Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the rel­a­tive short his­to­ry of in­flam­ma­some re­search, Adam Keeney sees two time points mark­ing ma­jor break­throughs: the ear­ly 2000s, when the role of in­flam­ma­somes as a ma­jor in­nate im­mu­ni­ty node was elu­ci­dat­ed; and 2015, when sci­en­tists ob­served that an old Pfiz­er com­pound they thought were block­ing IL-1 ac­tu­al­ly tar­get­ed NL­RP3. Keeney’s biotech, NodThera, was found­ed the year af­ter along­side sev­er­al oth­ers to cre­ate its own su­pe­ri­or small mol­e­cule drugs.

“It was a rel­a­tive­ly good NL­RP3 in­hibitor, just not a good drug in terms of PK and PD — it need­ed to be giv­en 3, 4 times a day at very high dos­es — but it is a good tool com­pound,” the CEO told End­points News.

Hav­ing made some break­throughs on the chem­istry side on the back of $40 mil­lion in Se­ries A cash, NodThera is now ready to har­vest Phase I da­ta on its lead com­pound, push a sec­ond one to­ward the clin­ic, and eval­u­ate sev­er­al more, all based on the same start­ing point.

Nan­na Lüneborg

No­vo Ven­tures is lead­ing the $55 mil­lion fund­ing, with both new in­vestors (Cowen Health­care In­vest­ments and Sanofi Ven­tures) and old sup­port­ers (5AM Ven­tures, F-Prime Cap­i­tal, Sofinno­va Part­ners and found­ing in­vestor Ep­i­darex Cap­i­tal) chim­ing in.

If noth­ing else, NodThera is “cer­tain­ly equal” to elite peers like IFM, In­fla­zome, Roche’s Je­cure and Olatec, said No­vo Ven­tures part­ner Nan­na Lüneborg. But giv­en the broad ap­pli­ca­tion of this mech­a­nism of ac­tion in in­flam­ma­to­ry con­di­tions, the top team — with Keeney lead­ing a grow­ing clin­i­cal group in Boston, CSO Alan Watt man­ning the head­quar­ters in Cam­bridge, UK and a lab in Seat­tle, WA — is per­haps a more im­por­tant part of the bet.

While No­vo had known NodThera since its found­ing and con­sid­ered NL­RP3 a wor­thy tar­get, the firm wait­ed un­til the C-suite was in place and the pipeline was more ma­ture.

“It’s not just about the mol­e­cules here, it’s very much about find­ing a clever clin­i­cal de­vel­op­ment path as well,” she said.

With quite a so­phis­ti­cat­ed un­der­stand­ing of how the tar­get in­ter­acts chem­i­cal­ly, Keeney said, NodThera al­so boasts of a plat­form that al­lows its sci­en­tists to de­sign drugs with new prop­er­ties to cater to dif­fer­ent dis­eases. The sec­ond can­di­date, for ex­am­ple, makes for a good neu­ro drug be­cause of its abil­i­ty to pen­e­trate the blood-brain bar­ri­er.

The com­ing months, though, will be ded­i­cat­ed to fin­ish­ing the healthy vol­un­teer study of NT-0167, the lead drug, through clin­i­cal proof of con­cept.

“It’s a very rich, bio­mark­er-dri­ven Phase I pro­gram that I think will build con­fi­dence in the mol­e­cule (and) that will have dose se­lec­tion da­ta avail­able for it to launch in­to a com­pre­hen­sive clin­i­cal pro­gram,” he said.

The re­sult­ing da­ta could po­si­tion NodThera for a pub­lic of­fer­ing, per­haps to be pre­ced­ed by a crossover round — hope­ful­ly one where due dili­gence and oth­er dis­cus­sions aren’t done in a pan­dem­ic-strick­en, locked-down world.

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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