Mi­rati and MD An­der­son team up on KRAS; Sanofi inks deal with a Har­vard spin­out for oral bi­o­log­ics

Mi­rati, the oth­er KRAS-fo­cused biotech, is get­ting some ex­tra am­mo as it looks to leapfrog Am­gen in the hunt for the first, most ef­fec­tive and most broad­ly ef­fec­tive for one of the most ubiq­ui­tous and hard-to-hit onco­genes.

The Cal­i­for­nia biotech has signed a re­search and de­vel­op­men­tal with MD An­der­son to help ad­vance both Mi­rati’s lead KRAS G12C mol­e­cule — the one that’s now proven ef­fec­tive in cer­tain lung can­cer pa­tients — and a pre­clin­i­cal mol­e­cule that goes af­ter an­oth­er KRAS mu­ta­tion, G12D. The Texas-based re­search in­sti­tute will help Mi­rati de­sign and run pre­clin­i­cal and clin­i­cal stud­ies for sev­er­al sol­id tu­mors, in­clud­ing non-small cell lung, pan­cre­at­ic, col­orec­tal and gy­ne­co­log­i­cal can­cers, over the next 5 years.

Al­though trail­ing Am­gen for the first ap­proval, both com­pa­nies are still work­ing to show how ef­fec­tive a KRAS drug can be in lung can­cer and, cru­cial­ly, in oth­er tu­mors, where Am­gen has on­ly shown mixed re­sults

“Ef­fec­tive tar­get­ed ther­a­pies against mu­tant KRAS could ad­dress a ma­jor un­met need for many pa­tients,” Christo­pher Flow­ers, in­ter­im head of Can­cer Med­i­cine at MD An­der­son, said in a state­ment. “Our col­lab­o­ra­tion with Mi­rati rep­re­sents an im­por­tant op­por­tu­ni­ty to work to­ward ad­vanc­ing new treat­ment op­tions for pa­tients us­ing nov­el KRAS in­hibitors that tar­get two of the most fre­quent KRAS mu­ta­tions in com­mon can­cers.” — Ja­son Mast

Sanofi en­lists i2O in the hunt for re­al­ly small drugs

Just ten months af­ter they spun out from Har­vard, i2O Ther­a­peu­tics has a big name col­lab­o­ra­tor: Sanofi.

The French phar­ma en­list­ed the small­er biotech to help them de­liv­er nanobod­ies — tiny ver­sions of an­ti­bod­ies that can be just as ac­cu­rate but po­ten­tial­ly con­fer a range of ad­van­tages, in­clud­ing bet­ter abil­i­ty to pen­e­trate tis­sues, greater scal­a­bil­i­ty, and a longer half-life. They’ve got at­ten­tion as po­ten­tial Covid-19 drugs, but Sanofi sees po­ten­tial in a wide va­ri­ety of fields, in­clud­ing di­a­betes and im­muno-on­col­o­gy.

i2O makes oral forms of bi­o­log­ics by en­cas­ing them in a kind of ion­ized slush as op­posed to wa­ter. They will help Sanofi re­search ways of mak­ing pill forms of the nanobod­ies.  — Ja­son Mast

As­traZeneca lends a hand with Hong Kong’s new biotech in­cu­ba­tor

Af­ter carv­ing out a valu­able fran­chise in Chi­na’s on­col­o­gy mar­ket, As­traZeneca is now help­ing set up a new in­cu­ba­tor in Hong Kong for biotech star­tups look­ing to hatch new can­cer drugs and di­ag­nos­tics.

The phar­ma gi­ant teamed with Hong Kong Sci­ence and Tech­nol­o­gy Parks, of­fer­ing sup­port ser­vices to the star­tups that are ac­cept­ed. The fledg­lings in turn gain ac­cess to cash and lab ser­vices as well as an ex­tend­ed set of sup­port ser­vices to help guide the ini­tial phase of their work.

Al­fred Sit, the sec­re­tary for in­no­va­tion and tech­nol­o­gy, had this to say:

This co-in­cu­ba­tion col­lab­o­ra­tion is a great leap in the biotech field of the lo­cal ecosys­tem. By cre­at­ing, as I would de­scribe, a unique “one-stop so­lu­tion in­te­gra­tion plat­form” for the whole course of ac­tion in com­bat­ing can­cer from di­ag­no­sis, to mon­i­tor­ing and treat­ment, the col­lab­o­ra­tion is a break­through in re­search on on­col­o­gy, which is cur­rent­ly con­duct­ed in a seg­men­tal man­ner pre­dom­i­nant­ly by look­ing in­to dis­crete ac­tions against can­cer. This will make re­search on on­col­o­gy more con­sol­i­dat­ed, stand­ing a high­er chance of ac­tu­al­is­ing new and bet­ter op­tions to fight against the life-threat­en­ing dis­ease.

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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