Mu­ta­bilis re­ceives CARB-X grant for 'night­mare bac­te­ri­a' treat­ment; Ab­Sci and Xyphos shake hands on dis­cov­ery deal

On a mis­sion to sub­due the ris­ing glob­al threat of an­tibi­ot­ic re­sis­tance, the CARB-X ini­tia­tive has inked yet an­oth­er grant — this one for a French phar­ma work­ing on a treat­ment for so-called “night­mare bac­te­ria.”

Ro­mainville-based Mu­ta­bilis is get­ting up to $6.4 mil­lion to de­vel­op its pre­clin­i­cal pro­gram for Car­bapen­em-re­sis­tant En­ter­obac­terales (CRE) bac­te­ria, dubbed EBL-1463. CRE got the no­to­ri­ous nick­name “night­mare bac­te­ria,” be­cause of its ten­den­cy to cause dead­ly in­fec­tions in health­care set­tings. And it can’t be treat­ed with ex­ist­ing an­tibi­otics, ac­cord­ing to CARB-X.

EBL-1463, an in­tra­venous drug, is in a new class of non-be­ta-lac­tam in­hibitors of peni­cillin-bind­ing pro­teins (PBPs) called dabocins. If cer­tain mile­stones are met, Mu­ta­bilis is en­ti­tled to an­oth­er $5.8 mil­lion, sub­ject to avail­able funds.

CARB-X is a glob­al part­ner­ship look­ing to spur the de­vel­op­ment of new an­tibac­te­r­i­al drugs. De­spite in­creas­es in re­sis­tance to cur­rent an­tibi­otics, Big Phar­ma has re­treat­ed from the risky field, fraught with cheap gener­ics and poor fi­nan­cial re­turns. CARB-X has promised to in­vest up to $480 mil­lion in the cause be­tween 2016 to 2022.

“The goal is to sup­port projects through the ear­ly phas­es of de­vel­op­ment so that they will at­tract ad­di­tion­al pri­vate or pub­lic sup­port for fur­ther clin­i­cal de­vel­op­ment and reg­u­la­to­ry ap­proval for use in pa­tients,” CARB-X said in a state­ment.

Since its launch, CARB-X has an­nounced 78 awards worth more than $284.4 mil­lion, not count­ing po­ten­tial mile­stones.

Ab­Sci and Xyphos shake hands on dis­cov­ery deal

A month af­ter buy­ing AI out­fit De­n­ovi­um to build on its pro­tein print­ing plat­form, Ab­Sci has inked a deal of­fer­ing its screen­ing ca­pa­bil­i­ties to Xyphos Bio­Sciences, a sub­sidiary of Astel­las.

Xyphos’ tech plat­form in­cludes the use of a bis­pe­cif­ic an­ti­body-like adap­tor mol­e­cule, which it has dubbed the Mi­cA­body. Ab­Sci has agreed to use its screen­ing tech to in­form Xyphos’ se­lec­tion of op­ti­mal vari­ants of its Mi­cA­body lead can­di­date for fur­ther de­vel­op­ment and cGMP man­u­fac­tur­ing. The com­pa­nies are keep­ing mum about the fi­nan­cial terms of the deal for now.

Ab­Sci was found­ed in 2011 in Port­land. The biotech, now based in Van­cou­ver, Wash­ing­ton, has been work­ing on a more ef­fi­cient way to man­u­fac­ture pro­teins — from full-length an­ti­bod­ies to in­sulin — us­ing E. coli. It went com­mer­cial in 2018 with its E. Coli ex­pres­sion plat­form, SoluPro, for pro­duc­ing sol­u­ble, com­plex pro­teins in high yields. The fol­low­ing year, it in­tro­duced its pro­tein print­ing plat­form, which builds on SoluPro with tech­nol­o­gy de­signed to pump out high-di­ver­si­ty strain li­braries and high-through­put screen­ing as­says.

Last month, Ab­Sci bought De­n­ovi­um and its AI en­gine, which is built to pre­dict the func­tion and be­hav­ior of pro­teins. CEO Sean Mc­Clain says it can be fur­ther trained us­ing bil­lions of da­ta points on man­u­fac­tura­bil­i­ty, func­tion­al­i­ty and ex­pres­sion.

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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