Nek­tar, stung by new in­vestor law­suit over IL-2 drug, se­cures $150M for Keytru­da com­bo piv­otal tri­al

Nek­tar Ther­a­peu­tics’ IL-2 drug hasn’t al­ways lived up to ex­pec­ta­tions in the four and a half years since it scored a promi­nent al­ly in Bris­tol My­ers Squibb — a pact that even­tu­al­ly bal­looned to $3.6 bil­lion.

The ear­ly da­ta snap­shots for a com­bo of be­m­pe­galdesleukin, or NK­TR-214, with Op­di­vo, in par­tic­u­lar, rat­tled in­vestors, and the biotech’s ex­pla­na­tion, pin­ning the blame on man­u­fac­tur­ing, did lit­tle to sal­vage their stock price. In fact, just yes­ter­day, two share­hold­ers sued the board of di­rec­tors for hyp­ing tri­al re­sults and then sell­ing $171 mil­lion worth of stock at an in­flat­ed price.

But it hasn’t stopped new part­ners from see­ing the po­ten­tial in this par­tic­u­lar I/O add-on to the main­stay check­point in­hibitors.

Mer­ck has jumped in for an ex­pand­ed col­lab­o­ra­tion to test Keytru­da with be­m­peg in a reg­is­tra­tional tri­al for squa­mous cell car­ci­no­ma of the head and neck, adding to a slate of on­go­ing Phase III pro­grams Nek­tar has with Bris­tol My­ers. And they won’t be run­ning the tri­al on their own dime; Abing­worth and Black­stone have promised, through their SFJ Phar­ma­ceu­ti­cals sub­sidiary, to bankroll the study with a com­mit­ment of up to $150 mil­lion.

In re­turn, Nek­tar would pay suc­cess-based an­nu­al mile­stone pay­ments over sev­en to eight years — but on­ly if be­m­peg is ap­proved for the spec­i­fied in­di­ca­tions.

The head and neck can­cer study — which fol­lows a dose op­ti­miza­tion study ex­plor­ing Keytru­da plus be­m­peg across a suite of can­cers in­clud­ing melanoma, non-small cell lung can­cer and urothe­lial car­ci­no­ma — is ex­pect­ed to wrap up in 2024.

Jonathan Za­levsky

“Ear­li­er stud­ies of BE­M­PEG in com­bi­na­tion with im­mune check­point in­hibitors, al­so known as ICIs, eval­u­at­ed in pa­tients with im­mune-sen­si­tive can­cers have shown the po­ten­tial to in­crease and deep­en treat­ment re­spons­es as com­pared to his­tor­i­cal rates for ICIs alone,” Jonathan Za­levsky, chief R&D of­fi­cer at Nek­tar, said in a state­ment.

Mer­ck’s PD-1, he added, is the lead­ing check­point in­hibitor in the set­ting of ad­vanced head and neck can­cer.

Bri­an Kotzin

The Nek­tar team led by Za­levsky and Bri­an Kotzin, who re­cent­ly re­placed Wei Lin as head of de­vel­op­ment, is tasked with plan­ning and car­ry­ing out the tri­al start­ing lat­er this year, which will tar­get 500 pa­tients with metasta­t­ic or un­re­sectable re­cur­rent SC­CHN whose tu­mors ex­press PD-L1.

With piv­otal Op­di­vo/be­m­peg da­ta loom­ing for can­cers of the skin, kid­ney and blad­der, they are bank­ing on a pipeline re­bound af­ter Nek­tar chopped an opi­oid pro­gram and sold off roy­al­ties to their two mar­ket­ed drugs to fo­cus on the I/O branch.

Back in 2019 CEO Howard Robin as­sured in­vestors that the “soft­en­ing up” of re­spons­es ob­served in the ear­ly tri­als had to do with a sub­op­ti­mal batch of drug ma­te­r­i­al. And he promised it won’t hap­pen again.

An­a­lysts aren’t ready to buy in just yet, es­pe­cial­ly giv­en the fierce com­pe­ti­tion from all the new play­ers that have shown up on the IL-2 scene.

As SVB Leerink an­a­lyst Daina Gray­bosch wrote in a re­cent note:

Pre­sen­ta­tions at re­cent sci­en­tif­ic con­fer­ences high­light the promise of Nek­tar’s ear­ly pipeline, but in­vestors have made up their mind on the promise of be­m­pe­galdesleukin and we ex­pect the stock to re­main stub­born­ly flat un­til ran­dom­ized da­ta — slip­ping an­oth­er quar­ter to 2022.

Billed as a CD122-pref­er­en­tial IL-2 path­way ag­o­nist, be­m­peg is de­signed to un­leash the can­cer-killing sig­nal while keep­ing tox­i­c­i­ty low enough for out­pa­tient ad­min­is­tra­tion.

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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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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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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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.

Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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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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