James Sabry adds an­oth­er weapon to Roche-Genen­tech ar­se­nal; Dai­ichi Sankyo adds ADC #6

James Sabry and Aviv Regev at Roche and Genen­tech have been rack­ing up ear­ly stage part­ner­ships, ty­ing up with ear­ly stage biotechs de­vel­op­ing every­thing from new AI en­gines to new ways of de­liv­er­ing gene ther­a­py. Now, they’ve signed on with an old­er play­er, join­ing a small mol­e­cule biotech that’s al­ready col­lab­o­rat­ed with many of the biggest names in drug de­vel­op­ment.

Genen­tech and X-Chem, a biotech that spe­cial­izes in DNA-en­cod­ed li­braries, have signed an agree­ment that will al­low the big biotech to both use their tech­nol­o­gy to find new mol­e­cules and give them an ex­clu­sive li­cense on a pre-ex­ist­ing pro­gram. De­tails for that pro­gram were undis­closed, as were up­front pay­ment and mile­stones.

One of the first biotechs to spe­cial­ize in mas­sive DNA-en­cod­ed li­braries — huge sets of mol­e­cules that can be rapid­ly screened for var­i­ous prop­er­ties be­cause they’re tagged with DNA iden­ti­fiers — X-Chem has racked up part­ner­ships with over a dozen ma­jor drug de­vel­op­ers. That in­cludes Servi­er, Ot­su­ka, Bris­tol My­ers Squibb, Ver­tex, Ab­b­Vie, As­traZeneca, Alex­ion, Astel­las, Bay­er, Gilead, J&J, Pfiz­er, Roche, and Sanofi.

Found­ed a decade ago by Glax­o­SmithK­line’s head of dis­cov­ery chem­istry, Matt Clark, X-Chem was bought out last year for an undis­closed sum by the British firm GHO Cap­i­tal. — Ja­son Mast

Dai­ichi Sankyo finds a sixth ADC to love — hit­ting a first-in-class tar­get

Dai­ichi Sankyo’s pro­lif­ic an­ti­body-drug con­ju­gate plat­form has spawned a sixth clin­i­cal can­di­date, with the first pa­tient dosed in a Phase I tri­al tar­get­ing ad­vanced re­nal cell car­ci­no­ma and ovar­i­an can­cer that pro­gressed fol­low­ing stan­dard treat­ment.

DS-6000 is di­rect­ed against CDH6, a cad­herin fam­i­ly pro­tein over­ex­pressed in sev­er­al can­cers.

Five-year sur­vival rates for re­nal cell car­ci­no­ma and ovar­i­an can­cer, Dai­ichi said, re­main low de­spite ad­vances in tar­get­ed treat­ment.

There aren’t cur­rent­ly any mar­ket­ed drugs hit­ting CDH6, mak­ing theirs a po­ten­tial first-in-class play — right along­side the pro­grams against known tar­gets that As­traZeneca has bet big mon­ey to part­ner with Dai­ichi on, in­clud­ing HER2 and TROP2.

This new drug is the third de­vel­oped in col­lab­o­ra­tion with Sarah Can­non Re­search In­sti­tute in Nashville, TN, Dai­ichi added. — Am­ber Tong

Jun­shi hands Co­herus back a few dol­lars

Here’s an un­usu­al way to spend cash from a col­lab­o­ra­tion an­nounce­ment: hand­ing it back to your col­lab­o­ra­tor.

A day af­ter the biosim­i­lar com­pa­ny Co­herus an­nounced they would pay Jun­shi Bio­sciences $150 mil­lion for the PD-1 an­ti­body tori­pal­imab, Jun­shi an­nounced they would in­vest $50 mil­lion in­to Co­herus. Al­though the stag­gered na­ture of the move was un­usu­al, Jun­shi CEO Ning Li said it was all part of a co­gent plan.

“We view our col­lab­o­ra­tion with Co­herus as a strate­gic long-term part­ner­ship for the de­vel­op­ment and com­mer­cial­iza­tion of tori­pal­imab and promis­ing PD-1 com­bi­na­tion can­di­dates,” Li said in a state­ment. “We want­ed to in­vest in Co­herus so we could share our fu­ture growth to­geth­er and mu­tu­al suc­cess with these pro­grams.”

The Jun­shi deal rep­re­sent­ed a shift for Co­herus, which has fo­cused ex­clu­sive­ly on copy­cat drugs to date. Al­though de­vel­op­ing a PD-1 is hard­ly nov­el — six are al­ready ap­proved in the US — the biotech said this would be the be­gin­ning of a push in­to new can­cer drug R&D.  — Ja­son Mast

Nan Fung-backed En­grail nabs a buy­out

En­grail Ther­a­peu­tics has on­ly been out of stealth for 7 months but they’ve al­ready se­cured a buy­out, scoop­ing up Neu­ro­Cy­cle Ther­a­peu­tics and their GA­BA-A mol­e­cules for an undis­closed sum Tues­day morn­ing.

The deal is the first pub­lic step in En­grail’s larg­er strat­e­gy of iden­ti­fy­ing and li­cens­ing in promis­ing mol­e­cules for brain dis­or­ders. Found­ed in 2017 by Glax­o­SmithK­line vet Matthew Toczko and  ETH Zurich sci­en­tist Jed Hubbs, Neu­ro­Cy­cle had been de­vel­op­ing a small mol­e­cule drug for the seizure dis­or­der Dravet syn­drome and oth­er dis­eases, and had large­ly re­lied on grant mon­ey.  — Ja­son Mast

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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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.