Weeks af­ter drop­ping big re­sponse da­ta, Am­gen lines up pri­or­i­ty re­view for KRAS hope­ful so­tora­sib in NSCLC

Am­gen is look­ing to go where no oth­er drug­mak­er has gone be­fore with the KRAS in­hibitor so­tora­sib, which post­ed big Phase II lung can­cer re­sponse da­ta in late Jan­u­ary. The FDA has been lis­ten­ing, and now it’s ready to give Am­gen its ear.

The FDA will speed­i­ly re­view so­tora­sib’s ap­pli­ca­tion to treat sec­ond-line pa­tients with lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer in what would be the first suc­cess­ful bid to in­hib­it KRAS, Am­gen said in a re­lease.

The agency set a tar­get date of Aug. 16 al­though un­der its re­al-time on­col­o­gy re­view, an ap­proval for so­tora­sib could come much soon­er.

So­tora­sib’s pick up for pri­or­i­ty re­view comes just weeks af­ter Am­gen re­leased ORR da­ta from its Phase III CODE­BREAK100 study show­ing the mol­e­cule post­ed a 37.1% over­all re­sponse rate among 126 pa­tients with ad­vanced, KRAS G12C-mu­tat­ed NSCLC. There were three com­plete re­spons­es and 43 par­tials, with a me­di­an du­ra­tion of re­sponse of 10 months. Pro­gres­sion-free sur­vival hit 6.8 months.

Those da­ta, which backed up find­ings from a much-small­er Phase I study, looked at the time like a text­book case for ap­proval, and now the FDA ap­pears set to give so­tora­sib its shot. SVB Leerink an­a­lyst Ge­of­frey Porges said at the time of the da­ta drop that he ex­pect­ed a quick ap­proval and $1 bil­lion in peak sales in the in­di­ca­tion.

A first in KRAS would come as a big mar­ket ad­van­tage with one ma­jor com­peti­tor — Mi­rati Ther­a­peu­tics — still in the clin­ic for their own can­di­date. Mean­while, Am­gen has had sig­nif­i­cant­ly less suc­cess in tak­ing so­tora­sib in­to oth­er sol­id tu­mor types and has fo­cused much of its R&D brain trust chas­ing com­bi­na­tion ther­a­pies for the drug to ex­pand its range in­to ear­li­er set­tings.

In a Phase I tri­al in col­orec­tal, so­tora­sib post­ed just a 7.1% re­sponse rate, with the ma­jor­i­ty of the 42 pa­tients in the tri­al hav­ing re­ceived at least three pri­or lines of ther­a­py — a tes­ta­ment to how hard the mu­ta­tion is to dose.

In oth­er tu­mors out­side of NSCLC and col­orec­tal, the drug fared even worse, with just three of 22 pa­tients show­ing par­tial re­spons­es sev­en weeks af­ter treat­ment.

So­tora­sib se­cured the pri­or­i­ty re­view af­ter the FDA grant­ed it a break­through des­ig­na­tion in NSCLC.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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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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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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