In­cyte scores speedy FDA re­view for JAK cream in atopic der­mati­tis; Lil­ly backs $90M raise for Re­gor

In­cyte’s stal­wart JAK in­hibitor Jakafi has raced out to block­buster sales with­out the safe­ty bur­den of oth­er drugs in the class. Now, the drug­mak­er’s quest to re­for­mu­late the drug for eas­i­er use could be near­ing fruition — but big chal­lengers await.

The FDA will give a pri­or­i­ty re­view to In­cyte’s top­i­cal cream re­for­mu­la­tion of JAK in­hibitor Jakafi in atopic der­mati­tis, the drug­mak­er an­nounced Fri­day.

The agency will base its re­view on da­ta from the TRuE-AD pro­gram, which has test­ed more than 1,200 patiet­nts with rux­oli­tinib cream, In­cyte said. The cream’s re­view date is set for June 21.

A top­i­cal ap­pli­ca­tion for AD would be a big step up in terms of pa­tient ease of use over Sanofi and Re­gen­eron’s Dupix­ent, an in­jec­tion that is the lead­ing drug on the mar­ket for that in­di­ca­tion. An ap­proval would al­so boost In­cyte’s block­buster Jakafi pro­gram, which raked in $1.94 bil­lion in 2020.

Un­like oth­er JAKs, in­clud­ing Eli Lil­ly’s Olu­mi­ant, which In­cyte de­vel­oped, Jakafi doesn’t sport the black box warn­ing la­bel for se­ri­ous in­fec­tions, ma­lig­nan­cies and throm­bo­sis com­mon to the class. — Kyle Blanken­ship

Lil­ly Asia Ven­tures backs a big B round for Shang­hai-based Re­gor

A group of Big Phar­ma vets from Pfiz­er and Am­gen have round­ed up a $90 mil­lion B round to back clin­i­cal de­vel­op­ment work at their Shang­hai-based start­up Re­gor Ther­a­peu­tics.

Found­ed by a team that in­cludes 2 Pfiz­er vets, CEO Xi­ayang Qiu and Min Zhong, and CTO Wenge Zhong, for­mer­ly with Am­gen’s Chi­na R&D op­er­a­tion, Re­gor has been build­ing up its plat­form tech with a fo­cus on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

The Chi­nese phar­ma com­pa­ny Qilu Phar­ma­ceu­ti­cal Group put up the A round for the com­pa­ny launch in 2018. Now there’s a whole new syn­di­cate, led by Lil­ly Asia Ven­tures, a pro­lif­ic ven­ture group with a fin­ger in many pies in Chi­na. Loy­al Val­ley Cap­i­tal, Lant­i­ng Cap­i­tal, TF Cap­i­tal and Ver­tex Ven­tures Chi­na all joined in.

“With the next decade comes a his­tor­i­cal mo­ment for Chi­na’s leap up­wards. We are de­light­ed to col­lab­o­rate with vet­er­an sci­en­tists, lead­ing en­tre­pre­neurs and in­vest­ment part­ners in bio­phar­ma in­dus­try,” not­ed Andy Lin, found­ing part­ner of Loy­al Val­ley Cap­i­tal. — John Car­roll

Eu­rofins Sci­en­tif­ic adds new CRO to port­fo­lio

Eu­rofins Sci­en­tif­ic, an in­ter­na­tion­al group of lab­o­ra­to­ries head­quar­tered in Lux­em­bourg, just bought a new CRO.

Gilles Mar­tin

The bio­an­a­lyt­i­cal test­ing com­pa­ny an­nounced Thurs­day that it had ac­quired Bea­con Dis­cov­ery, a CRO fo­cused on G-pro­tein cou­pled re­cep­tor re­search. Fi­nan­cial terms of the deal were not dis­closed, and Bea­con will be en­veloped in­to the Eu­rofins Dis­cov­ery CRO um­brel­la once the deal clos­es in the com­ing weeks.

Eu­rofins says the move will sup­port and ac­cel­er­ate drug dis­cov­ery re­search and de­vel­op­ment in or­der to cap­i­tal­ize on the grow­ing R&D out­sourc­ing mar­ket.

“Bea­con Dis­cov­ery adds the ex­per­tise in GPCR tar­gets and drug dis­cov­ery and de­vel­op­ment ex­pe­ri­ence that will ad­vance our of­fer­ing in in­te­grat­ed drug dis­cov­ery ser­vices for our clients,” Eu­rofins CEO Gilles Mar­tin said in a state­ment. — Max Gel­man

Chi­na’s Sci­wind hauls in $37M Se­ries B

Chi­nese biotech Sci­wind Bio­sciences has some new dough to throw around. The com­pa­ny an­nounced Fri­day it had com­plet­ed a $37 mil­lion Se­ries B round, led by LYFE Cap­i­tal and joined by ex­ist­ing in­vestors, Leg­end Cap­i­tal and Haibang Ven­ture Cap­i­tal.

Sci­wind fo­cus­es on chron­ic meta­bol­ic and im­muno­log­i­cal dis­eases, and has com­plet­ed a Phase I study of its lead pro­gram, XW003. Sci­wind is ex­pect­ed to launch sev­er­al Phase II tri­als for the can­di­date in 2021, in­clud­ing in Type II di­a­betes, obe­si­ty and NASH. — 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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