RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Bei­jing-based rare dis­ease and on­col­o­gy play­er has raised $98 mil­lion to help fund the ex­pan­sion of its pipeline as well as a com­mer­cial port­fo­lio.

CAN­bridge put out word Tues­day that the glob­al pri­vate eq­ui­ty play­er Gen­er­al At­lantic joined forces with Chi­nese CRO Wuxi AppTec to lead the Se­ries D, with both ready to chip in an ex­tra $10 mil­lion each un­der the right con­di­tions. The syn­di­cate in­cludes RA Cap­i­tal Man­age­ment, Hud­son Bay Cap­i­tal Man­age­ment, Yuan­Ming Pru­dence Fund and Tigermed.

The new in­fu­sion sets CAN­Bridge up for an IPO in a year or two, ac­cord­ing to CFO Glenn Has­san.

A spe­cial­ist in rare ge­net­ic dis­eases, CAN­bridge has been col­lab­o­rat­ing with WuXi Bi­o­log­ics, a sis­ter com­pa­ny of the CRO, on dis­cov­er­ing and de­vel­op­ing new drugs for its tar­get in­di­ca­tions.

Like a num­ber of top Chi­na drug play­ers, CAN­bridge is get­ting start­ed with some ex­ist­ing meds in-li­censed for the Asian mar­ket while fol­low­ing up with some more orig­i­nal work. Its drug Hunterase is an en­zyme re­place­ment ther­a­py un­der re­view now by Chi­nese reg­u­la­to­ry au­thor­i­ties. And the biotech has high hopes for Ner­l­ynx, the breast can­cer drug from Puma.

CAN­bridge has about 60 staffers on the ground in Chi­na, about half of whom sup­port the com­mer­cial or­ga­ni­za­tion, CEO James Xue told End­points News from their Cam­bridge, MA of­fice.

“We are def­i­nite­ly build­ing what I would say as one of the most ro­bust com­mer­cial plat­form for rare dis­ease in the Greater Chi­na re­gion that would re­al­ly en­able us to do what we call high-touch launch and op­er­a­tions of rare dis­ease prod­ucts,” he said.

Hav­ing repo­si­tioned the com­pa­ny to fo­cus on rare dis­ease rather than just on­col­o­gy, Xue — the for­mer gen­er­al man­ag­er of Gen­zyme — said the Chi­nese mar­ket is warm­ing up to rare dis­ease drugs. Take the up­take of Cerezyme, which launched in Chi­na in 2008 un­der his watch. It wasn’t un­til the end of 2012 that en­zyme re­place­ment ther­a­py re­ceived mu­nic­i­pal re­im­burse­ment from Shang­hai; but in the fol­low­ing years cov­er­age has ex­pand­ed in­to about 10 provinces and cities, with up to 100% cov­er­age.

Aware­ness is al­so clear­ly spread­ing from the pa­tient and physi­cian lev­el to the pol­i­cy­mak­ers, with rare dis­ease lan­guage and lists of­fi­cial­ly writ­ten in­to law. And the ag­gres­sive price ne­go­ti­a­tions that gov­ern­ment of­fi­cials have been do­ing for the Na­tion­al Re­im­burse­ment Drug List is a sign that they are mak­ing room for dis­eases cur­rent­ly com­plete­ly un­cov­ered, he added.

“Those are the el­e­ments or the mov­ing parts grad­u­al­ly in place that would al­low us to hope for and al­so plan for rare dis­ease mar­ket in a way that its re­im­bursed mar­ket is around the cor­ner,” he said.

So­cial im­age: James Xue, CAN­bridge CEO

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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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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Angie You (file photo)

With $117M in fresh cash, Amu­nix paves path to the clin­ic for 'u­ni­ver­sal mask' pro­drug on the hunt for HER2 tu­mors

Despite all the excitement over the possibility of T cell therapies to crack the code against solid tumors, early safety data have limited the burgeoning field’s promise. A clutch of players hope to solve that problem by “masking” their drugs, and now one of those outfits has snared fresh investor cash to take its shot in the clinic.

Amunix closed a $117 million Series B to guide AMX-818, a masked protease-activated T cell engager for HER2 expressing tumors, to the clinic as well as shepherding its bustling pipeline of tumor hunters through the preclinical stage, the company said Thursday.

Andrew Hopkins, Exscientia

Black­Rock push­es Ex­sci­en­tia Se­ries C to $100M as AI biotech boom con­tin­ues

The jury’s still out on whether the first wave of AI companies can significantly change drug development, but investors are increasingly buying into the hype.

Exscientia, the decade-old UK machine learning outfit, announced Thursday that they’ve expanded their Series C, first announced in May, from $60 million to $100 million. The expansion most notably includes BlackRock, the private equity firm that has been wading deeper and deeper into biotech. They now join Novo Holdings, Bristol Myers Squibb and others among the company’s most recent backers.

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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