Bank­ing on Shang­hai's biotech boom, this Eli Lil­ly-backed play­er grabs $100M to push next-gen I/O ther­a­pies

Every six months for the past two years or so, five renowned sci­en­tists and biotech vets — David Shen of NGM Bio, Ar­lene Sharpe and Vi­jay Kuchroo of Har­vard, Juno co-founder Phil Green­berg and Uni­ver­si­ty of Chica­go’s Tom Gajew­s­ki — would meet. There (most re­cent­ly at Na­pa Val­ley over wine), as a sci­en­tif­ic ad­vi­so­ry board, they would of­fer ad­vice to a biotech start­up based an ocean away in Shang­hai, on their quest to un­cov­er new tar­gets and new an­ti­body ther­a­peu­tics for im­muno-on­col­o­gy.

Dar­ren Ji

That com­pa­ny, Elpi­science, is now tak­ing the wraps off a $100 mil­lion Se­ries B to ush­er two of its 12 com­pounds through clin­i­cal tri­als, bring a cou­ple in­to the clin­ic, and in-li­cense more from glob­al part­ners.

Mean­while, thanks to a RMB$150 mil­lion ($21.4 mil­lion) col­lab­o­ra­tion with Bank of Chi­na and Agri­cul­tur­al Bank of Chi­na, they will al­so be build­ing their own man­u­fac­tur­ing fa­cil­i­ties — big enough to even­tu­al­ly trans­fer all pro­duc­tion back from con­tract man­u­fac­tur­ers.

Elpi­science found it­self in the right place at the right time, CEO Dar­ren Ji told End­points News, as Shang­hai es­tab­lish­es it­self as a biotech hub on par with both the Cam­bridges or the Bay Area.

“I told my in­vestors es­sen­tial­ly I will have my man­u­fac­tur­ing ca­pa­bil­i­ties, with all equip­ment and peo­ple in a year with­out spend­ing in­vestors’ mon­ey yet,” he said.

By this time next year, Ji added, he ex­pects to have grown his team from 50 to 120, in­clud­ing more staffers on the chem­istry, man­u­fac­tur­ing and con­trol as well as clin­i­cal and reg­u­la­to­ry sides.

Hong­tao Lu

The cur­rent team is heav­i­ly geared to­ward dis­cov­ery, with around 30 of them work­ing on Elpi­science’s three tech plat­forms: Elpisource for tar­get screen­ing and iden­ti­fi­ca­tion; Im­munoshine to as­sess po­ten­tial drug can­di­dates on im­mune cell lines; and AbLego to for­mu­late their own bis­pecifics.

Ji re­cent­ly wooed the ex­ec­u­tive di­rec­tor of No­var­tis In­sti­tute for Bio­med­ical Re­search in Chi­na, Robert Arch, to be­come Elpi­science’s head of re­search. Arch re­ports to Hong­tao Lu, co-founder and CSO, who brought sim­i­lar ex­pe­ri­ence build­ing a pipeline in Zai Lab’s ear­li­est days.

A new CMO will soon join from the US, Ji said, to help steer clin­i­cal pro­grams for ES101 and ES102, with an ini­tial fo­cus on lung can­cer. Elpi­science had in-li­censed the two com­pounds — the first a bis­pe­cif­ic hit­ting 4-1BB se­lec­tive­ly up­on PD-L1 bind­ing, the sec­ond an OX40 ag­o­nist — from La Jol­la-based In­hi­brx.

By re­cruit­ing from all over the world and putting to­geth­er a stel­lar sci­en­tif­ic ad­vi­so­ry board, Elpi­science is cir­cum­vent­ing a bar­ri­er that Ji be­lieves Shang­hai, or Chi­na for that mat­ter, needs to over­come for its biotech scene to re­al­ly boom. He calls it “brain­pow­er.”

“Aca­d­e­m­ic in­no­va­tion, aca­d­e­m­ic cal­iber, is re­al­ly the foun­da­tion for both sci­en­tif­ic dis­cov­ery and de­vel­op­ment and al­so peo­ple sup­ply,” he said. “These years, Chi­nese acad­e­mia has been re­al­ly ad­vanc­ing strong with pub­li­ca­tions, in­no­va­tions, all those, but be­ing able to trans­late those in­to com­mer­cial­ly vi­able tech­nolo­gies or ther­a­pies, there’s still a gap — a gap be­tween both tech­nol­o­gy trans­fer and al­so the gap be­tween trans­la­tion­al per­son­nel.”

Lil­ly Asia Ven­tures, where Ji is a part­ner, bought on­to the vi­sion ear­ly by launch­ing the start­up with the help of Hill­house Cap­i­tal Group and CHD In­vest­ments. Hyfin­i­ty In­vest­ments led the cur­rent round with new in­vestors Ten­cent, GT­JA In­vest­ment Group, Dy­ee Cap­i­tal, Oriza Hold­ings, Ming Bioven­tures, Wis­doMont, Park­way Glob­al and oth­ers.

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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