unit has brought fears of mass lay­offs to Ul­ver­ston, Eng­land, where the an­tibi­otics have been man­u­fac­tured.

Al­though GSK will con­tin­ue to sup­ply San­doz with the an­tibi­ot­ic, cephalosporin, for the next four years, the sale has put 130 jobs at “risk of re­dun­dan­cy,” The Mail re­port­ed.

This com­pa­ny has been a main­stay in the town, pro­vid­ing em­ploy­ment and re­sources,” town coun­cil­man David Web­ster told the British out­let. “It will be a great loss and a tremen­dous gap to fill in em­ploy­ment and co­op­er­a­tion.”

A GSK spokesper­son told The Mail that the sale was meant as part of a com­pa­ny-wide shift to fo­cus on R&D. The big phar­ma has pledged land to al­low Lake Bio­sciences, which man­u­fac­tures mon­o­clon­al an­ti­bod­ies, to build a £350 mil­lion fa­cil­i­ty there.  — Ja­son Mast

Seagen notch­es Tukysa OK in Eu­rope

Af­ter get­ting its Tukysa drug across the fin­ish line in the US last year, Seagen has done the same in Eu­rope.

The com­pa­ny an­nounced Fri­day morn­ing that the breast can­cer treat­ment had been giv­en the thumbs up by the Eu­ro­pean Com­mis­sion. Like in the US, it’s been ap­proved for the treat­ment of adults with HER2-pos­i­tive lo­cal­ly ad­vanced or metasta­t­ic breast can­cer, in com­bi­na­tion with Her­ceptin and capecitabine for those who have re­ceived at least two pri­or an­ti-HER2 treat­ments.

In Tukysa’s piv­otal tri­al in Eu­rope, the drug showed a 46% im­prove­ment for pro­gres­sion-free sur­vival com­pared to the con­trol arm of Her­ceptin and capecitabine, as well as im­prov­ing over­all sur­vival by 34%. Pa­tients were ran­dom­ized to the drug arm 2-to-1 in the dou­ble-blind­ed tri­al.

Tukysa is a ty­ro­sine ki­nase in­hibitor of the HER2 pro­tein and was orig­i­nal­ly de­vel­oped by Ar­ray Bio­Phar­ma, who li­censed it to Cas­ca­di­an Ther­a­peu­tics. Seat­tle Ge­net­ics bought Cas­ca­di­an for $614 mil­lion in 2018. — 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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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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