UCB builds on re­la­tion­ship with Mi­crosoft with new AI deal; Sanofi part­ners with Ger­man AAV vec­tor biotech

More biotechs are jump­ing on the AI band­wag­on, and you can count UCB as one of them.

The Bel­gian com­pa­ny inked a “mul­ti-year” deal with Mi­crosoft on Tues­day, gain­ing ac­cess to its com­pu­ta­tion­al ser­vices, cloud and AI tech. The col­lab­o­ra­tion builds on work UCB did with Mi­crosoft through the COVID Moon­shot project, a crowd­sourced ini­tia­tive to ac­cel­er­ate the de­vel­op­ment of an­tivi­ral can­di­dates.

“It’s one of the ex­pe­ri­ences that built up to this part­ner­ship,” CIO Her­man De Prins said in an in­ter­view with End­points News. 

There are three pil­lars to UCB’s ap­proach to AI and ad­vanced an­a­lyt­ics tech, ac­cord­ing to Roger Pal­fra­man, head of ex­ter­nal in­no­va­tion and US dis­cov­ery sci­ence. Bet­ter un­der­stand the pa­tient and their dis­ease pathol­o­gy, use that to iden­ti­fy bet­ter mol­e­c­u­lar tar­gets that are dri­ving the dis­ease — which will bring about small mol­e­cules, bi­o­log­ic an­ti­bod­ies and gene ther­a­pies — and then de­vel­op those mol­e­cules faster.

“It’s about help­ing our peo­ple pri­or­i­tize their de­ci­sions and make bet­ter de­ci­sions,” Pal­fra­man said. “It can save time, and… it’s max­i­miz­ing the prob­a­bil­i­ty that our dis­cov­ery in­vest­ment will trans­late in­to a ther­a­peu­tic that can ben­e­fit pa­tients.”

AI can al­so be used to de­sign bet­ter clin­i­cal tri­al pro­to­cols and op­ti­mize clin­i­cal de­vel­op­ment, he ex­plained. For ex­am­ple, pub­lic da­ta can be scoured to un­der­stand which hos­pi­tals are best suit­ed for a tri­al.

UCB is the fi­nan­cial terms and ex­act length of the deal un­der wraps for now.

News of the Mi­crosoft deal comes as more and more biotechs turn to AI for a smarter and faster way to get things done.  Ear­li­er this month, Dyno Ther­a­peu­tics sketched out more than 100,000 virus­es in a study meant to de­ter­mine how many vi­able vari­ants of the AAV2 cap­sid it could de­sign with the aid of ma­chine learn­ing. And just last month, Ab­Sci bought out De­n­ovi­um and its AI en­gine with the goal of even­tu­al­ly be­ing able to dis­cov­er a drug and cell line at the click of a but­ton.

“What we want to do is bring this much clos­er to the sci­en­tists who are mak­ing de­ci­sions, and re­al­ly ac­cel­er­ate that dis­cov­ery and de­vel­op­ment process and have those fast it­er­a­tion cy­cles,” Pal­fra­man said. — Nicole De­Feud­is 

Sanofi part­ners with Ger­man AAV vec­tor biotech

Sanofi has a new gene ther­a­py part­ner.

The French phar­ma is team­ing up with Ger­man out­fit Siri­on Biotech to de­vel­op im­proved tis­sue-se­lec­tive AAV vec­tors for gene ther­a­pies. Fi­nan­cial terms of the deal were not dis­closed, but Siri­on said the col­lab­o­ra­tion will fo­cus on dis­or­ders af­fect­ing ma­jor or­gans.

“This part­ner­ship adds to our ex­pand­ing tool­box of tech­nolo­gies in the im­por­tant, emerg­ing area of gene ther­a­peu­tics,” Sanofi ge­nom­ic med­i­cine chief Chris­t­ian Mueller said in a state­ment.

Siri­on was found­ed back in 2005 with the goal of cre­at­ing new vi­ral vec­tor tech­nolo­gies for gene and cell ther­a­pies, as well as vac­cines. Their pro­pri­etary tech­nol­o­gy plat­forms are based on lenti-, ade­no-, and ade­no-as­so­ci­at­ed virus­es. — Max Gel­man

No­vo Hold­ings snaps up CRO spe­cial­iz­ing in ear­ly drug de­vel­op­ment

No­vo Hold­ings has scooped up an ear­ly drug de­vel­op­ment ser­vice provider in North Amer­i­ca, with the goal of court­ing small and medi­um-sized bio­phar­ma clients.

Head­quar­tered in Laval, Cana­da, Al­ta­sciences op­er­ates six fa­cil­i­ties that run the gamut on ear­ly drug de­vel­op­ment: pre­clin­i­cal safe­ty test­ing, clin­i­cal phar­ma­col­o­gy, bio­an­a­lyt­i­cal, CRO ser­vices, and even CD­MO ca­pac­i­ty. The cur­rent head­count is 1,300, No­vo added.

Drug de­vel­op­ment ser­vices rep­re­sent a “fast-grow­ing mar­ket,” said Ab­hi­jeet Lele, se­nior part­ner, head of prin­ci­pal in­vest­ments in the US at No­vo Hold­ings.

Al­ta­sciences CEO Chris Perkin — who will con­tin­ue lead­ing the busi­ness unit, just like he has un­der the for­mer own­ers at Au­dax Pri­vate Eq­ui­ty — said be­com­ing a part of No­vo will fos­ter their am­bi­tious growth plans, “giv­en their ex­cep­tion­al rep­u­ta­tion, track record, and broad port­fo­lio of high-growth health­care com­pa­nies.” — Am­ber Tong

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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Hal Barron, Endpoints UKBIO19

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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